Building a Better Profile With One Lambda Technology

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2 Building a Better Profile With One Lambda Technology One Lambda is a pioneer in the field of HLA typing and antibody detection. The legendary and highly respected research of Dr. Paul I. Terasaki began in a laboratory at UCLA in 1964 and evolved into the company s founding in One Lambda has been, and continues to be, at the forefront as a world leader in HLA reagents for transplantation. FACILITATING A NEW STANDARD OF CARE IN TRANSPLANT MONITORING Having a strong foundation in HLA, we understand the challenges that laboratories face daily. Our commitment is to provide you with the most consistent and reliable reagents. Automation, reliability and speed are just as critical as the scientific advancements in HLA research. The driving force behind our product development and education is facilitating a new standard of care in transplant monitoring.

3 Transplant Monitoring and its Affect on Outcome Post-transplant, antibody presence may not be immediately apparent, but it can have long-term negative consequences for organ survival. Monitoring patients post-transplant may reveal the challenges at hand and enables intervention before damage or rejection occurs. Knowing a patient s antibody status may help to identify potentially harmful agents that may be highly predictive of poor allograft outcome. ONE LAMBDA Antibodies can develop over time without patient or physician knowledge By the time it presents clinically, severe damage can compromise the graft With simple screening done at regular intervals, antibody presence can be detected, providing more options for intervention When post-transplant screening is not performed, the risk of organ failure may increase with time and the presence of anti-hla II antibodies. Data indicates that DSA results in Transplant Glomerulopathy (TG) and chronic rejection. Patients diagnosed with TG experience 5-year graft survival rates of less than 50% from the time of diagnosis.* *(Current Opinion in Organ Transplantation :8-10) DSA Monitoring New Standard of Care Research demonstrates DSA Monitoring is crucial throughout the transplant process; it can reveal potential issues and give clinicians time to intervene. For the laboratory, monitoring at regular intervals provides a baseline for tracking antibodies. For the patient, screening before and after transplant could prevent repeat procedures or a return to dialysis. Our full line of antibody detection products and data analysis software can identify DSA and support clinical intervention and immunosuppressive treatment. Biomarker Detection Defines Patient Profiles The potential of antibody-mediated rejection (AMR) in those who have certain biomarkers is an area of increasing interest. Biomarkers can be present in a variety of clinical conditions and can cause immunemediated responses, conditions or diseases that lead to allograft rejection. Testing for biomarkers such as AT1R antibodies, complement (C1q) binding antibodies, and Cytokines, HNA, or KIR polymorphisms allows transplant clinics to better define profiles of their patients. Our extensive line of Biomarker Detection assays identify biomarkers implicated in immune-mediated responses that can cause allograft rejection. Solutions for All Monitoring Needs The technology underlying the products and reagents in this catalog reflect One Lambda s legacy of excellence since its inception. We help clinicians to build a better patient profile in all phases of transplantation. From helping to find the right donor-recipient match to monitoring for antibody presence post-transplant, One Lambda has solutions that can aid laboratories and clinicians in determining graft success.

4 TABLE OF CONTENTS

5 Antibody Detection... 4 Single Antigen Technology... 6 LABScreen Flow PRA Single Antigen Flow PRA Screening Flow PRA Specific Lambda Antigen Tray (LAT) Lambda Cell Tray (LCT) ibeads TABLE OF CONTENTS Molecular Products LABType SSO Micro SSP ConsenSys SBT Research Products Bulk Primer Sets Bulk Monoclonal Antibodies Serology Products Terasaki HLA Tissue Typing Trays Lambda Monoclonal Trays (LMT) Cell Isolation Reagents HLA Testing Reagents Other Specialty Products and Accessories Biomarker Detection C1qScreen KIR SSO Genotyping Test Cytokine Genotyping Trays and Primer Pack...96 HNA Genotyping Trays AT1R Automation and Software Equipment Software Education Publications and Workshop Visuals Appendix...112

6 ANTIBODY DETECTION A collection of integrated solutions to help you identify HLA antibodies that may cause graft rejection 4

7 Transplant Monitoring Solutions As the world leader in HLA tissue typing, One Lambda s HLA antibody detection technology is designed for highly specific pre-and posttransplant monitoring. Products are designed for ease of use, lab efficiency and optimized automation. ANTIBODY DETECTION Single Antigen Available on three testing platforms, the Single Antigen technology provides clinicians with flexible solutions to identify antibodies hidden by dominant epitopes in high PRA patients. Page 06 LABScreen Using Luminex xmap technology, our selection of LABScreen reagents provide several assays for determining percent PRA, in addition to identifying antibodies against both Class I and Class II antigens, MICA and HNA. Page 10 FlowPRA Designed for use in flow cytometric detection, your choice of FlowPRA test can screen human sera for antibodies, assigning percent PRA and antibody specificity for HLA Class I and Class II. Page 18 Lambda Antigen Tray (LAT) Features Terasaki-format trays pre-coated with HLA Class I and Class II antigens that perform antibody detection based on ELISA techniques. LAT reagents are an economical and convenient method for screening patients, determining percent PRA and identifying antibodies. Page 26 Lambda Cell Tray (LCT) Panels of frozen lymphocytes dispensed in Terasaki trays, designed to determine PRA and HLA antibody screening by complementdependent cytotoxicity. Page 30 ibeads Allows researchers to investigate antibody reactivity in unsensitized individuals. Powered by Luminex xmap technology, ibeads provides a comprehensive panel of HLA Class I antigens. For Research Use Only. Not for use in diagnostic procedures. Page 32

8 Single Antigen Single antigen is a premiere technology that identifies hidden antibodies in high PRA patients that cannot be distinguished using phenotypic antigen panels. The comprehensive determination of Class I and Class II HLA antibodies allows clinicians to select acceptably mismatched donor-recipient pairs. In the post-transplant process, single antigen may help physicians to detect early signs of graft failure. LABScreen, FlowPRA and LAT products are available with single antigen to provide greater identification in the monitoring process. In post-transplant monitoring, the single antigen assay may help physicians to detect early signs of graft failure. 6

9 Features and Benefits Clarifies analysis of HLA antibodies reactive to one or more dominant epitopes, providing more appropriate match for high PRA patients and possible donors Determines HLA antibodies with accuracy and speed Comprehensive determination of Class I and Class II HLA antibodies facilitates selection of acceptably mismatched donor-recipient pairs Provides a specific method for antibody identification that may be beneficial in reducing the occurrence of antibody mediated rejection Detection of HLA antibodies may be an important clinical tool for management of solid organ recipients, even before a decline in organ function is detected ANTIBODY DETECTION Available on three testing platforms: LABScreen (based on Luminex xmap technology) FlowPRA (flow cytometry) Lambda Antigen Trays (ELISA) Intended Use Applications Our single antigen products are used to determine HLA Class I and Class II antibodies for both pre- and post-transplant monitoring. Methodology Each product has its specific methodology. Refer to the product description below for methodology and additional information. LABScreen Single Antigen Powered by Luminex xmap technology; a multiplex assay composed of single antigens bound to colorcoded microbeads (Single Antigen-Beads), detected by fluorescent emissions from R-Phycoerythrin (PE) conjugated goat antihuman IgG. FlowPRA Single Antigen An alternative single antigen bead technology using flow cytometry. Assigns percent PRA or antibody specificity for both HLA Class I and Class II by measuring fluorescent channel shifts produced by specific antibody binding detected by FITC-labeled antihuman IgG, compared to a control background signal produced by a negative serum. LAT Single Antigen An ELISA approach for patient HLA-antibodies. Using alkaline phosphatase- conjugated secondary antibodies, LAT Single Antigen identifies antibody specificities by reaction patterns with a panel of selected recombinant human HLA antigens. Storage LABscreen FlowPRA LAT Single Antigen Single Antigen Single Antigen Storage -65 C or below -80 to -65 C 2 to 5 C Temperature: Shipping Dry Ice Dry Ice Cold Pack Considerations: Packaging: 25-test package 10-test package 20-test package For In Vitro Diagnostic Use.

10 Single Antigen Single Antigen Technology provides a level of clarity unmatched with conventional antibody screening assays. One Lambda s comprehensive collection of recombinant human single antigen products using LABScreen, FlowPRA or LAT methodology, provide determination of antibodies for either Class I or Class II HLA and MHC Class I related chain A (MICA) antigens. Clinicians are provided with reliable pre- and post-transplant antibody status, and the clinical laboratory has the flexibility of choosing individual Single Antigens for their convenience. Please refer to the product descriptions for each category of Single Antigen below. LABScreen Single Antigen Designed to screen HLA class I and class II antibodies that are reactive to one or more dominant epitopes found in high PRA patients. Each bead is coated with a single recombinant human antigen providing clinicians a comprehensive assay to evaluate antigens found frequently in the population. See page 12 for product listing LABScreen MICA Single Antigen LABScreen MICA Single Antigen is intended for MHC Class I related chain A (MICA) antibody screening by coating each bead with a single recombinant human MICA (rmica) antigen. The assay is comprised of a panel of MICA antigens found frequently in the population. See page 12 for product listing LABScreen Singles Single antigens that are available in the LABScreen Single Antigen HLA Class I and Class II groups are also sold individually as Singles. Each single antigen is packaged separately with wash buffer. The Singles option provides only the antigens needed - to be used when needed. Negative and positive control serum is sold separately. See page 12 for product listing 8

11 ANTIBODY DETECTION FlowPRA Single Antigen FlowPRA Single Antigen is designed for assigning PRA and HLA class I and class II antibody screening by flow cytometry. Provided with a control bead, the assay consists of 32 recombinant human single antigen beads in four groups, representing antigens found frequently in the population. Also available, there are six further groups of Class I single antigen beads (FL1HD05 FL1HD10) that provide supplemental specificities for the FlowPRA Class I Single Antigen Panel. See page 18 for product listing Lambda Antigen Trays (LAT ) Single Antigen Formatted on a Terasaki Tray, recombinant human HLA Class I single antigens are coated in each well for screening HLA antibodies in high PRA patients. Using ELISA based methods, LAT Single Antigen identifies the less common specificities that maybe masked or obscured by antibodies produced against the higher frequency antigens. See page 28 for product listing

12 LABScreen LABScreen reagents are powered by Luminex xmap technology, a microbead platform used to deliver multiplex antibody assays in high-pra patients. This single antigen-bead based assay allows for a precise determination of antibody profiles against HLA, MICA or HNA. The proven reliability of LABScreen s consistency, high sensitivity and robustness for PRA screening has gained rapid momentum in the transplant community. Features and Benefits Qualitatively measures the presence of specific HLA Class I and Class II antibodies in human serum or plasma samples Contains a defined pool of HLA antigens, including rare alleles Eliminates false positive reactions due to non-hla antibodies or auto-antibodies Multiplex analysis enhances lab automation and lowers labor costs, reagents and assay time 96 samples can be tested sequentially using the X-Y platform. Single antigen assay identifies negative or safe antigens, even for high PRA patients Detects IgG antibodies Principle LABScreen products use a panel of colorcoded microbeads, coated with purified HLA antigens. Up to 100 different beads can be combined in one suspension in a single test. The serum is incubated with LABScreen beads. Any HLA antibodies in the serum bind to the antigens and are labeled with PE-conjugated goat anti-human IgG. The LABScan 100 detects fluorescent emission of PE from each bead, allowing nearly real-time data acquisition. 10

13 Methodology Detection by R-Phycoerythrin Conjugated Antibody ANTIBODY DETECTION Add sample. Incubate. Wash. Add R-PE conjugated Anti-IgG. Incubate. 4 5 Wash. Read. Intended Use Applications LABScreen products are intended for use in the detection of HLA antibodies, using Luminex xmap technology. Interpretation software is available for LABScreen products. See page 14 for product listing Ancillary Reagents Storage LABscreen PE-Conj Goat IgG Negative Control Anti-Human Serum Storage -65 C or below 2-8º C -20º C or below Temperature: Shipping Dry Ice Cold Pack Dry Ice Considerations: Packaging: 25-test package 10-test package 20-test package For In Vitro Diagnostic Use.

14 LABScreen LABScreen LABScreen Single Antigen HLA Class I/ II In high PRA patients, the sera may contain antibodies reactive to one or more dominant epitopes. Using LABScreen Single Antigen for specificity is helpful, as conventional clarification methods may not be effective in these cases. Product Description Cat Id Sale Unit Tests LABScreen Single Antigen Class I - Combi LS1A04 pkg 25 tests LABScreen Single Antigen Class II - Group 1 LS2A01 pkg 25 tests LABScreen MICA Single Antigen Created for HLA antibody screening and identification of MHC class I related chain A (MICA) antibodies, LABScreen MICA Single Antigen is valuable for specificity assignment. Each recombinant MICA (rmica) antigen is coated on a separate bead population. Based on Luminex xmap technology, LABScreen MICA Single Antigen is comprised of a panel of 10 MICA antigens found frequently in the population. Product Description Cat Id Sale Unit Tests LABScreen MICA Single Antigen - Group 1 LSMICA001 pkg 25 tests LABScreen Singles Class I/ II Single antigens are available in the HLA Class I and Class II groups and are also sold individually as Singles. Each single antigen is packaged separately with an appropriate volume of wash buffer. The Singles option provides only the antigens needed - to be used when needed. Order the negative/positive control serum for the Singles separately. 12

15 LABScreen Singles Class I Product Description Cat Id Sale Unit Tests Class I A01 (A*0101) LSA1-A001 pkg 10 tests A02 (A*0201) LSA1-A002 pkg 10 tests A02 (A*0203) LSA1-A003 pkg 10 tests A03 (A*0301) LSA1-A005 pkg 10 tests ANTIBODY DETECTION A23 (A*2301) LSA1-A008 pkg 10 tests A24 (A*2402) LSA1-A009 pkg 10 tests A24 (A*2403) LSA1-A010 pkg 10 tests A29 (A*2902) LSA1-A014 pkg 10 tests A30 (A*3001) LSA1-A015 pkg 10 tests A32 (A*3201) LSA1-A018 pkg 10 tests B07 (B*0702), Bw6 LSA1-B001 pkg 10 tests B08 (B*0801), Bw6 LSA1-B002 pkg 10 tests B18 (B*1801), Bw6 LSA1-B013 pkg 10 tests B27 (B*2705), Bw4 LSA1-B014 pkg 10 tests B44 (B*4402), Bw4 LSA1-B024 pkg 10 tests B44 (B*4403), Bw4 LSA1-B025 pkg 10 tests B51 (B*5101), Bw4 LSA1-B032 pkg 10 tests B51 (B*5102), Bw4 LSA1-B033 pkg 10 tests B52 (B*5201), Bw4 LSA1-B034 pkg 10 tests B53 (B*5301, Bw4) LSA1-B035 pkg 10 tests B57 (B*5701), Bw4 LSA1-B039 pkg 10 tests B64 (B*1401), Bw6 LSA1-B004 pkg 10 tests C1 (C*0102) LSA1-C001 pkg 10 tests C12 (C*1203) LSA1-C011 pkg 10 tests C2 (C*0202) LSA1-C002 pkg 10 tests C6 (C*0602) LSA1-C008 pkg 10 tests C7 (C*0702) LSA1-C009 pkg 10 tests C8 (C*0801) LSA1-C010 pkg 10 tests

16 LABScreen Singles Class II LABScreen LABScreen Product Description Cat Id Sale Unit Tests Class II (DPB1*0301) LSA2-P003 pkg 10 tests (DQB1*0201, DQA1*0201) LSA2-Q001 pkg 10 tests (DQB1*0201, DQA1*0301) LSA2-Q002 pkg 10 tests (DQB1*0202, DQA1*0201) LSA2-Q004 pkg 10 tests (DQB1*0301, DQA1*0301) LSA2-Q012 pkg 10 tests (DQB1*0302, DQA1*0101) LSA2-Q030 pkg 10 tests (DQB1*0303, DQA1*0201) LSA2-Q018 pkg 10 tests (DQB1*0303, DQA1*0301) LSA2-Q017 pkg 10 tests (DQB1*0401, DQA1*0201) LSA2-Q005 pkg 10 tests (DQB1*0402, DQA1*0201) LSA2-Q006 pkg 10 tests (DQB1*0501, DQA1*0101) LSA2-Q008 pkg 10 tests (DQB1*0601, DQA1*0103) LSA2-Q010 pkg 10 tests (DQB1*0602, DQA1*0102) LSA2-Q011 pkg 10 tests (DRB1*0101) LSA2-R003 pkg 10 tests (DRB1*0102) LSA2-R004 pkg 10 tests (DRB1*0301) LSA2-R006 pkg 10 tests (DRB1*0401) LSA2-R008 pkg 10 tests (DRB1*0701) LSA2-R011 pkg 10 tests (DRB1*0801) LSA2-R012 pkg 10 tests (DRB1*0901) LSA2-R013 pkg 10 tests (DRB1*1101) LSA2-R015 pkg 10 tests (DRB1*1501) LSA2-R020 pkg 10 tests (DRB1*1502) LSA2-R021 pkg 10 tests (DRB3*0101) LSA2-R023 pkg 10 tests (DRB3*0202) LSA2-R024 pkg 10 tests (DRB4*0101) LSA2-R025 pkg 10 tests (DRB4*0103) LSA2-R026 pkg 10 tests (DRB5*0101) LSA2-R027 pkg 10 tests (DRB5*0202) LSA2-R028 pkg 10 tests 14

17 LABScreen PRA LABScreen PRA determines percent PRA and identifies antibody specificities using a panel of color-coded microbeads coated with HLA antigens purified from different cells. Using the LABScan 100 flow analyzer Class I and Class II may be tested separately or together. LABScreen PRA Class I/ II Product Description Cat Id Sale Unit Tests ANTIBODY DETECTION LABScreen PRA Class I LS1PRA pkg 25 tests LABScreen PRA Class II LS2PRA pkg 25 tests LABScreen PRA Class I & II Set LS12PRA 2 pkgs 2 x 25 tests LABScreen Mixed A screening test dedicated to detecting antibodies against HLA Class I and Class II in addition to MHC Class I related chain A (MICA), another factor shown to cause transplant rejection. With its ease of use, processing up to 96 samples simultaneously, LABScreen Mixed is well-suited for monthly patient antibody screening in both low and high throughput laboratories. Product Description Cat Id Sale Unit Tests LABScreen Mixed Class I & II LSM12 pkg 100 tests LABScreen Multi LABScreen Multi is a screening tool for antibodies against both the HLA and Human Neutrophil Antigens (HNA). Antibodies against HNA are implicated in a variety of clinical conditions, including TRALI (Transfusion Related Acute Lung Injury). Using microbeads coated with purified Class I or Class II HLA or HNA antigens and pre-optimized reagents for the detection of HLA/HNA antibodies, LABScreen Multi qualitatively measures the presence of specific antibodies in a human serum or plasma sample. Product Description Cat Id Sale Unit Tests LABScreen Multi LSMUTR pkg 100 tests

18 LABScreen LABScreen Ancillary Reagents One Lambda offers a selection of Ancillary Reagents for optimizing LABScreen testing. Storage Adsorb Out Negative PE-Conj Quantiplex Luminex Calibration Sheath Fluid Control Goat IgG Beads Control Microspheres Storage -65 C or below -20º C or below 2º to 8º C 2º to 8º C 2º to 8º C Room Tempature Temperature: Shipping Dry Ice Dry Ice Cold Pack Cold Pack Cold Pack Room Tempature Considerations: Packaging: 1 vial in foil bag 1 vial in foil bag 1 vial in foil bag 1 vial in foil bag 5ml per bottle Unless otherwise stated, For General Laboratory Use. Adsorb Out Adsorb Out beads remove reactivity to latex beads from test sera with high levels of non-specific binding. Preliminary adsorption of non-specific binding material from the serum can reduce or remove the high background in a flow cytometry test. Adsorb Out consists of a special preparation of microparticles without specific antigen coating. Product Description Cat Id Sale Unit Tests Adsorb Out (75µl) ADSORB vial 25 tests For General Laboratory Use. LABScreen Controls The serum establishes the background value for each test batch in the detection of Class I or Class II HLA antibodies. It contains a pool of negative sera and works with the coated microbeads of LABScreen products. Product Description Cat Id Sale Unit Tests LABScreen Singles Control Beads LSACNTBD vial 50 tests LABScreen Negative Control Serum LS-NC vial 20 tests For In Vitro Diagnostic Use. 16

19 PE-Conjugated Goat Anti-Human IgG PE-Conjugated Goat Anti-Human IgG is required with LABScreen tests and it must be purchased separately. Product Description Cat Id Sale Unit Tests PE - Conjugated Goat Anti-Human, Lyophilized, 1ml LS-AB2 vial 1,000 For In Vitro Diagnostic Use. ANTIBODY DETECTION Quantiplex Beads Quantiplex Beads consist of a set of Luminex microbeads with graduated levels of fluorochrome similar to PE. They are reference beads for standardization of the fluorescent signal generated by assays using Luminex xmap technology, which features the LABScan 100 flow analyzer for data acquisition and analysis Product Description Cat Id Sale Unit Tests Quantiplex Beads LXQNTPLX pkg 25 tests For Investigational Use Only. Luminex Microspheres & Sheath Fluid Product Description Cat Id Sale Unit For use with Luminex IS or Luminex IDS Luminex Calibration Microspheres (Classification and Reporter) LXCAL Set Luminex Calibration Microspheres (Classification and Reporter) LXCALX5 5 set Luminex Control Microspheres (Classification and Reporter) LXCON Set Luminex Control Microspheres (Classification and Reporter) LXCONX5 5 set Luminex Sheath Fluid - 20 liters LXSF20 bottle Luminex Sheath Fluid liters LXSF20X5 5-20L bottles For use with xponent 3.1* Luminex Calibration Kit (Classification and Reporter) LXCALK Set Performance Verification Kit (Classification, Reporter, and Fluidics) LXPERK Set Accesory: Automated Maintenance Plate LXAMP Each For General Laboratory Use.

20 FlowPRA Single Antigen FlowPRA Practical for identifying acceptable antigens prior to a solid organ transplant and for pre- and post-transplant screening, the FlowPRA Single Antigen products were created to profile high PRA patients using flow cytometry. Each bead is designed to react specifically to HLA Class I and HLA Class II antibodies, distinguished by different fluorescent properties leaving no concern for cross reactivity. The collection of FlowPRA reagents in Class I and Class II consists of a pool of 32 beads, separated into 4 groups, each coated with different antigens. Control beads are also included to demonstrate test reliability and inclusion of common HLA antigens provides optimal profiling for high PRA patients. Additionally, 6 supplemental groups of Class I single antigen beads offer extra specificities for antibody screening. Features and Benefits Quickly identifies Class I and Class II HLA antibodies in high PRA patients Identifies negative or safe antigens, even for high PRA patients Confirms specificity by replacing dilution and absorption as strategies Clarifies ambiguous results Clarifies analysis of antibodies reactive to one or several dominant epitopes Principle FlowPRA tests provide pre-optimized reagents for rapid flow cytometric detection of HLA antibodies and their specificities in human serum. The FlowPRA Single Antigen beads consist of a mixture of different colored beads with different fluorescent properties. These beads can be excited at 488 nm, generating a maximum emission of approximately 580 nm, similar to phycoerythrin (PE), which can be detected by the FL2 channel. Since different beads generate different FL2 channel shifts, different colored beads in a group can be separated by a flow cytometer on the FL2 channel. The testing procedure is the same as that of the FlowPRA Screening test. Each group of beads is incubated separately with the test serum and then stained with a FITC conjugated anti-human IgG antibody. Beads reacting positively show an FL1 channel shift on the FL1 vs. FL2 dot plots when compared to the negative control serum and the control beads. Intended Use Applications Results FlowPRA Single Antigen tests are used to screen highly sensitized patients, both pre- and post-transplant. They are used in identifying acceptable antigens prior to a solid organ transplant or re-transplant. The FlowPRA Single Antigen tests are designed for detailed discrimination of specificities in high PRA sera. 18

21 Storage Reagents Control Reagents Storage -80 to -65 C -80 to -20 C Temperature: Shipping Dry Ice Dry Ice Considerations: Packaging: 10-tests 10-tests For In Vitro Diagnostic Use. ANTIBODY DETECTION Flow PRA Single Antigen HLA Class I/II Tests Product Description Cat Id Sale Unit Tests Class I (A Locus/B Locus) FL1HD pkg 10 tests Group 1 (A Locus/ B Locus) FL1HD01 pkg 10 tests Group 2 (A Locus) FL1HD02 pkg 10 tests Group 3 (B Locus) FL1HD03 pkg 10 tests Group 4 (B Locus) FL1HD04 pkg 10 tests Supplement - Group 5 (B Locus) FL1HD05 pkg 10 tests Supplement - Group 6 (B Locus) FL1HD06 pkg 10 tests Supplement - Group 7 (B Locus) FL1HD07 pkg 10 tests Supplement - Group 8 (A Locus / B Locus) FL1HD08 pkg 10 tests Supplement - Group 9 (C Locus) FL1HD09 pkg 10 tests Supplement - Group 10 (C Locus) FL1HD10 pkg 10 tests Class II (DRB1/DRB3,4,5/DQB1) FL2HD pkg 10 tests Group 1 (DRB1) FL2HD01 pkg 10 tests Group 2 (DRB1) FL2HD02 pkg 10 tests Group 3 (DRB1/ DRB3,4,5) FL2HD03 pkg 10 tests Group 4 (DQB1) FL2HD04 pkg 10 tests Supplement - Group 5 (DPB1) FL2HD05 pkg 10 tests

22 FlowPRA FlowPRA Screening The FlowPRA Screening Tests can be used as a first test to detect HLA antibodies and percent PRA in human sera using flow cytometry. Each of the FlowPRA Class I and Class II assays consist of a pool of 30 different bead preparations, representing all common antigens as well as many rare HLA alleles. Intended to detect HLA-specific antibodies for pre- and post-transplantation monitoring, FlowPRA Screening provides a comprehensive and accurate assay. Features and Benefits The single tube method enables quick, easy use Class I and Class II antibodies can be screened separately or simultaneously Reduces false positive reactions due to non-hla antibodies Convenient and simple, no frozen panels must be maintained and no cell viability issues exist Works with most commercial flow cytometers Panel coverage is equivalent to 30 different lymphocytes Determines percent PRA for Class I and Class II Results are consistent, reproducibility is seamless Offers greater sensitivity than CDC-AHG Minimal shipping and storage costs incurred 20

23 Principle The FlowPRA Screening Test provides precalibrated reagents for rapid flow cytometric detection of PRA in human sera. Reactivity of FlowPRA beads has been confirmed by flow cytometry with human allosera and specific HLA monoclonal antibodies. HLA antibodies in the serum react specifically to the FlowPRA beads. After incubation of serum with FlowPRA beads, followed by a staining with fluorescentlabeled antihuman IgG antibody, the anti-igg positive serum shows a fluorescent channel shift, compared to the negative serum. Percent PRA is represented by the percentage of beads that react positively with the serum. ANTIBODY DETECTION Results FL2 histogram differentiating Class I and Class II beads FL1 histogram of FlowPRA beads reacting with negative control serum FL1 histogram of FlowPRA beads reacting with positive control serum Intended Use Applications Storage Reagents This test is intended for use in flow cytometric detection of HLA-specific antibodies in the sera of pre- and post-transplant organ recipients. Storage Temperature: Shipping Considerations: Packaging: -80 to -65 C Dry Ice 10-tests For In Vitro Diagnostic Use. FlowPRA HLA Class I/II Screening Tests Product Description Cat Id Sale Unit Tests Class l (30 Ag Panel) FL1-30 pkg 50 tests Class II (30 Ag Panel) FL2-30 pkg 50 tests Class I & II (60 Ag Panel) FL12-60 pkg 50 tests

24 FlowPRA FlowPRA Specific These assays calculate percent PRA and identifies specific HLA antibody with accuracy, using flow cytometry. Each test consists of a panel of 32 FlowPRA Specific Class I and Class II beads, each coated with different purified Class I or Class II antigens from human cell lines. The beads are divided into four HLA groups, eight beads in a collection. A serum sample must be tested separately with each group of beads to complete the bead panel analysis of the HLA Class I or Class II antibodies in that serum. U.S. Patents 5,948,627; 6,150,122; 6,514,714 Features and Benefits High sensitivity and reproducibility Class I and Class II tests offered Specific HLA antibody detection is achieved with purified HLA antigens Reduced false positive reactions due to non-hla antibodies and auto antibodies No frozen lymphocyte panels to maintain and no cell viability problems to address Comprehensive analysis is achieved with HLA antibody specificities Principle FlowPRA tests provide pre-optimized reagents for rapid flow cytometric detection of HLA antibodies and their specificities in human serum. The FlowPRA Specific Antibody Detection Test consists of a mixture of different colored beads with different fluorescent properties. These beads can be excited at 488 nm, generating a maximum emission of approximately 580 nm, similar to phycoerythrin (PE), which can be detected by the FL2 channel. Since different beads generate different FL2 channel shifts, different colored beads in a group can be separated by a flow cytometer on the FL2 channel. The testing procedure is the same as that of the FlowPRA Screening Test. Each group of beads is incubated separately with the test serum, then stained with a FITC conjugated anti-human IgG antibody. Beads reacting positively show an FL1 channel shift on the FL1 vs. FL2 dot plots when compared to the negative control serum and the control beads. Intended Use Applications 22 These tests are intended for use in flow cytometric detection of HLA antibodies and their specificities. FlowPRA Specific Antibody Detection Tests provide an extension to the FlowPRA Screening Tests. Both the specific and screening tests use microbeads coated with purified HLA antigens for flow cytometic detection of HLA antibodies in human sera. Screening tests can be used as a first test to detect HLA antibodies and percent PRA in human sera. Specific tests can subsequently be used to determine the antibody specificities in the serum.

25 Results FlowPRA Specific Class I Group 4* Figure 1. Sample dot plot for B13 positive alloserum ANTIBODY DETECTION FlowPRA Specific Class II Group 1* Figure 2. Sample dot plot for DR10 positive alloserum *Figures depict only one out of four groups. Actual assay results consist of four groups plus positive and negative controls. Please consult product insert for more information. Storage Reagents Storage Temperature: Shipping Considerations: Packaging: -80 to -65 C Dry Ice 10-tests For In Vitro Diagnostic Use. FlowPRA Specific HLA Class I/II Tests Product Description Cat Id Sale Unit Tests Class I (32 Ag Panel) FL1SP pkg 10 tests Class II (32 Ag Panel) FL2SP pkg 10 tests

26 FlowPRA FlowPRA Ancillary Reagents Storage Control Reagents Other Reagents Storage -80 to -20 C -80 to -65 C Temperature: Shipping Dry Ice Dry Ice Considerations: Packaging: Various Various Ancillary Reagents Product Description Cat Id Sale Unit Tests Control Reagents FlowPRA Control Beads (50 µl) FLCNTBD vial 50 tests FlowPRA Class l & II Negative Control Serum (240µl) FL-NC vial 10 tests FlowPRA Class l Positive Control Serum (240µl) FL1-PC vial 10 tests FlowPRA Class II Positive Control Serum (240µl) FL2-PC vial 10 tests Other Reagents FlowPRA Reagent Pack FL-RP pkg 10 tests (Anti-Human IgG, 60 µl vial plus Wash Buffer, 26 ml bottle) FlowPRA Wash Buffer (10X) ml FL-BF100 bottle For In Vitro Diagnostic Use. Adsorb Out (75µl) ADSORB vial 25 tests For General Laboratory Use. 24

27 ANTIBODY DETECTION

28 Lambda Antigen Tray (LAT ) For efficient processing and reliable identification, the LAT product line offers economical and convenient ELISA-based assays for the detection of HLA IgG antibody. Three tray categories, each with distinct capabilities, are available in this product line. These trays feature pools of HLA antigens, which allow the determination of percent PRA and the identification of specific HLA Class I and Class II antibodies on a single tray. Features and Benefits Antibody specificity is clear; LAT Class I or Class II panels allow detailed assignment of specificity LAT Mixed uses a pool of purified HLA Class I and Class II antigen for added specificity LAT ELISA results are comparable to CDC-AHG results Both cytotoxic and non-complement binding antibodies are recognized Eliminates interference from non-hla antibodies and auto antibodies Distinguishes between HLA Class I and Class II specificities Quickly detects IgG Superb signal to background ratio for consistent results Convenient Terasaki tray format with smaller volume of reagents required Produces a defined pool of antigens, including rare HLA alleles Principle The LAT provides pre-calibrated ELISA reagents for the detection of IgG antibody to HLA Class I or Class II antigens in human serum. Defined amounts of affinitypurified HLA antigens are presented in different wells of a Terasaki tray. The specific binding of antibody from the test sample with any of these antigens is detected by a subsequent incubation with alkaline phosphataseconjugated antibody that recognizes only human IgG. A quantitative measure of the extent of reaction is obtained by spectrophotometric determination following the addition of the appropriate enzyme substrate for the development of color. Qualitative assessment of antibody specificity is performed by analysis of the LAT reactivity pattern using the appropriate LAT worksheet. 26

29 Intended Use Applications Intended for the identification of HLA-specific antibody in the serum of pre- and post-transplant organ recipients. Methodology/Steps ANTIBODY DETECTION Dilute test samples. Add test samples to tray. Incubate one hour. Wash and flick Dilute secondary antibody. Add secondary antibody to tray. Incubate 45 minutest. Wash and flick. 7 8 Add substrate. Incubate 15 minutes. Add stop reagent. Read results. Storage LAT LAT MIxed Storage Temperature: 2º - 5º C 2º - 5º C Shipping Considerations: Cold pack Cold pack Packaging: 20 trays per kit 5 trays per kit For In Vitro Diagnostic Use.

30 Lambda Antigen Tray (LAT ) LAT Single Antigen Class I This ELISA-based assay detects and defines HLA antibodies in high PRA patients. Formatted on Terasaki trays, each Class I single antigen is coated in one well, allowing it to identify less common specificities that may be obscured by antibodies produced against the higher frequency antigens. Product Description Cat Id Sale Unit Tests LAT Single Antigen Class I LAT1HD 20 trays 20 tests LAT Class I/II The Lambda Antigen Trays are designed for the detection of HLA IgG antibody and feature purified HLA Class I and Class II antigens attached to each well of a Terasaki-format tray. With the addition of patient serum, the antibodies bind with the purified HLA antigens. The panel of HLA antigens can detect IgG complement-binding and non-complement-binding antibodies. Product Description Cat Id Sale Unit Tests Class I (40 Ag Panel) 2 test tray LAT140X2 20 trays 40 tests Class I (40 Ag Panel) 1 test tray LAT trays 20 tests Class II (32 Ag Panel) 2 test tray LAT trays 40 tests Class I & II (40 Ag Panel) 2 test tray LAT trays 40 tests Class I & II (88 Ag Panel) 1 test tray LAT trays 20 tests LAT Mixed Class I/II A cost-effective, HLA antibody pre-screening test that rapidly processes multiple samples on a single tray. The mixed tray contains a defined pool of HLA antigens from several different cells, including rare HLA coverage, coated to each well of a Terasaki format tray. Product Description Cat Id Sale Unit Tests Class I 20 test tray LATM120 5 trays 100 tests Class I & II Trays (96 well) 10 test tray LATM10X5 5 trays 50 tests Class I & II Trays (96 well) 20 test tray LATM20X5 5 trays 100 tests 28

31 ANTIBODY DETECTION

32 Lambda Cell Tray (LCT ) These trays are frozen cell panels designed for PRA and HLA antibody screening by complement-dependent cytotoxicity. They consist of panels of selected lymphocytes frozen onto Terasaki Tissue Trays, providing a diverse cell panel for cytotoxic screening of human sera. Class I panels are available in both 60 and 72 well formats. Features and Benefits Superb viability, accurate results Extensive antigen coverage Three panel sizes offered 30, 60 and 72 For larger cell panels, trays can be combined for greater efficiency Rapid test time 90 minutes Well suited for dye exclusion and fluorescence methods Principle Lymphocytes with known antigens are incubated with an unknown serum and rabbit complement. If the serum contains antibodies that are able to bind specifically to those antigens present on the lymphocyte surface, complement mediated cytolysis can occur. If the unknown serum contains HLA antibodies, they can be characterized. Intended Use Applications These trays are intended for the screening of sera for Class I and Class II antibodies with a complementdependent microlymphocytotoxic technique. 30

33 Methodology/Steps Thaw tray. Dispense McCoy s into each well. Flick tray to remove DMSO. Dispense oil into each well. ANTIBODY DETECTION Dispense sera into each well, except control wells. Incubate tray for 30 minutes. Dispense complement into each well. Incubate tray for 1 hour. Dispense stain/fixative into each well. Storage Storage Temperature: Shipping Considerations: Packaging: For In Vitro Diagnostic Use. -65 C or below Dry Ice 10 trays per box LCT Cell Panels Product Description Cat Id Sale Unit Tests 30 T Cell Panel (Wash version) - 2 test tray LCT1W30 10 trays 20 tests 60 T Cell Panel (Wash version) - 1 test tray LCT1W60 10 trays 10 tests 72 T Cell Panel (Wash version) - 1 test tray LCT1W72 10 trays 10 tests

34 ibeads Allows researchers to investigate antibody reactivity in unsensitized individuals. Powered by Luminex xmap technology, ibeads provides a comprehensive panel of HLA Class I antigens. Features and Benefits Research application for the characterization of HLA Class I antibodies in unsensitized individuals Comprehensive large representation of recombinant HLA Class I antigens Based on Luminex xmap technology - Minimal learning curve Real time acquisition Principle ibeads uses a panel of color coded microbeads that have a reduced amount of denatured antigens, compared to classic single antigen based products. Test serum is incubated with ibeads and any antibodies in the serum that bind to the antigens are detected using PE-conjugated goat anti-human IgG. The LABScan 100 detects the fluorescent emission of PE from each bead, allowing real time data-acquisition. Intended Use Applications Investigate Antibodies to Native Conformation HLA Antigens 32

35 Methodology/Steps ANTIBODY DETECTION 4 5 ibeads Storage Storage Temperature: Shipping Considerations: Packaging: -65 C or below Dry Ice 25 tests per kit For Research Use Only. Not for use in diagnostic procedures. ibeads Product Description Cat Id Sale Unit Tests IBeads Class I IBEADS1 pkg 25 tests

36 MOLECULAR PRODUCTS A comprehensive line of molecular products for HLA tissue typing that support laboratories and physicians worldwide. 34

37 DNA Technology Defined One Lambda is renowned for its HLA typing technology that identifies HLA alleles. We offer a comprehensive line of molecular products for HLA tissue typing that supports laboratories and physicians worldwide. LABType Reverse Sequence Specific Oligonucleotide (rsso), Micro SSP (Sequence Specific Primer), and ConsenSys sequence-based typing products are available for HLA Class I and Class II typing. HLA laboratories can choose the molecular DNA typing method that best meets their requirements. Our LABType product line is used to match donors and recipients for both solid organ and bone marrow typing. Based on Luminex xmap technology, our LABType SSO products use patented Specialty Probe Technology in resolving many of the ambiguities that exist in traditional SSO tests. These tools are ideal for low volume and high throughput laboratories. Up to 96 samples can be tested simultaneously. MOLECULAR PRODUCTS The Micro SSP DNA typing trays offer comprehensive HLA Class I and Class II DNA typing, with resolution from Generic to Allele Specific. Accessories include the Micro SSP Gel System and 96-Well Transfer Device. Both simplify the overall typing process, supporting workflow efficiency and laboratory automation. ConsenSys SBT provides sequencing primers for use with the amplified DNA samples generated from the LABType SSO DNA typing system. HLA Fusion Research software performs combined analysis of SSO and SBT results, providing the highest single round typing results. Robust interpretation software is available for the LABType, Micro SSP and ConsenSys SBT products. LABType Based on Luminex xmap Technology, LABType is a reverse SSO DNA typing system that consists of sequence specific oligonucleotide probes bound to color-coded microspheres Page 36 Micro SSP DNA Typing Products One Lambda s portfolio of MicroSSP typing trays utilizes a sequence specific primer DNA typing system that provides complete HLA Class I and Class II DNA Typing. ConsenSys SBT This test provides sequencing primers for use with the amplified DNA samples generated from the LABType SSO DNA typing system Page 44 Page 58

38 LABType Based on Luminex xmap Technology, LABType is a reverse SSO DNA typing system that consists of sequence specific oligonucleotide probes bound to color-coded microspheres. This multiplex analysis dramatically reduces labor, reagents, reaction-to-reaction inconsistencies, and assay time associated with a multi-well format assay. Our cost effective kits do not require handling of strips or membranes, colormetric reactions, nor visual analysis of colored bands or dots. With LABType you get superior resolution and a cost-effective solution for HLA A, B, C DRB1, DRB3, 4, 5, and DQA1,DQB1, DPA1,DPB1 HLA typing. Features and Benefits Offers complete HLA A, B, C, DRB1*, DRB3, 4, 5, DPA1, DPB1, and DQA1 and DQB1 typing, as well as MICA Exons 4-7 is a Class I supplement for A, B, C locus; B7 and Bw4 are supplements for B locus kits Principle LABType, utilizing the Luminex xmap platform, is based on the reverse SSO method on a suspension array platform using microspheres as a solid support to immobilize oligonucleotide probes. First, target DNA is amplified using biotinylated locus-specific primer. Hybrids formed between amplification products and beadbound probes are detected using R-Phycoerythrin-conjugated Streptavidin (SAPE). The PCR product is denatured and allowed to rehybridize to complementary DNA probes conjugated to fluorescently coded microspheres. A flow analyzer, the LABScan 100, identifies the fluorescent intensity of PE (phycoerythrin) on each hybrid. The assignment of the HLA typing is based on comparison of the obtained reaction patterns with that of HLA alleles derived from published HLA gene sequences. Australian Patent and Canadian Patent 2,460,759 Intended Use / Applications: DNA Typing of HLA Class I or Class II alleles. 36

39 Methodology/Steps LABType Principle 1 2 MOLECULAR PRODUCTS 3 4 Legend Storage 20, 40 & 100 Tests PE Conj. Streptavidan Storage Temperature: -80 to -20 C 2 to 8 C Shipping Considerations: Cold Pack Cold pack or ambient temperature Packaging: Various 2000 tests For In Vitro Diagnostic Use.

40 LABType LABType SSO HLA Class I/II Tests Typing spans A, B, C; DRB1; DRB3, 4 5; DPA1/DPB1; DQA1/DQB1; MICA. DQA1, DQB1, and DPB1 cover exon 2 and 3. Exon 4-7 is a Class I supplement for A, B, C locus; B7 and Bw4 are supplements for B locus kits. Based on proven Luminex xmap technology. Product Description Cat Id Sale Unit Tests Class I A Locus RSSO1A pkg 100 tests RSO1AT pkg 20 tests B Locus RSSO1B pkg 100 tests RSO1BT pkg 20 tests B7 Supplement RSSO1S1 pkg 100 tests RSO1S1T pkg 20 tests Bw4 Supplement RSSO1S4 pkg 100 tests RSO1S4T pkg 20 tests C Locus RSSO1C pkg 100 tests RSO1CT pkg 20 tests Exon 4-7 Supplement RSSO1E47 pkg 100 tests RSO1E47T pkg 20 tests Class II DPA1/DPB1 RSSO2P pkg 100 tests RSO2PT pkg 20 tests DQA1/DQB1 RSSO2Q pkg 100 tests RSO2QT pkg 20 tests DRB1 RSSO2B1 pkg 100 tests RSO2B1T pkg 20 tests DRB3,4,5 RSSO2345 pkg 100 tests RSO2345T pkg 20 tests 38

41 LABType HD HLA Tests LABType HD identifies over 90% of common allele pairs without any ambiguities. The use of over 300 probes allows users to eliminate a significant number of rare alleles and provides a higher resolution typing, distinguishing among known alleles. Since LABType HD uses the same platform, protocol and analysis software as other LABType products, crossover training is minimal. There is also no need to upgrade or purchase new instrumentation. Typing Results by SSO and HD* LABType SSO Results A*01XX2 A*11XX1 A*11XX2 A*24ZSE A*30XX1 A*68XX2 A*02EK A*32XX1 A*30XX1 A*30XX2 XX1:=:01/02/03/05/07/09/12/13/16/21N/22/29; XX2:= :01/01N/04N/09/11N/15N/16N/18N ZSE:=:03/10/22/23/33; XX2:=:01/02/03/04/05/07/12/13/16/21N/22/29 XX1:=:01/14L/15/18/19; XX2:=:02/18N/34 XX1:=:01/05/11Q/12/14; EK:=:05/08 XX1:=:01/14L/15/18/19; XX2:=:01/11/14L/15/18/19 LABType HD Results A*01XX2 A*11BDFZ A*11BDFZ A*24WCR BDFZ:=:1101/1121N; XX2:=:01/01N/04N/11N WCR:=:03/22/33; BDFZ:=:1101/1121N A*3001 A*68CZJ CZJ:=:02/34 A*0205 A*32XX1 XX1:=:01/11Q/12 A*3001 A*30VE VE:=:01/11 MOLECULAR PRODUCTS A*02XX1 A*8001 XX1:=:06/10/21/28/61/72/91 A*0206 A*8001 A*34AE A*34AE AE:=:01/05;AE:=:01/05 A*3401 A*3401 A*02XX2 A*31XX1 XX1:=:01/09/11/13/14N/15; A*02CAKM A*31XX1 XX1:=:01/14N; CAKM:=:0201/ 0201L/0209/0243N/0266/0275/ 0283N/0289/0297 A*24TSY A*68XX2 TSY:=:03/23/33; XX2:=:01/07/11N/16/17/21/32/33 A*24BMD A*68CAKR BMD:=:03/33; CAKR:=:6801/ 6811N/6833 B*07XX1 B*4802 XX1:=:02/10/21/22/23/30/35/39/41/44/45/46/49N B*07XX1 B*4802 XX1:=:02/44/49N/52/57/58 B*08XX2 B*27BWHH B*07XX1 B*35XX2 B*35XX2 B*44XX1 B*15BNYJ B*53JV B*15CCFP B*58CCVS B*44AGWY B*55XUB B*44XX1 B*44XX2 BWHH:=:03/05/07/11/13/17/32; XX2:=:01/08N/14/15/18/19N/22/27/30N XX1:=:02/09/10/11/12/18/21/22/23/26/30/35/39/44/45/ 46/ 49N; XX2:=:01/05/07/08/30/34/40N/42/48/51/53N/57/64 XX1:=:03/13/26/30/35/36/37/38/39; XX2:=:01/07/30/ 40N/42/48/50/53N/57/64/71 JV:=:01/10; BNYJ:=:16/67/95 CCVS:=:5801/5810N/5811/5813; CCFP:=:1502/9512 AGWY:=:4402/4402S/4419N/4423N/4427/4433; XUB:=:01/03/15 XX1:=:02/02S/05/14/19N/23N/27/33/35/42/48/51; XX2:=:02/02S/05/11/14/19N/23N/27/33/35/42/48/51 B*08XX1 B*27XX2 B*07XX1 B*35XX2 B*35XX1 B*44XX2 B*1516 B*5301 XX1:=:01/14/19N; XX2:=:05/07 XX1:=:02/12/44/49N/52/57/58; XX2:=:01/40N/42/51/57 XX1:=:01/40N/42/57/71/77; XX2:=:03/30/37 B*1502 B*58XX1 XX1:=:01/10N/11 B*44XX1 B*5501 B*44XX1 B*44XX1 XX1:=:02/02S/27/52N/53 XX1:=:02/02S/27/51/52N/53 B*40BRCW B*53JVJ V:=:01/10;BRCW:=:02/35/56/57/58 B*40XX1 B*5301 XX1:=:02/56 DRB1*11XX1 DRB1*15XX2 DRB1*13XX1 DRB1*1407 DRB1*13XX1 DRB1*1601 DRB1*0302 DRB1*07XX1 DRB1*1418 DRB1*15XX1 DRB1*0102 DRB1*07XX1 DRB1*0102 DRB1*07XX1 XX1=1101/1112/1115/1124/1127/1128/1129/1139/ 1149/1161/ 1162; XX2=1501/1506/1509/1513/1516/1520 DRB1*1101 DRB1*1501 XX1=1302/1373 DRB1*1302 DRB1*1407 XX1=1303/1333 DRB1*1303 DRB1*1601 XX1=0701/0703/0705/0707/0709/0710N/071 DRB1*0302 DRB1*0701 XX1=1501/1513/1516/1520/1522 DRB1*1418 DRB1*1501 XX1=0701/0703/0705/0707/0709/0710N/0711 DRB1*0102 DRB1*0701 XX1=0701/0703/0705/0707/0709/0710N/0711 DRB1*0102 DRB1*0701 *Results may vary depending on the sample tested. Class II DRBI includes 131 HD Probes.

42 LABType LABType HD HLA Tests Product Description Cat Id Sale Unit Tests Class I A Locus RSSOH1A pkg 100 tests RSOH1AT pkg 20 tests B Locus RSSOH1B pkg 100 tests RSOH1BT pkg 20 tests C Locus RSSOH1C pkg 100 tests RSOH1CT pkg 20 tests Class II DRB1 RSSOH2B1 pkg 100 tests RSOH2B1T pkg 20 tests LABType SSO MICA LABType SSO MICA types MICA alleles using Luminex xmap technology. Typing for MICA can be instrumental in determining HLA-compatible donor- recipient matches. But it is also helpful in assuring that a patient is matched with a MICA-compatible donor. The test is also used to determine a patient s MICA typing to assure that MICA antibodies are not auto-reactive antibodies. Product Description Cat Id Sale Unit Tests LABType SSO MICA RSSOMICA pkg 40 tests 40

43 MOLECULAR PRODUCTS

44 LABType Ancillary Reagents One Lambda offers a selection of Ancillary Reagents for optimizing LABType testing. Storage Storage Temperature: 2 to 8 C Shipping Considerations: Cold Pack Packaging: 1 Vial SAPE Product Description Cat Id Sale Unit Tests PE - Conjugated Streptavidin, Lyophilized, 1ml LT-SAPE vial 2000 tests Storage Storage Temperature: -20 or below Shipping Considerations: Dry Ice Packaging: bottle TAQ Polymerase Product Description Cat Id Sale Unit Taq Polymerase - 30µl TAQ30 bottle Taq Polymerase - 50µl TAQ50 bottle Taq Polymerase - 75µl TAQ75 bottle For General Laboratory Use 42

45 Storage Calibration and Sheath Fluid Control Microspheres Storage Temperature: 2 to 8 C Room Temp Shipping Considerations: Cold Pack Room Temp MOLECULAR PRODUCTS Packaging: 5ml per bottle 20 L bottle Luminex Microspheres & Sheath Fluid Product Description Cat Id Sale Unit For use with Luminex IS or Luminex IDS Luminex Calibration Microspheres (Classification and Reporter) LXCAL Set Luminex Calibration Microspheres (Classification and Reporter) LXCALX5 5 set Luminex Control Microspheres (Classification and Reporter) LXCON Set Luminex Control Microspheres (Classification and Reporter) LXCONX5 5 set Luminex Sheath Fluid - 20 liters LXSF20 bottle Luminex Sheath Fluid liters LXSF20X5 5-20L bottles For use with xponent 3.1* Luminex Calibration Kit (Classification and Reporter) LXCALK Set Performance Verification Kit (Classification, Reporter, and Fluidics) LXPERK Set Accesory: Automated Maintenance Plate LXAMP Each For General Laboratory Use. Accessory Product Description Cat Id Sale Unit Tray Aspirator LT (for 96-well PCR plates) TASPCR box For General Laboratory Use

46 Micro SSP DNA Typing Products One Lambda s portfolio of Micro SSP typing trays provide complete HLA Class I and Class II DNA typing. Using Generic Trays, technologists can either assign HLA Class I or Class II alleles individually or simultaneously. If more detailed typing is needed, the High Resolution Allele Specific Trays will help eliminate redundancies. Features and Benefits Products for both serological and allele level typing Generic trays: Class I, Class II; combined Class I and II; 384-well format for ABDR High resolution trays: DPA1/DPB1, DQA1 and DRB1,3, 4, 5 Allele specific trays: Refines results for specific alleles Class I and Class II null trays to resolve common null alleles Principle The PCR-SSP methodology is based on the principle that completely matched oligonucleotide primers are more efficiently used in amplifying a target sequence than a mismatched oligonucleotide primer by recombinant Taq polymerase. Primer pairs are designed to have perfect matches only with a single allele or group of alleles. Under strictly controlled PCR conditions, perfectly matched primer pairs result in the amplification of target sequences (i.e., a positive result), while mismatched primer pairs do not result in amplification (i.e., negative result). After the PCR process, the amplified DNA fragments are separated by agarose gel electrophoresis and visualized by staining with ethidium bromide and exposure to ultraviolet light. Interpretation of PCR-SSP results is based on the presence or absence of a specific amplified DNA fragment. U.S. Patent 6,207,379 44

47 Storage Generic Trays High-Resolution Allele Specific Seramates Trays Trays Storage -80 to -20 C -80 to -20 C -80 to -20 C -80 to -20 C Temperature: Shipping Cold Pack Cold Pack Cold Pack Cold Pack Considerations: Packaging: 4 trays or 10 trays 4 trays or 10 trays 4 trays in box 4 trays in box in box in box MOLECULAR PRODUCTS For In Vitro Diagnostic Use. Intended Use Applications DNA typing of Class I and Class II HLA alleles. Methodology/Steps Add Taq polymerase and DNA to D-mix tube. Add DNA/D-mix solution to each well of the test (except negative control well). Perform PCR. 4 5 Perform electrophoresis. Photograph gel and analyze results.

48 Micro SSP DNA Typing Products Micro SSP Generic HLA Class I/II - DNA Typing Trays These basic trays are available to assign either HLA Class I, or Class II alleles, or both Class I and Class II alleles simultaneously. Product Description Cat Id Sale Unit Tests Class I Class I SSP1L 10 trays 10 tests A Locus Specific SSP1A 4 trays 12 tests AB SSP1AB 10 trays 10 tests B Locus Specific SSP1B 4 trays 8 tests B Locus (LT Supplement) SSP1-LTS1 4 trays 8 tests C Locus Specific SSP1C 4 trays 16 tests Class II DRB Only SSP2LB 10 trays 40 tests DQB Only SSP2LQB1 4 trays 24 tests DRB/DQB SSP2L 10 trays 30 tests DRB/DQB1/DPB1 SSPDRQP1/LSSPDRQP1 10 trays 10 tests Class I & II ABDRDQ SSPML02 4 trays 4 tests ABDR SSPABDR 10 trays 10 tests ABDR 384 SSPABDRX 10 trays 40 tests *Licensed product is available only outside the United States Micro SSP High Resolution HLA Class II Trays High Resolution trays offer more detailed subtyping information for Class II alleles (DPA1/DPB1, DQA1 and DRB1,3, 4, 5). They allow for focused testing eliminating ambiguities, and confirm questionable results. Product Description Cat Id Sale Unit Tests Class II DRB1,3,4,5 SSP2H 10 trays 10 tests DPA1/DPB1 SSP2HDP/ LSSP2HDP 4 trays 4 tests DQA1 SSP2HQA1 4 trays 8 tests 46 *Licensed product is available only outside the United States

49 Micro SSP Allele Specific HLA Class I/II Trays Allele Specific trays are designed for HLA Class I and Class II sub-typing. They may be used alone or in combination with our generic and high resolution HLA typing trays. Product Description Cat Id Sale Unit Tests Class I (A*01/36) SSPR trays 8 tests (A*02) SSPR1-A2 4 trays 4 tests (A*03) SSPR trays 8 tests (A*11) SSPR trays 8 tests MOLECULAR PRODUCTS (A*23) SSPR trays 8 tests (A*24) SSPR trays 4 tests (A*25/34/66) SSP trays 16 tests (A*26) SSPR trays 8 tests (A*29) SSPR trays 8 tests (A*30) SSPR trays 8 tests (A*31) SSPR trays 8 tests (A*32) SSPR trays 8 tests (A*33) SSPR trays 8 tests (A*68) SSPR trays 8 tests (A*74) SSPR trays 8 tests (B*07) SSPR trays 8 tests (B*08) SSPR trays 8 tests (B*13) SSPR trays 8 tests (B*14) SSPR trays 8 tests (B*15) SSPR trays 4 tests (B*18) SSPR trays 8 tests (B*27) SSPR trays 8 tests (B*35) SSPR trays 4 tests (B*37) SSPR trays 8 tests (B*38/39) SSPR trays 8 tests (B*40) SSPR trays 8 tests (B*41) SSPR trays 8 tests (B*42) SSPR trays 8 tests

50 Micro SSP DNA Typing Products Micro SSP Allele Specific HLA Class I/II Trays (continued) Product Description Cat Id Sale Unit Tests Class I (B*44) SSPR trays 8 tests (B*45) SSPR trays 8 tests (B*46/67/81/82) SSPR trays 8 tests (B*47) SSPR trays 8 tests (B*48) SSPR trays 8 tests (B*49/50) SSPR trays 6 tests (B*51/52/78) SSPR trays 4 tests (B*53) SSPR trays 8 tests (B*54-56) SSPR trays 8 tests (B*57) SSPR trays 8 tests (B*58) SSPR trays 8 tests (Cw*01) SSPR1-C01 4 trays 8 tests (Cw*02) SSPR1-C02 4 trays 8 tests (Cw*03) SSPR1-C03 4 trays 8 tests (Cw*04) SSPR1-C04 4 trays 8 tests (Cw*05) SSPR1-C05 4 trays 8 tests (Cw*06) SSPR1-C06 4 trays 8 tests 48

51 Micro SSP Allele Specific HLA Class I/II Trays (continued) Product Description Cat Id Sale Unit Tests Class I (C*07) SSPR1-C07 4 trays 8 tests MOLECULAR PRODUCTS (C*08) SSPR1-C08 4 trays 8 tests (C*12) SSPR1-C12 4 trays 8 tests (C*14) SSPR1-C14 4 trays 8 tests (C*15) SSPR1-C15 4 trays 8 tests (C*16/17/18) SSPR1-C16 4 trays 8 tests Null Allele SSP1-NL 4 trays 24 tests Class II (DQB1) SSPR2-Q1 4 trays 8 tests (DRB1*01) SSPR trays 8 tests (DRB1*03) SSPR trays 8 tests (DRB1*04) SSPR trays 8 tests (DRB1*07/09/10) SSPR trays 8 tests (DRB1*08) SSPR trays 8 tests (DRB1*11) SSPR trays 8 tests (DRB1*12) SSPR trays 8 tests (DRB1*13) SSPR trays 8 tests (DRB1*14) SSPR trays 8 tests (DRB1*15) SSPR trays 8 tests (DRB1*16) SSPR trays 8 tests (DRB3) SSPR2-3 4 trays 8 tests (DRB4) SSP2-4 4 trays 24 tests (DRB5) SSP2-5 4 trays 24 tests Null Allele SSP2-NL 4 trays 24 tests

52 Micro SSP DNA Typing Products MicroSSP AmbiStrips The Micro SSP AmbiStrips platform offers a simple PCR method for resolving Ambiguities and Null Alleles commonly found in allelic typing strings, or determine between heterozygous variants of B27 typings. The eight well strip design lets users target single allele specificities on an as need basis. Product Description Resolved Ambiguities Cat Id Sale Unit Tests Micro SSP AmbiStrips HLA Class I AmB15 15:GTCC*, 35:FMTY / 35:XX1, 35:XX2 SSPT1-B2 1 Strip 8 Tests AmB46 15:GUVW, 48:02 / 46:RXE*, 48:02 SSPT1-G3 1 Strip 8 Tests AmB55 37:GNSP, 55:GNUM* / 37:13, 56:19N SSPT1-D3 1 Strip 8 Tests AmB :KCXA, 56:HXPW / 18:36*, 55:XX1 SSPT1-B3 1 Strip 8 Tests AmB :FXED, 41:WG / 35:63, 35:87* SSPT1-H3 1 Strip 8 Tests AmB :HKET, 40:80* / 40:CVR, 81:MN SSPT1-D2 1 Strip 8 Tests AmB :63, 48:03* / 40:EPTJ, 48:02 SSPT1-C2 1 Strip 8 Tests AmB :HAMH, 45:KBCW / 44:GMVY, 50:01* SSPT1-F3 1 Strip 8 Tests 44:KBHE, 45:KBCW / 44:JZSJ, 50:01* AmB :GW, 51:01 / 49:GW, 52:01* SSPT1-E3 1 Strip 8 Tests AmB5619N 55:GXMA, 55:GMWT / 55:GXMA, 56:19N* SSPT1-C3 1 Strip 8 Tests AmB :FMEE, 59:AD / 53:GMWM, 56:23* SSPT1-A2 1 Strip 8 Tests Product Description Resolved Null Allele Micro SSP AmbiStrips HLA Class I A0101N A*01:01:01:02N SSPT1-E1 1 Strip 8 Tests A0301N A*03:01:01:02N SSPT1-D1 1 Strip 8 Tests A2409N A*24:09N SSPT1-C1 1 Strip 8 Tests B5111N B*51:11N SSPT1-B1 1 Strip 8 Tests C0320N C*03:20N SSPT1-A1 1 Strip 8 Tests C0409N C*04:09N SSPT1-H2 1 Strip 8 Tests *indicates targeted allele group 50

53 (continued) Product Description B27 Variants Cat Id Sale Unit Tests Micro SSP AmbiStrips HLA Class I B27+B73 B*27 with B*73:02 SSPT1-G1 1 Strip 8 Tests B27+B81 B*27 with B*81:01 SSPT1-F1 1 Strip 8 Tests Product Description Resolved Null Allele MOLECULAR PRODUCTS Micro SSP AmbiStrips HLA Class II DRB40103N DRB4*01:03:01:02N SSPT1-G2 1 Strip 8 Tests DRB50108N DRB5*01:08N SSPT1-F2 1 Strip 8 Tests DRB50110N DRB5*01:10N SSPT1-E2 1 Strip 8 Tests Product Description Negative Control Micro SSP AmbiStrips Negative Control SSPT1-H1 1 Strip 8 Tests Micro SSP Seramates HLA Class Seramates offer a focused approach to resolving questionable typings found in serology by providing a DNA backup to individually confirm selected specificities not always resolved by the HLA serological testing. Note: All Seramates products, except SSPSB5, have been discontinued Product Description Cat Id Sale Unit Tests (B5) SSPSB5 4 trays 24 tests For Research Use Only. Not for use in diagnostic procedures.

54 Micro SSP DNA Typing Products Storage Ancillary Products One Lambda has a variety of ancillary products and reagents to optimize Micro SSP DNA Typing. Storage Temperature: Shipping Considerations: Packaging: -65 or below Cold Pack Primer set (This is for Primer Sets) SSP B27 Bulk Primer Set The B27 Liquid Bulk Primer Sets use SSP technology to type for SSP alleles. The primers allow customers to configure their own typing tests and to use only the primers they need. Product Description Cat Id Sale Unit SSP B27 Primer Set Combo (BSSPB2773, BSSPB2781) BSSPB27C combo SSP B27 Primer Set (B27, 73) BSSPB2773 vial SSP B27 Primer Set (B27, 81) BSSPB2781 vial For Research Use Only. Not for use in diagnostic procedures. Storage Storage Temperature: Shipping Considerations: Packaging: -20 or below Dry Ice bottle Taq Polymerase Product Description Cat Id Sale Unit Taq Polymerase - 30µl TAQ30 bottle Taq Polymerase - 50µl TAQ50 bottle Taq Polymerase - 75µl TAQ75 bottle For General Laboratory Use. 52

55 Storage Storage Temperature: Shipping Considerations: Packaging: Buffer with EB 20 to 25 C Ambient temperature 100 ml bottle MOLECULAR PRODUCTS For General Laboratory Use. Buffer with Ethidium Bromide Use this product with the Micro SSP Gel System for optimal results. Product Description Cat Id Sale Unit 5XTB Buffer with Ethidium Bromide ml 5XTBE100 bottle Storage SSP Wipe Test Storage Temperature: Shipping Considerations: Packaging: -65 to -20ºC Dry Ice Primer (200μl vial) D-Mix (1,000 μl tube) For General Laboratory Use. SSP Wipe Test SSP Class I and Class II wipe tests are used to test for PCR amplicon contamination. The wipe test primer set amplifies the internal control amplicon generated in the typing trays to determine if there is contamination by human DNA. Product Description Cat Id Sale Unit Tests SSP Class I & II Wipe Test SSPWT12 vial 100 tests

56 Micro SSP DNA Typing Products Storage DNA Size Markers These are used as a reference in agarose gel electrophoresis for sizing PCR amplicons and restriction fragments less than 2564 bp in size. They consist of five DNA fragments with sizes of 50, 150, 400, 750 and 2564 base pairs DNA Size Markers Storage Temperature: Shipping Considerations: Packaging: -80º to -20ºC Dry ice 500 μl vial For In Vitro Diagnostic Use. Product Description Cat Id Sale Unit Tests DNA Size Marker SSP-SM vial 50 tests Storage SSP D-Mix Storage Temperature: Shipping Considerations: Packaging: -80 to -20ºC Cold pack 5 vials in a foil bag For In Vitro Diagnostic Use. SSP D-Mix Available in several volumes, SSP D-Mix may also be ordered separately if additional volumes are required for use with Micro SSP and SSP products. Product Description Cat Id Sale Unit DNA SSP D-mix µl vial DM pk DNA SSP D-mix µl vial DM pk DNA SSP D-mix µl vial DM pk DNA SSP D-mix µl vial DM pk 54 DNA SSP D-mix µl vial DM pk

57 Storage Storage Temperature: Shipping Considerations: Packaging: PCR Tray/ Seal Bundle 20 to 25 C Ambient temperature 25 blank trays and 80 tray seals MOLECULAR PRODUCTS For General Laboratory Use. PCR Tray/Seal Bundle Blank PCR trays and tray seals are packaged together for convenience. Sets of both accessories may be ordered as a single item. Product Description Cat Id Sale Unit PCR Tray/Seal Bundle PCRTRAC pkg Storage Micro SSP Gel System Shipping Considerations: Ambient temperature U.S. Patent 5,785,835 Micro SSP Gel System This patented design has a small footprint and mirrors a 96-well PCR plate. The small box size reduces reagent requirements and has a shorter run time than conventional gel boxes. The system has a 108-well format and supports a 96-well microplate. Product Description Cat Id Sale Unit Micro SSP Gel System Wells MGS108 each

58 Micro SSP DNA Typing Products 96-Well Transfer Device Designed for use with 96-well plates or the Micro SSP Gel System, this device is easy to load, aspirate and wash. Made from durable, non-corrosive materials, it simplifies the reagent transfer process, reducing multiple transfer actions into one simple step. The device uses 96 pipettes to transfer reagents quickly and simultaneously across the tray, ensuring consistency throughout the array. Although suited for numerous applications when transferring from a 96-well plate, it is standardized for the One Lambda Micro SSP 96- and 384-well DNA typing trays. Product Description Cat Id Sale Unit 96-Well Transfer Device TRNDV96 each 96-Well Transfer Device Alignment Plate TRNDVAP each 96-Well Transfer Device Combo TRNDCOMBO combo PCR Pressure Pads Our Micro SSP DNA typing system features a tray-sealing mechanism that uses a PCR pressure pad. The pads are available in 96 or 384-well formats for the PE 9600, the PE 9700 and for MJ Research thermo cyclers. Product Description Cat Id Sale Unit MSSP PCR Pressure Pad (for 9600 PE Thermocycler, 96 wells) SSPPAD pad MSSP PCR Pressure Pad (for 9600 PE Thermocycler, 96 wells) SSPPAD5 5 pads MSSP PCR Pressure Pad (for MJR Thermocycler, 96/384 wells) SSPPADGRY pad MSSP PCR Pressure Pad (for MJR Thermocycler, 96/384 wells) SSPPADGY5 5 pads MSSP PCR Pressure Pad (for 9700 PE Thermocycler, 96/384 wells) SSPPADTN pad MSSP PCR Pressure Pad (for 9700 PE Thermocycler, 96/384 wells) SSPPADTN5 5 pads 56

59 FPO MOLECULAR PRODUCTS

60 ConsenSys SBT This test provides sequencing primers for use with the amplified DNA samples generated from the LABType SSO DNA typing system. Sets consist of ready-to-use sequencing primer mixes for forward and reverse orientations and two buffers for post-extension product clean up. Storage ConsenSys SBT Storage Temperature: Shipping Considerations: Packaging: - 80 to -15 C Cold pack 40-test package European Union customers: For In Vitro Diagnostic Use. This product is CE marked for use in the European Union. *US and Canada customers: For Research Use Only. Not for use in diagnostic procedures. See for updated information. Product Description Cat Id Sale Unit Tests ConsenSys SBT Class I A Locus CS1A/CS1AX* Pkg 40 tests ConsenSys SBT Class I B Locus CS1B/CS1BX* Pkg 40 tests ConsenSys SBT Class I C Locus CS1C/CS1CX* Pkg 40 tests ConsenSys SBT Class II DRB1 CS2B1/CS2B1X* Pkg 40 tests 58

61 MOLECULAR PRODUCTS

62 RESEARCH TOOLS Laboratories worldwide use One Lambda research products to support the study of the impact of antibodies. 60

63 RESEARCH TOOLS HLA Research Tools Modern HLA testing results continue to be incorporated into clinical transplant decisions and One Lambda is dedicated to furthering this advancement. With a variety of research tools designed to expand and improve upon Histocompatibility research, One Lambda continues to shape the future of HLA. The Primer Sets and Monoclonal Antibodies help research the influence of antigens and antibodies in organ transplants and other immunologic applications. Bulk Primer Sets These primer sets are used in the research of Acute Graft Versus Host Disease (GvHD), which occurs frequently after bone marrow transplants. Page 62 Bulk Monoclonal Antibodies HLA Monoclonal Antibodies are available for a variety of research applications. Page 64

64 Bulk Primer Sets These primer sets are a used in the research of Acute Graft Versus Host Disease (GvHD), which occurs frequently after bone marrow transplants. Its occurrence has been linked to the mismatching of Minor Histocompatibility Antigens (mhag). mhag Primers Minor Histocompatibility Antigen (mhag) primer sets are used for research of Acute Graft Versus Host Disease (GvHD). GvHD occurs regularly following bone marrow transplantation and its occurrence has been linked to the mismatching of Minor Histocompatibility Antigens (mhag), namely the two alleles of the HA-1 Locus. One Lambda s mhag primers can distinguish between the two HA-1 alleles and can be used to research the relationship between HA-1 matching and GvHD. Product Description Cat Id Sale Unit Tests SSP mhag Antigen Primer Sets BSSPMHAG pkg 30 tests Storage Bulk Primer Sets Storage Temperature: Shipping Considerations: Packaging: -65ºC to -20ºC Dry Ice Primer set For Research Use Only. Not for use in diagnostic procedures 62

65 RESEARCH TOOLS

66 Bulk Monoclonal Antibodies HLA Monoclonal Antibodies are available for a variety of research applications. Bulk volume HLA monoclonal antibodies are available for a wide variety of applications including flow cytometry, animal cell typing, tissue staining, and chimerism studies B27 Monoclonal Antibody For In Vitro Diagnostic Use. Product Description Cat Id Tests Sale Unit HLA Class I (IgG1) Positive Control FITC Conj. HLA1F50X 50 test vial MoAB (for flow cytometry) - 100µl HLA B27 (IgG2b) FITC Conj. B27F50X 50 test vial MoAB (for flow cytometry) - 500µl Mouse (IgG2b) Neg. Control FITC Conj. G2BF50X 50 test vial MoAB (for use with B27F50X) - 500µl For Research Use Only. Not for use in diagnostic procedures. CD3 R-PE Conjugated (IgG1) FITC Conj. MoAB PEH test vial HLA B7, 27 (lgg) Biotinylated Conj. MoAB, 250µl BIH test vial HLA B7, 27 (lgg) FITC Conj. MoAB, 250µl, FH test vial FITC Conjugated Monoclonal Antibodies Conjugated HLA Monoclonal Antibodies are supplied in liquid form. For Research Use Only. Not for use in diagnostic procedures. HLA Specificities Isotype Cat Id Tests A2,A28 IgG2a FH tests A9 IgG2b FH tests B7,27 IgG FH tests B8 IgG2b FH0536A 25 tests B12 IgG2b FH tests Bw4 IgG2a FH tests Bw6 IgG3 FH tests 64

67 FITC Conjugated Monoclonal Antibodies (continued) HLA Specificities Isotype Cat Id Tests Anti Class I IgG2b FH tests HLA Class II IgG2a FH tests RESEARCH TOOLS Anti Granulocyte IgM FH tests ß2 - Microglobulin IgG1 FH tests Non-HLA Antibodies CD20 IgG2a FH tests CD3 IgG1 FH tests CD3 R-PE Conjugated IgG1 PEH tests Biotinylated Monoclonal Antibodies Conjugated HLA Monoclonal Antibodies are supplied in liquid form. For Research Use Only. Not for use in diagnostic procedures. HLA Specificities Isotype Cat Id Tests A1,A36 IgM BIH tests A2 IgM BIH tests A2,A28 IgG2a BIH tests A3 IgM BIH tests A9 IgM BIH tests A9 IgG2b BIH tests A11 IgM BIH tests A25,A26 IgM BIH tests A29 IgM BIH tests A30,A31 IgM BIH tests B7, B27 IgG BIH tests B5,B7801 IgM BIH tests B8 IgG2b BIH0536A 25 tests B12 IgG2b BIH tests

68 Bulk Monoclonal Antibodies Biotinylated Monoclonal Antibodies (continued) Conjugated HLA Monoclonal Antibodies are supplied in liquid form. For Research Use Only. Not for use in diagnostic procedures. HLA Specificities Isotype Cat Id Tests B13 IgM BIH tests B13,B15 IgM BIH tests B15,B57 IgM BIH tests B57,B58 IgM BIH tests Bw4 IgG2a BIH tests Bw6 IgG3 BIH tests DR1,10,103 IgM BIH tests DR2 IgM BIH tests DR3 IgM BIH tests DR4 IgM BIH0453B 25 tests DR7 IgM BIH tests DR9,14 IgM BIH tests DR12 IgM BIH tests Class I IgG1 BIH tests Class II IgG2a BIH tests 66

69 Unconjugated Lyophilized Monoclonal Antibodies These antibodies are supplied in lyophilized form (reconstitute to 100ul with distilled water). Specificity was determined at a 1:10 dilution by the microcytotoxicity assay using standard NIH conditions. For Research Use Only. Not for use in diagnostic procedures. RESEARCH TOOLS HLA Specificities Isotype R-Value Cat Id HLA Class I A1,A11,A26+ IgM HA A1,A36 IgM HA A2 IgM HA A2 IgM HA A2 IgG HA A2,A3,A29+ IgM HA A2,A24 IgM HA A2,A25,A32+ IgM AHA A2,A28+ IgM HA A2,A69 IgG HA A2,+/-A69 IgM HA A2,B5 IgM AHA A2,B17 IgM HA A2,B17 IgM BHA A3 IgM HA A3 IgM HA A3 IgM HA A9,A25,A32 IgM HA A9,A32,B13+ IgM HA A10,A11+ IgM HA A10,A28,B75+ IgM HA A10,B62,B71+ IgM HA A11, +/-A3 IgG HA

70 Bulk Monoclonal Antibodies Unconjugated Lyophilized Monoclonal Antibodies (continued) HLA Specificities Isotype R-Value Cat Id A23,A24 IgG2b HA A23,A24 IgM HA A24,A11,A2403+ IgM AHA A25,A26,A34 IgM AHA A25,A32 IgM HA A25+ IgG HA A25, A26,A34,B71,B62 IgM HA A29 IgM HA A30,A31 IgM HA A30,A31 IgM HA A33,B8 IgM HA A34,B71,-/+A26 IgM HA B5,B49,B56+ IgM HA B7,B27,B42+ IgM HA B8 IgM HA B8 IgM HA B8 IgM HA B8,B14 IgM HA B12,B76+ IgG AHA B13 IgM BHA B13,B62,B15 IgG HA 68

71 Unconjugated Lyophilized Monoclonal Antibodies (continued) HLA Specificities Isotype R-Value Cat Id B14+ IgM HA B14 IgM HA RESEARCH TOOLS B17 IgM HA B17,B35,B44+ IgM BHA B21,B70,B55+ IgM HA B27,B44,B47+ IgG AHA B35,B57,B75,B77+ IgM AHA B44,B75,B17+ IgM HA B48,B60+ IgM HA Bw4,A9,A32 IgM HA Bw4, A9, A32 IgM AHA Bw6,B77 IgM AHA B63 IgM BHA HLA Class II DR3,6+ IgM HA DR3,6 IgG 0219HA DR4+ IgM 0222HA DR7+ IgM AHA DR8,12+ IgM AHA DR8,12+ IgM HA DR9+ IgM HA DR11 IgG HA DR11 IgM HA DR13+ IgG HA DR15,16 IgG HA DR15,16 IgM AHA DR17,18 IgM HA

72 Bulk Monoclonal Antibodies Storage FITC/Biotinylated Unconjugated/Lyophilized Storage Temperature: 2 to 5 C 2 to 5 C Shipping Considerations: Cold Pack Ambient temperature Packaging: Vial in foil bag Vial in foil bags For Research Use Only. Not for use in diagnostic procedures - unless specified otherwise. Unconjugated Lyophilized Monoclonal Antibodies (continued) HLA Specificities Isotype R-Value Cat Id DR17,18 IgM HA DR52 IgM HA DR52+ IgM HA DR53+ IgG HA DQ1,7 IgM HA DQ3+ IgM HA DQ4+ IgM HA DQ6+ IgM HA DQ7 IgM HA DQ7 IgM AHA DQ7 IgM HA DQ7 IgM HA DQ7+ IgM AHA DQ7 IgM HA 70

73 RESEARCH TOOLS

74 SEROLOGY PRODUCTS An industry vanguard in HLA tissue typing, One Lambda developed the first assays that accurately determine HLA antigens 72

75 HLA Serological Typing Serological HLA typing is a time honored methodology used in the majority of laboratories around the world. One Lambda is recognized globally for its Terasaki Tissue Typing Trays, created by company founder Dr. Paul I. Terasaki. These typing trays were the first commercial assays capable of consistent and accurate determination of HLA antigens. As a proven technology, these assays are among the many products associated with One Lambda s pre-eminence in the field of HLA. SEROLOGY PRODUCTS Our serological product line offers a broad spectrum of typing trays. In addition to the Terasaki T1, T2 and T3 NIH method typing trays, we offer a variety of specialty products that include locus specific, ethnic, supplemental and dry trays. One Lambda is the only commercial company that offers Lambda Monoclonal Typing Trays (LMT), a selection of typing trays that are completely composed of monoclonal antibodies pre-mixed with complement. Our tissue typing family also includes lymphocyte isolation reagent products, LymphoKwik and FluoroBeads, staining reagents FluoroQuench and Stain-Fix, and other ancillary reagents optimized for use with HLA typing trays. Terasaki HLA Tissue Typing Trays Containing well-characterized antisera, this selection of 72-well format trays produce consistent and accurate HLA typing with complement dependent cytotoxicity methods. Page 74 Lambda Monoclonal Trays (LMT) Featuring premixed monoclonal antibodies and rabbit complement, One Lambda Monoclonal Trays offer a fast and dependable method for determining HLA Class I or Class II antigens. Page 78 Cell Isolation Reagents These reagents provide a unique method for isolating specific lymphocyte populations Page 80 HLA Testing Reagents One Lambda has developed a host of ancillary reagents optimized for use with our HLA typing trays Page 82 Specialty Typing Products One Lambda offers a variety of products that aid in the process of tissue typing Page 88

76 Terasaki HLA Tissue Typing Trays Producing consistent, accurate HLA typing of Class I or Class II antigens, this selection of trays is available in a 72-well format. Each tray contains positive and negative controls and accommodates most complement dependent cytotoxicity (CDC) methods. They are designed for use with both staining techniques dye exclusion and fluorescence. Each well of the tray contains 1 µl of specific antiserum and 5 µl of heavy mineral oil. Dry Tissue Typing Trays contain 1µl of dried HLA monoclonal antibody in each well. The Dry Class II trays also include anti-b and anti-t lymphocyte controls. Pre-screened rabbit complement is provided with all trays. Features and Benefits Produces accurate typing assignments May support consistent results due to long-lasting lots Offers a diverse tray selection Includes well-characterized antisera May be used with dye exclusion or fluorescent techniques Includes prescreened rabbit complement at no additional cost 72-well Terasaki format Principle Viable lymphocytes are incubated with complement-binding antibody. If the lymphocytes express an antigen recognized by a specific antibody, the Fab portion of the antibody binds to the antigen, forming the antigen-antibody complex. After these complexes have formed, rabbit complement is added. The C1q and Ca++ from the complement binds to the FC portion of the antibody. One IgM antibody is required to bind one molecule of C1q or two IgG antibodies are required to bind one molecule of C1q. Binding of C1q with antigen-antibody complexes initiates the complement cascade that leads to cell lysis. In a negative reaction, the majority of lymphocytes appear intact and, in a positive reaction, the majority of lymphocytes have been lysed. A score is assigned depending on the percent of cells that have been lysed. 74

77 Intended Use Applications For use in the determination of HLA cell surface antigens with a complement dependent microlymphocytotoxic technique. Methodology/Steps *Does not apply to Dry Trays SEROLOGY PRODUCTS 2X10 6 cells/ml lymphocytes. Dispense 1 µl of lymphocytes into each well. Incubate for 1/2 hour at room temperature (20-25 C) Dispense 5 µl of rabbit complement into each well. 4 Incubate for 1 hour at room temperature (20-25 C). Add 10 µl of Stain-Fix or 5µl of FluoroQuench into each well. Read trays. Storage Tissue Typing Trays Dry Tissue Typing Trays Storage Temperature: -65 C or below 2 to 5 C or below Shipping Considerations: Dry ice Cold pack Packaging: 10 trays per box 10 trays per box (must be ordered in units of 10) (must be ordered in units of 10) For In Vitro Diagnostic Use.

78 Terasaki HLA Tissue Typing Trays Product Description Cat Id Package Tests HLA Class I Tissue Typing Trays HLA Class I Dry 72 well AB72D 10 trays 10 tests HLA Class I First - 72 well T trays 10 tests HLA Class I Second - 72 well T trays 10 tests HLA Class I Third - 72 well T trays 10 tests A Locus Supplement - 72 well AS72 10 trays 10 tests B Locus Supplement - 72 well BS72 10 trays 10 tests B7/40 Supplement - 72 well BS trays 10 tests B27 Dry 72 well 27-06D 10 trays 60 tests C Locus - 72 well C72 10 trays 10 tests C Locus Supplement - 72 well, 2-test tray C trays 20 tests Asian Dry 72 well ASN72D 10 trays 10 tests Oriental - 72 well OT trays 10 tests HLA Class I Set (TM144A,TM144B) - 72 well TM trays 10 tests Class II Tissue Typing Trays HLA Class II - 72 well DR72 10 trays 10 tests HLA Class II Dry 72 well DR72D 10 trays 10 tests 76

79 SEROLOGY PRODUCTS

80 Lambda Monoclonal Trays (LMT) Lambda Monoclonal Trays, a One Lambda exclusive, are extremely dependable for determining HLA Class I or Class II antigens. Each tray is comprised exclusively of monoclonal antibodies, rather than human anti-serum, and has both positive and negative controls and will accommodate most CDC methods. They are designed for use with both staining techniques dye exclusion and fluorescence. Each well of a monoclonal tray contains 1 µl of specific monoclonal antibody pre-mixed with complement, and 5 µl of heavy mineral oil. In addition, the Fast Monoclonal Trays (FMT) save test time by using B-cells for both Class I and Class II phenotyping. Features and Benefits Offers batch-to-batch consistency Eliminates complement Q.C. testing Produces test results in one hour or less May be used with dye exclusion or fluorescent techniques Provides a consistent source of reagents Monoclonal antibodies and complement are pre-mixed in each well Intended Use Applications For use in the determination of HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique. Methodology/Steps 1 2 Add 1µl of lymphocytes. Thaw the LMT (s) at room temperature. Dispense 1µl of lymphocytes into each well. Incubate for 1 hour. Stop trays. Add the appropriate staining/ fixing reagent to the LMT (s). The best reagents for this purpose are FluoroQuench or Stain-Fix. These have been standardized for use with the LMT. 78

81 Storage Storage Temperature: Shipping Considerations: Packaging: Lambda Monoclonal Trays -65 C or below Dry ice 10 trays per box (must be ordered in units of 10) SEROLOGY PRODUCTS For In Vitro Diagnostic Use. LMT HLA Class I/II Product Description Cat Id Package Tests Class I LMT First- 72 well LM trays 10 tests LMT Second - 72 well LM trays 10 tests LMT Set (LM172, LM272) - 72 well, 2-tray set 2LM72 10 sets 10 tests LMT - 72 well LM trays 10 tests LMT Oriental - 72 well LM72OR 10 trays 10 tests LMT Black - 72 well LMBL72 10 trays 10 tests LMT Set (LM144A,B) - 72 well, 2-tray set LM sets 10 tests LMT B27-60 well LMB trays 10 tests LMT B27-60 well, 3-test tray LMB trays 30 tests Fast Monoclonal Trays Class I - 72 well FTAB72 10 trays 10 tests Class II LMT First - 60 well MDR trays 10 tests LMT First - 72 well MDR trays 10 tests LMT Second - 72 well MDR trays 10 tests Fast Monoclonal Trays - 72 well FTDR72 10 trays 10 tests

82 Cell Isolation Reagents LymphoKwik These reagents provide a unique method for isolating specific lymphocyte populations. Unlike standard density gradients, LymphoKwik utilizes a combination of monoclonal antibodies, complement and a stable density gradient to isolate the desired lymphocyte population. The procedure provides high purity and viability, saving valuable time in the process. Storage LymphoKwik Storage Temperature: -65 C or below Shipping Considerations: Dry ice Packaging: 20 ml bottle (25 isolations) or 40 ml bottle (50 isolations) For General Laboratory Use. Lympho-Kwik Cell Isolations Product Description Cat Id Package Tests LK Mononuclear Cell - 50 isolations LK-50-MN Bottle 50 tests LK T Lymphocyte - 25 isolations LKT25 Bottle 25 tests LK T Lymphocyte - 50 isolations LK-50-T Bottle 50 tests LK T/B Lymphocyte - 25 isolations LKTB25 Bottle 25 tests LK T/B Lymphocyte - 50 isolations LK-50-TB Bottle 50 tests 80

83 FluoroBeads FluoroBeads T and FluoroBeads B Isolation Reagents are supraparamagnetic particles coupled to monoclonal antibodies specific to either T or B lymphocytes. The end result is a pure T or B lymphocyte population in less than 10 minutes. FluoroBeads feature a particle size less than one micron in diameter, minimizing cell membrane damage, facilitating the use of automation, and increasing fluorescence intensities. SEROLOGY PRODUCTS Storage FluoroBeads Magnets & PBS/Citrate Developer Storage 2 to 5 C Not applicable 2 to 5 C Temperature: Shipping Cold pack Strong magnetic field Ambient Considerations: generated temperature Packaging: Box Individually boxed Box For General Laboratory Use. FluoroBeads Isolation Reagents Product Description Cat Id Package Tests FB T Lymphocyte - 25 isolations FB1-25 bottle 25 tests FB T Lymphocyte isolations FB1-100 bottle 100 tests FB T Lymphocyte Developer (10X) - 22 ml, FB1-DEV bottle included with FluoroBeads T FB B Lymphocyte - 25 isolations FB2-25 bottle 25 tests FB B Lymphocyte isolations FB2-100 bottle 100 tests Phosphate Buffered Saline/Citrate Reagent ml PC1-500 bottle FB Magnet (for 12 mm diameter tube) FBAMAG tube

84 HLA Testing Reagents One Lambda has developed a host of ancillary reagents optimized for use with our HLA typing trays. These products include rabbit complement, staining, quenching and fixing reagents, mineral oil, AHG and controls. Bulk Rabbit Complement Our Class I and Class II rabbit complements are screened for activity and cytotoxicity using highly selected lymphocyte panels and characterized antisera to minimize lot-to-lot variation. Rabbit serum is the most effective source of complement for HLA typing, antibody screening and crossmatching. Complement effectiveness is related to the titer, and to complement factors and heterophile antibodies. Storage Frozen Lyophilized Complement Complement Storage -65 C or below 2 to 5 C Temperature: Shipping Dry ice Ambient Considerations: temperature Packaging: Complement: 100 ml bottles 5 ml or 50 ml bottle 500 ml bottles For General Laboratory Use. Product Description Cat Id Package HLA Class I Complement - 5 ml CABC-5 bottle HLA Class I Complement - 50 ml CABC-50 bottle HLA Class II Complement - 5 ml CDR-5 bottle HLA Class II Complement - 50 ml CDR-50 bottle Lyophilized HLA Class I Complement - 1 ml CABC-1D bottle Lyophilized HLA Class II Complement - 1 ml CDR-1D bottle For In Vitro Diagnostic Use. 82

85 FluoroQuench Staining/Quench Reagent FluoroQuench is a unique mixture of fluorescent dyes and quench, used to stain lymphocytes, quench background fluorescence and stop the reaction in one simple step. FluoroQuench AO/EB distinguishes both live and dead cells by dye color and preserves the reaction in a micrototoxicity assay. No additional dyes are required. Storage Fluoroquench SEROLOGY PRODUCTS Storage Temperature: Shipping Considerations: Packaging: 2 to 5 C Ambient temperature 100 ml bottles 500 ml bottles For General Laboratory Use. FluoroQuench Acridine Orange/Ethidium Bromide FQAEZ100 Product Description Cat Id Package FQ Acridine Orange/Ethidium Bromide ml FQAE100 bottle FQ Acridine Orange/Ethidium Bromide ml FQAE500 bottle FQ Acridine Orange/Ethidium Bromide - 2 l FQAE ml bottles FQ Plus Acridine Orange/Ethidium Bromide ml FQAEZ100 bottle For General Laboratory Use.

86 HLA Testing Reagents Stain-Fix Stain-Fix is a combination stain and fixative. It simplifies the overall test procedures and replaces eosin/formalin used to stain and fix lymphocytes. Storage Stain-Fix Storage Temperature: Shipping Considerations: Packaging: 2 to 5 C Ambient temperature 100 ml bottles 500 ml bottles For General Laboratory Use. Terasaki Stain-Fix Staining and Fixing Reagent Product Description Cat Id Package TSF Staining and Fixing Reagent ml SF-500 bottle TSF Staining and Fixing Reagent - 2 l SF ml bottles For General Laboratory Use. (Note: Stain-Fix can be absorbed through skin. Read product insert prior to use.) 84

87 Goat IgG Anti-Human Kappa Goat IgG Anti-Human Kappa augments the cytotoxic reactivity of HLA antibodies, cytotoxic negative absorption positive (CYNAP) reactive antibodies, by at least 4 to 8-fold, depending on the titer of HLA serum. Storage IgG Storage -65 C or below Temperature: Shipping Dry ice Considerations: SEROLOGY PRODUCTS Packaging: IgG: 1 ml or 50 ml tube For Research Use Only. Not for use in diagnostic procedures. Product Description Cat Id Package Goat IgG Anti-Human Kappa - 1 ml AHG1 tube Goat IgG Anti-Human Kappa - 50 ml AHG50 tube For Research Use Only. Not for use in diagnostic procedures. Mineral Oil Mineral oil is used in the microcytotoxicity assay to prevent the evaporation of antisera dispensed onto a Terasaki Typing Tray. One Lambda offers a heavy mineral oil that prevents evaporation and facilitates the mixing of reagents in each well Storage Mineral Oil Storage Temperature: Shipping Considerations: Packaging: 20 to 25 C Ambient temperature 1 gallon bottle For General Laboratory Use. Product Description Cat Id Package Heavy Mineral Oil, 1 gallon MO bottle For General Laboratory Use.

88 HLA Testing Reagents Controls Designed for the microcytotoxicity assay, One Lambda cytotoxic controls are used to test various conditions from the viability of a lymphocyte preparation to the reactivity of complement. One Lambda cytotoxic controls are provided in frozen form in 1 ml aliquots. Storage Controls Storage Temperature: Shipping Considerations: Packaging: -20 C Dry ice 1 ml bottle For Research Use Only. Not for use in diagnostic procedures. Product Description Cat Id Package Anti-T Lymphocyte, IgG ATSG tube (Not for use with FluoroBeads cell preparations) Anti-T Lymphocyte, IgM ATSM tube (Not for use with FluoroBeads cell preparations) Anti-T Lymphocyte, IgM ATSMX tube (For use with FluoroBeads cell preparations) Anti-B Lymphocyte, IgG ABSG tube Anti-B Lymphocyte, IgM ABSM tube Anti-Monocyte, IgM AMSM tube Anti-Granulocyte, IgM AGSM tube Anti-Lymphocyte, IgG ALSG tube Anti-Lymphocyte, IgM ALSM tube Negative Control NS tube For Research Use Only. Not for use in diagnostic procedures. 86

89 SEROLOGY PRODUCTS

90 Other Specialty Products & Accessories Specialty Products One Lambda offers a variety of products that aid in the process of tissue typing. Tools such as SeraSets and the B27 FITC monoclonal antibody meet the specialized needs of your laboratory. Sera Sets The reagents on the Terasaki HLA Class I and Class II typing trays are available as tubed 100 µl Sera Sets Storage Storage Temperature: -65 C or below Shipping Considerations: Dry ice Packaging: 100 µl sera sets Product Description Cat Id Package Terasaki HLA Class I and Class II Typing - multiple 100ul Microliter Sera Set 88

91 B27 Monoclonal Antibody The HLA B27 FITC conjugated monoclonal antibody will confirm the presence of HLA B27, as well as all eight sub-types associated with ankylosing spondylitis*. Requiring no additional testing reagents or analysis software, HLA B27 FITC is a cost effective and reliable solution for confirmation of HLA B27 antigen, which is strongly associated with ankylosing spondylitis. SEROLOGY PRODUCTS Storage B27 Monoclonal Antibody Storage Temperature: 2º to 5 C Shipping Considerations: Cold pack Packaging: Vials in foil bag For In Vitro Diagnostic Use. *Product does not diagnose ankylosing spondylitits Product Description Cat Id Package Tests HLA Class I (IgG1) FITC Conj. HLA1F50X vial 50 tests MoAB Positive Control, 100 µ HLA B27 (IgG2b) FITC Conj. B27F50X vial 50 tests MoAB, 500 µ (for flow cytometry) Mouse (IgG2b) Neg. Control FITC Conj. G2BF50X vial 50 tests MoAB, 500 µl (for use with B27F50X) For In Vitro Diagnostic Use.

92 Other Specialty Products & Accessories Accessories Terasaki Cover Slides FluoroSeal and InstaSeal Cover Slides are designed specifically for One Lambda s 60 and 72-well Terasaki Typing Trays. When applied to the Terasaki Typing Tray, a barrier is formed over the reaction area to prevent skin contact with reagents. FluoroSeal Cover Slides: Used in fluorescence testing, black plastic cover slides minimize occurrence of photo-bleaching. InstaSeal Cover Slides: Used in standard dye exclusion testing, clear plastic covers provide a clear and distortion-free view of live and dead cells. Storage Terasaki Cover Slides Storage Temperature: 20 to 25 C Shipping Considerations: Ambient temperature Packaging: 250 slides per box Product Description Cat Id Package Insta-Seal Cover Slides slides TIS-250U box Insta-Seal Cover Slides slides TIS-1000U 4 boxes FluoroSeal Cover Slides slides TFS-250U box FluoroSeal Cover Slides slides TFS-1000U 4 boxes 90

93 SEROLOGY PRODUCTS Terasaki Trays Terasaki Typing Trays are available with 72-wells, in packages of 100 each. The plastics used in producing these trays are the same material used by One Lambda for Terasaki Tissue Typing Trays and other One Lambda products. Product Description Cat Id Package Terasaki Tray (STD) 60 well trays TH box Terasaki Tray (STD) 72 well trays TH box Terasaki Tray (STD) 96 well trays TH box

94 BIOMARKER DETECTION Diagnostic innovation is marked with the discovery of new concepts that go beyond modern HLA methods and evaluate non-hla biomarkers 92

95 A New Direction in Transplant Monitoring* The future of successful transplant outcomes requires more than just modern HLA Testing. It begins with expanding our own horizons and discovering new testing opportunities for the Transplant Community. With the introduction of Biomarker Detection products that evaluate specific non- HLA biomarkers, One Lambda is once again, pioneering a new direction in transplant monitoring. Biomarkers in body fluids or tissues are important indicators of biological states that can provide measurable characteristics of normal or pathogenic processes, and their progression or response to therapy. Testing for biomarkers such as complement (C1q) binding antibodies, AT1R antibodies and Cytokine, KIR or HNA polymorphisms allows Transplant Clinics to better define profiles of their patients. BIOMARKER DETECTION C1qScreen Driven by a Luminex xmap platform, C1qScreen delivers a reliable tool for distinguishing between complement binding and non-complement binding antibodies. Page 94 KIR SSO Genotyping Test Designed to advance research on the impact of killer cell immunoglobulin-like receptors (KIR) and patient survival. Page 95 Cytokine Genotyping Tray and Primer Pack Employing sequence specific primer (SSP) PCR methodology detects cytokine polymorphic variants that researchers suggest as indicators of graft rejection. Page 96 HNA Genotyping Tray Designed to identify HNA polymorphisms, this sequence specific primer (SSP) PCR- based genotyping tray allows blood centers to effectively assign HNA alleles to donors and recipients in just a few hours. Page 97 AT1R Identify the presence of non-hla antibodies against AT1R, a receptor expressed on common solid organs. This ELISA based assay addresses a new direction for suggested transplant monitoring. Page 98 Research Use Only. Not for diagnostic use. HNA Genotyping Tray is for In Vitro Diagnostic use. * Limitation: These product are not intended to provide information for the diagnosis, prevention, or treatment of a disease or disease state.

96 Biomarker Detection C1qScreen Investigate complement fixing antibody s possible involvement in Antibody Mediated Rejection. With C1qScreen you may differentiate complement binding from non-complement binding antibodies. Principle C1qScreen consists of two reagents, C1q and PE Conjugated C1q antibody. The complement component (C1q), bound by the antigen-antibody complex, is detected with an R-phycoerythrin (PE) labeled C1q antibody. The fluorescence intensity measured on a Luminex analyzer or flow cytometer indicates the relative amount of antibody bound to the test sample (either antigencoated beads or cells). Intended Use Applications This product may be used in the identification and screening of complement binding antibodies in human serum. Component Storage Each component reagent has its own storage guidelines. (Components not sold separately). C1q (PEPC1Q) PE Conjugated Anti-C1q (PEPAC1Q) Storage -65 C or below 2-8 C Temperature: (See Product Insert for more information.) (See Product Insert for more information.) Shipping Dry Ice Cold Pack Considerations: For Research Use Only. Not for use in diagnostic procedures. Patent pending. C1qScreen Product Description Cat Id Sale Unit Tests C1qScreen PEC1Q 2-Boxes 25 tests 94

97 KIR SSO Genotyping Test Research suggests that natural killer cell immunoglobulin-like receptor (KIR) incompatibility may have an influence on bone marrow transplant patient outcome. Our KIR SSO Genotyping Test was designed to advance research on the impact of KIR and patient survival. Featuring Luminex xmap technology, this test uses the same reverse SSO protocol used by our LABType products. BIOMARKER DETECTION The KIR SSO Genotyping Test covers the following KIR genes and variants: 2DL1 2DS1 3DL1 2DL2 2DS2 3DL2 2DL3 2DS3 3DL3 2DL4 2DS4* 3DS1 2DL5* 2DS5 2DP1** 3DP1** *Plus null alleles **Pseudogenes Storage KIR SSO Genotyping Test Storage Temperature: Shipping Considerations: Packing: -80 to -20 C Cold Pack 40 Test Package For Research Use Only. Not for use in diagnostic procedures. KIR SSO Genotyping Test Product Description Cat Id Sale Unit Tests KIR SSO Genotyping Test RSSOKIR Pkg 40 tests

98 Biomarker Detection Cytokine Genotyping Tray and Primer Pack Ongoing research continues to reveal the role of cytokine expression levels in organ transplants, cancer, AIDS and autoimmune diseases. Cytokines are crucial in cellular communication, and are key elements in controlling the immune response. One Lambda s Cytokine Genotyping Tray is a proven tool in identifying cytokine genotypes, while using the same simple testing procedure employed by our Micro SSP product line. Storage Cytokine Genotyping Trays Cytokine Genotyping Primer Pack Storage -65 C to -20 C -65 C to -20 C Temperature: Shipping Cold pack Dry Ice Considerations: Packing: 24 test package 100 test package For Research Use Only. Not for use in diagnostic procedures. Cytokine Genotyping Tray Product Description Cat Id Sale Unit Tests Cytokine Genotyping CYTGEN 4 trays 24 tests Cytokine Genotyping Primer Pack PCYTGEN each 100 tests 96

99 HNA Genotyping Tray Human Neutrophil antigens (HNA) are involved in a variety of clinical conditions, including immune neutropenias, transfusion related acute lung injury (TRALI), refractoriness to granulocyte transfusions and febrile transfusion reactions. Due to the unavailability of certain HNA antibodies and type specific neutrophil antigens, serological methods are limited in detection and time consuming. With One Lambda s sequence specific (SSP) PCR based genotyping tray, blood centers can blood centers can effectively assign HNA alleles, including HNA-3a. BIOMARKER DETECTION Storage HNA Genotyping Tray Storage Temperature: Shipping Considerations: Packing: -80 to -20 C Cold Pack 4 Trays in a Box For In Vitro Diagnostic Use. HNA Genotyping Tray Product Description Cat Id Sale Unit Tests HNA Genotyping Tray HNAGEN 4 trays 8 tests

100 Biomarker Detection AT1R Non-HLA Antibodies and Antibody Mediated Rejection? Angiotensin II Type I Receptors (AT1R) are expressed in multiple organs of the body; heart, liver, lungs, kidneys etc. Research studies have investigated the impact of antibodies against AT1R receptors, concluding a possible risk of Antibody Mediated Rejection. Exclusive to One Lambda, the AT1R ELISA based assay can address the potential need of non-hla antibody monitoring for AT1R. Storage Storage Temperature: Shipping Considerations: Packing: 2 C to 8 C Ambient Temperature 40 test package For Research Use Only. Not for use in diagnostic procedures (USA and Canada) For In Vitro Diagnostic Use (Europe Only) AT1R Product Description Cat Id Sale Unit Tests EIA for Quantitative Determination of EIA-AT1R 1 tray 40 tests anti-angiotensin II Receptor 1 (AT1)-Antibodies 98

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102 AUTOMATION PRODUCTS Simplify laboratory procedures and diagnostic analysis with One Lambda s automation and software solutions. 100

103 Automation and Software Flexibility Workflow, effectiveness and the optimal use of resources are central to modern laboratory functionality. One Lambda s automation and software products help managers to streamline processes for increased efficiency. Designed with function and cost effectiveness in mind, our technology supports the accurate automation of tasks in the HLA laboratory. When well-designed automation and robust software solutions are at work, laboratories can deliver test results with greater confidence and ease. AUTOMATION PRODUCTS One Lambda s state of the art equipment provides optimal support for high and low through-put laboratories. The LABScan 100, based on Luminex xmap technology, can perform up to 96 samples simultaneously. When your laboratory staff is pressed for time, the Lambda Jet system streamlines procedures by systematically dispensing reagents into Terasaki Typing Trays and a variety of microtiter plates (96, 192, 384 wells). The Lambda Scan system facilitates tray reading of LCT and LMT. Scan 96-well microplates, as well as a variety of Terasaki Typing Trays with the BioTek ELX800NB. Bring automation to new a level with the LABXpress Pipettor supports faster processing time, enhances automation and is optimal for high throughput testing. Equipment Designed specifically to automate laboratory procedures. Page 102 Software A variety of software applications to aid in the evaluation and analysis of data retrieved through HLA testing. Page 106

104 Equipment LABScan 100 State of the art optics, electronics and software make the LABScan 100 a flow analyzer capable of processing up to 96 assays simultaneously. It uses xponent software for data acquisition and analysis. When used with One Lambda s LABType and LABScreen family of products, this system can assign percent PRA, determine HLA antibody and make HLA Class I and Class II allele assignments for tissue typing. The LABScan 100 is based on proven Luminex xmap technology. Note: The LABScan 100 flow analyzer is equivalent to the Luminex 100 or 200 systems. Product Description Cat Id Package LABScan System LABSCNXS2 each (Includes LX200, XY Platform, and Sheath Delivery System) 102

105 BioTek Mixcroplate Reader This instrument reads standard 96-well microplates and 60-, 72-, and 96-well Terasaki trays. Used with a PC, data from the BioTek Microplate Reader is stored and reviewed with One Lambda s HLA Fusion software. Service contracts are available for automation systems. Call One Lambda for pricing and information. Product Description Cat Id Package AUTOMATION PRODUCTS Bio-Tek Microplate Reader (w/lat Software) ELX800NB each Lambda Jet III MT The Lambda Jet III MT Cell Dispenser sets the standard for economy and reliability in the HLA laboratory setting. Designed to quickly and accurately dispense lymphocytes and other reagents into each well of a Terasaki tray or microtiter plate, the Lambda Jet t III MT also minimizes the possibility of carry-over contamination, preventing false positive reactions. Product Description Cat Id Package Lambda Jet III MT Cell Dispenser - 60, 72, & 96 Well LJ3MT each

106 Equipment Lambda Scan Plus II The Lambda Scan Plus II is a system that streamlines the tray evaluation and analysis process. Using one of the many analysis programs included with the system, reaction scores are input directly into the computer at the time of evaluation. The Lambda Scan Plus II is designed to easily integrate upgrades, allowing your system s capabilities to expand with your needs. Product Description Cat Id Package Lambda Scan Plus II Stage & Windows Software LS2W50 each Lambda Scan Plus II Stage, Stacker & Windows Software LS2FW50 each LABXpress Pipettor The LABXpress Pipettor handles dispensing and mixing with precision and ease. Perfect for high throughput testing, LABXpress reduces turnaround time and enhances automation. With worry-free tracking and a walk-away capability, it also frees technologists for other essential tasks. LABXpress aspirates and dispenses precise volumes into test wells of a 96-well reaction plate and reagent vials. It features barcode readers for all reaction plates, sample tubes and reagent reservoirs for easy tracking. Eight pipetting channels facilitate quick processing. With a short set-up time of 30 minutes to one hour (depending on assay), LABXpress can improve laboratory efficiency. Product Description Cat Id Package LABXpress Pipettor LXPRP each This product is for investigational use. 104

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108 Software For a listing of our software solutions and latest versions, upgrades and downloads, please visit HLA Fusion HLA Fusion Software is a companion to our HLA screening and DNA typing products. It features analysis modules for One Lambda s FlowPRA, LABScreen, LABType, LCT, Micro SSP and more. The HLA Fusion Research Software features modules for ConsenSys, KIR, analyzing SSP results via capillary electrophoresis and more. Analysis results can be reviewed in graphical form, allowing easy adjustment of cut-off values to clarify results. Data can be exported or formatted into custom reports. This software runs in both stand-alone and network environments. In addition, HLA Fusion allows you to import raw data from the LABScan 100 flow analyzer, manually enter reactions and read ELISA results for LAT products. Users can also search for specific data and create standard or customize reports, as well as compare results to One Lambda quality control data. Product Description Cat Id Package HLA Fusion Software For In Vitro Diagnostic Use. FUSPGR CD-ROM HLA Fusion Research Software FUSREPGRX CD-ROM For Research Use Only. Not for use in diagnostic procedures. 106

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110 EDUCATION Bringing the global HLA and Transplant community together with interactive workshops and engaging forums to share HLA trends and advancements. 108

111 Expanding Horizons and Sharing Ideas Knowledge and the exchange of ideas create a deeper understanding of the issues, trends and scientific developments in HLA and Transplantation. One Lambda s educational programs foster an interactive and focused approach to learning how to deal with the day to day challenges in the HLA laboratory, while providing a platform for discussion about advancements in transplantation, including the latest developments in post-transplant monitoring. EDUCATION We offer detailed training on our product lines and software, which assists customers with their HLA typing and antibody detection challenges. All of our workshops offer CHT, CHS and DIP (ABHI) continuing educational credits. One Lambda offers an array of learning opportunities for the global HLA community, including: Advanced User Workshops, providing comprehensive training on our LABType, LABScreen, and HLA Fusion products Advanced Flow Cytometry Workshops for in-depth understanding and skill enhancement of our FlowPRA product line Clinical Histocompatibility Workshops that give HLA and Transplant scientists a forum to discuss research projects and technical advancements Annual Advanced HLA Technical Workshops for the presentation of information and data relevant to the operation of HLA laboratories worldwide - these sessions also give our European colleagues an opportunity to participate in product/software training Affiliations with global transplant societies, including American Society of Histocompatibility and Immunogenetics (ASHI), European Immunogenetics and Histocompatibility Conference (EFI), American Foundation for Donation & Transplantation (AFDT), Asia- Pacific Histocompatibility and Immunogenetics Association (APHIA), and the British Society for Histocompatibility and Immunogenetics (BSHI). To make our programs more accessible to a broader audience, workshops are held in many countries around the world, including our corporate headquarters in Canoga Park. Handson training with our products and technology provide real-world experience and help participants maximize their resources.

112 Education Publications One Lambda publishes abstracts, known as Visuals, from the Clinical Histocompatibility and Advanced HLA Technical Workshops. These reference papers serve as a historical record of topics discussed at the workshop. Product Description Cat Id Package Clinical Transplant 2010 CLTX-10 each Workshop Visuals Product Description Cat Id Package 2011 Clinical Histocompatibility Workshop - Punta Cana, DR HLA-VIS11 each 2011 Clinical Histocompatibility Workshop - Croatia VIS11E each 2010 Clinical Histocompatibility Workshop - Malta VIS10E each 2010 Clinical Histocompatibility Workshop - Maui, Hawaii HLA-VIS10 each 110

113 EDUCATION