Thermo Scientific Drug Monitoring and Quality Control Products and Instrumentation. One Resource. Multiple technologies

Transcription

1 Thermo Scientific Drg Monitoring and Qality Control Prodcts and Instrmentation One Resorce Mltiple technologies

2 Experience or Qality Improve yor reslts

3 Contents Introdction 4-7 The Vale Of Innovation 8-9 One Resorce: Mltiple Technologies Drgs Of Abse 12 CEDIA/DRI Urine Assays 13 Indiko DAT Reagents CEDIA Calibrators DRI Calibrators CEDIA/DRI Controls 19 MAS DOA Total Controls 20 Analyzer Applications Instrction Oral Flids Assays, Reagents, Calibrators & Controls Specimen Validity Tests Assays, Reagents, Calibrators & Controls 29 Analyzer Applications Instrction Endocrine Assays, Reagents, Calibrators & Controls 31 Analyzer Applications Instrction Serm Toxicology Assays, Reagents, Calibrators & Controls 33 Analyzer Applications Instrction Therapetic Drg Monitoring CEDIA & DRI Assays, Calibrators & Controls 35 Analyzer Applications Instrction QMS Assays, Calibrators & Controls 37 QMS Instrment References Immnosppressive Drg Management Assays, Calibrators & Controls 39 Analyzer Applications Instrction Instrmentation Indiko Clinical & Specialty Chemistry Systems 45 Indiko Consmables Thermo Scientific MAS Controls Omni Consolidated Controls Serm Chemistries Urine Chemistries Immnoassay 56 Cardiac & Diabetes 57 Immnology & Protein 58 Toxicology Dimension Vista Controls Thermo Scientific MAS Programs LabLink xl Qality Assrance Program 64 Vale Assignment Program Thermo Scientific MAS Control References Analytes Instrments General Ordering Information 75 To Place An Order 75 Technical Service & Spport

4 The vale of innovation An endring history of serving science From rotine chemistries to highly sensitive tests that will enable the discovery of new biomarkers for disease diagnosis, 21st Centry immnoassay techniqes are bilt on the fondation of the radio-immnoassay (RIA). This revoltionary concept was developed for measrement of endogenos plasma inslin by Solomon Berson and Rosalyn Yalow in Working together as a team, these two scientists proposed the se of the interaction between antibodies and antigens to detect the presence or qantify the concentration of specific analytes in hman body flids. An isotope of a radioactive element was sed to label antibodies and antigens. Researchers and clinicians worldwide soon began to recognize the exciting potential of this breakthrogh techniqe and nmeros laboratories were bilt and eqipped to condct tests that reqired the se of radioisotopes. As the technology was fine-tned, RIAs for many new analytes were pblished. Althogh the RIA techniqe was valed for its sensitivity and specificity, there was growing concern abot workplace safety, the expense of the eqipment reqired for handling radioactive materials and the ability to properly dispose of radioactive waste. 4

5 The limitations of the RIA combined with contined innovation in biomedical research created the perfect environment to take immnoassays in a new direction. The Enzyme Immnoassay (EIA) and the Enzyme-Linked Immnosorbent Assay (ELISA) were envisioned in the 1960s, bt it took almost a decade for researchers to demonstrate conclsively that the EIA/ELISA was the next step in bilding a new generation in immnoassays. These techniqes replaced radioisotopes with enzymes in the labeling of antigens and antibodies which cold then be detected by spectrophotometric means. The first tests were not as precise and sensitive as the RIA; however, improvements in techniqes accelerated dring the 1970s. Today Thermo Scientific CEDIA technology is the platform spporting a broad men of immnoassays for drgs of abse screening, therapetic and immnosppressant drg monitoring and toxicology testing. Cloned Enzyme Donor Immnoassay technology (CEDIA ) was developed by Microgenics (Thermo Fisher Scientific) in the early 1980s. This homogeneos enzyme immnoassay has proven to be one of the important advancements in the evoltion of immnoassays, enabling the atomation of the immnoassay test and facilitating its transition from speciality laboratories to general labs and clinical settings. Today CEDIA technology is the platform spporting a broad men of immnoassays. Thermo Fisher Scientific contines to forge the way with new immnoassays for drgs of abse screening and therapetic drg monitoring. The fll potential of the homogeneos enzyme immnoassay is jst beginning to be explored. Thermo Fisher Scientific contines to forge the way with new immnoassays for drgs of abse screening and therapetic drg monitoring that provide cstomized soltions for large reference and hospitalbased laboratories as well as a growing list of non-traditional testing venes sch as the workplace, government instittions, drg detection and treatment programs, and physician offices and clinics. 5

6 We never forget That behind every assay performed is a story Dring the mid 1990s, Thermo Fisher Scientific introdced its DRI prodct line. The marketplace reception to these liqid, ready-to-se assays was nparalleled. Increased lab prodctivity, low cost per test and short trnarond times withot sacrificing precision, accracy and lot-to-lot consistency were right on target with clinical laboratory needs. More recently, we have strengthened or technological leadership with the introdction of the Qantitative Microsphere System (QMS). Or ctting edge Thermo Scientific QMS assays are the clmination of more than two decades of research and development in the application of microparticle technology to immnodiagnostics. The QMS method employs advanced particle technology to develop a wide range of particle-enhanced trbidimetric immnoassays for se on atomated chemistry analyzers. Arond the world thosands of Thermo Scientific assays are loaded every day on a wide range of testing platforms. At Thermo Fisher Scientific, we have been at the forefront of enzyme-based trbidimetric immnoassay evoltion for more than three decades. The spectrm of or integrated prodcts and services offers both breadth and depth in the areas 6

7 of drgs of abse, specimen validity testing and toxicology testing; therapetic and immnosppressive drg monitoring; and qality control and data management. The synergy of mltiple technologies, a robst men of homogenos enzyme immnoassays optimized for most clinical chemistry analyzers and the global reach of or cstomer-responsive training and prodct spport has made Thermo Scientific prodcts the preferred resorce for reference and hospital laboratories and other drg monitoring facilities. That s why or research and development endeavors are driven by a sense of rgency and gided by the spirit of innovation. Arond the world thosands of Thermo Scientific assays are loaded every day on a wide range of testing platforms. While we are prod of the trst or cstomers have placed in s we never lose sight of the fact that behind every assay performed is a story men, women and children facing challenges and ncertainty with hope for a healthier ftre. That s why or research and development endeavors are driven by a sense of rgency and gided by the spirit of innovation. 7

8 One Resorce Mltiple Technologies CEDIA Thermo Scientific CEDIA method is a single phase, competitive binding process that combines analyte-specific antibodies and two genetically engineered fragments of the bacterial enzyme ß-galactosidase to accrately and reliably detect the presence of drgs and their metabolites as well as other sbstances in serm, plasma, whole blood, rine and oral flids. Benefits Garanteed consistency: kit-to-kit, lot-to-lot, year-to-year Lower limits of detection of analytes in test matrix Linear dose response crve Accrate and specific reslts Excellent low-end sensitivity and specificity Urine, oral flids, serm, plasma and whole blood DRI Thermo Scientific DRI prodcts are proven and trsted testing soltions that offer high analytical accracy while eliminating time-consming steps in reagent preparation. DRI technology is based on the competition between a drg or drg metabolite labeled with the enzyme glcose-6-phosphate dehydrogenase (G6PDH) and free drg from the sample for a fixed amont of specific antibody binding sites. In the absence of free drg from the sample, the specific antibody binds to the drg labeled with G6PDH. As a reslt, enzyme activity is inhibited. Benefits Applications for low, medim and high volme laboratories Assays optimized for most clinical chemistry analyzers Minimizes nnecessary confirmations Accrate and specific reslts Excellent low-end sensitivity and specificity Garanteed consistency: kit-to-kit, lot-to-lot, year-to-year QMS Thermo Scientific QMS (Qantitative Microsphere System) assays are particlarly well sited to measring therapetic drgs in whole blood, serm or plasma. Or QMS two component assay system is based on the competitive inhibition immnoassay principle: If the drg targeted by the assay is present in the sample, these free drg molecles compete with a microparticle-bond drg in one reagent for a limited nmber of antibody combining sites spplied by antibody in a second reagent. The competition for antibody binding sites inhibits the ability of the antibody to aggltinate the drg-coated microparticles. Benefits Excellent sensitivity and precision Optimal dynamic range High specificity and accracy to target analyte Does not involve enzymes and chemical sbstrates Low interference from endogenos sbstances Whole blood, serm and plasma Complete soltions for drg monitoring 8 8

9 Genetic Engineering [ ] Enzyme Acceptor (EA) Enzyme Donor (ED) Enzyme Fragment Complementation Active Enzyme Inactive Enzyme Fragments Reconstitted Active Enzyme CEDIA Technology: genetic engineering of enzyme fragments. + + Enzyme-labeled Molecles of the compond to be measred ENZ-CONJUGATE Cofactor NAD SUBSTRATE G6P DRI Technology G6PDH in the presence of Cofactor and Sbstrate forms NADH. The NADH absorbs light at 340 nm. NADH + + Antibody Free Drg Particle Bond Drg No Inhibition Aggltination Partial Inhibition Partial Aggltination Complete Inhibition No Aggltination Rate (mabs/min) Calibrator Concentrations QMS Technology: time-saving convenience and redced costs. 9 9

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11 Assays, Calibrators & Controls Drgs of Abse Specimen Validity Tests Endocrine & Serm Toxicology Therapetic Drg Monitoring Immnosppressive Drg Management

12 Thermo Scientific DAU CEDIA & DRI Assays Prodct CEDIA DRI TSC 3 x 17 ml MCC 65 ml LC 495 ml 68 ml 100 ml 500 ml Amphetamine Amphetamine/Ecstasy Barbitrate Benzodiazepine Bprenorphine Cocaine Cotinine Ecstasy Ethyl Alcohol Ethyl Glcronide (EtG) CE** Ethyl Glcronide (EtG)* Fentanyl* Heroin Metabolite (6-Acetylmorphine) Hydrocodone* LSD (15 ml) Methadone Methadone Metabolite Methaqalone Opiate Opiate 2K Oxycodone Phencyclidine (PCP) Propoxyphene THC (Cannabinoid) Specialty Prodcts Size Cat # b-glcronidase 5 ml * For Criminal Jstice and Forensic se only ** For International se only - not for sale in USA 12

13 DAU Drgs of Abse in Urine Now, the most extensive men of drgs of abse assays are available as Open and Go system reagents on or self-contained bench-top analyzer, the Thermo Scientific Indiko. Or system packaged reagents are bar-coded to allow flexibility and ease of se for the end ser. Indiko is an efficient, cost effective, atomated bench top chemistry system designed for p-load and walk-away convenience. Intitive ser interface and many atomated featres help to manage the daily workflow. The selfcontained Indiko, with its small footprint, fits ideally in laboratories with space limitations. Indiko and Indiko Pls Kits Prodct CEDIA DRI Indiko 3 x 17 ml Indiko 3 x 18 ml Amphetamine Amphetamine/Ecstasy Barbitrate Benzodiazepine Bprenorphine Cocaine Cotinine Ecstasy Ethyl Alcohol Ethyl Glcronide (EtG)* Ethyl Glcronide (EtG) CE** Fentanyl* Fentanyl CE** Heroin Metabolite (6-Acetylmorphine) Hydrocodone* Methadone Methadone Metabolite Opiate Oxycodone Phencyclidine (PCP) Propoxyphene THC (Cannabinoids) * For Criminal Jstice and Forensic se only ** For International se only - not for sale in USA 13

14 Thermo Scientific DAU CEDIA Calibrators Calibrators Size (ml) Part # Assay ng/ml Assay ng/ml Negative Calibrator Mlti-Drg Primary Clinical Calibrator Mlti-Drg Primary Calibrator Mlti-Drg Secondary Calibrator Mlti-Drg Optional Calibrator Mlti-Drg Intermediate Calibrator Mlti-Drg High Calibrator PPX/Methadone Ctoff Calibrator Intermediate Calibrator High Calibrator Refer to the specific assay Application or IPS for calibration configration. Prodct availability may vary by contry. Mltiple Assays 0 Mltiple Assays 0 Amphetamine Barbitrate Benzodiazepine Cocaine Amphetamine Barbitrate Benzodiazepine Cocaine Amphetamine Barbitrate Benzodiazepine Cocaine Amphetamine Barbitrate Benzodiazepine Cocaine Amphetamine Barbitrate Benzodiazepine Cocaine Amphetamine Barbitrate Benzodiazepine Cocaine Propoxyphene Methadone Metabolite Opiate Phencyclidine Methadone Metabolite Opiate Phencyclidine Methadone Metabolite Opiate Phencyclidine Methadone Metabolite Opiate Methadone Metabolite Opiate Phencyclidine Methadone Metabolite Opiate Phencyclidine Methadone

15 Calibrators Size (ml) Part # Assay ng/ml Mlti-Level THC 25 Calibrator 50 Calibrator 75 Calibrator 100 Calibrator 150 Calibrator LSD Ct-Off Calibrator Intermediate Calibrator High Calibrator Heroin Metabolite Ct-Off Calibrator High Calibrator Bprenorphine Negative Calibrator 5 ng/ml Calibrator 20 ng/ml Calibrator 50 ng/ml Calibrator 75 ng/ml Calibrator nor-Δ 9 THC-COOH d-lsd 6-Acetylmorphine Bprenorphine

16 Thermo Scientific DAU DRI Calibrators Calibrators Size (ml) Part # Assay ng/ml Assay ng/ml Negative Cal Mlti-Drg Urine Cal 1 Mlti-Drg Urine Cal 2 Mlti-Drg Urine Cal 3 Mlti-Drg Urine Cal Low Urine Cal High Urine Cal Mltiple Assays 0 Mltiple Assays 0 Amphetamine Barbitrate Benzodiazepine Cocaine Methadone Amphetamine Barbitrate Benzodiazepine Cocaine Methadone Amphetamine Barbitrate Benzodiazepine Cocaine Methadone Amphetamine Barbitrate Benzodiazepine Cocaine Methadone Amphetamine Cocaine Amphetamine Cocaine Refer to the specific assay Application or IPS for calibration configration. Prodct availability may vary by contry. Methaqalone Opiate Phencyclidine Propoxyphene Methaqalone Opiate Phencyclidine Propoxyphene Methaqalone Opiate Phencyclidine Propoxyphene Methaqalone Opiate Phencyclidine Propoxyphene Opiate Phencyclidine Opiate Phencyclidine

17 Calibrators Size (ml) Part # Assay ng/ml Opiate 150 ng/ml Cal Opiate 500 ng/ml Cal Mlti-Level THC 20 ng/ml Cal ng/ml Cal 100 ng/ml Cal 200 ng/ml Cal Ethyl Alcohol Negative Alcohol Cal * For Criminal Jstice and Forensic se only ** For International se only - not for sale in USA Prodct availability may vary by contry nor-Δ 9 THC-COOH Ethyl Alcohol mg/dl 100 mg/dl 100 mg/dl Cal Ethyl Glcronide* ETG Negative Cal ETG 100 Cal ETG 500 Cal Ethyl Glcronide ETG 1000 Cal ETG 2000 Cal Ethyl Glcronide CE** ETG Negative Cal ETG 100 Cal ETG 500 Cal Ethyl Glcronide ETG 1000 Cal ETG 2000 Cal Ecstasy 250 ng/ml Ecstasy Cal ng/ml Ecstasy Cal ng/ml Ecstasy Cal Ecstasy 1000 ng/ml Ecstasy Cal Cotinine Cal Kit 0 ng/ml Cotinine Cal 100 ng/ml Cotinine Cal 250 ng/ml Cotinine Cal 500 ng/ml Cotinine Cal Cotinine 1000 ng/ml Cotinine Cal 2000 ng/ml Cotinine Cal Hydrocodone* 100ng/mL Hydrocodone Cal ng/mL Hydrocodone Cal ng/mL Hydrocodone Cal Hydrocodone 1000ng/mL Hydrocodone Cal Methadone Metabolite 150 ng/ml Meth Metab Cal ng/ml Meth Metab Cal ng/ml Meth Metab Cal EDDP 2000 ng/ml Meth Metab Cal Oxycodone 100 ng/ml Oxycodone Cal ng/ml Oxycodone Cal ng/ml Oxycodone Cal Oxycodone 1000 ng/ml Oxycodone Cal Fentanyl* Fentanyl 2 ng/ml Cal Fentanyl 2 Fentanyl CE** Fentanyl 2 ng/ml Cal Fentanyl

18 Thermo Scientific DAU CEDIA, DRI & MAS Controls Controls Size (ml) Part # Assay Low High MGC Primary DAU Control Set MGC Clinical DAU Control Set MGC Select DAU Control Set MGC Optional DAU Control Set MGC Specialty DAU Control Set 3 x x x x x Amphetamine (d-methamphetamine) Barbitrate (secobarbital) Benzodiazepine (oxazepam) Cocaine (benzoylecgonine) Methadone (methadone) Methadone Metabolite (EDDP) Methaqalone (methaqalone) Opiate 2000 (morphine) Phencyclidine (PCP) Propoxyphene (PPX) Amphetamine (d-methamphetamine) Barbitrate (secobarbital) Benzodiazepine (nitrazepam) Cocaine (benzoylecgonine) Methadone (methadone) Methadone Metabolite (EDDP) Opiate 300 (morphine) Phencyclidine (PCP) Propoxyphene (PPX) Benzodiazepine (nitrazepam) Cocaine (benzoylecgonine) Ecstasy (MDMA) Heroin Metabolite (6-Acetylmorphine) LSD (LSD) Amphetamine (d-methamphetamine) Barbitrate (secobarbital) Benzodiazepine (nitrazepam) Cocaine (benzoylecgonine) Methadone Metabolite (EDDP) Opiate 300 (morphine) Amphetamine (d-methamphetamine) Barbitrate (secobarbital) Benzodiazepine (nitrazepam) Cocaine (benzoylecgonine) Methadone Metabolite (EDDP) Opiate 300 (morphine)

19 Controls Size (ml) Part # Assay Low High DOAT-1 Level 1 (Negative) DOAT-2 Level 2 DOAT-3 Level 3 DOAT-4 Level 4 (SAMHSA -25%) DOAT-5 Level 5 (SAMHSA +25%) DOAT-6 Level 6 DOAT-MP Mlti-Pack MAS DOA Total Controls 6 x 18 DOAT-1 DOAT-2 DOAT-3 DOAT-4 DOAT-5 DOAT-6 DOAT-MP Refer to MAS DOA Total Control, page 62 for specific target analytes and concentrations. CEDIA Single Analyte Controls Bprenorphine Control Set Bprenorphine Control Set 2 x Bprenorphine 3 7 Mlti-Level THC Control Sets THC 25 Control Set THC 50 Control Set THC 100 Control Set 2 x nor-Δ 9 THC-COOH Cotinine Controls Low Cotinine Control High Cotinine Control Ethyl Alcohol Controls 50 mg/dl Ethyl Alcohol Control 300 mg/dl Ethyl Alcohol Control Ethyl Glcronide Controls* ETG 375 Control ETG 625 Control ETG 750 Control ETG 1250 Control Ethyl Glcronide Controls CE** ETG 375 Control ETG 625 Control ETG 750 Control ETG 1250 Control Fentanyl Controls* 1 ng/ml Fentanyl Control 3 ng/ml Fentanyl Control Fentanyl CE Controls** 1 ng/ml Fentanyl Control 3 ng/ml Fentanyl Control DRI Single Analyte Controls Cotinine Ethyl Alcohol Ethyl Glcronide Ethyl Glcronide Fentanyl Fentanyl 3 Hydrocodone Control Set* Hydrocodone Control Hydrocodone Oxycodone Control Set 100 ng/ml Oxycodone Controls 300 ng/ml Oxycodone Controls THC Controls Oxycodone ng/ml THC Urine Control ng/ml THC Urine Control nor-Δ 25 9 THC-COOH 75 ng/ml THC Urine Control ng/ml THC Urine Control 1404 * For Criminal Jstice and Forensic se only ** For International se only - not for sale in USA Prodct availability may vary by contry

20 Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 20

21 Oral Flids DAT Testing Using the Oral-Eze Collection Device Applications for Yor Analyzer Oral Flid Reagents Oral Flids Q&A Calibrators and Controls

22 Thermo Scientific DAT Oral Flids Oral-Eze Testing Oral Flid Testing sing Oral-Eze Or innovative oral flid collection system simplifies the collection of oral samples for rotine drg testing. The Oral-Eze Oral Flid Collector provides all the advantages of previos collection systems, with the added benefit of or indicator window technology. The indicator window takes the gesswork ot of collecting samples and trns ble when the sample qantity is sfficient for processing, thereby redcing repeat collections. Oral Eze Collection Devices Description 50 /kit 500/kit Oral Eze Collection Device Oral Eze Sample Extractor

23 Collection process after the contents are removed from packaging: 1. Collect. The donor inserts the Oral-Eze collection pad between the lower cheek and gm. 2. Check. When the indicator window on the handle trns ble, the collector is removed. 3. Detach. The collection pad is inserted into the transport tbe and detached from the collector. 4. Cap. The cap is pressed ntil completely sealed and a tamper-evident seal is placed across the top and down the sides of collection tbe. Ship the specimen to the testing laboratory. 23

24 Thermo Scientific DAT Oral Flids Oral-Eze Q&A Redce the risk today with Oral Flids Immnoassay Q: Is the Oral-Eze test FDA-cleared? A: Yes, both the Oral-Eze Oral Flid Collection System and the drg tests sing the Oral-Eze collection system are FDA-cleared. Q: What are the benefits of sing the Oral-Eze collection device? A: The Oral-Eze Oral Flid Collector has a bilt-in indicator for determining when a sfficient qantity of oral flid has been collected. This will redce the nmber of tests that are reported as qantity insfficient. Another benefit is that the oral flid collector does not have a salty or citric taste. Q: Is the pad safe to pt in my moth? A: Yes, the pad is a cotton-fiber filter paper that has not been treated with any salts or flavorings. Q: How long does it take to collect an oral flid sample with Oral-Eze? A: The Oral-Eze collection is complete when the indicator window trns ble. This typically occrs within 3-5 mintes althogh all donors are different. Before beginning the collection, instrct the donor to pool their saliva. Ask them to refrain from swallowing and talking, instead directing that saliva towards the device. Ensre that they keep the device in their moth for the allotted time or ntil the indicator window trns ble. Q: What is the liqid in the vial? A: The liqid is a bffer, preservative soltion that stabilizes the oral flid sample and helps prevent the sample and drgs/metabolites from deteriorating dring storage or shipping to the laboratory. Q: Will recent oral srgery (root canals, extraction s, etc.) or stres make a difference? A: Neither will affect the collection; however, if stres are located between the lower cheek and gm, it is better to collect the sample from the opposite side of the moth. Q: When collecting an oral flid specimen, I noticed a small amont of blood on the collection pad. Is this normal? A: Althogh this is not common, it may occr in some individals and shold not adversely affect the specimen collected. Q: What is the best practice for transferring the pad from the collector to the tbe? A: Once the indicator window trns ble, instrct the donor to remove the pad from the moth. Place the pad of the device into the bffer tbe. Using the thmb, place on the ridge of the collector handle and slide toward the pad to detach the pad into the bffer. If the pad does not immediately detach, se the lid on the tbe to withdraw the pad from the collection handle. It may be more difficlt to detach if the pad is not sfficiently satrated. Q: How long is the specimen stable after it has been collected? A: The specimen and any drgs in the specimen are stable for 21 days after collection. Non-negative specimens tested by the laboratory are stable for at least one year when stored frozen. 24

25 Thermo Scientific DAT Oral Flids Applications & Reagents Applications for Yor Analyzer CEDIA Oral Flid Reagent applications are available on the following chemistry analyzers with plans for additional applications in the ftre. MGC 240 Beckman Colter and AU680 Hitachi 917 Thermo Scientific Indiko/Indiko Pls Oral Flids for North America Reagent Kits Indiko Reagent Kits Description MCC (1 x 65 ml) 3 x 17 ml Amphetamine OFT Cannabinoids OFT Cocaine OFT Methamphetamine OFT Opiate OFT PCP OFT Oral Flids for International** Reagent Kits Description TSC (3 x 18 ml) MCC (1 x 65 ml) Amphetamine OFT Cannabinoids OFT Cocaine OFT Methamphetamine OFT Opiate OFT PCP OFT ** For International se only - not for sale in USA Prodct availability may vary by contry 25

26 Thermo Scientific DAU Oral Flids Calibrators & Controls Oral Flid Calibrators & Controls for North America Catalog # Kit Size Cocaine Opiates Description Amphetamine (ml) (Benzoylecgonine) (Morphine) Phencyclidine CEDIA Mlti-Drg OFT Negative Calibrator CEDIA Mlti-Drg OFT Ctoff Calibrator x 15 CEDIA Mlti-Drg OFT Control Set- Low CEDIA Mlti-Drg OFT Control Set- High Catalog # Kit Size (ml) Description Methamphetamine CEDIA Methamphetamine OFT Negative Calibrator CEDIA Methamphetamine OFT Ctoff Calibrator x 10 CEDIA Methamphetamine OFT Low Control 20 CEDIA Methamphetamine OFT High Control 60 Catalog # Kit Size (ml) Description THC CEDIA THC OFT Negative Calibrator CEDIA THC OFT Ctoff Calibrator x 10 CEDIA THC OFT Low Control 0.5 CEDIA THC OFT High Control 1.5 Oral Flid Calibrators & Controls for Astralia** Catalog # Kit Size Cocaine Opiates Description Amphetamine (ml) (Benzoylecgonine) (Morphine) CEDIA Mlti-Drg OFT Negative Calibrator CEDIA Mlti-Drg OFT Calibrator CEDIA Mlti-Drg OFT Calibrator CEDIA Mlti-Drg OFT Calibrator CEDIA MltiDrg OFT Control CEDIA MltiDrg OFT Control CEDIA MltiDrg OFT Control Catalog # Kit Size (ml) Description Methamphetamine CEDIA Methamphetamine OFT Negative Calibrator CEDIA Methamphetamine OFT Calibrator CEDIA Methamphetamine OFT Calibrator CEDIA Methamphetamine OFT Calibrator CEDIA Methamphetamine OFT Control CEDIA Methamphetamine OFT Control CEDIA Methamphetamine OFT Control 3 25 Catalog # Kit Size (ml) Description THC CEDIA THC Negative Calibrator CEDIA THC OFT Calibrator CEDIA THC OFT Calibrator CEDIA THC OFT Calibrator CEDIA THC OFT Control CEDIA THC OFT Control CEDIA THC OFT Control 3 10 ** For International se only - not for sale in USA. Prodct availability may vary by contry 26

27 Oral Flid Calibrators & Controls for United Kingdom** Catalog # Kit Size Cocaine Opiates Description Amphetamine (ml) (Benzoylecgonine) (Morphine) CEDIA Mlti-Drg OFT Ctoff Calibrator x 15 CEDIA Mlti-Drg OFT Control Set 5 & & & 15 Catalog # Kit Size (ml) Description Methamphetamine CEDIA Methamphetamine OFT Ctoff Calibrator x 10 CEDIA Methamphetamine OFT Control Set 5 & 15 Catalog # Kit Size (ml) Description THC CEDIA THC OFT Ctoff Calibrator x 10 CEDIA THC OFT Control Set 0.5 & 1.5 Oral Flid Calibrators & Controls for Erope** Catalog # Kit Size Cocaine Opiates Description Amphetamine (ml) (Benzoylecgonine) (Morphine) PCP CEDIA Mlti-Drg OFT Negative Calibrator CEDIA Mlti-Drg OFT Calibrator CEDIA Mlti-Drg OFT Calibrator CEDIA Mlti-Drg OFT Calibrator CEDIA Mlti-Drg OFT Calibrator x 15 CEDIA Mlti-Drg OFT Control Set 6.7 & & & & 5.0 Catalog # Kit Size (ml) Description Methamphetamine CEDIA Methamphetamine OFT Negative Calibrator CEDIA Methamphetamine OFT Calibrator CEDIA Methamphetamine OFT Calibrator CEDIA Methamphetamine OFT Calibrator CEDIA Methamphetamine OFT Calibrator x 10 CEDIA Methamphetamine OFT Control Set 6.7 & 20 Catalog # Kit Size (ml) Description THC CEDIA THC OFT Negative Calibrator CEDIA THC OFT Calibrator CEDIA THC OFT Calibrator CEDIA THC OFT Calibrator CEDIA THC OFT Calibrator x 10 CEDIA THC OFT Control Set 1.7 & 5.0 ** For International se only - not for sale in USA Prodct availability may vary by contry 27

28 Thermo Scientific Specimen Validity Assays, Reagents, Calibrators & Controls Reagent Kits Catalog # Description Kit Size (ml) 1797 Creatinine-Detect DRI Creatinine-Detect for Indiko 3 x 18 Catalog # Description Kit Size (ml) General Oxidant-Detect 2 x DRI General Oxidant-Detect for Indiko 6 x 18 Catalog # Description Kit Size (ml) 1194 Gravity-Detect 2 x DRI Gravity-Detect for Indiko 6 x 18 Catalog # Description Kit Size (ml) ph-detect 2 x DRI ph-detect for Indiko 6 x 18 Catalog # Description Kit Size (ml) CEDIA Sample Check** Indiko Sample Check** 3 x 18 **For International se only - not for sale in USA Calibrators & Controls Catalog # Kit Size (ml) Description (mg/dl) Ct-off Levels x 25 Creatinine Calibrator Set 2.0 & Creatinine 1.3 Control Creatinine 7.5 Control Creatinine 23.0 Control 23 Catalog # Kit Size (ml) Description (µg/ml) Ct-off Levels x 25 General Oxidant Cal Set 0 & x 25 General Oxidant Control Set 100 & 300 Catalog # Kit Size (ml) Description Ct-off Levels x 25 Low Gravity Calibrator High Gravity Calibrator Level 1 Gravity Control Level 2 Gravity Control Catalog # Kit Size (ml) Description ph Level x 25 ph Calibrator Set 3.0 & ph 3.6 Control ph 7.0 Control ph 10.0 Control ph 11.5 Control 11.5 Catalog # Kit Size (ml) Description Ct-off Levels CEDIA Negative Cal CEDIA Negative Cal x 5 CEDIA Sample Check** Mltilevel - See Control Set package insert 28

29 Identify Adlterated Samples The se of additives and adlterants to mask controlled sbstances in rine samples is a difficlt and ongoing challenge to drgs of abse screening. We offer the indstry s most extensive men of detection tests. As new adlterant trends sweep throgh the testing pool, rely on or fast-track prodct development team to deliver a timely, economical detection soltion. All of or rine adlteration assays are liqid, ready-to-se and can be performed on a variety of general chemistry analyzers. The adlteration assays provide a complete and atomated way to test for sample integrity and adlteration. Associated Cals and Controls are offered in convenient sizes. Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 29

30 Thermo Scientific Endocrine Assays, Calibrators & Controls Endocrine Assays To rond ot yor rotine chemistry profile, the T4 and T Uptake endocrine prodcts are available in both CEDIA and DRI formats. They are packaged in convenient sizes and have applications on a mltitde of clinical chemistry analyzers. Similar to or TDM and Drgs of Abse prodcts, these prodcts provide excellent workflow management, cost savings, and sperior performance. CEDIA Assays* Catalog # Description Kit Size (ml) T4 SC Open System 39, T Uptake LC Open System 2 x 588, 2 x 191 * Calibrators are inclded in the reagent kit. DRI Reagents Catalog # Description Kit Size (ml) 0723 T Uptake 100, Total Thyroxine (T4) 100, Total Thyroxine (T4) 500,

31 Calibrators & Controls for DRI T Uptake Assay Catalog # Kit Size (ml) Description T Uptake (%) bottles x 2 ml ea T Uptake Calibrator 1 15 T Uptake Calibrator 2 20 T Uptake Calibrator 3 30 T Uptake Calibrator 4 40 T Uptake Calibrator 5 50 Calibrators & Controls for DRI T4 Assay Catalog # Kit Size (ml) Description Thyroxine (µg/dl) bottles x 2 ml ea Thyroxine Negative Cal 0 Thyroxine Cal 1 2 Thyroxine Cal 2 4 Thyroxine Cal 3 8 Thyroxine Cal 4 12 Thyroxine Cal 5 20 MAS Liqimmne Controls Catalog # Kit Size (ml) Description T Uptake (%) MAS Control LIG x 5 Liqimmne Level 1 MAS Control LIG x 5 Liqimmne Level 2 MAS Control LIG x 5 Liqimmne Level 3 See page 58 for more information Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 31

32 Thermo Scientific Serm Toxicology Assays, Calibrators & Controls Serm Toxicology The Serm Toxicology assays are excellent tools for physicians in an emergency room sitation. When rine specimens are not conveniently available, these serm-based assays are sed to identify the class of drg of the overdose. The Serm Toxicology Tricyclics assay has the added flexibility of analyzing serm or rine samples. Assays Catalog # Description Kit Size (ml) 1086 Acetaminophen 25, Barbitrate 25, Benzodiazepine 25, Salicylate Tricyclics 25, 8 Calibrators & Controls for Serm Toxicology Catalog # Kit Size Serm Serm Serm Description (ng/ml) (ml) Barbitrate Benzodiazepine Tricyclics Negative Calibrator Calibrator Calibrator Calibrator Calibrator x 5 MAS TOX Control Level 1-3 See page 62 for more information 32

33 Calibrators & Controls for Acetaminophen Assay Catalog # Kit Size (ml) Description Analyte Acetaminophen (µg/ml) 5 Acetaminophen Neg Calibrator 0 2 Acetaminophen 10 Calibrator Acetaminophen 25 Calibrator 25 2 Acetaminophen 50 Calibrator 50 2 Acetaminophen 100 Calibrator Acetaminophen 200 Calibrator 200 Calibrators & Controls for Salicylate Assay Salicylate Catalog # Kit Size (ml) Description Analyte (µg/ml) 1 x 5 Salicylate Negative Calibrator x 2 Salicylate 800 Calibrator 800 MAS PAR TDM Controls Catalog # Kit Size (ml) Description Analyte (µg/ml) PTD1-1001* 6 x 5 PAR TDM Level 1 PTD2-2002* 6 x 5 PAR TDM Level 2 PTD3-3003* 6 x 5 PAR TDM Level 3 Salicylate Refer to page 59 for more information * Refer to page 70 for list of analytes. Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 33

34 Thermo Scientific CEDIA & DRI TDM Assays, Calibrators & Controls Backed by a proven track record of reliable reslts and troble-free performance on a wide range of analyzers, we have been manfactring TDM Assays since CEDIA TDM Assays Catalog # Description Kit Size (ml) Carbamazepine 17, Gentamicin II 13, NAPA 17, Phenobarbital II 17, Phenytoin II 17, Procainamide 17, Theophylline II 17, Tobramycin II 13, Valproic Acid 13, 11 DRI TDM Assays Catalog # Description Kit Size (ml) 1669 Digoxin** 25, A Digoxin # 25, 8 # Calibrators are inclded in the reagent kit. ** For International Use only - not for sales in USA MAS PAR TDM Controls for TDMs Catalog # Description Kit Size (ml) PTD Par TDM Level 1 6 x 5 PTD Par TDM Level 2 6 x 5 PTD Par TDM Level 3 6 x 5 Refer to analyte lists beginning on page

35 CEDIA MltiDrg Calibrators CEDIA TDM Assays with Mlti Constitent Calibrators CORE CARDIAC ANTIBIOTIC Carbamazepine Phenobarbital Phenytoin Theophylline Valproic Acid Digoxin NAPA Procainamide Gentamicin Tobramycin Catalog # Kit Size (ml) Description NAPA* µg/ml 2 x 7.5 TDM Cardiac Cal Low 2 x 5.0 TDM Cardiac Cal High 2 x 7.5 TDM Core Cal Low 2 x 5.0 TDM Core Cal High 2 x 7.5 TDM Antibiotic Cal Low 2 x 5.0 TDM Antibiotic Cal High Procainamide* µg/ml Carbamazepine* µg/ml Phenobarbital II* µg/ml Phenytoin II* µg/ml Theophylline II* µg/ml Valproic Acid µg/ml Gentamicin II µg/ml Tobramycin II µg/ml * Calibrator concentrations for each assay are printed on a calibrator vale assignment card and are located in each TDM calibrator kit. Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 35

36 Thermo Scientific TDM QMS Assays, Calibrators & Controls Advanced microparticle technology is the fondation for a rapidly growing men of QMS particle enhanced trbidimetric immnoassays for therapetic and immnosppressive drg management. Clinicians in the fields of infection, epilepsy, cardiology and organ transplantation have fond QMS assays are particlarly well sited to measring therapetic drgs in whole blood, serm or plasma. Developed for se on general chemistry analyzers, the QMS liqid-ready-to-se format has been proven to be a convenient alternative to more expensive and time-consming assays employing HPLC or LC/MS technologies. In side-by-side comparisons, QMS assays have demonstrated: Excellent correlation to reference methods Optimal sensitivity, precision and dynamic range Or QMS two-component assay system is based on the competitive inhibition immnoassay principle: If the drg targeted by the assay is present in the sample, these free drg molecles compete with a microparticle-bond drg in one reagent for a limited nmber of antibody combining sites spplied by antibody in a second reagent. The competition for antibody binding sites inhibits the ability of the antibody to aggltinate the drg-coated microparticles. The degree that aggltination is inhibited is directly related to the concentration of the target drg in the sample. In the absence of competing free-drg in the sample, the drg-coated microparticle reagent is rapidly aggltinated in the presence of the antibody reagent. The rate of absorbance change is measred photometrically and is proportional to the rate of aggltination of the microparticles. Exceptional reliability, precision and lot-to-lot consistency Low cross-reactivity with metabolites and commonly co-administered drgs Low interference from endogenos sbstances 36

37 Indiko TDM Assays Catalog # Description Kit Size (ml) QMS Amikacin 19, QMS Gentamicin 19, QMS Lamotrigine 19, QMS Teicoplanin* 19, QMS Tobramycin 14, QMS Topiramate 19, QMS Vancomycin 19, QMS Zonisamide 19, 8 QMS TDM Assays Catalog # Description Kit Size (ml) Amikacin Reagent Kit 2 x 19, 2 x Lamotrigine Reagent Kit 19, Lidocaine Reagent Kit 2 x 18, 2 x Qinidine Reagent Kit 2 x 19, 2 x Teicoplanin Reagent Kit* 21, Topiramate Reagent Kit 22, Vancomycin Reagent Kit 22, Zonisamide Reagent Kit 2 x 22, 2 x 8 QMS TDM Calibrators Catalog # Description Kit Size Amikacin Calibrators Levels A-F 1 x 1 ml ea Gentamicin Calibrators Levels A-F 1 x 1 ml ea Lamotrigine Calibrators Level A 1 x 2 ml ea Levels B-F 1 x 1 ml ea Lidocaine Calibrators Levels A-F 1 x 1 ml ea Qinidine Calibrators Levels A-F 1 x 1 ml ea Teicoplanin* Calibrators Levels A-F 1 x 1 ml ea Tobramycin Calibrators Levels A-F 1 x 1 ml ea Topiramate Calibrators Levels A-F 1 x 1 ml ea Vancomycin Calibrators Levels A-F 1 x 1 ml ea Zonisamide Calibrators QMS TDM Controls Level A 1 x 2.5 ml ea Levels B-F 1 x 1 ml ea Catalog # Description Kit Size Lamotrigine Control Set 3 Levels 1 x 2.5 ml ea Teicoplanin* Control Set 3 Levels 1 x 2.0 ml ea Topiramate Control Set 3 Levels 1 x 2.0 ml ea Zonisamide Control Set 3 Levels 1 x 2.5 ml ea For additionl TDM controls for the QMS Assays, refer to page 59. * For International se only - not for sale in USA Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 37

38 Thermo Scientific Immnosppressant Drg Management Immnosppressant drg testing One of the most effective therapies for patients with endstage organ failre is solid organ transplantation. Typically, one or more immnosppressive drgs (ISD) are sed to prevent rejection of transplanted organs and tisses. Periodic measrements of a drg s concentrations are performed to allow physicians to make adjstments to the patient s drg therapy, ensring long-term sccess. Immnosppressant drg monitoring can be done by several methods; the most common is immnoassay. Thermo Fisher Scientific offers the most comprehensive men of Immnosppressant Drg Monitoring assays which are recognized worldwide for their ease-of-se, qality, performance, and lot-to-lot consistency. Accrate 4 Excellent low-end sensitivity 4 Correlation with gold standard methods 4 Lot-to-lot consistency Efficient 4 Improved trn-arond-time 4 Applications for a variety of analyzers Convenient 4 Simple sample preparation step 4 Broad dynamic range for Cyclosporine ( ng/ml) 4 Mix and Rn reagent systems or liqid, ready to se Mlticonstitent Immnosppressant Controls for se with Cyclosporine and Tacrolims Target Vales Catalog # Description Kit Size (ml) CsA TACRO Rap/Tac/CsA Control Level 1 - ble 4 x Rap/Tac/CsA Control Level 2 - green 4 x Rap/Tac/CsA Control Level 3 - red 4 x Q Rap/Tas/CsA Contol Level Q - yellow 4 x 4 Refer to vale assignment sheet 38

39 ISD Assays Catalog # Description Kit Size (ml) CEDIA Cyclosporine PLUS* 41, QMS Everolims 22, QMS Everolims** 22, CEDIA Mycophenolic Acid 26, 11 * Low Range CsA calibrators are inclded in the reagent kit ** For International se only - not for sale in USA ISD Reagents for the Indiko Catalog # Description Kit Size (ml) CEDIA Cyclosporine 41, QMS Everolims 22, QMS Everolims** 22, CEDIA Mycophenolic Acid 26, QMS Tacrolims 18, 12 ** For International se only - not for sale in USA ISD Calibrators & Controls Catalog # Description Kit Size CsA Control High Level 4 6 x 2 ml ea, 2 x 8 dilent CsA Control High Level 5 6 x 2 ml ea, 2 x 8 dilent CsA PLUS High Cal Set 4 x 2 ml each level, low & high Mycophenolic Acid Calibrator Set 2 x 5 ml 2 ea level Mycophenolic Acid Control 1 4 x 5 ml each level, low and high Mycophenolic Acid Control 2 4 x 5 ml each level, low and high Mycophenolic Acid Control 3 4 x 5 ml each level, low and high QMS Everolims Calibrator Set 6 levels, 1 bottle each 3 ml QMS Everolims Calibrator Set** 6 levels, 1 bottle each 3 ml QMS Everolims Control Set 3 Levels, 1 bottle each, 3 ml QMS Everolims Control Set** 3 levels, 1 bottle each 3 ml QMS Tacrolims Calibrator Set 6 levels, A 4 ml, B-F 2 ml ea ** For International se only - not for sale in USA See Mlticonstitent ISD Controls on page 38 for levels 1, 2, and 3 Analyzer Applications Applications are available for major clinical analyzers. Please contact yor local Thermo Scientific Sales Representative, Athorized Distribtor or Thermo Scientific Technical Service Representative for available applications. 39

40

41 Instrments Indiko Clinical & Specialty Chemistry Systems

42 Thermo Scientific Indiko Specialty Chemistry Systems Thermo Scientific Indiko and Indiko Pls analyzers and immnosppressant and therapetic drg monitoring Thermo Scientific Indiko, together with a complete men of immnosppressant and therapetic drg monitoring assays, provide an excellent soltion for patient monitoring. Indiko allows for patient testing at a monitoring site, therefore improving trnarond time and enabling doctors to make critical decisions sooner. The Indiko bench top analyzer also provides a single platform soltion for all Thermo Scientific ISD and TDM immnoassays, improving laboratory efficiency. The continos access allows for samples and reagents to be added withot interrpting the testing process. Fll ISD/TDM men on a single analyzer Convenient on-site testing Improved laboratory efficiency and trnarond time Flexibility in instrment placement ISD Men CEDIA Cyclosporine PLUS Assay CEDIA Mycophenolic Acid Assay QMS Everolims Assay QMS Tacrolims TDM Men Antiepileptics/Anticonvlsants Assays Antibiotic Immnoassays Antiarrythmics/Cardiacs Assays Bronchodilator Assay Ready-to-se Drgs of Abse screening assays for Indiko benchtop analyzers Or experience in drgs of abse testing allows s to anticipate new drg screening challenges and have leading edge soltions available when needed. Or mltiple technologies provide important advantages of integrating both Thermo Scientific DRI and/or Thermo Scientific CEDIA technologies into yor testing program. URINE DRI Assays CEDIA Assays Specimen Validity Tests Amphetamine Amphetamine/Ecstasy Creatinine Barbitrate Barbitrate General Oxidant Benzodiazepine Benzodiazepine ph Cannabinoid Bprenorphine Sample Check** Cocaine Cannabinoid Specific Gravity Cotinine Cocaine Ecstasy Heroin Metabolite Ethyl Alcohol Methadone Ethyl Glcronide** Methadone Metabolite Fentanyl** Opiate Methadone Methadone Metabolite Opiate Oxycodone PCP PPX ORAL FLUID CEDIA Oral Flid (OFT) Assays Amphetamine Cannabinoid Cocaine Methamphetamine Opiate PCP More OFT nder development SERUM Toxicology Assays* Barbitrate Benzodiazepine Tricyclics * Coming soon ** For International and Criminal Jstice, Forensic se only 42

43 Indiko and Indiko Pls are flly atomated bench top analyzers for drg monitoring and specialty testing Indiko is an easy to se, cost-effective system designed for load-p and walk-away convenience. Intitive ser interface and many atomated featres help to manage the daily workflow. The self-contained Indiko, with its small footprint, fits ideally to laboratory space limitations. Flexible, easy operation Intitive ser interface with toch-screen option Streamlined information management with varios reporting options, and advanced reslt inventory management A mix of sample cps and barcoded primary tbes can be sed Atomatic start-p protocol Loadable application data and calibrator and control vales Tre walk-away analysis Different sample types can be analyzed at the same time Real-time QC program with mltiple Westgard rles Continos access to samples, reagents and cvettes withot interrpting the testing process Up to two hors walk-away time Cost-effective soltion Uniqe, low-volme cvette technology Very low volme of samples (2 to 120 L) and reagents (2 to 240 L) reslt in overall low waste Real-time QC program assres reliable performance Minimal daily maintenance maximizes analyzer ptime Water consmption: 1.5 liter/hor 43

44 Thermo Scientific Indiko Specialty Chemistry Systems Indiko System Specifications Capacity Up to 200 tests per hor for 1 reagent assays, approximately 100 tests per hor for 2 reagent assays Dimensions & Weight 29.5 in / 75 cm (W) x 27.6 in / 70 cm (D) x 24.4 in / 62 cm (H), 51 in / 130 cm (H) with cover open, 187 lbs / 85 kg Power Spply V ± 10%, Hz, ± 5%, 250 W Average Noise Level at 1 meter < 60 db (A) Deionized Water Consmption 1.5 liters/hor Environmental Conditions Operating temperatre range 18 to 30 ºC, hmidity 40-80% ( non condensing) Confirms with CAN/CSA-C22.2 No Reglatory FDA clearance, 510(k) nmber: k (Indiko ) 98/79/EC IVD MD Directive Filter Rate nm Measrement Temperatre 37 ºC Light Sorce Flash Lamp Absorbance Range A, resoltion of A and reprodcibility of SD <0.005A at 2A Reaction Vessels On-board Capacity 360 measrement cells - 36 cvettes with 10 reaction cells each, p to 2 hor walk-away time Reaction End Volme µl Samples & Reagents On-board Capacity Maximm 6 racks - 9-position sample rack or 6-position reagent rack in disk cooled abot 8 ºC below ambient temperatre Sample Volme Size µl Sample Containers 0.5 ml, 2.0 ml cps and sample tbes (diameter mm, length mm) Sample Barcode Code 128 and barcodes USS Codabar, Interleaved 2 of 5 and Code 39 with a check digit Reagent Volmes µl Reagent Containers 10 ml and 20 ml vials Sample & Reagent Dispensing CV 2% for volmes 2 µl Calibration Factor, Bias, linear, logit-log, spline, polynomial and point-to-point calibration Data Management Windows workstation - data inpt online, via mose, keyboard, barcode reader, and toch screen (optional) Catalog Nmber Description Indiko Indiko with ISE** Indiko Pls Indiko Pls with ISE** PC accessories ordered based on geographic area ** For International se only - not for sale in USA 44

45 Indiko Pls System Specifications Capacity Up to 350 tests per hor for 1 reagent assays, approximately 200 tests per hor for 2 reagent assays Dimensions & Weight 37 in / 94 cm (W) x 27.6 in / 70 cm (D) x 24.4 in / 62 cm (H), 51 in / 130 cm (H) with cover open, 242 lbs / 110 kg Power Spply V ± 10%, Hz, ± 5%, 250 W Average Noise Level at 1 meter < 60 db (A) Deionized Water Consmption 2.5 liters/hor Environmental Conditions Operating temperatre range 18 to 30 ºC, hmidity 40-80% ( non condensing) Confirms with CAN/CSA-C22.2 No Reglatory FDA clearance, 510(k) nmber: k (Indiko ) 98/79/EC IVD MD Directive Filter Rate nm Measrement Temperatre 37 ºC Light Sorce Flash Lamp Absorbance Range A, resoltion of A and reprodcibility of SD <0.005A at 2A Reaction Vessels On-board Capacity 360 measrement cells - 36 cvettes with 10 reaction cells each, p to 2 hor walk-away time Reaction End Volme µl Samples & Reagents Sample On-board Capacity 54 Samples, - 9-position sample rack; maximm 6 Sample Volme Size µl Sample Containers 0.5 ml, 2.0 ml cps and sample tbes (diameter mm, length mm) Sample Barcode Code 128 and barcodes USS Codabar, Interleaved 2 of 5 and Code 39 with a check digit Sample Dispensing CV 2% for volmes 2 μl Reagent Volmes µl Reagent Containers 10 ml and 20 ml vials, reagent rack with 42 reagent positions Sample & Reagent Dispensing CV 2% for volmes 2 µl Calibration Factor, bias, linear, logit-log, spline, polynomial and point-to-point calibration Data Management Windows workstation - data inpt online, via mose, keyboard, barcode reader, and toch screen (optional) Consmable Ordering Information Part Nmber Description Kit Configration TENCELL cvettes 1 box (10,800 pcs) ml sample cps 1000 pcs ml sample cps 1000 pcs ml reagent bottles 5 pcs ml reagent bottles 16 pcs SP06662 Reagent rack 3 pcs SP06666 Sample rack 6 pcs Washing soltion 4.5% 4 x 20 ml Tbing maintenance soltion 6 x 20 ml Sample tbes 13 x 75 ml 1000/pk Nesting cps 1 ml 1000/pk 45

46

47 Thermo Scientific MAS Qality Control Prodcts Qality Assrance Program

48 Thermo Scientific MAS Omni Controls Cardiac Panel QC STAT QC consolidated into: Omni CARDIO Rotine Immnoassay QC Tmor Marker QC Specialty Immnoassay QC consolidated into: Omni IMMUNE or Omni IMMUNE PRO General Chemistry QC Serm Protein / Immnology QC consolidated into: Omni CORE MAS Omni CARDIO Thermo Scientific MAS Omni CARDIO consolidates a comprehensive cardiac marker panel with the new generation of STAT analytes inclding D-Dimer, hcg, Myeloperoxidase and Procalcitonin. Vale assignment is provided for key instrment systems inclding Abbott Architect, Beckman Colter Access, AU and UniCel systems, Ortho Clinical Diagnostics VITROS, Roche Cobas and Elecsys systems and Siemens Advia, Dimension, Dimension Vista, Immlite and Strats systems. Part Nmber Level Bottles & Size Storage & Stability Matrix OCRD-UL Ultra Low OCRD-L Low OCRD OCRD OCRD OCRD-MP Tri-Level Mlti-Pack (2 vials each level 1/2/3) 6 x 3 ml Assayed to -15 ºC ºC (for BNP-32, CK-MB, D-Dimer, Digitoxin, hcg, hscrp, Myeloperoxidase, Procalcitonin, Total CK, Troponin-I and Troponin-T) ºC (for Myoglobin and NT-proBNP) Hman Serm Analytes Beta Hman Chorionic Gonadotropin (b-hcg) Brain Natriretic Peptide-32 (BNP-32) Creatine Kinase (CK) Creatine Kinase-MB (CK-MB) D-Dimer Digitoxin High Sensitivity C-Reactive Protein (hscrp) Hman Chorionic Gonadotropin (hcg) Myeloperoxidase (MPO) Myoglobin N-Terminal Brain Natriretic Peptide (NT-proBNP) Procalcitonin (PCT) Troponin I Troponin T MAS Omni IMMUNE Thermo Scientific MAS Omni IMMUNE & Omni IMMUNE PRO Controls provide consolidation for rotine immnoassay, tmor marker and specialty immnoassay QC processing into a single prodct, offering three distinct levels. Vale assignment is provided for key integrated instrment systems inclding Abbott Architect, Beckman Colter Access and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Centar, Dimension, Dimension Vista and Immlite. Part Nmber Level Bottles & Size Storage & Stability Matrix OIM month shelf -25 to -15 ºC OIM x 5 ml Assayed Hman Serm 30 days open 2 to 8 ºC OIM Analytes See list on opposite page nder MAS Omni IMMUNE PRO 48 Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N

49 MAS Omni IMMUNE PRO Thermo Scientific MAS Omni IMMUNE PRO Control provides Anti-Thyrogloblin (Anti-Tg), Anti-Thyroid Peroxidase (Anti-TPO) and Sex Hormone Binding Globlin (SHBG), in addition to the same analyte panel provided in the MAS Omni IMMUNE prodct. Part Nmber Level Bottles & Size Storage & Stability Matrix OPRO month shelf -25 to -15 ºC OPRO x 5 ml Assayed Hman Serm 30 days open 2 to 8 ºC OPRO Analytes 17-OH-Progesterone 25-OH-Vitamin D Acetaminophen Adrenocorticotropic Hormone (ACTH) Aldosterone Alpha-fetoprotein Amikacin Anti-Thyrogloblin (Anti-Tg) (PRO) Anti-Thyroid Peroxidase (Anti-TPO) (PRO) Beta Hman Chorionic Gonadotropin (b-hcg) Beta-2-microgloblin C-Peptide CA 125 CA 15-3 CA 19-9 Carbamazepine Carcinoembryonic Antigen (CEA) Cortisol DHEA Slfate Lithim Digoxin Disopyramide Estradiol Estriol, Free Ethosximide Ferritin Folate (vitamin B9) Follicle Stimlating Hormone (FSH) Frctosamine* Gastrin Gentamicin Growth Hormone Hman Chorionic Gonadotropin (hcg) IGF-1 (inslin-like growth factor 1) Immnogloblin E (IgE) Inslin* Lidocaine Ltenizing Hormone (LH) N-acetylprocainamide (NAPA) Parathyroid Hormone (PTH) Phenobarbital Phenytoin Phenytoin, Free Pregnancy Associated Plasma Protein (PAPP-A) Primidone Procainamide Procalcitonin Progesterone Prolactin Prostate Specific Antigen, Free (FPSA) Prostate Specific Antigen, Total (TPSA) Prostatic Acid Phosphatase (PAP) Qinidine Salicylate * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Sex Hormone-Binding Globlin (SHBG) (PRO) Testosterone Theophylline Thyrogloblin Thyroid Uptake (T-Uptake) Thyroid-Stimlating Hormone (TSH) Thyroxine-Binding Globlin (TBG) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants (TCA) Triiodothyronine, Free (FT3) Triiodothyronine, Total (TT3) Valproic Acid Valproic Acid, Free Vancomycin Vitamin B12 MAS Omni CORE Thermo Scientific MAS Omni CORE Control consolidates general chemistry and serm protein QC processing into a single prodct, offering three distinct levels. Vale assignment is provided for key integrated instrment systems, inclding Abbott Architect, Beckman Colter AU, Synchron and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Advia, Dimension and Dimension Vista. Part Nmber Level Bottles & Size Storage & Stability Matrix OCR month shelf -25 to -15 ºC OCR x 5 ml Assayed 30 days open 2 to 8 ºC Hman Serm OCR (Bilirbin is 15 days open 2 to 8 ºC) Analytes Acetaminophen Alanine Aminotransferase (ALT) Albmin Alkaline Phosphatase (ALP) Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Alpha-2-Macrogloblin Amikacin Amylase Amylase (pancreatic) Antistreptolysin O (ASO) Apolipoprotein A1 Apolipoprotein B Aspartate Aminotransferase (AST) Beta-2-Microgloblin Bile Acids Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Bilirbin, Unconjgated Blood Urea Nitrogen (BUN) C-Reactive Protein (CRP) C3 Complement C4 Complement Caffeine Calcim Carbamazepine Carbon Dioxide (CO2) Cerloplasmin Chloride Cholesterol Copper Cortisol Creatine Kinase (CK) Creatinine Digoxin Disopyramide Ethanol Ethosximide Ferritin Gamma-Gltamyl Ttransferase (GGT) Gentamicin Glcose Haptoglobin HDL Cholesterol Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Iron Iron Binding Capacity (IBC) Iron Binding Capacity, Total (TIBC) Iron Binding Capacity, Unsatrated (UIBC) Lactate Dehydrogenase (LDH) Lactic Acid LDL Cholesterol Lidocaine Lipase Lipoprotein(a) Lithim Magnesim Methotrexate N-acetylprocainamide (NAPA) Osmolality Phenobarbital Phenytoin Phospholipids Phosphors Potassim Prealbmin Primidone Procainamide Psedocholinesterase (PCHE) Qinidine Rhematoid Factor Salicylate Sodim Theophylline Thyroid Uptake (T-Uptake) Thyroid-Stimlating Hormone (TSH) Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin Tricyclic Antidepressants (TCA) Triglycerides Uric Acid Valproic Acid Vancomycin Zinc 49

50 Thermo Scientific MAS Serm Chemistry Controls MAS chemtrak H This is a comprehensive mlti-analyte control, designed to monitor general chemistry and TDM methods. Available in an assayed or nassayed format. Both formats are liqid, ready-to-se and no additional preparation is reqired. Assayed vales are available for most major platforms. Part Nmber Level Bottles & Size Storage & Stability* Matrix CHA x 5 ml Assayed 30 month shelf -25 to -15 ºC Analytes CHA-2 2 CHA-3 3 CHU-1 1 CHU-2 2 CHU-3 3 Acetaminophen Alanine Aminotransferase (ALT) Albmin Alkaline Phosphatase Amikacin Amylase Amylase (Pancreatic) Apolipoprotein A Apolipoprotein B Aspartate Aminotransferase (AST) Bilirbin Unconjgated Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Blood Urea Nitrogen (BUN) C3 Complement* C4 Complement* Caffeine Calcim Carbamazepine 10 x 15 ml Unassayed 14 days 2 to 8 ºC; nassayed 7 days 2 to 8 ºC; assayed Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Dropper Tips - Pkg MAS P/N Carbon Dioxide (CO2) Chloride Cholesterol Creatine Kinase (CK) Creatinine Digoxin Disopyramide Ethanol Ethosximide Ferritin* Gamma-Gltamyl Transferase Gentamicin GLDH* Glcose Haptoglobin* HBDH* HDL Cholesterol Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Iron Iron Binding Capacity, Total (TIBC) Iron Binding Capacity, Unsatrated (UIBC)* Lactate Dehydrogenase (LDH) Lactic Acid LDL Cholesterol Lidocaine Lipase Lipoprotein (a) Lithim Magnesim Methotrexate N-acetylprocainamide (NAPA) Osmolality Phenobarbital Phenytoin Phosphors Potassim Prealbmin Primidone Hman Serm Procainamide Psedocholinesterase Qinidine Salicylate Sodim Theophylline Thyroid Stimlating Hormone Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4)* Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin* Tricyclic Antidepressants Triglycerides Triiodthyronine, Free (FT3)* Triiodthyronine, Total (TT3)* Uric Acid Valproic Acid Vancomycin 50

51 MAS Alcohol/Ammonia An assayed, bi-level control for monitoring ethanol and ammonia levels in serm. This ready-to-se prodct is packed in convenient mltipacks and has been assayed for most major instrments. Normal Ammonia vales in Level 1. Part Nmber AAC-MP Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 6 x 3.5 ml 24 month shelf 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Analytes Ammonia Ethanol MAS Bilirbin This assayed, tri-level control has been designed to monitor the performance of total, direct, conjgated, nconjgated and neonatal bilirbin. There are no additional preparation steps reqired for this liqid, ready-to-se prodct. An elevated Bilirbin is inclded in level 3 for neonatal applications. Part Nmber Level Bottles & Size Storage & Stability Matrix BC month shelf 2 to 8 ºC BC x 5 ml 14 days 2 to 8 ºC Bovine Serm BC103 3 when stored in the dark Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Analytes Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Bilirbin, Unconjgated Dropper Tips - Pkg MAS P/N

52 Thermo Scientific MAS Urine Chemistry Controls MAS UA Control A bi-level control that is liqid and ready-to-se with improved room temperatre storage capability. This rine control was designed for monitoring rine dipstick and microscopic components and is assayed for most major reagent strips and strip systems. It incldes ten commonly tested dipstick tests pls Microalbmin, Creatinine and hcg. Part Nmber Level Bottles & Size Storage & Stability Matrix UAB x 15 ml UAB-160 (normal) 4 x 60 ml 24 month shelf 2 to 8 ºC UAB x 15 ml Open Vial: Hman UAB-260 (abnormal) 4 x 60 ml Refrigerated 3 2 to 8 C Urine UAB-MP Bi-level, Room temperatre 6 18 to 25 C 6 x 15 ml Mlti-Pack Analytes Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Osmolality ph Potassim Protein Protein-to-creatinine ratio Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells MAS UA DipTbe MAS UA prodct packed into convenient dip tbes to simplify manal testing of rinalysis strips. Part Nmber UAT-MP MAS Urinalysis Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 10 x 12 ml 24 months shelf 2 to 8 ºC Open Vial: Refrigerated 8 weeks or 20 2 to 8 ºC Room temp 2 weeks or to 30 ºC A bi-level rine control designed for monitoring rine dipstick and microscopic components. This liqid control is assayed for most major reagent strips and strip systems. Hman Urine Part Nmber Level Bottles & Size Storage & Stability Matrix x 15 ml 12 month shelf 2 to 8 ºC (abnormal) 4 x 60 ml 30 days 2 to 8 ºC Hman x 15 ml 18 month shelf 2 to 8 ºC Urine (normal) 4 x 60 ml 30 days 2 to 8 ºC Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N Analytes Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Analytes Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Osmolality Osmolality ph Potassim Protein Protein-to-creatinine ratio Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells ph Potassim Protein Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells

53 Sentry Urine Dipstick Control Ideal for se otside the clinical laboratory where refrigerated storage isn t always available. The Sentry Urine Dipstick Control offers 12 months room temperatre stability for an immediate, ready to se rinalysis strip control. Sitable for Mtistix, Chemstrips, Diascreen and other rinalysis strips as well as atomated strip readers. Spplied in two levels, normal and abnormal. Part Nmber URN5005 Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 4 x 25 ml 18 months shelf life 2 to 8 ºC 12 months room temperatre Synthetic Analytes Bilirbin Blood Glcose Hman Chorionic Gonadotropin (hcg) Lekocytes Ketones Microalbmin Nitrite ph Protein Specific Gravity Urobilinogen MAS UrichemTRAK UrichemTRAK is designed to qantitatively monitor the most commonly tested rine chemistry analytes. This liqid, assayed control is ready-to-se, reqires no additional preparation and the non-azide formlation will not interfere with ISEs. It incldes general chemistry, physical properties and hcg tests. Part Nmber Level Bottles & Size Storage & Stability Matrix UR UR month shelf 2 to 8 ºC Hman 6 x 15 ml Bi-level, opened and nopened Urine UR-MP Mlti-Pack Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Analytes Amylase Calcim Chloride Cortisol Creatinine Glcose Hman Chorionic Gonadotropin (hcg) Magnesim Microalbmin Osmolality ph Phosphors Potassim Sodim Specific Gravity Total Protein Urea Nitrogen Uric Acid Dropper Tips - Pkg MAS P/N

54 Thermo Scientific MAS Immnoassay Controls MAS Liqimmne Save time and extra costs associated with lot changes sing the MAS Liqimne controls now with and extended shelf life. This mlti-analyte immnoassay control is liqid based and designed to monitor immnoassay test procedres on atomated instrments. Provides coverage of fertility, thyroid, iron deficiency, endocrine and allergy parameters. Assayed vales are provided for major instrment systems. Part Nmber Level Bottles & Size Storage & Stability Matrix LIG month shelf -25 to -15 ºC LIG x 5 ml 90 days 2 to 8 ºC Hman Serm LIG days 2 to 8 ºC Analytes 17-a-OH-Progesterone Acetaminophen Aldosterone Alpha-Fetoprotein (AFP) Amikacin Carbamazepine Carcinoembryonic Antigen (CEA) CK-MB (activity) CK-MB (mass) Cortisol DHEA-Slfate Digoxin Disopyramide Estradiol Ethosximide Ferritin Folate Follicle Stimlating Hormone (FSH) Gentamicin Homocysteine Hman Chorionic Gonadotropin (beta-hcg) Hman Chorionic Gonadotropin (hcg) Hman Growth Hormone Immnogloblin A (IgA)* Immnogloblin E (IgE) Immnogloblin G (IgG)* Immnogloblin M (IgM)* Inslin Lidocaine Lithim Lteinizing Hormone (LH) N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Progesterone Prolactin Prostate Specific Antigen, Total (TPSA) Prostate Specific Antigen, Free (FPSA) Qinidine Salicylate Testosterone Theophylline Thyrogloblin Thyroid Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Free (FT3) Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Vitamin B12 * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N

55 MAS PTH Control PTH (Parathyroid Hormone) is commonly tested to assess Calcim reglation in blood. The MAS PTH Control offers three distinct PTH levels for evalation of atomated PTH methods across the assay range. Provided in a liqid format for ease of se, the MAS PTH Control offers 10 days open vial stability when stored at 2-8 ºC. Vale assignment is provided for the key atomated PTH methods available in today s clinical laboratory. Part Nmber PTH-MP Level Bottles & Size Storage & Stability Matrix Tri-level Mltipack 6 x 3 ml to 15 ºC 10 days 2 to 8 ºC Hman Serm Analytes Parathyroid Hormone (PTH) MAS PAR TDM This liqid therapetic drg control is a mlti-analyte control with assayed vales designed for therapetic drgs and common immnoassay test procedres on most atomated instrments. No additional preparation is reqired for this liqid, ready-to-se prodct that offers three significant levels. Part Level Bottles & Size Storage & Stability Matrix Nmber PTD month shelf 2 to 8 ºC Bovine PTD x 5 ml 30 days 2 to 8 ºC Serm PTD Analytes Acetaminophen Amikacin Caffeine Carbamazepine Digoxin Disopyramide Estriol Ethanol Ethosximide Gentamicin Lidocaine Lithim Methotrexate N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Qinidine Salicylate Theophylline Thyroid Stimlating Hormone (TSH) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Total (TT3) Valproic Acid Vancomycin MAS T-Marker This liqid, assayed, mlti-analyte control is designed to monitor performance of varios cancer antigen tests on atomated instrments, sch as Abbott Architect, Beckman Access/Dxl, Ortho Vitros ECi, Roche Modlar Elecsys, Siemens Advia Centar and Immlite, and Tosoh AIA 600II. No additional preparation steps are reqired for these ready-to-se prodcts. Part Nmber TUM TUM TUM Level Bottles & Size Storage & Stability Matrix 6 x 3 ml 36 month shelf -25 to -15 ºC 90 days 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * Not cleared by FDA. No claims can be made. Dropper Tips - Pkg MAS P/N Analytes ACTH* Aldosterone Alpha-Fetoprotein (AFP) Beta Hman Chorionic Gonadotroopin (beta-hcg) Beta-2-Microgloblin CA 125 CA 15-3 CA 19-9 CA CA 72-4 Calcitonin Carcinoembryonic Antigen (CEA) Cortisol CyFRA 21-1* Estradiol Ferritin Gastrin Hman Chorionic Gonadotroopin (hcg) Inslin NSE* Prolactin Prostate Specific Antigen, Total (TPSA) Prostate Specific Antigen, Free (FPSA) Prostatic Acid Phosphatase (PAP) Thyrogloblin 55

56 Thermo Scientific MAS Cardiac & Diabetes Controls MAS CardioImmne XL This mlti-analyte control is designed to monitor serm cardiac marker test methods. No additional preparation is reqired for this liqid, ready-to-se prodct. It offers for distinct levels, and is also available in a tri-level mltipack. Part Nmber Level Bottles & Size Storage & Stability Matrix CAI-XLL L 36 month shelf -25 to- 15 C CAI-XL days 2 to 8 C (for hscrp, CAI-XL2 2 Digitoxin, Troponin I and Homocysteine) 6 x 3 ml CAI-XL days 2 to 8 C Hman Serm CAI-XL4 Tri-level for BNP32, Myoglobin (when a dropper tip is Mlti-Pack sed), NT-proBNP, Troponin T, CK-MB Analytes BNP 32 CK-MB Digitoxin Homocysteine C-Reactive Protein high sensitivity (hs-crp) Myoglobin NT-pro BNP Troponin I Troponin T MAS CardioImmne Ultra Low A single analyte control designed to challenge the low end sensitivity of the next generation high sensitivity Troponin assays. Part Nmber Level Bottles & Size Storage & Stability Matrix CAI-UL UL 6 x 3 ml 36 month shelf -25 to -15 ºC 30 days 2 to 8 ºC Hman Serm MAS Diabetes This liqid assayed diabetes control is a bi-level control designed to monitor hemoglobin A1c methods. Assayed for most major instrment systems. The liqid, ready-to-se prodct reqires no additional preparation. Part Nmber Level Bottles & Size Storage & Stability Matrix 24 month shelf -25 to -15 ºC Bi-level Hman DBCL-MP 6 x 1 ml 60 days 2 to 8 C Mlti-Pack Whole Blood 30 days 2 to 8 ºC Analytes Troponin I Analytes Hemoglobin A1c (HbA1c) Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. Dropper Tips - Pkg MAS P/N

57 Thermo Scientific MAS Immnology & Protein Controls MAS Immnology This mlti-analyte immnology liqid assayed control is designed to monitor the performance of varios serm protein and serology test procedres inclding Antistreptolysin O, C-Reactive Protein, Prealbmin and Rhematoid Factor. It is assayed for major instrment systems and is ready-to-se, reqiring no additional preparation. Three levels provide monitoring of the fll assay range. Part Nmber Level Bottles & Size Storage & Stability Matrix IC IC IC x 3 ml 24 month shelf 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Analytes Albmin Alpha-1-Antitrypsin Alpha-2-Macrogloblin Antistreptolysin O Antithrombin III Apha-1-Acid-Glycoprotein Apolipoprotein A-1* Apolipoprotein B* Beta-2-Microgloblin C-Reactive Protein (CRP) C3 Complement C4 Complement Cerloplasmin Ferritin* Haptoglobin Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Kappa Light Chain Lambda Light Chain Prealbmin Properdin Factor B Rhematoid Factor (RF) Total Protein Transferrin MAS CSF This assayed, bi-level control is designed to monitor the performance of qantitative and manal chemical analysis of hman cerebrospinal flid. Mltiple oligoclonal bands are present in Level 2. Assayed for major instrment systems as well as for celllose acetate and agarose gel electrophoresis. These prodcts are liqid, ready-to-se and reqire no additional preparation. Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC CSF-MP 6 x 3.5 ml Hman Serm Mlti-Pack 30 days 2 to 8 ºC Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Dropper Tips - Pkg MAS P/N Analytes Albmin Alpha-1-Globlin Alpha-2-Globlin Beta-Globlin Chloride Gamma-Globlin Glcose Gltamine Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Lactate Dehydrogenase (LDH) Lactic Acid Oligoclonal Bands Potassim Prealbmin Sodim Total Protein 57

58 Thermo Scientific MAS Toxicology Controls MAS DOA TOTAL This mlti-constitent rine toxicology control offers 19 analytes with 4 distinct levels at drg concentrations 25% below and above commonly sed screening and SAMHSA* ctoffs. A drg-free level and high positive level are also available (6 levels total). The control is a liqid, ready-to-se prodct available for se on a variety of instrment platforms. Each level of control is individally packed which gives yo the flexibility to choose yor levels according to yor drg screen panel ctoffs while keeping the nmber of control vials to a minimm. Part Nmber Level Bottles & Size Storage & Stability Matrix DOAT-1 1 DOAT-2 2 DOAT x 18 ml DOAT month shelf 2 to 8 ºC Hman Urine DOAT days open 2 to 8 ºC DOAT-6 6 DOAT-MP Mlti Pack 1 bottle per level, 18 ml each Analytes 11-nor-9-COOH-D9-THC Benzoylecgonine Bprenorphine Cotinine d-methamphetamine EDDP Ethanol Ethyl Glcronide LSD Methadone Methaqalone Morphine, free Nitrazepam Nortriptyline Oxazepam Oxycodone Phencyclidine Propoxyphene Secobarbital MAS TOX Control This mlti-analyte control is developed for se with the Thermo Scientific MAS Toxicology immnoassays for the semiqantitative measrement of barbitrates, benzodiazepine, and tricyclic antidepressants in either serm or plasma. Part Nmber Level Bottles & Size Storage & Stability Matrix Mlti-Pack 3 levels 6 x 5 ml 24 months shelf 2 to 8 ºC 20 days open 2 to 8 ºC Bovine Plasma Analytes Barbitrate (Secobarbital) Benzodiazepine (Diazepam) Tricyclic Antidepressants (Nortriptyline) (for se with DRI Reagents) Dropper Tips - Pkg MAS P/N

59 Thermo Scientific MAS Qality Control Soltions for Vista Designed for se with the Siemens Dimension Vista instrmentation Thermo Scientific MAS qality control prodcts are available in vials specifically designed for se with the Siemens Dimension Vista instrmentation. Flly validated onboard QC stability claims provide assrance that long-term qality assrance is maintained when performing rotine qality control on the Dimension Vista instrment. Nine individal Thermo Scientific MAS qality control prodcts are available in a Dimension Vista specific format covering the instrment assay portfolio. Six vials are provided in each kit for convenience. MAS Alcohol/Ammonia Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC x 2 ml Hman Serm Mlti-Pack 7 days onboard instrment Analytes Ammonia Ethanol MAS CardioImmne XL Part Nmber Level Bottles & Size Storage & Stability Matrix L month shelf -25 to -15 ºC 6 x 2 ml days onboard instrment Hman Serm Analytes C-Reactive Protein high sensitivity (hscrp) CK-MB Digitoxin Homocysteine Myoglobin NT-pro BNP Troponin I 59

60 Thermo Scientific MAS Qality Control Soltions for Vista MAS chemtrak H Part Nmber Level Bottles & Size Storage & Stability Matrix x 2 ml 30 month shelf -25 to -15 ºC Hman Serm Assayed 7 days onboard instrment Analytes Acetaminophen Alanine Aminotransferase (ALT) Albmin Alkaline Phosphatase Amylase Apolipoprotein A Apolipoprotein B Aspartate Aminotransferase (AST) Bilirbin Direct (DBIL) Bilirbin Total (TBIL) Blood Urea Nitrogen (BUN) C3 Complement* C4 Complement* Calcim Carbamazepine Carbon Dioxide (CO2) Chloride Cholesterol Creatine Kinase (CK) Creatinine Digoxin Ethanol Ferritin* Gamma-Gltamyl Transferase (GGT) Gentamicin Glcose Haptoglobin HDL Cholesterol Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Iron Iron Binding Capacity, Total (TIBC) Lactate Dehydrogenase (LDH) Lactic Acid LDL Cholesterol Lidocaine Lipase Lithim Magnesim N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Phosphors Potassim Prealbmin Procainamide Psedocholinesterase Salicylate Sodim Theophylline Thyroid Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4)* Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin* Tricyclic Antidepressants Triglycerides Triiodthyronine, Free (FT3)* Triiodthyronine, Total (TT3)* Uric Acid Valproic Acid Vancomycin MAS CSF Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC 6 x 2 ml Mlti-Pack 7 days onboard instrment Hman Serm Analytes Albmin Chloride Glcose Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Lactate Dehydrogenase (LDH) Lactic Acid Potassim Prealbmin Sodim Total Protein Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents 60

61 MAS Diabetes Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level 24 month shelf -25 to -15 ºC Hman Whole DBCL-V 6 x 2 ml Mlti-Pack 7 days onboard instrment Blood Analytes Hemoglobin A1c (HbA1c) MAS Immnology Part Nmber Level Bottles & Size Storage & Stability Matrix IC-V month shelf 2 to 8 ºC IC-V2 2 6 x 2 ml Hman Serm 7 days onboard instrment IC-V3 3 Analytes Albmin Alpha-1-Acid-Glycoprotein Alpha-1-Antitrypsin Alpha-2-Macrogloblin Antistreptolysin O (ASO) Apolipoprotein A1* Apolipoprotein B* Beta-2-Microgloblin C-Reactive Protein (CRP) C3 Complement C4 Complement Cerloplasmin Ferritin* Haptoglobin Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Kappa Light Chain Lambda Light Chain Prealbmin Rhematoid Factor (RF) Total Protein Transferrin MAS Liqimmne Part Nmber Level Bottles & Size Storage & Stability Matrix month shelf -25 to -15 ºC x 2 ml Hman Serm 7 days onboard instrment Analytes Acetaminophen Alpha-Fetoprotein (AFP) Carbamazepine Carcinoembryonic Antigen (CEA) CK-MB (activity) CK-MB (mass) Digoxin Estradiol Ferritin Folate Folate Stimlating Hormone (FSH) Gentamicin Homocysteine Hman Chorionic Gonadotropin (beta-hcg) Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Lidocaine Lithim Ltenizing Hormone (LH) N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Procainamide Prolactin Prostate Specific Antigen (PSA) Prostate Specific Antigen Free (FPSA) Salicylate Testosterone Theophylline Thyroid Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Free (FT3) Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Vitamin B12 MAS UrichemTRAK Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC 6 x 2 ml Mlti-Pack 7 days onboard instrment Hman Urine Analytes Amylase Calcim Chloride Cortisol Creatinine Glcose Magnesim Microalbmin Phosphors Potassim Sodim Total Protein Urea Nitrogen Uric Acid Refer to package insert for specific analyte and stability claims. Shelf life starts from the date of manfactre. * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. 61

62 Thermo Scientific LabLink xl Qality Assrance Program Used in conjnction with the Thermo Scientific MAS qality controls, LabLink xl offers a 100% web-based qality assrance soltion comprised of for integrated modles: 1. LabLink xl Web (interlaboratory QC program) 2. LabLink xl Commnicator (flly and semi-atomated QC data transfer from instrment, LIS or middleware) 3. LabLink xl Daily (day-to-day QC analysis) 4. LabLink Extra (online access to package inserts and other docments) FEATURES Flly web based QC data is processed in real-time Peer comparison to a worldwide peer grop User friendly screen layot and intitive to se Available in mltiple langages BENEFITS Instant access to yor QC data, anytime and anywhere Immediate access to reports and comparative peer data for improved trobleshooting trnarond time Early detection of shifts, trends and system errors in qality system No monthly ctoff dates - yor QC data sbmission is never late Participation in an interlaboratory QC program helps meet reqirements as specified by local reglatory agencies and accreditation organizations. Provides added assrance and certainty in EQA and proficiency testing reslts. Setting p yor laboratory s LabLink xl accont for data sbmission is qick and simple One-on-one training is offered to new sers Convenience of navigating the website in yor local langage LabLink xl Web LabLink xl Web is an interlaboratory QC program that offers an external perspective on yor internal day-to-day QC. 100% Real-time data processing - QC data that is sbmitted is immediately inclded with the peer statistics and available for peer comparison Simple to setp - Flly web-based therefore no software to install - Instrment, QC and tests configred within mintes Easy data entry by day or month with shift option Sperior reporting capabilities - Real-time report generation - Reports generated on-demand showing the latest p to the minte peer comparison data - Basic and complex statistical calclations and indices provided for cmlative and crrent months data Mean SD CV Standard Deviation Index (SDI) Coefficient of Variation Index (CVI) - Varios inter and intralaboratory reports available for review - Reports bilt on-line in PDF format - Interactive reports with e-signatre capabilities Instant access to worldwide peer grops Comparison of QC data across affiliate laboratories - QC sbmission by affiliate laboratories can be conveniently managed by the Laboratory Manager or QC Coordinator - Separate affiliate comparison and exception reports are available Each ser has their own niqe login credentials - Locally defined access privileges - Accessibility determined by the Laboratory Manager 62

63 LabLink xl Daily LabLink xl Daily is a flly integrated modle of the LabLink xl qality assrance soltion which allows laboratories to perform rotine QC day-to-day performance verification and maintain stringent qality control by employing mlti-rle QC procedres. Integrated modle within LabLink xl Web-based application for daily QC comparison - No software to install Option to setp Westgard and Rilibäk mlti-rle criteria for QC performance tracking Advanced reporting and review featres - Interactive Levey-Jennings plotting tool provides a single screen for QC review and approval - Interactive QC Exclsion report for qick review and convenient commenting Option to setp and evalate non-mas QC prodcts Real-time data processing / report prodction - Allowing for immediate review of QC data and performance check against Westgard Rle criteria LabLink Extra LabLink Extra is an online information portal that works in nison with the LabLink xl Qality Assrance Program providing easy access to package inserts and other spport docmentation for QC prodcts manfactred by Thermo Scientific. Instant access to package inserts, MSDS s and Certificates of Analysis Receive prodct pdates and Rilibäk pdates via Additional information on QC related topics sch as QC handling gidelines LabLink xl Commnicator Option for both semi-atomated or flly-atomated connectivity for the transfer of QC data from laboratory instrment, LIS and middleware to LabLink xl. Completely integrated modle within LabLink xl - Easy and efficient installation and setp completed remotely by the LabLink xl spport organization Upload data from instrment, LIS or middleware Hassle free atomatic pload - Eliminates QC transcription error - No manal data entry is necessary - Saves time and redces cost Real-time transfer of QC data - Instantaneos access to data in LabLink xl - Immediate comparison, review and approval of QC data LabLink xl Clod Commnicator An enhancement of the existing LabLink commnicator modle. The LabLink xl Clod Commnicator offers flly atomated connectivity for the real-time transfer of QC data from Data Innovations Instrment Manager to LabLink xl. MAS LabLink xl Modles Part Nmber Modle LLXLW LabLink xl Web LLXLC LabLink xl Commnicator LLXLDM LabLink xl Daily LLXLF LabLink xl Ato-Connectivity License Fee (Annal) LLXLFA LabLink xl Ato-Connectivity License Fee - For Affiliate Labs (Annal) 63

64 Thermo Scientific MAS QC Vale Assignment Program Testing Gidelines Each new lot of QC will tilize a different grop of vale assignment partner laboratories as participants are not reqired to test every QC lot. Advance notification of when to expect samples will be sent ot prior to testing. Instrctions for testing and data entry forms are sent with all vale assignment samples. Most tests are rn in dplicate over three separate days. All testing mst to be completed within 4-6 weeks of receiving the samples. Vale assignment is an important reqirement when rolling over to a new lot of QC material. The ability to provide fll coverage of instrment target vales involves the partnership of Thermo Fisher Scientific with laboratories performing the reqired testing. Withot involvement of these external laboratories, the ability to provide vale assignment coverage is significantly redced. Thermo Fisher Scientific is actively looking for new laboratories that are willing to assist with MAS QC Vale Assignment in retrn for monetary compensation or free QC prodcts. The reslts received from the participating laboratories are sed to establish QC ranges in the lot specific package inserts for the MAS Qality Controls. Compensation Options Monetary: This is typically based pon a flat fee per data point pls reagent costs. As this varies between test systems and methods, there is no standard amont. The different reimbrsement options will be discssed prior to prodct shipment. Free of charge MAS QC prodct: This is based pon the nmber of tests and MAS prodcts being vale assigned. Free QC prodct is given at the discretion of yor sales representative. Frther details will be provided by a member of the vale assignment team. Participation Reqirements CLIA certification or eqivalent local accreditation. A completed W-9 form (US only). A completed srvey noting instrments and testing capabilities. Steps to follow if yo are interested in participating in the MAS Vale Assignment Program Step 1: Complete the form below. Step 2: Fax this page to or to MGC-VA@thermofisher.com. Step 3: A vale assignment introdction pack will be sent via mail or . Please complete the forms and retrn to s. Step 4: Once the introdction pack is received, a member of the vale assignment team will notify yo to discss acceptance into the program and the different methods of compensation. Lab Name: Lab Address: Contact Name: Alternate Contact: Phone Nmber: Fax Nmber: Accreditation #: Fax to: to: MGC-VA@thermofisher.com 64

65 Reference & Ordering Analytes Instrments Order Placement Technical Service & Spport