CLEARLLAB LS LYMPHOID SCREEN REAGENT

Transcription

1 CLEARLLAB LS LYMPHOID SCREEN REAGENT CE MARKED ANTIBODY COMBINATION FOR LEUKEMIA / LYMPHOMA ANALYSIS Because Your Patient is Her Everything

2 BECAUSE YOUR PATIENT IS HER EVERYTHING ClearLLab LS Lymphoid Screen is the first CE-IVD-marked 10-color L&L reagent. For use as an aid in the differential diagnosis of your patients with signs or symptoms of hematolymphoid malignancies, it features a standardized pre-mixed combination of 12 antibodies in a shelf-stable, unitized, dry format that meets CE-IVD clearance standards. Setting a new benchmark in standardized clinical flow cytometry, ClearLLab LS provides reliable information to support your treatment decision. For your patient s family, this decision means everything. Every Event Matters

3 ClearLLab LS LYMPHOID SCREEN CE-IVD-MARKED ANTIBODY COMBINATION FOR LEUKEMIA / LYMPHOMA ANALYSIS The ClearLLab LS Lymphoid Screen reagent is intended for the identification of hematolymphoid cell populations by immunophenotyping on a 10-color NAVIOS flow cytometer. The reagent can be used with peripheral whole blood and bone marrow specimens collected in EDTA (K 2 and K 3 ), ACD-A and Heparin (Lithium and Sodium) as well as lymph node specimens. The results should be interpreted in conjunction with additional laboratory and clinical findings. Pre-mixed 10-color 12 antibody tube CE-IVD-marked for use with NAVIOS flow cytometers Unitized dry reagent using Beckman Coulter proprietary format 25 tests/package Compatible with WHO 2008-Revised Classification PART NUMBER 405 nm EXCITATION 488 nm EXCITATION PB 1 KrO 2 FITC PE ECD PC5.5 PC7 APC 638 nm EXCITATION APC- AF700 3 APC- AF750 4 B74073 CD3 CD45 Kappa/ CD8 Lambda/ CD4 CD19 CD56 CD10 CD34 CD5 CD20 1. Pacific Blue 2. Krome Orange 3. APC Alexa Fluor APC Alexa Fluor 750 Streamlined Compensation Optimize assay performance and reduce your compensation workload using the new ClearLLab Compensation Kit. Unitized dry format reagents for optimized 10-color compensation Compensation performed only once per month 5 compensations per kit

4 EMPOWER YOUR LAB S WORKFLOW: ACCURACY AND RELIABILITY Laboratory Developed Test Workflow TIME-CONSUMING AND ERROR-PRONE Panel Creation Method Validation Stability Testing Antibody Cocktailing Analyze literature Optimize staining procedure Establish cocktail stability Prepare antibody cocktails Choose antibody specificities Design validation study Draft SOP for cocktailing Perform quality control on cocktail Select potential fluorophor combinations Execute validation study Draft SOP for stability testing Evaluate fluorophor combinations Document validation study Repeat as necessary ClearLLab LS Simplifies the Workflow Referencing the LDT workflow above, ClearLLab LS eliminates 14 steps and streamlines 5 more. It establishes the benchmark in standardized clinical flow cytometry. LDT steps eliminated by ClearLLab LS LDT steps streamlined by ClearLLab LS Every Event Matters

5 Sample Processing Sample Acquisition Analysis Report Results Prepare samples according to procedure Define instrument settings Create analysis templates Correlate with additional clinical and laboratory findings Create acquisition strategy Analyze data Run samples ClearLLab LS Workflow STANDARDIZED AND STREAMLINED Sample Processing Sample Acquisition Analysis Report Results Prepare samples according to ClearLLab LS Instructions for Use Acquire data according to ClearLLab LS templates Analyze data according to ClearLLab LS templates Correlate with additional clinical and laboratory findings

6 SAMPLE RESULTS WITH ClearLLab LS Normal Bone Marrow CD10 PC CD45 Kro This CD45 x Side Scatter dot plot demonstrates typical components of a normal bone marrow, including granulocytes (blue), monocytes (red), lymphocytes (green), myeloblasts (pink) and B-lymphoid progenitors aka hematogones (orange). This CD19 x CD10 dot plot demonstrates characteristic CD19/ CD10 co-expression by hematogones (orange). CD19-positive B lymphocytes (green) and CD10-positive granulocytes (blue) are also noted. CD34 APC This CD34 x CD19 dot plot demonstrates characteristic CD34 expression by a subset of hematogones (orange) as well as by myeloblasts (pink). CD19-positive B lymphocytes (green) are also noted. Lymph Node with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma CD45 Kro This CD45 x Side Scatter dot plot demonstrates both normal T lymphocytes (green) and a large population of cells displaying slightly lower CD45 expression (red) CD5 AA700 This CD5 x CD19 dot plot demonstrates both normal CD5-positive T lymphocytes (green) and CD5/CD19 co-expression characteristic of CLL/SLL. Note that this immunophenotype is not specific for CLL/SLL, and additional testing may be warranted to further characterize this process. Bone Marrow with B Lymphoblastic Leukemia/ Lymphoma CD45 Kro This CD45 x Side Scatter dot plot demonstrates both normal T lymphocytes (green) and a large population of cells displaying lower CD45 expression (red) CD34 APC This CD34 x CD19 dot plot demonstrates CD34/CD19 co-expression characteristic of B lymphoblastic leukemia/ lymphoma (red). CD10 PC7 CD5 AA700 This CD5 x CD10 dot plot demonstrates CD10 expression by the B lymphoblastic leukemia/lymphoma (red) and CD5 expression by the normal T lymphocytes (green). Bone Marrow with Acute Myeloid Leukemia CD45 Kro This CD45 x Side Scatter dot plot demonstrates typical components of a normal bone marrow, including granulocytes (blue) and lymphocytes (green), as well as a large population of cells displaying lower CD45 expression (pink) CD34 APC This CD34 x Side Scatter dot plot demonstrates CD34 expression by the low density CD45 population (pink). Neither the lymphocytes (green) nor the granulocytes (blue) display CD34 expression CD3 PBE This CD3 x CD19 dot plot demonstrates that the normal lymphocytes (green) are split into CD19- positive B-cells and CD3-positive T-cells. The granulocytes (blue) are negative for both CD19 and CD3, consistent with their myeloid origin. The CD34-positive cells (pink) are also negative for both CD19 and CD3, as well as for CD4, CD5, and CD8 (data not shown), suggesting that they may represent acute myeloid leukemia. Additional testing is warranted to further characterize this process.

7 GETTING STARTED ClearLLab LS Case Book Become familiar with ClearLLab LS analysis results by using our ClearLLab LS Case Book. Cases with characteristic findings typical of common lymphoid and myeloid neoplasms are included, as are cases from patients with clinical and/or laboratory findings that suggest an underlying neoplastic process, but in which no immunophenotypic abnormality is identified. Each case includes a clinical vignette that describes the patient demographics and clinical history, case-specific listmode data files, ClearLLab LS-specific analysis templates, and analysis results. Each case concludes with an Analysis Notes section that highlights the immunophenotypic findings as well as potential pitfalls. Try It Today See for yourself. Try ClearLLab LS on your NAVIOS flow cytometer today. A free of charge demonstration kit is available. Contact your local Beckman Coulter representative, or visit beckman.com/clearllab-ls. NAVIOS Flow Cytometry Platform NAVIOS Flow Cytometers deliver highly sensitive detection, outstanding data interrogation, and exceptional workflow efficiencies. The NAVIOS enables seamless transition from lower complexity assays to advanced applications. You can trust the NAVIOS to deliver consistent results, with software tools that ensure robust quality control and audit capabilities. We offer a full suite of service level options to suit the needs of an array of laboratories or operations and our instruments are supported by our expert application engineers who provide support and training to help drive our customers success. beckman.com/coulter-flow-cytometry/ instruments/flow-cytometers/navios NAVIOS is CE marked for 10-color in-vitro diagnostic use.

8 Choose Beckman Coulter for Benchmark Expertise and Innovation For over 80 years Beckman Coulter has driven innovation. We remain committed to creating flow cytometry solutions that fit seamlessly into your lab s workflow. When you choose a Beckman Coulter product you re choosing expertise, innovation, and quality assurance. Contact your local Beckman Coulter sales representative. beckman.com 2016 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. For Beckman Coulter s worldwide office locations and phone numbers, please visit Contact Us at beckman.com FLOW-2063STE10.16