Cardiac Assessment Controls - Bio-Rad

1 Bio-Rad Laboratories Cardiac Assessment Controls Cardiac Assessment Controls Value Assigned for Clinical Laboratory and Point of Care Test Systems Solving the Challenges of Troponin I Testing for the Central Laboratory and POCT Systems Quality control of Troponin I (TnI) at low levels is critical. At least one value above the 99th percentile upper reference limit (URL) designates myocardial Yet TnI test methods vary. The FDA has stated, different troponin assays have wide variations in lower detection limits, upper reference limits, diagnostic points, assay imprecision (CV), and specimen matrices.

2 2. But physicians rely greatly on TnI results due to their critical significance which means it is best if the control materials you use reflect precision at diagnostic levels. Achieve better control of Troponin with QC from Bio-Rad . Bio-Rad provides a selection of multiple Level 1 Controls for TnI assays to allow each laboratory to select the low TnI value which best suits their platform. Typical product level selections by platform: control Level Relative Tnl Value Manufacturer Instrument Beckman Coulter Access.

3 BioMerieux VIDAS *. 1 100%. Mitsubishi PATHFAST *. Radiometer AQT90 FLEX*. IMMULITE . 1A 120% Siemens Dimension Series - CTNI. Stratus CS*. Siemens ADVIA Centaur . 1B 60%. TOSOH ST AIA-Pack ARCHITECT iSystems Abbott i-STAT System*. 1C 40% Ortho VITROS ECi (ES). Siemens Dimension EXL LOCI Module Dimension Vista Systems LOCI. *POCT Methods Listed 1. Joint ESC/AACF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal universal definition of myocardial Infarction.

4 European Heart Journal 2012; 33: 2551-2567. Available online at: 2. Troponin: What Laboratorians Should Know to Manage Elevated Results, accessed May 16, 2012, Cardiac Assessment Controls The Right Quality Controls at the Level of Assessment You Need for Your Cardiac Testing Packaged how you need it with our new mL fill size for the Dimension Vista . Liquichek Cardiac Markers Plus control LT. A comprehensive Cardiac Assessment control designed to monitor assay precision across the range of clinically significant values such as lower levels of Troponin.

5 3 mL Fill Size mL Fill Size Liquid, human serum based Offers 7 analytes to match the Dimension Vista test menu 3 year shelf life at -20 C to -70 C Shared lot numbers and Unity peer groups with existing 20 day open-vial stability at 2 8 C for most analytes 3mL fill size Choice of four low Troponin I levels (1, 1A, 1B and 1C) Compatible with on-board refrigerated storage on the Includes values for Troponin T (GEN 4 and hs) and Dimension Vista . hs-CRP 2D barcode for quick and easy product insert and vial Offers both BNP and NT-proBNP label scanning Level Low offers lower target values for all analytes 10 day open-vial (punctured) stability for all analytes when stored at 2-8 C.

6 Analytes BNP** CK-MB Isoenzyme Digitoxin Myoglobin Troponin I. CK (Total) CRP Homocysteine* NT-proBNP Troponin T**. With Bio-Rad Quality Controls , you choose the products best suited for your Cardiac Assessment needs. Correct diagnosis regarding the source of chest pain if laboratories choose QC product at decision levels that is a pivotal decision that can rely on accurate Assessment are appropriate for the Cardiac markers they test. So much of specific Cardiac markers. So many variables markers, is at stake!

7 Does that one-size-fits-all control acutally indicate platforms, sites affect Cardiac marker results that carry performance where the laboratory needs it most? sizeable outcomes for both patients and providers. It is best If not, it's time to look at Bio-Rad for a QC solution. *No claim is made for expected values or stability. **Not claimed under mL fill size. For specific analyte, open-vial stability, methods, mean values and ranges, refer to the package inserts of currently available lots at There is no one-size-fits-all Quality control in a State-of-the-Art Cardiac Program Because no single marker provides the complete picture of a Cardiac patient's clinical status.

8 Liquichek D-dimer control Liquichek Homocysteine control Provides the laboratory with a four level control for A single analyte control designed to monitor Homocysteine monitoring the precision of D-dimer testing on most precision across a wide range of target values. automated coagulation, chemistry and immunoassay Liquid, human serum based analyzers. 3 year shelf life at -20 C to -70 C. Liquid, human plasma based Includes values on all three levels for HPLC and 3 year shelf life at -20 C to -70 C which allows for fewer automated immunoassays (Abbott, Beckman Coulter , crossover studies Roche and Siemens).

9 15 day open-vial stability at 2 8 C. Target Value Target Value D-dimer ng/mL (FEU) . Level 1 Level 2 Level 3. Level Low 250. Homocysteine ( mol/L) 28. Level 1 550. Recovered values may vary with methodology. Level 2 1600. Level 3 3200.. Fibrinogen Equivalent Units (FEU) = twice the mass of the D-DU (D-dimer units). The values listed are approximate targets. The actual observed values will vary depending upon lot number, analyzer, reagent, method, and calibrator. Complete the clinical picture using Liquichek D-dimer and Liquichek Homocysteine Controls .

10 Markers signify different health conditions at different control is particularly useful for monitoring test precision concentrations. Running two concentrations of a control over a wide assay range. These single analyte Controls for material may meet minimum regulatory requirements but D-dimer and Homocysteine also spare consumption may not adequately address the need to provide control of multi-analyte Controls where these two markers are across the Analytical Measurement Range (AMR). Having measured on separate platforms.