Abstract Number: PB0679
Meeting: ISTH 2020 Congress
Background: Clinical laboratories increasingly need simple, rapid, highly stable routine coagulation assays. A complete line of fully automated liquid global screening assays was developed to facilitate routine tests on citrated human plasma, on any laboratory instrument.
Aims: To report performance characteristics of new liquid clotting Fibrinogen (Fbg), Thrombin Time (TT), Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) assays on CS series, STAR, ACLTOP, BCSXP.
Methods: Performances were evaluated using proposed plasma calibrators and controls by testing within (n=40) and between-run (n=20 to 30) precision, interferences, stability. Comparison studies with commercial predicates were performed on CS-5100 using plasmas samples from healthy subjects or various pathologies.
Results: All ready to use reagents generate highly accurate results, with low within- and between-run coefficients of variation on all analyzers: 0.3% to 5.0%. Extended dynamic range 0.25 – 12 g/L Fbg is obtained on multiple analyzers, without Heparins and DOACs interferences at usual therapeutic concentrations. TT assay is very sensitive to low levels of anti-IIa drugs and heparins. Combined APTT reagents demonstrate good sensitivity and specificity for screening patients with Lupus anticoagulant; PT/APTT are sensitive to low factors concentrations. Ready to use recombinant PT with ISI about 1.0 offers an easy tool for VKA monitoring. Reagents can be used within 5 minutes, and are highly stable up to 3 months at 2-8°C and 15 days onboard. Excellent correlations are obtained with predicates (r 0.918 to 0.999, p< 0.0001, CS-5100).
Conclusions: Ready to use liquid FIBRIPHEN LRT, HEMOCLOT TT LRT, CEPHEN and PTPhen LRT are fully automatable, standardized, highly sensitive global screening/monitoring assays, safe and effective on citrated plasma. They provide enhanced practicability tools to optimize laboratory practice, with low CVs, extended stabilities, good sensitivity and limited interferences. Those polyvalent multiplatform assays can be used within few minutes on all available instruments.
To cite this abstract in AMA style:Peyrafitte M, Dunois C, Molton S, Villedieu V, Amiral J. New Ready-to-Use Liquid Multiplatform Global Screening Assays with Extended Stabilities to Facilitate Laboratory Practice [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/new-ready-to-use-liquid-multiplatform-global-screening-assays-with-extended-stabilities-to-facilitate-laboratory-practice/. Accessed September 21, 2023.
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