A multi-laboratory assessment of congenital thrombophilia assays performed on the ACL TOP 50 family for harmonisation of thrombophilia testing in a large laboratory network.

Clinical Chemistry and Laboratory Medicine : CCLM
Emmanuel J FavaloroLeonardo Pasalic

Abstract

Thrombophilia testing is commonly performed within hemostasis laboratories, and the ACL TOP 50 family of instruments represent a new 'single platform' of hemostasis instrumentation. The study objective was to evaluate these instruments and manufacturer reagents for utility of congenital thrombophilia assays. Comparative evaluations of various congenital thrombophilia assays (protein C [PC], protein S [PS], antithrombin [AT], activated protein C resistance [APCR]) using newly installed ACL TOPs 550 and 750 as well as comparative assessments with existing, predominantly STAGO, instrumentation and reagents. Verification of manufacturer assay normal reference ranges (NRRs). HemosIL PC and free PS assays showed good comparability with existing Stago methods (R>0.9) and could be considered as verified as fit for purpose. HemosIL AT showed high relative bias with samples from patients on direct anti-Xa agents, compromising utility. Manufacturer NRRs for PC, PS and AT were verified with minor variance. Given the interference with direct anti-Xa agents, an alternate assay (Hyphen) was evaluated for AT, and the NRR also verified. The HemosIL Factor V Leiden (APC Resistance V) evidenced relatively poor performance compared to existing ass...Continue Reading

References

Feb 21, 2009·International Journal of Laboratory Hematology·M MilosR Zadro
Dec 17, 2009·Seminars in Thrombosis and Hemostasis·Emmanuel J FavaloroGiuseppe Lippi
Mar 14, 2013·Seminars in Thrombosis and Hemostasis·Emmanuel J FavaloroGiuseppe Lippi
Aug 14, 2013·Clinical Chemistry and Laboratory Medicine : CCLM·Emmanuel J Favaloro
Aug 15, 2017·Methods in Molecular Biology·Martina MontagnanaElisa Danese
Aug 15, 2017·Methods in Molecular Biology·Richard A Marlar, Jana N Gausman
Aug 15, 2017·Methods in Molecular Biology·Richard A Marlar, Jana N Gausman
Aug 15, 2017·Methods in Molecular Biology·Jana N Gausman, Richard A Marlar
Aug 6, 2020·Pathology·Emmanuel J FavaloroGiuseppe Lippi
Jan 9, 2021·International Journal of Hematology·Masahiro IekoDongchon Kang

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