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.

Abstract

OBJECTIVES:

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.

METHODS:

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).

RESULTS:

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 assays, and could not be adopted for use in our network.

CONCLUSIONS:

This evaluation of HemosIL reagents on ACL TOP 50 family instruments identified overall acceptable performance of only two (PC, free PS) of four thrombophilia assays, requiring use of third-party reagents on ACL instruments for the other two assays (AT, APCR).

• Authors: Emmanuel J Favaloro, Soma Mohammed, Ronny Vong, Kent Chapman, Priscilla Swanepoel, Geoff Kershaw, Nancy Cai, Sarah Just, Lynne Connelly, Timothy Brighton, Leonardo Pasalic
• Journal: Clinical chemistry and laboratory medicine (Clin Chem Lab Med) Vol. 59 Issue 10 Pg. 1709-1718 (09 27 2021) ISSN: 1437-4331 [Electronic] Germany
• PMID: 34116591 (Publication Type: Journal Article)
• Copyright: © 2021 Walter de Gruyter GmbH, Berlin/Boston.

Chemical References

• Protein C
• Factor V

Topics

• Activated Protein C Resistance
• Blood Coagulation Tests
• Factor V (analysis)
• Humans
• Laboratories
• Protein C (analysis)
• Thrombophilia (diagnosis)