TY - JOUR
T1 - 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
AU - Favaloro, Emmanuel J.
AU - Mohammed, Soma
AU - Vong, Ronny
AU - Chapman, Kent
AU - Swanepoel, Priscilla
AU - Kershaw, Geoff
AU - Cai, Nancy
AU - Just, Sarah
AU - Connelly, Lynne
AU - Brighton, Timothy
AU - Pasalic, Leonardo
N1 - Publisher Copyright:
© 2021
PY - 2021/9/27
Y1 - 2021/9/27
N2 - 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).
AB - 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).
KW - activated protein C resistance (APCR)
KW - antithrombin
KW - laboratory testing
KW - protein C
KW - protein S
KW - thrombophilia
KW - assays verification
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U2 - 10.1515/cclm-2021-0499
DO - 10.1515/cclm-2021-0499
M3 - Article
C2 - 34116591
AN - SCOPUS:85108105065
VL - 59
SP - 1709
EP - 1718
JO - Clinical Chemistry and Laboratory Medicine
JF - Clinical Chemistry and Laboratory Medicine
SN - 1434-6621
IS - 10
ER -