TY - JOUR
T1 - A multi-laboratory assessment of lupus anticoagulant assays performed on the ACL TOP 50 family for harmonized testing in a large laboratory network
AU - Favaloro, Emmanuel J
AU - Mohammed, Soma
AU - Vong, Ronny
AU - Chapman, Kent
AU - Swanepoel, Priscilla
AU - Kershaw, Geoffrey
AU - Cai, Nancy
AU - Just, Sarah
AU - Connelly, Lynne
AU - Brighton, Timothy
AU - Pasalic, Leonardo
N1 - © 2022 The Authors. International Journal of Laboratory Hematology published by John Wiley & Sons Ltd.
Publisher Copyright:
© 2022 The Authors. International Journal of Laboratory Hematology published by John Wiley & Sons Ltd.
PY - 2022/6
Y1 - 2022/6
N2 - INTRODUCTION: Lupus anticoagulant (LA) testing is commonly performed within hemostasis laboratories, and the ACL TOP 50 family of instruments represent a new "single platform" of hemostasis instrumentation. Our aim was to evaluate these instruments and manufacturer reagents or alternatives for utility in LA testing.METHODS: Comparative evaluations of LA testing using newly installed ACL TOPs 550 and 750 as well as comparative assessments with existing "reference," predominantly Stago, instrumentation, and reagents. Evaluations comprised both dilute Russell viper venom time (dRVVT) and activated partial thromboplastin time (APTT)-based assays. Establishment of normal reference ranges (NRR).RESULTS: The HemosIL dRVVT-based assays showed good comparability with the existing Stago reference method (R > 0.9) and could be considered as verified as fit for purpose. A variety of APTT assays was additionally evaluated for LA utility, and we identified from the assessment good utility of a non-Werfen solution in Hyphen BioMed Cephen reagents. NRR were established based on ≥120 normal individual plasma samples.CONCLUSION: This evaluation of LA reagents on ACL TOP 50 Family instruments identified overall acceptable performance of both dRVVT (Werfen solution) and APTT (non-Werfen solution) to enable harmonization of LA testing in our large network.
AB - INTRODUCTION: Lupus anticoagulant (LA) testing is commonly performed within hemostasis laboratories, and the ACL TOP 50 family of instruments represent a new "single platform" of hemostasis instrumentation. Our aim was to evaluate these instruments and manufacturer reagents or alternatives for utility in LA testing.METHODS: Comparative evaluations of LA testing using newly installed ACL TOPs 550 and 750 as well as comparative assessments with existing "reference," predominantly Stago, instrumentation, and reagents. Evaluations comprised both dilute Russell viper venom time (dRVVT) and activated partial thromboplastin time (APTT)-based assays. Establishment of normal reference ranges (NRR).RESULTS: The HemosIL dRVVT-based assays showed good comparability with the existing Stago reference method (R > 0.9) and could be considered as verified as fit for purpose. A variety of APTT assays was additionally evaluated for LA utility, and we identified from the assessment good utility of a non-Werfen solution in Hyphen BioMed Cephen reagents. NRR were established based on ≥120 normal individual plasma samples.CONCLUSION: This evaluation of LA reagents on ACL TOP 50 Family instruments identified overall acceptable performance of both dRVVT (Werfen solution) and APTT (non-Werfen solution) to enable harmonization of LA testing in our large network.
KW - activated partial thromboplastin time
KW - lupus anticoagulant assays
KW - Russell viper venom time
KW - verification
KW - Antiphospholipid Syndrome
KW - Prothrombin Time/methods
KW - Laboratories
KW - Partial Thromboplastin Time
KW - Humans
KW - Blood Coagulation Tests/methods
KW - Lupus Coagulation Inhibitor
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U2 - 10.1111/ijlh.13818
DO - 10.1111/ijlh.13818
M3 - Article
C2 - 35234361
SN - 1751-553X
VL - 44
SP - 654
EP - 665
JO - International Journal of Laboratory Hematology
JF - International Journal of Laboratory Hematology
IS - 3
ER -