PMID- 34116591
OWN - NLM
STAT- MEDLINE
DCOM- 20220314
LR  - 20220705
IS  - 1437-4331 (Electronic)
IS  - 1434-6621 (Linking)
VI  - 59
IP  - 10
DP  - 2021 Sep 27
TI  - 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.
PG  - 1709-1718
LID - 10.1515/cclm-2021-0499 [doi]
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).
CI  - (c) 2021 Walter de Gruyter GmbH, Berlin/Boston.
FAU - Favaloro, Emmanuel J
AU  - Favaloro EJ
AUID- ORCID: 0000-0002-2103-1661
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, NSW, Australia.
AD  - Sydney Centres for Thrombosis and Haemostasis, Westmead, NSW, Australia.
AD  - School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, NSW, 
      Australia.
FAU - Mohammed, Soma
AU  - Mohammed S
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, NSW, Australia.
FAU - Vong, Ronny
AU  - Vong R
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, NSW, Australia.
FAU - Chapman, Kent
AU  - Chapman K
AD  - Haematology, NSW Health Pathology, John Hunter Hospital, Newcastle, NSW, 
      Australia.
FAU - Swanepoel, Priscilla
AU  - Swanepoel P
AD  - Haematology, NSW Health Pathology, John Hunter Hospital, Newcastle, NSW, 
      Australia.
FAU - Kershaw, Geoff
AU  - Kershaw G
AD  - Haematology, NSW Health Pathology, Prince Alfred Hospital, Camperdown, NSW, 
      Australia.
FAU - Cai, Nancy
AU  - Cai N
AD  - Haematology, NSW Health Pathology, Prince Alfred Hospital, Camperdown, NSW, 
      Australia.
FAU - Just, Sarah
AU  - Just S
AD  - Haematology, NSW Health Pathology, Royal North Shore Hospital, St Leonards, NSW, 
      Australia.
FAU - Connelly, Lynne
AU  - Connelly L
AD  - Haematology, NSW Health Pathology, Royal North Shore Hospital, St Leonards, NSW, 
      Australia.
FAU - Brighton, Timothy
AU  - Brighton T
AD  - Haematology, NSW Health Pathology, Prince of Wales Hospital, Randwick, NSW, 
      Australia.
FAU - Pasalic, Leonardo
AU  - Pasalic L
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, NSW, Australia.
AD  - Sydney Centres for Thrombosis and Haemostasis, Westmead, NSW, Australia.
LA  - eng
PT  - Journal Article
DEP - 20210614
PL  - Germany
TA  - Clin Chem Lab Med
JT  - Clinical chemistry and laboratory medicine
JID - 9806306
RN  - 0 (Protein C)
RN  - 9001-24-5 (Factor V)
SB  - IM
MH  - *Activated Protein C Resistance
MH  - Blood Coagulation Tests
MH  - Factor V/analysis
MH  - Humans
MH  - Laboratories
MH  - Protein C/analysis
MH  - *Thrombophilia/diagnosis
OTO - NOTNLM
OT  - activated protein C resistance (APCR)
OT  - antithrombin
OT  - laboratory testing
OT  - protein C
OT  - protein S
OT  - thrombophilia assays
OT  - verification
EDAT- 2021/06/12 06:00
MHDA- 2022/03/15 06:00
CRDT- 2021/06/11 20:31
PHST- 2021/04/26 00:00 [received]
PHST- 2021/05/31 00:00 [accepted]
PHST- 2021/06/12 06:00 [pubmed]
PHST- 2022/03/15 06:00 [medline]
PHST- 2021/06/11 20:31 [entrez]
AID - cclm-2021-0499 [pii]
AID - 10.1515/cclm-2021-0499 [doi]
PST - epublish
SO  - Clin Chem Lab Med. 2021 Jun 14;59(10):1709-1718. doi: 10.1515/cclm-2021-0499. 
      Print 2021 Sep 27.