PMID- 33891005
OWN - NLM
STAT- MEDLINE
DCOM- 20211018
LR  - 20211018
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 156
IP  - 4
DP  - 2021 Sep 8
TI  - Verification of the ACL Top 50 Family (350, 550, and 750) for Harmonization of 
      Routine Coagulation Assays in a Large Network of 60 Laboratories.
PG  - 661-678
LID - 10.1093/ajcp/aqab004 [doi]
AB  - OBJECTIVES: To verify a single platform of hemostasis instrumentation, the ACL 
      TOP 50 Family, comprising 350, 550, and 750 instruments, across a large network 
      of 60 laboratories. METHODS: Comparative evaluations of instrument classes (350 
      vs 550 and 750) were performed using a large battery of test samples for routine 
      coagulation tests, comprising prothrombin time/international normalized ratio, 
      activated partial thromboplastin time (APTT), thrombin time, fibrinogen and 
      D-dimer, and using HemosIL reagents. Comparisons were also made against existing 
      equipment (Diagnostica Stago Satellite, Compact, and STA-R Evolution) and 
      existing reagents to satisfy national accreditation standards. Verification of 
      manufacturer normal reference ranges (NRRs) and generation of an APTT heparin 
      therapeutic range were undertaken. RESULTS: The three instrument types were 
      verified as a single instrument class, which will permit standardization of 
      methods and NRRs across all instruments (n = 75) to be deployed in 60 
      laboratories. In particular, ACL TOP 350 test result data were similar to ACL TOP 
      550 and 750 and showed no to limited bias. All manufacturer NRRs were verified 
      with occasional minor variance. CONCLUSIONS: This ACL TOP 50 Family (350, 550, 
      and 750) verification will enable harmonization of routine coagulation across all 
      laboratories in the largest public pathology network in Australia.
CI  - (c) American Society for Clinical Pathology, 2021. All rights reserved. For 
      permissions, please e-mail: journals.permissions@oup.com.
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, Australia.
AD  - Sydney Centres for Thrombosis and Haemostasis, Westmead, Australia.
AD  - School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, Australia.
FAU - Mohammed, Soma
AU  - Mohammed S
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, Australia.
FAU - Vong, Ronny
AU  - Vong R
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, Australia.
FAU - McVicker, Wendy
AU  - McVicker W
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, Australia.
FAU - Chapman, Kent
AU  - Chapman K
AD  - Haematology, NSW Health Pathology, John Hunter Hospital, Newcastle, Australia.
FAU - Swanepoel, Priscilla
AU  - Swanepoel P
AD  - Haematology, NSW Health Pathology, John Hunter Hospital, Newcastle, Australia.
FAU - Kershaw, Geoff
AU  - Kershaw G
AD  - Haematology, NSW Health Pathology, Prince Alfred Hospital, Camperdown, Australia.
FAU - Cai, Nancy
AU  - Cai N
AD  - Haematology, NSW Health Pathology, Prince Alfred Hospital, Camperdown, Australia.
FAU - Just, Sarah
AU  - Just S
AD  - Haematology, NSW Health Pathology, Royal North Shore Hospital, St Leonards, 
      Australia.
FAU - Connelly, Lynne
AU  - Connelly L
AD  - Haematology, NSW Health Pathology, Royal North Shore Hospital, St Leonards, 
      Australia.
FAU - Prasad, Ritam
AU  - Prasad R
AD  - Haematology, NSW Health Pathology, John Hunter Hospital, Newcastle, Australia.
FAU - Brighton, Timothy
AU  - Brighton T
AD  - Haematology, NSW Health Pathology, Royal North Shore Hospital, St Leonards, 
      Australia.
FAU - Pasalic, Leonardo
AU  - Pasalic L
AD  - Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), NSW 
      Health Pathology, Westmead Hospital, Westmead, Australia.
AD  - Sydney Centres for Thrombosis and Haemostasis, Westmead, Australia.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
SB  - IM
MH  - Blood Coagulation Tests/*instrumentation
MH  - Humans
MH  - International Normalized Ratio
MH  - Laboratories/*standards
MH  - Partial Thromboplastin Time
MH  - Pathology/*instrumentation
MH  - Prothrombin Time
OTO - NOTNLM
OT  - APTT
OT  - Laboratory testing
OT  - PT
OT  - Routine coagulation tests
OT  - Verification
EDAT- 2021/04/24 06:00
MHDA- 2021/10/21 06:00
CRDT- 2021/04/23 12:27
PHST- 2021/04/24 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2021/04/23 12:27 [entrez]
AID - 6247941 [pii]
AID - 10.1093/ajcp/aqab004 [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2021 Sep 8;156(4):661-678. doi: 10.1093/ajcp/aqab004.