Verification of the ACL Top 50 Family (350, 550, and 750) for Harmonization of Routine Coagulation Assays in a Large Network of 60 Laboratories.
Am J Clin Pathol
; 156(4): 661-678, 2021 Sep 08.
Article
em En
| MEDLINE
| ID: mdl-33891005
ABSTRACT
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 (nâ =â 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Patologia
/
Testes de Coagulação Sanguínea
/
Laboratórios
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Revista:
Am J Clin Pathol
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Austrália