Verification of the ACL Top 50 Family (350, 550, and 750) for Harmonization of Routine Coagulation Assays in a Large Network of 60 Laboratories

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 (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.

A multi‐laboratory assessment of lupus anticoagulant assays performed on the ACL TOP 50 family for harmonized testing in a large laboratory network

“…provider in Australia, the RCPAQAP. We also confirmed this threeinstrument "equivalence" in a previous evaluation study in relation to routine coagulation assays 14 and also previously assessed the instruments and applicable reagents for congenital thrombophilia tests. 15 The current evaluation also assessed IL methods/instruments/reagents against those already existing at the evaluation sites, but focussed on LA assays.…”

“…This process is summarized in Figure S1. It should be noted that these evaluations supplement previous evaluations performed and as recently published by our group for routine coagulation tests 14 and congenital thrombophilia testing 15 performed of this instrument platform.…”

“…We recently reported a major evaluation of routine coagulation tests (prothrombin time [PT], APTT, fibrinogen, thrombin time, Ddimer) as performed on the three-instrument platform, and which formed the basis for a 75 instrument rollout to 60 laboratory sites in our organization, New South Wales (NSW) Health Pathology (NSWHP), being the largest public pathology testing service in Australia. 14 In this prior evaluation, we essentially confirmed the "equivalence" (or "interchangeability") of all three TOP instrument types (350, 550, 750) in terms of assay results. More recently, we further reported an evaluation of congenital thrombophilia assays on this platform, using both manufacturer and alternate reagents.…”

“…The LA guidance from CLSI, however, tends to argue against use of the 99th percentile approach, given the multiple steps in the LA process. 7 Some evaluations of ACL TOP instruments have been previously published, as also previously reported by us, 14,15 but none of those previous reports discussed evaluation of LA assays on ACL TOPs, as did none of the cited literature, which was largely focused…”

“…Subsequent to the prior evaluations, and based on contractual arrangements, the group agreed on the use of IL SynthASil APTT reagent as the standard APTT reagent for use in the entire 75 instrument/60 laboratory network of NSW Health Pathology. 14 Unfortunately, this reagent is LA sensitive, and IL does not manufacture an LA insensitive APTT reagent that can also provide good factor level sensitivity and also heparin sensitivity for use as a heparin therapeutic range. In this respect, the current evaluation has identified acceptable NRR for these reagents, as well as the IL recommended 1.2 as an acceptable cutoff LA dRVVT screen/confirm normalized ratio for accreditation purposes (Figure 3; Table 2).…”