Performance evaluation of a new Stago® automated haemostasis analyser: The STA R Max® 2.

Abstract:

INTRODUCTION:The STA R Max® 2 is a new coagulation analyser developed by Diagnostica Stago, able to perform clotting, chromogenic and immuno-turbidimetric tests. A pre-analytical module build into the cap-piercing needle performs the sample integrity verification (sample tube filling and measurement of haemolysis, icterus, lipaemia). The STA R Max® 2 analyser incorporates an accreditation program tools to assist technical validation of the analyser. We assessed the analytical performance of the STA R Max® 2. MATERIALS AND METHODS:The following tests were assessed: prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, factor V (FV), antithrombin (AT), D-dimers (DDI) and von Willebrand factor antigen. The assay precisions were assessed using fresh plasma samples or internal quality controls. An inter-analyser comparison was performed with a STA-R Evolution® analyser or, for the FV, with a BCS® XP System. Haemolysis and icterus detection were also verified. RESULTS:For the intra-assay precision, the coefficients of variation (CV%) were all less than 5% and for DDI, the standard deviation (SD) was less than 0.1. For the inter-assay study, all CV% were less than 5%, with the exception of FV and AT (FV: 6.68% and 5.27%; AT: 7% and 12.14% for normal and pathological values, respectively). SD was less than 0.1 for DDI. The inter-analyser comparison demonstrated good results. Haemolysis and icterus were detected correctly for all our assessed samples. CONCLUSION:According to our methods validation's recommendations, the results demonstrated a good technical and analytical performance of the STA R Max® 2 analysers for the tests assessed.

journal_name

Int J Lab Hematol

authors

Cupaiolo R,Govaerts D,Blauwaert M,Cauchie P

doi

10.1111/ijlh.13100

subject

Has Abstract

pub_date

2019-12-01 00:00:00

pages

731-737

issue

6

eissn

1751-5521

issn

1751-553X

journal_volume

41

pub_type

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