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Performance evaluation of a new Stago ® automated haemostasis analyser: The STA R Max ® 2
Author(s) -
Cupaiolo Roberto,
Govaerts Danielle,
Blauwaert Marine,
Cauchie Philippe
Publication year - 2019
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.13100
Subject(s) - analyser , haemolysis , partial thromboplastin time , prothrombin time , chromatography , coagulation testing , medicine , chemistry , coagulation , surgery , immunology
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.