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 Hematoljournal_title
International journal of laboratory hematologyauthors
Cupaiolo R,Govaerts D,Blauwaert M,Cauchie Pdoi
10.1111/ijlh.13100subject
Has Abstractpub_date
2019-12-01 00:00:00pages
731-737issue
6eissn
1751-5521issn
1751-553Xjournal_volume
41pub_type
杂志文章abstract:INTRODUCTION:The blood count provides qualitative and quantitative essential information on bloodlines. Reference hematologic parameters have been established in children and neonates, but few data are available regarding the premature population during the first month of life. The main objective of this study was to e...
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