Abstract
ObjectivesFor new analyzers or tests, analytical evaluation is required before implementation in the clinical laboratory. We evaluated the novel Roche Cobas t711 analyzer with six newly developed coagulation assays: the activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen, d-dimer and anti-Xa. The evaluation included imprecision experiments, method comparison with the currently used Stago STA-R Evolution, monitoring of unfractionated heparin (UFH) with aPTT, a fast centrifugation protocol to improve turn-around time, and determination of sample stability in whole blood and plasma. Design and methodsImprecision and method comparison were assessed using commercial quality control samples and patient samples, respectively. For dose monitoring of UFH with the aPTT, samples from patients treated with UFH were used. Samples from healthy volunteers were collected for evaluation of the fast centrifugation protocol (5’ 2750×g) and for investigating sample stability over 6–8 h. ResultsResults for between-run precision were within the desirable specification. Method comparison showed an excellent agreement for fibrinogen, d-dimer and anti-Xa. For aPTT, PT and INR, a good correlation was found, but results were significantly lower on the t711 compared to the STA-R Evolution, which is caused by different coagulation activators. Results from the fast centrifugation protocol differed not significantly from the standard protocol (15’ 2500×g). Blood and plasma samples were stable at room temperature up to 6 and 8 h, respectively. ConclusionsThe t711 coagulation analyzer with 6 novel tests is suitable for routine use in clinical laboratories.
Highlights
Laboratory accreditation according to the international standard ISO15189:2012 demands that laboratories validate each novel assay and instrument before it can be used in clinical practice [1]
ISO15189 standard does not specify which performance characteristics need to be evaluated, common verification procedures include at least analysis of imprecision and method comparison [2,3]
No explanation was found for the higher CV% of the anti-Xa for unfractionated heparin (UFH) measured in the current study
Summary
Laboratory accreditation according to the international standard ISO15189:2012 demands that laboratories validate each novel assay and instrument before it can be used in clinical practice [1]. When methods developed by certified in vitro diagnostic companies are implemented without any modification, verification (instead of validation) of the method will suffice (ISO15189 paragraph 5.5.1.2). This implies that the laboratory should confirm that the performance characteristics as stated by the manufacturer are met. ISO15189 standard does not specify which performance characteristics need to be evaluated, common verification procedures include at least analysis of imprecision and method comparison [2,3]. Additional performance characteristics can be included in the verification process based on national or local guidelines, or the laboratory specialist’s professional opinion
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