The performance evaluation of emergency immunological parameters in Johnson Vitros 5600 fully automatic biochemical analyzer / 中国医学装备

ABSTRACT

Objective:To have the performance verification of Johnson Vitros 5600 fully automatic biochemical analyzer (hereinafter referred to as Vitros 5600 analyzer) emergency immunological parameter is to provide more accurate and more efficient service for the patients in emergency inspection items.Methods: According to the clinical laboratory standards institute (CLSI) evaluation criterion and Johnson validation plan, we verified the precision, accuracy, linear range, reference range, and carry pollution rate detection indexes of Myoglobin, Troponin I (TropI), N-terminal brain natriuretic titanium (NTproBNP) and total beta human chorionic gonadotropin (TβHCG) about the Vitros 5600 analyzer emergency projects evaluated the performance of the analyzer.Results: The batch precision CV of Myoglobin, TropI, NTproBNP and TβHCG tested by Vitros 5600 analyzer is 0.58~2.02%, < 2.5%, and the inter assay CV is 1.43~3.15%, < 5.0%. Accuracy relative bias is -3.52~4.21%. Linearity relationship is good within the scope of testing,r2 is 0.9836~0.9998, and the slope (a) is 0.9865~1.0207. Carry pollution rate is 0.096~0.180%. Reference range verification coincidence rate is R≥95%.Conclusion: The detection index performance of Vitros 5600 analyzer detecting immune emergency projects is good. It can meet the demand of emergency immune inspection work.