Performance Verification of FDP kits made in Sekisui Medical CO .,LTD on STAGO STA-R automatic coagulation analyzer / 国际检验医学杂志

ABSTRACT

Objective To verify the analytical performance of fibrin/fibrinogen degradation products(FDP) detection on STAGO STA‐R automatic coagulation analyzer by using the FDP kits made in Sekisui Medical CO .,LTD .Methods In this study ,the vali‐dations of FDP′s precision ,detection limit ,linear range ,accuracy ,the clinical allowable range and reference range were according to a series of files of American clinical laboratory standardization institute(CLSI) and other relevant experimental documents and com‐pared with its quality performance which showed in kit introductions .Results PrecisionThe within‐run coefficients of variations (CV)were less than 5 .0% ,between‐run coefficients of variations were less than 10 .0% .The detection limit of FDP was 0 .44 mg/L .It was less than that in the kit introductions ,the detection 1imit meets the requirement .The linear equation of FDP was Y=1 .003X+0 .675 ,r2 =0 .995 ,its 1inear range was 0 .44-150 .00 mg/L .Interference testthere was no obvious interference observed when the concentration of total bilirubin <220 μmol/L ,hemoglobin<4 .0 g/L and triglyceride<7 .5 mmol/L in the sample .The relative deviation was <10% .Reference rangethe measured results of FDP in 20 normal individuals were a11 in the reference in‐terval of producers .Conclusion The main performance index of FDP kits made in Sekisui Medical CO ,LTD is comply with the re‐quirements on STAGO STA‐R automatic coagulation analyzer .