Evaluation of the Nanopia P-FDP Reagent Kit for Use in the STA-R EVOLUTION Automated Blood Coagulation Analyzer / 임상검사와정도관리

ABSTRACT

BACKGROUND: In this study on fibrinogen/fibrin degradation products (FDPs), we evaluated the performance of a quantitative immunoturbidimetric assay (ITA) using the new Nanopia P-FDP reagent kit (Sekisui Medical Co., Japan) in comparison with a semiquantitative latex agglutination assay (LA) currently performed using the FDP PLASMA kit (Diagnostica Stago SAS, France). METHODS: The quantitative Nanopia P-FDP method using the STA-R EVOLUTION automated coagulation analyzer (Diagnostica Stago SAS) was evaluated with respect to precision, linearity, carryover, and reference interval. The correlations were measured for each of the 145 samples by using the Nanopia P-FDP method and the semiquantitative FDP PLASMA method. RESULTS: The coefficients of variation with regard to precision in low and high control concentrations were 2.97% and 5.77%, respectively. The correlation coefficient of linearity (r) was 0.990 in the measurement range of 2.4-122.8 microg/mL. The level of carryover was 0.83%, while the reference interval range was 0.22-4.32 microg/mL. The results of FDP assay showed an acceptable accord in 115 samples (79%) among the 145 samples by both LA method and ITA method. Seventeen samples (12%) showed relatively lower FDP values in the LA method than those in the ITA method. Thirteen cases (9%) showed relatively higher FDP values in the LA method than those in the ITA method. CONCLUSIONS: The quantitative Nanopia P-FDP method showed good precision, linearity, carryover, reference interval, and an acceptable concordance rate with the semiquantitative FDP PLASMA method. Thus, the Nanopia P-FDP reagent using the STA-R EVOLUTION automated coagulation analyzer can replace the FDP PLASMA reagent for the quantitative analysis of FDPs.