Objective Using the CLSI EP09c guideline as the standard, this study evaluated the comparability and bias of measurement procedures for detecting fibrin/fibrinogen degradation products (FDP) and D-dimers (DD) in plasma using chemiluminescence and latex immunoturbidimetry methods, providing a reference basis for mutual recognition of FDP and DD results obtained using different methods. Methods Latex immunoturbidimetry was used as the reference method (X) and chemiluminescence immunoassay as the test method (Y). Passing-Bablok regression was used to perform linear fitting of the results, and the bias at the selected concentration levels was calculated separately. Using 1/2 TEa (the total allowable error permitted by the National Health Commission Clinical Laboratory Center's interlaboratory quality assessment) as the evaluation criterion, the test results were subjected to methodological comparison and bias assessment, and the correlation, consistency, and superiority of the two measurement procedures were assessed. Results The bias of chemiluminescence method was -9.59% (<17.5%) for FDP at 5.0 mg/L and 14.29% (<25.0%) for DD at 0.5 mg/L, both within acceptable ranges. The chi-square test results of DD and FDP showed that the two methods had a good correlation (P<0.001), The Kappa test results of FDP were k=0.66(P<0.001) and the Kappa test of DD was k=0.85(P<0.001), both indicating good agreement, and the McNemar test showed no significant difference between the two methodologies (P>0.05), and the two measurement procedures were comparable. Conclusion The measurement procedures for FDP and DD using the two methods show good consistency and correlation. The bias at the upper limit of the clinical reference range is within an acceptable range, meeting clinical testing requirements, and mutual recognition is possible within a certain range.
Key words
EP09c /
fibrin degradation products /
D-Dimer /
chemiluminescence method /
latex immunoturbidimetry /
measurement procedure
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