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The performance of quantitative D-dimer assays in Chinese clinical laboratories by analyzing data from National
Chenbin Li1, Chengshan Xu1, Gaofeng Hu1
1National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital,National Center of Gerontology, P.R. China.
Background And Aims:
To investigate performance of D-dimer assays in China and address analytical quality issues.
Materials And Methods:
D-dimer assays data were collected from China National External Quality Assessment Scheme (China NEQAS) from 2014 to 2022. We analyzed reagents, assay results, reporting unit and cutoffs in 2022 China NEQAS. Interlaboratory coefficient variations (CVs) and influence of modified/unmodified test systems on CVs were investigated over 9 years.
Results:
There were 82 reagent brands in China NEQAS, but 55 reagent instructions did not indicate expression unit (DDU or FEU). Up to 7-fold of the ratio of max-to-min mean results was shown among different assays with same unit on the same sample. A prevalence of FEU (63.4%) over DDU (17.1%) was observed. Although 669 laboratories (37.9%) among 1766 laboratories used reagents without VTE exclusion claim, they also reported cutoffs. The CVs of only two assays were decreasing over years. CVs of modified test systems were higher than those of unmodified systems before improvement.
Conclusions:
Expression unit should be required to label in package inserts by regulatory authority. Laboratory professionals should follow instructions for use and prefer unmodified test systems for clinical safely application. Harmonization of reporting units through collaborative efforts is the promising step.
