Abstract:

Objective To evaluate the analytical quality of homocysteine（Hcy） in Shanghai clinical laboratories，through analyzing the results of Hcy trueness verification of 2021，Shanghai. Methods Residual samples from clinical laboratory tests were collected and prepared into high and low concentrations of frozen mixed serum samples（HCY2021-A and HCY2021-B）. Participating clinical laboratories measured the samples for several times in 3 consecutive working days and reported the results through the network platform. The deviation between clinical laboratory test data and target value，coefficient of variation（CV），deviation and CV after grouping by different reagents were analyzed. Results The CV of HCY2021-A and HCY2021-B were 0.28%-9.44% and 0.25%-10.69%，respectively. The deviations between HCY2021-A and target value were -20.21%-31.39%. The deviations between HCY2021-B and target value were -29.66%-23.93%. Grouped by reagents，the deviations between the mean value of HCY2021-A and target value were -25.33%-20.27%，and the deviations between the mean value of HCY2021-B and target value were -18.41%-23.00%. The qualified rates of clinical laboratories with the results of reference method as the target value and the standard of 1/2 allowable total error（TEa） were 62.07% and 65.52%，respectively. Conclusions The accuracy of Hcy determination in Shanghai clinical laboratories remains to be improved.

Key words: Homocysteine, Reference measurement procedure, Trueness verification