[Study and analysis of national current status and problems of anticoagulant proteins assay].

Abstract

<b>Objective:</b> To investigate current status and problems of anticoagulant proteins assay in domestic laboratories so as to provide suggestions for implementing the standardization and quality improvement. <b>Methods:</b> Two hundred and seventy-four laboratories those had developed or prepared to do anticoagulant proteins assay were selected from one thousand and five hundred participants in the national coagulation screening External Quality Assessment(EQA) program by an internet survey and then a questionnaire and quality control materials were sent to them to carry out a further survey. The questionnaire information was analyzed statistically. The results of quality control materials were grouped by the reagents and the average, median, standard deviation(<i>s</i>), coefficient variation(<i>CV</i>) of each group were calculated. The deviations or percentage deviations were determined by comparing the results of each laboratory to the target defined as the peer-group median after exclusion of outliers, and then the pass rates were calculated based on the criterion of RCPA, DGKL and the allowable total error based on biological variation. <b>Results:</b> Two hundred and thirty-five questionnaires were collected. The number of laboratories testing antithrombin(AT), protein C(PC) and protein S(PS) activity were 194, 63 and 50 respectively. The instruments and reagents were mainly from abroad (more than 96%), the matching rate of which were above 94%. For AT, PC and PS activity testing, there were 30.4%, 33.3%, 34.0% of laboratories did not perform verification assays respectively, and 8.8%, 7.9%, 14.0% of laboratories did not renew calibration curve when the reagent lots were changed. 11.3%, 17.5%, 16.0% of laboratories didn't run internal quality control, and 34.9%, 26.9%, 21.4% of laboratories only performed a single level of quality control. 4.1% of laboratories set the reference intervals of AT activity according to different age groups, and the percentage of that of PC and PS activity were 1.6% and 2.0%. 16.0% of laboratories set the reference interval of PS activity by sex. For normal control materials, the <i>CV</i> of AT, PC and PS activity results were 5.7%-12.9%, 4.2%-7.7% and 18.4%-33.1% while the <i>CV</i> for abnormal level were 13.3%-38.3%, 6.1%-14.4% and 31.5%-34.5% respectively. The pass rate was different when it was judged by different criteria. A suitable criterion for each item should be selected according to the concentration level of quality control materials. <b>Conclusion:</b> The comparability between laboratory results are not satisfactory and in order to promote quality improvement, it is necessary to develop guidelines, organize trainings and establish a national EQA scheme.

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