Abstract：Objectives To verify the detection limit (LOD) of hepatitis B surface antigen (HBsAg) by time-resolved fluorimmunoassay, and to evaluate the suitability of the reference interval. Methods From October 2017 to January 2018, the HBsAg secondary standard substance was diluted and then paired with time-resolved fluorescence method and enzyme-linked immunosorbent assay (ELISA) for detection, the detection limit was the last dilution degree with negative test results after standard substance concentration divided by dilution, to verify the manufacturer′s statement, the results of samples with the same dilution degree detected by the two methods was compared, and the suitability of the reference interval declared by the manufacturer was evaluated. According to the American clinical laboratory standards board (CLSI) EP17-A2 method, create blank limits (LOB) and LOD, and the suitability of the established LOD as the upper limit of the reference interval was evaluated. Results The detection limit of time-resolved fluorimmunoassay method was 0.1 U/mL, which was consistent with the manufacturer′s statement. If the reference interval declared by the manufacturer of the time-resolved fluorimmunoassay detection system was used, the standard substance was diluted 3 times and the result was found to be false negative, which was inconsistent with the ELISA test result, the LOB and LOD of HBsAg established in Department Clinical Laboratory, Yongchuan Hospital of Chongqing Medical University (hereinafter heferred to as "our hospital"), were 0.048 ng/mL and 0.137 ng/mL, respectively. If the reference interval was established with the LOD established chinical laboratory of our hospieal, the results of the two methods were consistent after 3 times of dilution, and both were positive. Conclusion The detection limit declared by the time-resolved fluorimmunoassay analysis system is acceptable, but the reference interval declared by the manufacturer is not appropriate, which is likely to lead to false negative. The clinical laboratory should establish its own LOD to establish the reference interval. It is suggested to increase the validation of the reference interval in the performance verification of the quantitative detection items of virus markers.
黄利君 常凡 莫展 刁奇志. 时间分辨荧光法检测乙肝表面抗原LOD及参考区间的验证和建立[J]. 中国医药导报, 2019, 16(7): 149-152.
HUANG Lijun CHAN Fan MO Zhan DIAO Qizhi. Verification and establishment of detection limit and reference interval for detection of HBsAg by time - resolved fluoroimmunoassay. 中国医药导报, 2019, 16(7): 149-152.
2019, Vol. 16 
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