关键词: 酶免检测, 质量监控指标, 分析

Abstract: Objective: To analyze the testing data of enzyme linked immunosorbent assay（ELISA）laboratories, and discuss the
methods to improve the testing ability by monitoring the testing quality through quality monitoring indicators. Method: The test data of
a laboratory from January 2018 to August 2019 were statistically analyzed. The retest/initial reactivity rate of each reagent, the
dispersion index of retest reactivity rate of each batch of the same reagent, and the monthly detection reactivity rate distribution of each
reagent were analyzed. The quality monitoring index values and the trend of changes in the line chart were observed, and a
retrospective analysis of the ELISA was conducted. Results: A total of 54 622 specimens were tested, using 62 batches of 8 ELISA
reagents; the highest retest/first test reactivity rate was 51.88%（HBsAg reagent 2）, and the lowest was 20.59%（anti-HCV reagent 1）.
Using χ2 test to compare the retest reactivity rate of two reagents in the same project, it was found that the reactivity rates of HBsAg
retests were statistically significant（P < 0.05）, and the reactivity rates of anti-HCV, anti-HIV and anti-TP were not statistically
significant（P＞0.05）. There are 4 kinds of reagents with retest/initial test reactivity rate >35%, and among the index of dispersion
degree of retest rate of the same reagent in each batch, there are 5 types with CV < 50%. Conclusion: Through continuous monitoring
and periodic and retrospective analysis of the laboratory quality monitoring indicators of ELISA, it is conducive to the evaluation and
improvement of the test process control, and gradually improve the laboratory testing quality.

Key words: ELISA, quality monitoring indicators, analysis