核酸检测质量监测指标评价与无效结果成因分析

Objective To systematically evaluate nucleic acid testing(NAT) quality monitoring indicators and thoroughly investigate the causes of invalid results and provide a scientific basis for improving nucleic acid testing(NAT) testing quality by retrospectively analyzing NAT results from voluntary blood donors. Methods We collected data from 201,186 voluntary blood donors tested between January 1, 2023, and December 31, 2024 at the Xuzhou Red Cross Blood. We calculated the following parameters: NAT reactive rate, NAT resolution reactive rate, NAT invalid batch rate, and reagent utilization rate, and compared them with data published by the National Center for Clinical Laboratories. Results From 2023 to 2024, the average NAT reactive rate was 0.06%, with no statistically significant differences across quarters(P>0.05), and all quarterly NAT reactive rates were not higher than the national average for the same reagent group. The average NAT resolution reactive rate was 47.20%, showing no significant differences across quarters(P>0.05), and four quarters exhibited rates below the national average for the same reagent group. The average NAT invalid batch rate reached 2.14%, without statistically significant differences across quarters(P>0.05), and six quarters recorded rates higher than the national benchmark for the same reagent group. The average reagent utilization rate was 144.49%, demonstrating statistically significant differences across quarters(P<0.05), and six quarters exceeded the national average for the same reagent group. Equipment failure and invalid controls were the two primary reasons for NAT invalid results, accounting for 46.52% and 38.37% respectively. Conclusion The trend analysis of annual NAT quality indicators and comparison with national data show that monitoring indicators can reflect the whole process of nucleic acid testing, alert potential risks and optimize the quality control system. Invalid test results caused by equipment failures and failed controls remain urgent problems to be solved in laboratories.