External quality assessment for nucleic acid quantitative testing of human hepatitis B and hepatitis C virus in Chongqing, China: 2009–2024

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Background: To achieve the goal of eliminating viral hepatitis as a public health threat by 2030, accurate detection of HBV-DNA and HCV-RNA is crucial. This study presents the implementation of HBV-DNA and HCV-RNA External Quality Assessment (EQA) programs conducted in Chongqing, China, from 2009 to 2024, highlighting the significant contributions made by clinical laboratories. Methods: Over a span of 16 years, a total of 160 samples were distributed in the HBV-DNA EQA program, while the HCV-RNA EQA program disseminated 105 samples encompassing diverse concentration levels. Factors such as the number of participating laboratories, employed detection methodologies, utilized reagents, and test outcomes were evaluated to assess the HBV-DNA and HCV-RNA detection capabilities of clinical laboratories over the past decade. Results: By 2024, the number of laboratories participating in HBV-DNA EQA activities had increased from 45 in 2009 to 110 in 2024, representing a 144.44 % increase. Similarly, the number of laboratories participating in HCV-RNA EQA activities had risen from 7 in 2014 to 30 in 2024, marking a 328.57 % increase. The accuracy rate for HBV-DNA EQA activity results improved from 85.37 % in 2009 to 98.18 % in 2024, while the accuracy rate for HCV-RNA EQA activity results rose from 66.67 % in 2014 to 96.67 % in 2024. Satisfactory reproducibility was observed in parallel samples. However, certain laboratories exhibited significant bias in low- and high-concentration samples. Conclusion: The performance of laboratories in Chongqing, China, for HBV-DNA and HCV-RNA testing has consistently improved through their participation in EQA programs. In the future, sample distribution should include more challenging ones, particularly low- or high-concentration samples. Emphasis should also be placed on standardized operation and performance validation of the assay system.