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| Performance verification of Mx3000pTM real-time fluorescent quantitative PCR HBV-DNA detection system |
| WANG Jiao1,2 QIAN Jun1,2 SHI Ying1,2 CAI Wangxi1,2 LIU Guangzhong1,2▲ |
1.Department of Clinical Laboratory, Hubei Provincial Hospital of Traditional Chinese Medicine, Hubei Province, Wuhan 430074, China;
2.Hubei Province Academy of Traditional Chinese Medicine, Hubei Province, Wuhan 430074, China |
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Abstract Objective To verify the performance of Mx3000pTM real-time fluorescent quantitative PCR HBV-DNA detection system, in order to confirm its stability, accuracy and reliability. Methods According to the EP series of document issued by the National Committee for Clinical Laboratory Standards (NCCLS) and requirements for the assessment of laboratory testing systems issued by China National Accreditation Service for Conformity Assessment (CNAS), the precision, accuracy, linear, measurement and/or reportable range and anti-interference ability of Mx3000pTM real-time fluorescent quantitative PCR were performed and evaluated. Results The within-batch precision CV of low value and high value of Mx3000pTM real-time fluorescent quantitative PCR HBV-DNA testing system was 5.21% and 3.40%,respectively, and the between-batch precision CV of middle value and high value was 3.45% and 1.39% respectively. The correctness was valuated by participating in verification of room to judge the qualitative evaluation of the project and PT result was 100%. The linear regression equation was Y = 1.010X +0.004, R2 = 0.991. The linearity range was 5.00×102 - 2.84×108 U/mL, the clinical reportable range was 103 - 108 U/mL; five samples was tested to assess the anti-interference capability, four sample measurement results according to the concentration of expected bias was < ±7.5%. Conclusion The performance of Mx3000pTM real-time fluorescent quantitative PCR HBV-DNA testing system conforms to the requirements in precision, accuracy, linear range, clinical reportable range, anti-interference ability and can be applied to the clinical detection.
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