Exploration of the verification process for the analytic performance of the quantitative project of molecular diagnosis
10.3969/j.issn.1673-4130.2015.16.030
- VernacularTitle:分子诊断定量项目分析性能验证程序探讨
- Author:
Huili LUO
;
Hang YUAN
;
Yuan MAO
;
Houzhi ZHANG
- Publication Type:Journal Article
- Keywords:
performance verification;
accuracy;
precision;
linear validation;
interference test
- From:
International Journal of Laboratory Medicine
2015;(16):2360-2362
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the verification process for the analytic performance of the quantitative project of molecular di-agnosis.Methods Based onMedical laboratory accreditation criteria for quality and competence in the field of molecular diagnos-tics application note(CL-36)(2014)and the relevant documents published by Clinical and Laboratory Standards Institute (CLSI), the performance verification methodology of PCR detection for hepatitis b virus nucleic acid was achieved.for.Results The within-run precision of DNA detection for the hepatitis b virus was 0.109 and 0.105;and the between-run precisionwas 0.1 57 and 0.137. Compared with the reference laboratory,the regression equation was Y =0.947+0.343X ,and the linear correlation coefficient was 0.990.The linear range was 5.00-1.10 and thequantitative detection limit was 500 IU/mL.Hemolysis had no effect on the detec-tion of samples.Conclusion The laboratory with molecular diagnostic program should conduct analytic performance verification,and the appropriate method should be chosen to clear performance verification.Conclusion Clearing the performance indicators of de-tection projects has a very positive role in the clinical use of detection projects..
