Performance verification of a hepatitis B virus DNA quantitative detection kit

Objective To verify and evaluate the performance characteristics of a newly purchased HBV-DNA quantitative detection reagent kit.Methods According to the EP series of document issued by the National Committee for Clinical Laboratory Standards(NCCLS)and the Accreditation Criteria for the Quality and Competence of Medical Laboratories,the precision,correctness,linear range and lower detection limit of the reagent kit and its consistency with different detection reagents were performed.Results The low value and middle value intra-assay precision CV were 3.2% and 3.4% respectively,total precision CV were 4.6% and 3.7% respectively;the correctness was within acceptable range;the linear regression equation was Y=0.958 X+0.355,r2=0.999,the linearity range was(1.48×103-1.48×108)U/mL;the low limit of detection was 500U/mL;compared with original detection reagent kit,the detection results had no difference.Conclusion The new reagent kit has the performance according with the statement of manufacturer and can be used in clinical work.