Performance validation of ABI ViiA 7 Taqman HBV-DNA detecting system / 国际检验医学杂志

ABSTRACT

Objective To verify the performance of the ABI ViiA 7 Taqman HBV-DNA detecting system for confirming its sta-bility,accuracy and reliability.Methods According to the evaluation protocols of Clinical and Laboratory Standards Institute (CLSI),the performance of ABI ViiA 7 Taqman HBV-DNA detecting system was assessed in the aspects of precision,accuracy,lin-earity and comparability;the quantitative detection limit validation experiments was performed by diluting specimen until quantita-tive detection limit is lower than the lower limit of detection,and the detection results were compared with the quality target re-quirements and the analysis capability declared by manufacturers.Results The CV in within-run precision of this detection system was 1.485%,1.990% and 0.932% respectively;the total CV was 1.876%,3.361% and 1.891%,respectively;the maximum devia-tion of accuracy was -6.8%;the linear correlation coefficient was 0.998 3;the regression equation was Y =0.974 8X +0.050 7. The linear range was 1.00E2 - 2.00E8;the quantitative detection limit was 100 IU/mL;the comparability of ABIViiA7 and ABI7500P =0.115,r2 =0.994,the linear regression equation was Y =0.987 2X +0.051 7.Conclusion The ABI ViiA 7 Taqman HBV-DNA detection system has excellent precision,accuracy,sensitivity and linearity and has a good correlation with ABI7500, which can be used for the detection of clinical specimens.