Performance verification of a individual donation nucleic acid detection system for blood screening / 中国输血杂志

ABSTRACT

【Objective】 To verify the detection performance of a newly introduced individual donation(ID) nucleic acid detection(NAT) system, and to confirm whether its main test parameters meet the expected requirements of blood screening. 【Methods】 Standard serum and plasma negative for HBV DNA, HCV RNA, and HIV RNA were diluted to different multiples samples (0.5~3 times) of the detection system′s limit of detection (LoD). These samples were conducted NAT test for HBV DNA, HCV RNA and HIV-1 RNA, to verify the testing sensitivity, stability, accuracy and anti-interference ability. 【Results】 The sensitivity of 3× LoD concentration of HBV DNA, HCV RNA and HIV-1 RNA was tested by the system, and the yielding rates were all 100%, with 1 ×LoD at 95.0%~100% and 0.5×LoD at 70.0%~90.0%. The intra-assay and inter-assay precision variation coefficient was 2.07%~2.62% and 2.33%~2.88%, respectively. The accuracy of 10 external quality assessment samples of National Center for Clinical Laboratories was 100%. Severe hemolysis and fatty blood had no effect on the detection of samples with 3×LoD concentration of HBV DNA, HCV RNA and HIV-1 RNA. Any combinations by samples with 2 × LoD concentration of HBV DNA, HCV RNA, and HIV-1 RNA were not inhibited by high concentrations of other viruses. Among 2 041 sero-negative samples from blood donor, the NAT yield of this system was 1.67% (34/2 041), which was a little bit higher than that of a imported minipool system (1.66%, 33/2 041) (P>0.05). 【Conclusion】 The ID-NAT system can meet the requirements in terms of sensitivity, stability, accuracy and anti-interference ability, and can be used for blood screening of blood donors.