Use of COBAS S201 nucleic acid detection system in screening blood donors.

Objective To investigate the residual risk in the current blood screening system in Dongguan City by Roche COBAS S201 nucleic acid detection system, in order to assess the necessity and feasibility of nucleic acid amplification technique (NAT). Methods 40 018 ELISA-negative samples were detected for HBV DNA, HCV RNA as well as HIV RNA by Roche COBAS S201 detection system from July 31,2008 to March 31, 2009. Positive samples were under quantitative detection of nucleic acid by COBAS Ampliprep/Taqman platform as well as "two pairs of semi "-experiments of hepatitis B by Roche ECL electrochemiluminescence detection system, aiming at helping to analyze the infection status of samples.Results 31 NAT-reactive samples were found, and the positive rate was 0.77‰. 17 of 31 samples were HBV DNA-reactive, and the residual risk was 1/2354-1/1291. The clinical specificity of COBAS S201 nucleic acid detection system was 99.97%. Conclusions The current blood screening strategy is that the samples are under twice ELISA detections, but the risk of transfusion-transmitted diseases still lies in it.COBAS S201 nucleic acid detection system, safe and easily operative, including Roche's patented antipollution technology, can ensure the accuracy and reliability for test results and is suitable for the routine use in blood screening. Key words: Blood donors;  Hepatitis B virus;  Hepatitis C;  HIV;  Nucleic acid amplification techniques