Performance verification of Roche Cobas s201 nucleic acid test system in Dongguan Blood Center
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Graphical Abstract
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Abstract
In order to verify the performance of the nucleic acid test (NAT) system, the precision and accuracy of the Hamilton STAR pipetting instrument in both single and pool modes were evaluated using pure water simulated for pipetting. The sensitivity, repeatability, anti-interference and anti-contamination ability of the NAT system (Roche Cobas s201) were evaluated using standard serum diluted to different concentrations. The results showed the precisions of the STAR instrument in single and pool modes were 0.07% and 0.09%, respectively, at the accuracies of 3.33% and 5.66%. The sensitivity coincidence rate of Roche Cobas s201 was 100% at the concentration of 3×LoD (Limit of Detection). The amplification was inhibited at the concentration of 2×LoD for the HBV DNA and HCV RNA when the concentration of hemolysis was greater than 7.5%. Lipemia had no effect, and the anticontamination ability was good. The detection rate in the single mode was higher than the pool mode (t=214.3156, P<0.01). This report suggests that the performance of the NAT system is adequate for laboratory purposes.
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