This study validated and evaluated the performance of the full-process integrated Point-of-Care Testing(POCT)device for the novel coronavirus(SARS-CoV-2),focusing on whether it meets the requirements of rapid on-site detection of SARS-CoV-2 at customs ports.100 samples of throat swabs at customs ports and third-party quality controls were used to comprehensively evaluate the conformity rate,precision,detection limit and other technical parameters of the full-process integrated POCT nucleic acid detection device.The results showed that the coincidence rates of positive and negative samples were both 100%.The reproducibility CV values of precision test were 1.47%and 1.68%,respectively,both of which were less than 5%.The detection limit of sensitivity was 100 copies/mL.The detection time was 25 minutes.The test results show that the conformity rate,sensitivity,precision and other performance indicators of the SARS-CoV-2 detection method of the equipment can be applied to the intended use and meet the needs of rapid detection at customs ports.
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