Abstract:
OBJECTIVE To explore the problems such as ’false negative’ and ’false positive’ in nucleic acid test for 2019-nCoV during the diagnosis of Corona Virus Disease 2019(COVID-19).
METHODS The causes of ’false negative’ and ’false positive’ for 2019-nCoV nucleic acid tests were analyzed on the basis of basic principles and conditions of 2019-nCoV nucleic acid test, involving the means of collection, delivery and storage of samples, quality of kit and management of clinical laboratories.
RESULTS The possible causes of the ’false negative’ and ’false positive’ for 2019-nCoV nucleic acid tests were discussed. The optimization of procedures of sample collection, enhancement of quality control management, development and application of new technology and enhancement of diagnosis and management of suspected and discharged cases were the coping strategies for avoiding the ’false negative’ 2019-nCoV nucleic acid test, which have great significance in assuring the timely and accurate result of nucleic acid test and provide related departments with the reference in formulating prevention and treatment strategies.
CONCLUSION The positive nucleic acid test is considered as the gold standard for diagnosis of 2019-nCoV infection, while the negative nucleic acid test can neither be taken as the gold standard for exclusion of 2019-nCoV infection nor the gold standard for exclusion of COVID-19.