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COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

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Recent reports have compared the analytical sensitivities of some SARS-CoV-2 RT-PCR assays, but differences in the viral materials used for these evaluations made comprehensive conclusions difficult. We carried out a direct comparison of the analytical sensitivities of 14 conventional and three rapid RT-PCR assays for the detection of SARS-CoV-2. The comparison was performed utilizing a certified reference material for SARS-CoV-2 RNA that was serially two-fold diluted in RNA storage solution. Our results show that the analytical sensitivities of the 17 assays varied within an 8-fold range (100–800 copies/mL). Moreover, a trend with some rapid assays yielding slightly higher analytical sensitivities (2- to 4-fold) compared with conventional assays was observed. We conclude that most of the RT-PCR assays can be used for routine COVID-19 diagnosis, but some assays with the poorest analytical sensitivities may lead to false-negative results when used to identify asymptomatic individuals who can carry a low viral load but still be infectious. These findings should be kept in mind when selecting high-sensitivity and rapid assays.

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