At the same time, a premature reduction in the rate testing positive for IgG antibodies in later stages of the disease could also indicate poor reagent sensitivity. cases have been confirmed and 4634 deaths reported [2]. diagnostic reagents are a tool for identifying viral infections as part of the coronavirus disease 2019 (COVID-19) control measures in the various countries, enabling rapid detection and identification of those infected. Nucleic acid testing is a reference method for viral p85 infections. Even though research into nucleic acid testing has revealed that it has a high sensitivity during the first 2?weeks of infection, some patients still show negative results due to sample quality, viral load and reasons during the Rilpivirine (R 278474, TMC 278) test. Serological testing will help such patients confirm their disease status and then carry out disease treatment and disease epidemic control accordingly. After 2?weeks, nucleic acid tests show gradually fewer positives as the antiviral therapy takes effect and antibody levels gradually reach the peak detectable level, Rilpivirine (R 278474, TMC 278) although the vast majority of infected people can still test positive for IgM and/or IgG. When IgM antibodies turn negative with IgG antibodies persistently positive, this is an indicator of past infections that is effective in the later stages of the disease. These characteristics of serological tests make antibody testing an important supplement to nucleic acid testing [3]. However, the development and verification of antibody Rilpivirine (R 278474, TMC 278) detection reagents as an immunological method is more complex than nucleic acid detection reagents. There are huge differences in the recombinant antigens used in different products. Some products make use of recombinant N protein, while other products also employ recombinant S protein. There is a dearth of reference material for the development of reagents due to the lack of research into the human immune response to the novel coronavirus, making it difficult to achieve adequate verification of clinical performance in the laboratory validation process. This situation was particularly prominent in the early stages of the epidemic. The intended use of the reagent should be adapted to the epidemiological characteristics of the disease. In order to understand the significance of antibody detection reagents in the early stages of an epidemic, their performance should be fully and effectively observed through large-sample clinical studies that can be carried out quickly Rilpivirine (R 278474, TMC 278) to evaluate the clinical significance. At the beginning of the epidemic, some diagnostic reagent manufacturers started research and development of antibody reagents and the Center for Medical Device Evaluation of the China National Medical Products Administration released The Key Points of Technical Review for the Registration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen/Antibody Detection Reagents (hereinafter referred to Rilpivirine (R 278474, TMC 278) as Key Points). Key Points was released with the aim of guiding applicants in conducting laboratory and clinical research, preparing registration application documents and providing reference for technical review departments based on the complementary role of antibody testing with regard to the nucleic acid gold standard testing and the characteristics of the epidemic in the early stage of outbreak. This article will elaborate on the China National Medical Products Administrations ideas for clinical testing of antibody reagents based on the requirements for clinical evaluation in the Key Points, to provide reference for relevant workers. Key points Determination of clinical reference methods SARS-CoV-2 antibody detection reagents are a supplement to nucleic acid detection methods used for auxiliary diagnosis of COVID-19. Therefore, the main evaluation index of clinical trials.