Summary of the Detection Kits for SARS-CoV-2 Approved by the National Medical Products Administration of China and Their Application for Diagnosis of COVID-19

Abstract

The on-going global pandemic of coronavirus disease 2019 (COVID-19) caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been underway for about 11 months. Through November 20, 2020, 51 detection kits for SARS-CoV-2 nucleic acids (24 kits), antibodies (25 kits), or antigens (2 kits) have been approved by the National Medical Products Administration of China (NMPA). Convenient and reliable SARS-CoV-2 detection assays are urgently needed worldwide for strategic control of the pandemic. In this review, the detection kits approved in China are summarised and the three types of tests, namely nucleic acid, serological and antigen detection, which are available for the detection of COVID-19 are discussed in detail. The development of novel detection kits will lay the foundation for the control and prevention of the COVID-19 pandemic globally.

Ten Years of Lateral Flow Immunoassay Technique Applications: Trends, Challenges and Future Perspectives

“…This is also due to the fact that in contrast to other promising paper-based analytical platforms that mainly remain as laboratory prototypes, LFIA devices easily enter into real-life applications with a high market penetration mainly because they do not need extensive upgrades to become an end-user device [ 18 ]. The wide acceptance of LFIA devices also played an eminent role in the use of the platform for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in the current pandemic situation, as we can still notice and as extensively reported in the literature [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ].…”

Development of a rapid neutralizing antibody test for SARS-CoV-2 and its application for neutralizing antibody screening and vaccinated serum testing

“…Prevention and control of SARS-CoV-2 mainly follows the principle of ‘early identification, early detection, early reporting, early treatment’; timely detection and diagnosis are now the most essential steps. Detection of viral nucleic acid is the ‘gold standard’ for monitoring SARS-CoV-2 infections [ 18 , 27 ]. Detection of IgM antibodies is also a widely used and effective approach to diagnosing infection because such assays are quick and easy to perform; detection of IgG antibodies is used mainly for epidemiological investigations.…”

Microfluidic particle dam for direct visualization of SARS-CoV-2 antibody levels in COVID-19 vaccinees

“…Measurement of antibody level provides a direct index for evaluation of an individual’s immune status. Conventional immunoassay assays such as enzyme-linked immunosorbent assay (ELISA) and chemiluminescence immunoassay have been the standard tests for antibody detection ( 13 – 17 ). However, these assays require professional experts in accredited laboratories to carry out the procedures and interpret results, and they are expensive and technically intensive.…”