October 28, 2020, SARS-CoV-2 Antigen Rapid Test Kit of Nanjing Liming Bio-products Co., Ltd. was accepted by the U.S. FDA (EUA). Following the SARS-CoV-2 antigen detection kit obtained Guatemala certification and Indonesia FDA certification, this is another major positive news.

Figure 1 US FDA EUA acceptance letter

Figure 2 Indonesian registration certificate of  SARS-CoV-2 Antigen Rapid Test Kit

Figure 3 Guatemala certification of SARS-CoV-2 Antigen Rapid Test Kit

Compared with PCR nucleic acid detection technology, immunological methodology is easier to be widely used due to its rapid, convenient and low-cost advantages. For antibody detection, the window period of antigen detection is earlier, which is more suitable for early large-scale screening, and is Nucleic acid and antibody detection is also of great significance for clinical auxiliary diagnosis.

Comparison of the advantages of nucleic acid detection method and antigen detection technology:

	RT-PCR nucleic acid detection	Immunological Methodology Antigen Detection Technology
Sensitivity	The sensitivity is more than 95%. In theory, because nucleic acid detection can amplify virus templates, its sensitivity is higher than that of immunological detection methods.	Sensitivity ranges from 60% to 90%, immunological methods require relatively low sample requirements, and antigen proteins are relatively stable, so the sensitivity of the antigen detection kit is stable.
Specificity	above 95%	More than 80%
Time-consuming detection	The test results can be obtained more than 2 hours, and due to equipment and other reasons, on-site quick inspection cannot be performed.	A sample only needs 10-15 minutes to produce results, which can be quickly inspected on site.
Whether to use equipment	Requires expensive equipment such as PCR instruments.	No equipment is required.
Whether single operation	No, they are all batch samples.	Can.
Technical difficulty of operation	Complex and require professionals.	Simple and easy to operate.
Transportation and storage conditions	Transport and store at minus 20℃.	Room temperature.
Reagent price	Expensive.	Cheap.

SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2 Antigen Rapid Test Kit