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Is the Quality of the Novel Coronavirus Test Kit Reliable?

Theory

The new coronary pneumonia detection reagents currently approved for the domestic market mainly include two types: one is nucleic acid detection reagents, and the other is antibody detection reagents. Our company provides antigen detection kit.

There are certain differences in the detection methods of these two kits:

The method of performing RT-PCR amplification reaction on the characteristic RNA sequence of novel coronavirus (hereinafter referred to as "novel coronavirus") is currently the main method of nucleic acid detection of the novel coronavirus. Through nucleic acid detection, in vitro qualitative detection of novel coronavirus nucleic acid in alveolar lavage fluid and pharyngeal swab samples of suspected cases of new pulmonary virus infection in pneumonia, patients with suspected aggregation cases, and others who need to be diagnosed or differentially diagnosed with novel coronavirus infection. Because nucleic acid is the genetic material of the virus, theoretically performing nucleic acid detection on the characteristic sequence of the novel coronavirus can determine whether it is infected by the novel coronavirus. In practice, the accuracy of nucleic acid detection is affected by factors such as virus characteristics, the detection product or technology itself, the sampling process, sample storage, transportation, and detection capabilities.

Antigen Detection Kit

The antibody detection method is mainly used for the qualitative detection of novel coronavirus antibodies in human serum, plasma, and venous whole blood samples in vitro to determine whether the subject is infected with the novel coronavirus. Antibody testing requires the test subject to have a sufficient amount of antibody production. Since the production and disappearance of antibodies is a dynamic process, it is critical to choose a reasonable sampling time. The content of antibodies will affect the accuracy of the detection. In addition, the sampling process, sample storage, transportation, and other factors will also affect the accuracy of antibody detection.

According to the documents issued by the Medical Device Technology Evaluation Center of the National Drug Administration, the US Food and Drug Administration and the World Health Organization, nucleic acid testing is the preferred method of detection for new coronary pneumonia. Antibody testing cannot be the sole basis for the diagnosis and elimination of new coronary pneumonia. It is not suitable for the screening of the general population and can be used as a supplement to viral nucleic acid detection. The joint detection of the two will increase the sensitivity of the detection and reduce the rate of misdiagnosis or missed diagnosis.

The above information is provided by antigen detection kit supplier.