Rumor:
The new coronavirus test kit is available in a home self-test version.
Rumor:
The colloidal gold antibody test reagent is easy to operate, similar to the early pregnancy test reagent, and may be mistaken for the so-called "home self-test version", but in fact, the state approved the use of the purpose of the clear provisions can only be used by medical institutions, is not suitable for use by the general population, because the collection of The reason is that the collection of blood samples requires certain conditions, the test requires the appropriate temperature and humidity, and the determination of the results requires the appropriate professional knowledge (especially in the critical state). In addition, any test reagent is an aid in the diagnosis of disease.
At present, the new coronavirus detection kits are divided into pathogen antigen, antibody and nucleic acid detection reagents, belonging to the third class of medical devices, which must be approved by the State Drug Administration to obtain a medical device registration certificate, these approved and registered new coronavirus detection kits, are required to have the conditions of the laboratory and professional medical institutions in order to complete the test, the nucleic acid detection kits require the appropriate proprietary Nucleic acid test kits require appropriate proprietary testing equipment, and chemiluminescent antibody detection reagents also require proprietary equipment. Therefore, these kits should not be used for personal use, and should not be sold to consumers through the Internet.
The pathogenicity reagent test includes viral nucleic acid detection and virus-specific antigen detection, kits generally have two categories of immunodiagnostic and nucleic acid detection.
Immuno-diagnosis is the application of antigen-antibody specific binding principle, the use of specific markers for analysis and detection of technology. Immunological testing generally have ELISA (enzyme-linked immunosorbent assay), chemiluminescence (CLIA) and colloidal gold rapid test, ELISA and chemiluminescence detection time is relatively long, high sensitivity, generally need 30-120 minutes; colloidal gold rapid test is generally 5-15 minutes, the detection of sensitivity is relatively low, do not need specialized laboratories and equipment, suitable for grass-roots operations.
Nucleic Acid
Nucleic acid detection is accomplished through the detection of pathogen-specific nucleic acid sequences, the main application of polymerase chain reaction, which is usually referred to as PCR detection, the advantages of its extremely high sensitivity, while the specificity of strong, high degree of automation of the amplification process, the window period is shorter, generally 3-5 days (theoretically, nucleic acid as long as the infection of mucous membranes, can be detected), the relative closure of the operating environment can reduce the The relatively closed operating environment can reduce the pollution of the sample to the environment. Nucleic acid diagnostics include: fluorescent quantitative PCR, digital PCR, high-throughput sequencing (NGS) and thermostatic amplification techniques.
Attachment: List of NGS test reagents that have been approved by the state (as of March 6)
The state has now approved 11 products for NGS detection reagents, including 8 fluorescent PCR, 1 thermostatic amplification, 1 sequencing, 2 colloidal gold, and 3 chemiluminescent methods.
Discrediting expert: Zeng Ming, a researcher and member of the vaccine committee of the National Pharmacopoeia Commission
Reviewing expert: Yue Bingfei, a researcher at the China Academy of Food and Drug Testing and Certification