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Current status of marketed new coronavirus detection kits
Since the outbreak of the new coronavirus pneumonia, my country's in vitro diagnostic companies have responded quickly and organized elite forces to conduct scientific research.
In addition, the drug regulatory department has set up a green approval channel, and a large number of new coronavirus detection kits have been successfully launched on the market, making outstanding contributions to the fight against the epidemic .
As of March 29, 2021, 56 new coronavirus detection kits have been registered and marketed by the China Food and Drug Administration (calculated by the registration certificate number), which come from 41 domestic in vitro diagnostic companies.
▲Related number of new coronavirus detection kits on the market in my country
Data source: State Drug Administration
Nucleic acid testing and antibody testing are the mainstream of my country's new coronavirus testing products.
The quantity of the two products is basically the same, and the total quantity accounts for 95% of the testing products.
Among the 56 products, there are 26 nucleic acid detection kits, 27 antibody detection kits, and 3 antigen detection kits; the daily production capacity of nucleic acid detection reagents is 6.
656 million copies, the daily production capacity of antibody detection reagents is 16.
▲Features of various types of new coronavirus detection kits
Different types of new coronavirus detection kits have different characteristics.
The nucleic acid detection kit has high sensitivity and is suitable for the entire infection stage, but the operation is complicated and the detection speed is slow; the antibody detection kit has high sensitivity and fast detection speed, but it can only be detected 3-5 days after infection; antigen detection The kit has simple operation and fast detection speed, but it is only suitable for the acute phase of infection, and the detection sensitivity is low.
(1) Nucleic acid detection kit
At present, the mainstream technology of nucleic acid detection kits in my country is still the fluorescent PCR method.
Among nucleic acid products, there are 18 fluorescent PCR products, accounting for 69%; RNA capture probe method, hybrid capture immunofluorescence method, RNA constant temperature amplification-gold probe chromatography method and double amplification method, etc.
The number of technical route products is only one.
New nucleic acid detection technology may be more excellent in sensitivity, but it still needs to continue to improve in terms of technology maturity and product stability.
▲The distribution of the number of new coronavirus nucleic acid detection kits in different technical routes
Data source: State Drug Administration
(2) Antibody detection kit
At present, the mainstream technology of antibody detection kits in my country is mainly magnetic particle chemiluminescence and colloidal gold method.
Among the antibody products, there are 9 products of magnetic particle chemiluminescence method and colloidal gold method products, which together account for 66%; in addition, new technology route products such as quantum dot fluorescence immunochromatography and enzyme-linked immunoassay There are also listings.
In the antibody detection kit, there are products that specifically detect viral IgM protein or IgG protein, and there are products that can detect both proteins (IgM/IgG).
▲The distribution of the number of new coronavirus antibody detection kits in different technical routes
Data source: State Drug Administration
(3) Antigen detection kit
In addition to antibody and antigen detection kits, there are currently 3 antigen detection kits on the market in my country.
The technologies used are fluorescence immunochromatography, latex and colloidal gold.
The antigen detection time is off and can be used for rapid screening of suspected cases.
Spatial distribution of manufacturers of new coronavirus detection kits
There are a total of 41 new coronavirus detection kit companies, which are mainly distributed in core cities in economically developed areas, close to both the research and development end and the market end.