The first batch of “self-test version” covid-19 antigen detection kit is coming!
On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application in Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology since then, five covid-19 antigen self-test products have been officially launched
In March 11th, the State Health Protection Commission website yesterday reported that the State Council should issue the “COVID-19 virus antigen detection application plan” (the Trial Implementation) to the comprehensive group of New Coronavirus pneumonia epidemic prevention and control mechanism (hereinafter referred to as the “notice”). It is mentioned that if community residents have self-test needs, can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels p align = “center” the first batch of “self-test version” covid-19 antigen detection kits have been approved for marketing p align = “center” retail pharmacies have taken rapid action
Xiaobian noted that the information on the approval documents (changes) of medical devices issued by the State Administration of drug supervision website on 11 may show that the New Coronavirus (2019-nCoV) antigen detection kit (fluorescence immunochromatography) of Beijing Hua Ke Tai bio has been changed through the registration information of the drug administration.
Figure source | official website of the State Food and Drug Administration
The pending information of the medical device approval document (change) released on the website of the State Food and Drug Administration on the 12th shows that the four covid-19 antigen detection kits developed by Guangzhou Wondfo Biotech Co.Ltd(300482) , Huada Yinyuan, Beijing jinwofu and Nanjing Vazyme Biotech Co.Ltd(688105) 4 companies have passed the registration information change of the State Food and drug administration.
Figure source | official website of the State Food and Drug Administration
According to the Beijing Youth Daily, professionals said that the core of this “registration change” is that the relevant testing reagents are no longer limited to “only used by professional technicians”
For example, Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen detection kit’s registration certificate before change stipulates that “the product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions”, and the scope of application / intended use of the product after registration change will no longer include this provision.
Figure | the registration certificate before the change of the covid-19 antigen detection kit of Huada Yinyuan also stipulates that the product should be used by professionally trained personnel in an environment that ensures biosafety and meets the use conditions.
According to the analysis of Kechuang board daily, some insiders told reporters that although the “registration change” did not clearly indicate that it can be used for “home self-test”, it is no longer limited that the relevant testing reagents are “only used by professional technicians”, which also means that the relevant testing reagents are no longer just “professional” products, its scope of use will be further expanded, Including other scenes that can be used for home self-test, social health test and so on
Now, the testing reagent after the “registration change” is no longer limited to “only used by professional technicians”, and its scope of use is further expanded. It also has the “self-test qualification” means it has the qualification to sell in retail pharmacies and online sales platforms
According to the science and Innovation Board daily, “we have begun to take action.” an insider of a chain drugstore in South China told reporters, “we will reach an ‘initial’ agreement with the antigen reagent manufacturer as soon as possible to win the management right of the other party’s products.”P align = “center” what is antigen detection? What is the difference with nucleic acid detection p align = “center” can the self-test result of antigen test replace the nucleic acid result
According to Shangguan news, “covid-19 antigen detection technology is not new. In the past, antigen detection was also a conventional and effective means during the influenza epidemic.” Zhuang Jianlin, deputy director of the center for Disease Control and prevention of Changning District, introduced that the main purpose of antigen detection is to “screen” , that is, the auxiliary tool for diagnosis can not be distinguished by routine hemogram alone.
What is the principle of antigen detection? Experts explained: Taking the detection of influenza antigen as an example, take samples from the patient’s pharyngeal isthmus through pharyngeal swab for influenza virus antigen and typing detection. Combined with blood routine, CRP (determination of high-sensitivity C-reactive protein), SAA (serum amyloid A) and other joint detection methods, the project can be carried out in just 15 to 20 minutes, Preliminarily determine whether fever is influenza virus and secondary bacterial infection of influenza virus, and point out the direction for clinicians to use anti infective drugs.
Hu Bijie, director of the medical treatment expert group of New Coronavirus pneumonia, director of infectious diseases and infection management section of Zhongshan Hospital Affiliated to Fudan University, told reporters that up to now, COVID-19 nucleic acid detection is the gold standard, accuracy, sensitivity and specificity are close to 100%. In contrast, the sensitivity of antigen detection is slightly worse than that of . It only appears when the symptoms of virus growth and reproduction and mucosal infection are serious. Generally speaking, there are fever and cough, and the positive rate can reach 70% – 80%. If multiple antigen tests are carried out, the positive rate can exceed 95%. However, compared with nucleic acid detection, antigen detection has the advantages of short time and high coverage
“At present, the positive rate of nucleic acid detection can be almost 100%, while the positive rate of antigen is far less than 100%. Some will be missed. Different reagent companies may produce different products. On the whole, the positive rate of antigen is far lower than that of nucleic acid.”
In addition, the notice issued last night also made it clear that after the study, the State Council responded to the joint prevention and control mechanism of New Coronavirus pneumonia, and decided to add antigen tests on the basis of nucleic acid detection. Nucleic acid detection is still the basis for the diagnosis of covid-19 virus infection.
The basic requirements and procedures for covid-19 virus antigen self-test in the pilot scheme also emphasize that antigen test is generally used in the acute infection period, that is, the sample test within 7 days of symptoms in the suspected population.
suspected people should be further tested for nucleic acid antigen positive and negative results. The positive results can be used for early diversion and rapid management of suspected people, but can not be used as the basis for the diagnosis of covid-19 virus infection
asymptomatic infected people increase “forced” self-test
Antigen detection, which is unfamiliar to the Chinese people, has actually been promoted and implemented in many overseas countries. The reporter learned that it is not difficult to find Chinese enterprises in antigen detection products in overseas markets. Up to now, Zhejiang Orient Financial Holdings Group Co.Ltd(600120) biogenes, Beijing Beijing Hotgen Biotech Co.Ltd(688068) , Beijing Andon Health Co.Ltd(002432) etc. are major exporters of antigen detection reagents in China.
The symptoms of Omicron mutant are mild and there are many asymptomatic infections. Timely detection and blocking the transmission chain as soon as possible are very important for disease control. Not long ago, who made it clear that self-test is an important tool for human beings to fight covid-19 pneumonia, and the new recommendations of self-test are expected to solve the unfairness in the test
In the view of experts, the number of asymptomatic infections in China is increasing, which requires faster and more accessible detection methods. Recently, the amount of nucleic acid detection in China has increased sharply, and the time of queuing for nucleic acid detection has been prolonged, often for several hours, which brings risks to aggregation and infection. promoting antigen detection can solve this problem .
Hu Bijie said, “Nucleic acid testing must go to medical institutions with fever clinic and respiratory disease diagnosis and treatment ability. In contrast, the advantage of antigen testing is that it is very convenient to use, does not need special instruments and equipment, can be carried out anytime and anywhere, and even does not need special training. It can be tested by comparing the instructions at home. The results are fast, and the results can be reported in about 30 minutes. This is also true It is the basis for overseas countries to promote home isolation. “P align = “center” how to self test
In the pilot scheme, it is proposed that if community residents have self-test needs, they can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels.
There are three steps in antigen self-test.
first, preparation before antigen self-test
1. Wash hands. Wash hands with flowing water or hand disinfectant.
2. Understand the testing process. Carefully read the supporting instructions of antigen self-test reagent and precautions related to antigen self-test.
3. Reagent preparation. Check whether the antigen self-test reagent is within the shelf life, and check whether the contents such as nasal swabs, sampling tubes and test cards are missing or damaged. If the reagent expires or the contents of the reagent are missing or damaged, the test reagent shall be replaced in time.
4. Confirm the requirements for ambient temperature and humidity. The colloidal gold test strip is generally required to be tested under the normal temperature of 14 ℃ – 30 ℃, so as to avoid abnormal test results caused by supercooling, overheating or excessive humidity. The antigen detection card shall be placed in a flat and clean place after the package is removed.
second, sample collection
1. Those over 14 years old can conduct nasal swab sampling by themselves. The self inspector first blows his nose with toilet paper. Carefully unpack the nose swab and avoid touching the swab head with your hands. Then tilt your head slightly, hold the tail of the swab in one hand and stick it to one side of the nostril to enter, slowly penetrate 1-1.5cm backward along the bottom of the lower nasal tract, then stick it to the nasal cavity and rotate it for at least 4 turns (the residence time shall not be less than 15 seconds), and then repeat the same operation for the other nasal cavity with the same swab.
2. Those aged 2-14 years should be sampled by other adults. When sampling, first blow your nose with toilet paper, and then tilt your head slightly. The sampling personnel shall carefully unpack the nasal swab, avoid touching the swab head with their hands, gently hold the head of the person to be collected with one hand, stick the swab into one side of the nostril with the other hand, slowly penetrate 1 cm backward along the bottom of the lower nasal tract, and then rotate the nasal cavity for at least 4 turns (the residence time shall not be less than 15 seconds), and then repeat the same operation with the same swab for the other nasal cavity.
third, antigen detection
1. According to the reagent instructions, put the nasal swab after collecting the sample into the sampling tube immediately. The swab head should be rotated and mixed in the preservation solution for at least 30 seconds. At the same time, squeeze the swab head by hand across the outer wall of the sampling tube for at least 5 times to ensure that the sample is fully eluted in the sampling tube.
2. Squeeze the liquid of the swab head by hand across the outer wall of the sampling tube, and then discard the swab. After the sampling tube is covered, drop the liquid vertically into the sample hole of the detection card.
3. Interpret the results after waiting for a certain time according to the reagent instructions. Positive results: both “C” and “t” show red or purple bands, and the bands at “t” can be dark or light, which are positive results. Negative results: red or purple bands are displayed at “C” and no bands are displayed at “t”. Invalid result: no red or purple band is displayed at “C”, regardless of whether the band is displayed at “t”. If the result is invalid, take the test strip again and retestP align = “center” how to dispose of test results
If antigen test is positive, regardless of respiratory tract, fever and other symptoms, residents should immediately report to the community (village and town) where they live. The community (village and town) will contact the emergency center to transfer the residents to the medical institution with fever clinic for nucleic acid test in accordance with covid-19 guidelines for the transfer of personnel related to the epidemic of pneumonia. The sampling swabs, sampling tubes and test cards used by positive personnel are put into sealed bags and transferred to medical institutions for medical waste disposal.
If the antigen test is negative, the asymptomatic residents can observe closely and carry out antigen test or nucleic acid test when necessary; Residents with symptoms are advised to go to the medical institution with fever clinic as soon as possible for nucleic acid testing; If it is inconvenient to see a doctor, you should isolate yourself at home, avoid going out, wear a mask correctly, wash your hands and ventilate frequently, and conduct antigen self-test once a day for 5 consecutive days.
