In addition to nucleic acid testing, covid-19 self-test policy has also been officially implemented.
On March 11, the official website of the National Health Commission issued the notice on printing and distributing the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the “notice”), indicating that it decided to add antigen detection as a supplement on the basis of nucleic acid detection, and organized the formulation of the application scheme for covid-19 virus antigen detection (Trial) (hereinafter referred to as the “trial scheme”).
The pilot scheme introduces in detail the application of antigen detection in grass-roots medical and health institutions, isolated observers and community residents. According to the plan, the use of antigen detection in grass-roots medical and health institutions has professionals to collect samples, while the application of isolation observers and community residents involves self-test.
This is the first time to clarify the relevant policies of community residents’ self-test covid-19.
Can self-test results replace nucleic acid results? Who can test themselves? How to determine the self-test frequency? What are the steps of self-test? How to deal with the used self-test reagent? Where can I buy self-test reagent? What’s the cost? Can it be used as proof of travel? Surging journalists combed the above eight key self-test issues according to public data.
can self test results replace nucleic acid results
No.
The announcement 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 detection is generally used in the acute infection period, that is, the sample detection within 7 days of symptoms in the suspected population. Further nucleic acid detection should be carried out for the antigen positive and negative results of the suspected population. The positive results can be used for the early diversion and rapid management of the suspected population, but can not be used as the basis for the diagnosis of covid-19 virus infection.
who can self test
There are two major groups of people.
The basic requirements and procedures for covid-19 virus antigen self-test specify that covid-19 virus antigen self-test is applicable to isolated observers and community residents. Among them, personnel in home isolation, close contact and secondary close contact, entry isolation observation, sealing and control areas shall conduct antigen self-test under the organization and management of relevant management departments.
how to determine the self-test frequency of covid-19
It depends on the crowd.
For isolation observers, nucleic acid detection shall be carried out according to the requirements of the current relevant prevention and control plan during the isolation observation period, and antigen self-test shall be carried out once a day in the first five days.
For community residents who need self-test, they can purchase it for self-test. If the antigen test is negative, 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 for activities, and conduct antigen self-test once a day for 5 consecutive days.
What are the precautions for self-test
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 retest.
how to deal with the used self-test reagent
Equally divided into groups.
Isolate the observer: whether the test result is negative or positive, all used sampling swabs, sampling tubes, test cards, etc. shall be put into sealed bags and handled by the management personnel according to the medical waste or procedures.
Community residents: if the test result is negative, all nasal swabs, sampling tubes, test cards, etc. after use shall be put into sealed bags and treated as general garbage; If the test result is positive, it shall be handed over to the medical institution for treatment as medical waste when the personnel are transferred.
where can I buy a self-test kit
According to the query results and announcements of the regulatory authorities’ database, there is no covid-19 antigen detection kit approved for self-test in China. Therefore, there is no covid-19 self-test kit available for purchase in China.
Insiders pointed out to surging journalists that the self-test part of this document is “ahead of schedule” at present, and the drug regulatory department may also be stepping up its examination and approval.
Shortly after the announcement of the above-mentioned trial documents, Nanjing Vazyme Biotech Co.Ltd(688105) ( Nanjing Vazyme Biotech Co.Ltd(688105) , Nanjing Vazyme Biotech Co.Ltd(688105) ) announced that, The New Coronavirus antigen detection kit developed by New Coronavirus, a wholly owned subsidiary of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd. (recently referred to as “medical treatment”) has received the medical device registration certificate issued by the State Administration of drug supervision (Registration Certificate No. 20223400346).
However, Nanjing Vazyme Biotech Co.Ltd(688105) ‘s products should still be used by professionally trained personnel in an environment that ensures biosafety and meets the conditions of use, rather than for home self-test.
In addition to the professional operators of Beijing Huajin Pharmaceutical Co., Ltd. and wojin Pharmaceutical Co., Ltd., there are also the most important products approved by Beijing Huajin Pharmaceutical Co., Ltd. and wojin Pharmaceutical Co., Ltd. respectively.
what is the cost of self test kit
As there is no approved covid-19 self-test kit product in China, the price is unknown.
However, with reference to the overseas price of domestic self-test Kit: at the end of 2021, Andon Health Co.Ltd(002432) once mentioned when replying to investors on the interactive platform that the company’s covid-19 antigen test kit currently sells for $6.99 per person in Amazon America, and there is no plan to reduce the price for sale at present.
The detection reagent required by the isolation observer does not need to be at his own expense. According to the pilot scheme, the management department organizing isolation observation (such as communities, villages and towns, isolation points, etc.) is responsible for the procurement, distribution, management and other related work of antigen detection reagents.
what is the practical use of the test results
The National Health Commission said that antigen detection, as a supplementary means, can be used for screening of specific populations, which is conducive to improving the ability of “early detection”. Whether covid-19 antigen self-test results can be used as travel vouchers and other issues have not been clarified yet, which remains to be further refined by relevant departments.
