Who can self-test when the new crown antigen self-test product is approved for marketing?

On March 12, the State Food and Drug Administration issued a notice approving the application changes for self-testing of novel coronavirus antigen products of Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, and Beijing Huaketai Bio
.
Since then, five new coronavirus antigen self-test products have been officially launched
.
Previously, the National Health and Health Commission issued a notice stating that it decided to add antigen testing as a supplement on the basis of nucleic acid testing, and organized the formulation of the "New Coronavirus Antigen Testing Application Program (Trial)"
.
Who can self-test? Can self-test results replace nucleic acid results? Can it be used as proof of travel? Where can I buy self-tests? 1.
Who can self-assess? The "New Coronavirus Antigen Detection Application Plan" clearly states that three types of people can self-test: (1) People who go to primary medical and health institutions for treatment, have respiratory symptoms, fever and other symptoms and have symptoms within 5 days
.
(2) Isolation and observation personnel, including those in home isolation observation, close contact and sub-close contact, entry isolation observation, closed area and control area
.
(3) Community residents who need antigen self-testing
.
2.
Can self-test results replace nucleic acid results? No, nucleic acid testing is still the basis for the diagnosis of new coronavirus infection
.
The "Basic Requirements and Procedures for Self-Testing of New Coronavirus Antigens" in the trial plan emphasizes that antigen testing is generally used in the acute infection period, that is, sample testing within 7 days of the onset of symptoms of suspected people
.
Both positive and negative antigen results of suspected populations should undergo further nucleic acid testing.
Positive results can be used for early triage and rapid management of suspected populations, but cannot be used as the basis for the diagnosis of new coronavirus infection
.
3.
Where can I buy self-testing reagents? The plan pointed out that community residents who have self-test needs can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels
.
The management department (such as communities, villages and towns, isolation points, etc.
) that organizes the isolation and observation of the isolation observation personnel is responsible for the procurement, distribution, management and other related work of antigen detection reagents.

.
It should be noted that in order to ensure the quality of sampling and testing, residents must read the instructions carefully, and conduct operations such as sampling, sample addition, and result interpretation in accordance with the prescribed requirements and procedures
.
4.
What are the precautions for self-testing? There are three steps in antigen self-test
.
First, prepare for the antigen self-test
.
1.
Wash your hands
.
Wash hands with running water or hand sanitizer
.
2.
Understand the testing process
.
Carefully read the instruction manual of the antigen self-test reagent and the precautions related to the antigen self-test
.
3.
Reagent preparation
.
Check whether the antigen self-test reagent is within the shelf life, and check whether the contents of the nasal swab, sampling tube, test card, etc.
are missing or damaged
.
If the reagent expires or the contents of the reagent are missing or damaged, the detection reagent should be replaced in time
.
4.
Confirm the testing requirements for ambient temperature and humidity
.
The detection of colloidal gold test strips generally requires normal temperature conditions of 14°C to 30°C to avoid abnormal test results caused by excessive cooling, overheating or excessive humidity
.
Unpack the antigen test card and place it in a flat, clean place
.
Second, sample collection
.
1.
Those over 14 years old can perform nasal swab sampling by themselves
.
The self-tester first blows his nose with toilet paper
.
Carefully unpack the nasal swab to avoid touching the swab tip with your hands
.
Then tilt the head slightly, hold the swab in one hand and stick the tail of the swab into one nostril and enter it slowly along the bottom of the inferior meatus to go back 1 to 1.
5 cm, and then stick to the nasal cavity and rotate at least 4 times (the residence time is not less than 15 seconds), and then Repeat the same for the other nasal cavity using the same swab
.
2.
Self-inspection persons aged 2-14 should be sampled by other adults
.
When sampling, blow your nose with toilet paper first, then tilt your head slightly.

.
Sampling personnel carefully unpack the nasal swab, avoid touching the swab head with hands, gently support the head of the person being collected with one hand, hold the swab in the other hand and stick it into one nostril, and slowly penetrate backward along the bottom of the lower nasal passage.
After 1 cm, stick to the nasal cavity and rotate at least 4 times (remaining time not less than 15 seconds), and then repeat the same operation for the other nasal cavity using the same swab
.
Third, antigen detection
.
1.
According to the instructions of the reagent, 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.
5 times to ensure that the sample is fully eluted in the sampling tube
.
2.
Squeeze the liquid from the swab head through the outer wall of the sampling tube by hand, and then discard the swab
.
After capping the sampling tube, drop the liquid vertically into the sample hole of the test card
.
3.
According to the reagent instructions, wait for a certain period of time to interpret the results
.
Positive results: red or purple bands are displayed at both "C" and "T", and the color of the band at "T" can be dark or light, all of which are positive results
.
Negative Result: Red or purple band at "C", no band 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, you need to take the test strip and test again
.
5.
How to deal with the used self-test reagent? Isolation observers: Regardless of whether the test results are negative or positive, all used sampling swabs, sampling tubes, test cards, etc.
are put into sealed bags, and the management personnel refer to medical waste or dispose of them according to procedures
.
Community residents: If the test result is negative, all nasal swabs, sampling tubes, test cards, etc.
after use will be placed in a sealed bag and treated as general garbage; if the test result is positive, it will be handed over to the medical institution when the person is transferred.
waste disposal
.
6.
How to deal with the self-test results? 1.
If the antigen test is positive, regardless of whether there are symptoms of respiratory tract, fever, etc.
, residents should immediately report to the community (village) where they are located, and the community (village) will contact the emergency center to transfer the residents to the setting according to the guidelines for the transfer of personnel related to the new coronary pneumonia epidemic.
Nucleic acid testing is carried out in medical institutions in fever clinics
.
2.
If the antigen test is negative, asymptomatic residents can be closely observed, and antigen test or nucleic acid test can be carried out when necessary; symptomatic residents are advised to go to a medical institution with a fever clinic as soon as possible to conduct nucleic acid test; if it is inconvenient to seek medical treatment, then You should self-isolate at home, avoid going out, and take an antigen self-test every day for 5 consecutive days
.
7.
What are the uses of the test results? As a supplementary method, antigen detection can be used for screening of specific populations, which is beneficial to improve the ability of "early detection"
.
It is not clear whether the self-test results of the new crown antigen can be used as travel vouchers
.