This Friday (28), the board of the National Health Surveillance Agency (Anvisa) released the possibility of marketing covid-19 tests that can be applied by laypeople, on themselves or friends and family, the so-called self-tests.
Until now, the tests could only be administered by healthcare professionals or pharmacy workers. There are different types of tests on the market, from the most accurate laboratory tests, such as RT PCR, to antibody tests, including antigen tests, which provide a quick diagnosis but have a lower accuracy rate than RT-PCR.
In this matter, the Brazil Agency explains what was approved and how it will be possible for citizens to use self-tests.
What are self-tests?
According to Anvisa, self-tests are an “orientation” procedure. They indicate that someone may be infected with the new coronavirus. However, effective diagnosis can only be performed by a healthcare professional.
Anvisa explains that the covid-19 self-test should be used as a screening, to allow early self-isolation and, thus, to break the chain of transmission of the virus as quickly as possible, “but the diagnosis depends on confirmation in a health service. ”, warns the agency’s publication on the subject.
Thus, the self-test is not limited to collection only. In this type of exam, the individual performs the entire procedure, from collection to interpretation of results.
Can the self-test already be purchased?
No. Manufacturers of this product will have to apply for registration with Anvisa. According to the decision taken, these requests will be evaluated with priority by the body.
Anvisa has provided a site where the tests will be listed (look here). Thus, when the self-tests begin to be sold in the market, it is important for the citizen to find out if that brand has, in fact, obtained the Anvisa registration for that product.
How much should such a test cost?
Anvisa has not yet released a price estimate.
What type of test do laypeople use?
According to Anvisa’s decision, only types of antigen test can be authorized for use by laypeople as self-tests. Will not be allowed for use by the population, therefore, antibody tests.
Does the self-test result count as an official document?
No. In places where there are negative test results for covid-19, it will be necessary to carry out the tests according to the requirements (which may be RT-PCR or antigen, depending on the case) at a health post, hospital, pharmacy or other unit authorized health.
What are the requirements for registering self-tests?
Anvisa’s board has established a series of requirements for self-test manufacturers who apply for registration. Instructions for use, storage and disposal must be clear. It will be necessary to use illustrations to exemplify the forms of application and the interpretation of the results (if positive, negative or inconclusive).
Manufacturers must also provide a service channel to guide consumers and answer questions. The attendants must be trained to respond to demands about the use of the product and to guide the citizen on the procedures based on the test results. Channels must also inform the telephone number of the health hotline, an official service of the Ministry of Health.
Who can sell self-tests?
Only pharmacies and healthcare facilities licensed to sell medical devices. When looking for one of these stores, make sure that it has the proper registration for these activities with the health surveillance.
Therefore, the sale by other types of establishments or the offer of self-tests on the Internet, on platforms or websites of companies or of any other type that do not fit into the authorized modalities.
When to use self-tests?
Self-tests are indicated for application when a person has symptoms of covid-19. In this situation, it is recommended to perform the test between the 1st and 7th day of the symptom.
It is also recommended to perform the self-test when there has been contact with someone who has tested positive for a diagnostic test. In this case, the self-test must be applied from the 5th day of contact.
Can I use professional antigen tests as a self-test?
No. Professional antigen tests, offered in pharmacies or health units, are different from the self-tests that may be offered when manufacturers obtain registrations from Anvisa.
Professional use antigen tests may have differences in performance in, for example, sample type. This requires the presence of a healthcare professional to perform the exam.
What will be the procedure used to perform the self-test?
Each self-test will be one way. There is no standard procedure. Each manufacturer should explain how their self-test will work.
What to do in case of a positive result?
If a person tests positive for covid-19 when testing, they should immediately isolate themselves, even if they do not have symptoms. In addition, Anvisa recommends wearing a mask and warning people with whom you have had recent contact.
Isolation can occur for different periods depending on the patient’s condition (look here the guidelines of the Ministry of Health).
As self-tests can give erroneous results (false positive or false negative), it is important to seek a diagnostic test to confirm a positive result.
What to do in case of a negative result?
As the self-test has limitations as to effectiveness, in case of a negative result, Anvisa’s guidance is that if there are no symptoms, the person should maintain preventive measures. If symptoms appear, she should perform a new self-test or diagnostic test.
What happens if there is a reaction?
As with any medication or medical procedure, there can be adverse events. The person who had the reaction must report it to the manufacturer’s customer service or can make the notification directly on the Anvisa website.
For these cases, there is the Health Surveillance Notification and Investigation System (Vigipós). The self-test manufacturer has to pass information on technical complaints and adverse events to the system.
If Anvisa determines the collection of a batch or even the whole of the product, the company must also be responsible for the logistics of this type of recall.
Whoever sells the product is also responsible for reporting complaints and adverse events. But this type of information must be entered in the Health Surveillance Notification System (Notivisa).
Will the self-test be offered at public health clinics and hospitals?
So far, the Ministry of Health has not announced a public policy for making self-tests available to the population. Therefore, there is still no prediction whether this type of exam will be offered free of charge to the population.
