Autotest of COVID-19: the Government established how the procedure will be to report the result

The self-tests were approved by the ANMAT (Matias Arbotto)

As planned, the Government regulated the sale and use of the so-called COVID-19 self-tests, which can only be obtained in pharmacies and under the commitment by the user to report the result once the test has been carried out. This was reported by the Resolution 28/2022, published this Tuesday in the Official bulletin.

Specifically, what was done was to approve, with the signature of the Minister of Health, Carla Vizzotti, the so-called “Procedure for reporting the use and notification of the result of individual self-assessment tests for the detection of SARS-CoV-2 (COVID-19)”.

The regulations indicate, among other points, that the buyer must inform the health authorities if the diagnosis was positive or negative. It will do it ”individually (pay attention to the barcode of each package) once opened within 24 hours. after it has been carried out, and within 7 days of being acquired when they have not been used ”.

In the event that the product is purchased by a private user in a participating pharmacy, the use report is always made at the same point of sale, either in person or by phone, through a website or by other means that may be developed.

However, if the test was acquired and / or used by a public or private institutionThese must designate a health reference responsible for the use report, and report the destination and the results to the place of acquisition or, failing that, to the health authorities of their jurisdiction.

For their part, both the pharmacies and the professionals designated by the institutions, or failing that the local authorities, will then have to upload the results of each of the tests in the National Health Surveillance System (SNVS), also indicating some personal data of the person who made the self-diagnosis, such as their name and surname; legal sex; date of birth; Type and number of document; full address, and contact telephone number.

The person will be able to check for himself if he is infected or not with coronavirus (Getty)
The person will be able to check for himself if he is infected or not with coronavirus (Getty)

If the pharmacist does not receive the user’s report within the aforementioned deadlines, he must inform the jurisdictional health authority of this situation, which in turn, within the framework of its powers, may disable the point of sale if it is noticed that the charge is actually in the SNVS it has not been made effective.

Once the test results are available, positive cases will be integrated into the SNVS system and will be classified as “probable”, while negative cases will be considered “negative, unclassified.” Those tests that were invalid must be repeated.

However, it was established that, “given the epidemiological context, the jurisdictions, in agreement with the national health authority, they will be able to consider as confirmed cases “of coronavirus those people” whose self-assessment test for the detection of SARS-CoV-2 (COVID-19) has been positive “.

Likewise, it was noted that “drug stores, distributors and laboratories that supply the retail channel” may sell these products “only to pharmacies that comply with the established procedure.”

The measure had already been anticipated on Monday by the Minister of Health of the Nation, Carla Vizzotti, who during a television interview confirmed that the sale and use of these so-called COVID-19 self-tests would be regulated.

“The industry, the private sector, will also be able to verify, if there is positive, that the person does not go, so that it does not generate transmission or isolation,” the official reported in dialogue with the TN channel.

The self-assessment tests are performed at the nasal level or by saliva, as specified by the manufacturer (REUTERS / Toby Melville)
The self-assessment tests are performed at the nasal level or by saliva, as specified by the manufacturer (REUTERS / Toby Melville)

In the recitals of the Resolution published this Tuesday, the Government indicated that these tools collaborate “in the decentralization process necessary to provide a better response to a situation that affects public health, since they do not require highly complex equipment or technology.” .

In addition, he noted that the National Administration of Medicines, Food and Medical Technology (ANMAT) has already approved one of these products for “exclusive sale in pharmacies, which” ensures their traceability and legitimacy.

“For this reason, the use of these COVID-19 self-assessment tests as a complementary tool for pandemic management is considered convenient, since it facilitates access to the diagnosis of COVID-19, and broadens the offer in testing strategies and its accessibility ”, explained the national authorities.


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