Argentina's sanitary agency ANMAT has issued the green light Wednesday to the distribution and commercialization of COVID-19 self-testing kits, as coronavirus infections soar nationwide.
The kits -available from 4 different brands- can be marketed in pharmacies all across the country. They come with instructions for users to collect their own samples, National Administration of Medicines, Food and Medical Technology (ANMAT) sources explained.
After choosing among Abbott, Roche, Vyam Group and Wiener laboratories, users must follow the instructions on the package to take the sample and report the result of the diagnostic orientation test within 24 hours of the test, the agency reported in a statement.
ANMAT's decision came consensus was reached at COFESA, the Federal Health Council made up of health ministers from all national districts (23 provinces plus the Autonomous City of Buenos Aires) plus the one from the national Government.
After the ANMAT's approval, the pharmaceutical companies may now start importing these kits, so it is yet unknown when exactly they will be available to Argentine customers.
ANMAT warned, however, that these tests provide indicative results, without conclusive diagnostic value, except that the jurisdictions, in agreement with the Ministry of Health of the Nation and based on the epidemiological situation, consider the result as positive.
The health agency also explained that these tests use samples collected at nasal level or from saliva, depending on the manufacturer's specifications, unlike professional tests which use samples at nasopharyngeal level. For this reason, samples must be taken correctly and the test must be carried out immediately to avoid erroneous results, ANMAT went on.
Negative results from these tests do not rule out infection since ”if the person has no symptoms or if the viral load is low (which can occur during the initial or final days of infection), SARS-CoV-2 may not be detected by the test.
To have a follow-up, the results must be reported immediately (based on the barcode of each package) once the test is performed,” ANMAT added.
The result provided by the user will be stored in the pharmaceutical information base and will be reported to the National Health Surveillance System (SNVS) by the authorized pharmaceutical groups. Positive cases will be integrated into the notification of Covid-19 cases, while negative cases will be labeled as negative, unclassified.
Pharmacies hope to have the kits ready for sale sometime next week at prices between AR $ 2,000 and AR $ 2,500 (around US $ 9 to US $ 11, at the unofficial exchange rate).