People who carry out self-tests to detect COVID-19 and obtain a positive or inconclusive result should report this to the SNS24 line (808 24 24 24) or fill out a form that will be available on covid19.min-saude.pt , according to a joint statement by the Directorate-General for Health, Infarmed and the National Institute of Health Dr. Ricardo Jorge, released on Friday.
There is still no date for when these rapid antigen detection tests will become available, which require individuals to interpret the results by themselves. But they will soon be sold in pharmacies to citizens over the age of 18, and will be available in health centres.
Those who have a positive or inconclusive result must perform a molecular test (PCR). The exception will be people who have already had a positive result with this type of test, which are the most reliable, in the last 90 days. As long as they do not know the result of the PCR test, people will be provisionally isolated.
Negative results should also be reported – not through the SNS24 line, but through an electronic form that will be available on the same website.
“The notification of these results is also important for monitoring the national testing activity,” according to the statement.
Distributors, pharmacies and parapharmacies will have to regularly report sales to Infarmed, so that the national drug authority is able to monitor the dispensing of self-tests.
The self-tests will include a swab to collect secretion removed from the nasal fossa. They will have easy to understand instructions in Portuguese with illustrations on how to collect the sample and how to perform the test and also a label: “Autotest COVID-19 – Exceptional Regime.” Only by fulfilling these requirements and others of a technical nature – a sensitivity equal to or greater than 80% and a specificity equal to or greater than 97% – will they obtain authorisation from Infarmed to be sold.
The three entities recognize that “when performed by laymen, rapid tests have lower performance characteristics than those observed in use by professionals”. However, they justify that, in the case of self-tests, “there are factors that counterbalance this loss in terms of performance, such as a higher frequency of testing and accessibility to tests.”
According to the statement, the SARS-CoV-2 self-tests are not a substitute, but “complement the tests for professional use.”