Lisbon, 19 March 2021 (Lusa) – Rapid antigen tests for the detection of SARS-CoV-2 can only be sold to people over the age of 18 and all results must be communicated to health authorities, determines a circular published today .
The rules are contained in a joint circular from the Directorate-General for Health (DGS), the National Authority for Medicines and Health Products (Infarmed) and the National Health Institute Doctor Ricardo Jorge (INSA) that defines the inclusion criteria, operationalization of the use and reporting of results of covid-19 self-tests.
According to the rules now established, these screening tests can only be made available in the health system units, in pharmacies and in places of sale of non-prescription drugs and can only be “dispensed to individuals aged 18 or over years old”.
In addition, self-tests, including the necessary test, cannot be carried out in the places where they are dispensed.
Bearing in mind that these rapid tests “constitute an additional instrument for the early detection of cases of infection, thus contributing to the control of transmission chains, the results obtained must be reported to the health authorities”, also determines the circular, which defines the procedures to be adopted by those who carry them out.
Therefore, people who are symptomatic or who are in contact with a confirmed case of covid-19 should contact the SNS24 Contact Center (808 24 24 24), regardless of the test result.
When the test is carried out on its own initiative, a positive or inconclusive result must be communicated directly by telephone to the SNS24 Contact Center or by filling in an electronic form that will be created.
In the context of use in specific contexts, the communication of this result can be made to the attending physician or occupational health or occupational medicine, advances the circular of the health authorities.
According to the document, regardless of the context in which the test is carried out, the report of obtaining a positive result should be accompanied whenever possible with information regarding the commercial identification of the self-test (brand), manufacturer and identification code of the batch used.
In addition, the communication of the result triggers the prescription for confirmation test with PCR test, if there has been no laboratory test report with a positive result for the person in question in the last 90 days.
The Contact Center SNS24 shall transmit indications for the isolation of the person with a rapid positive result, including the issuance of the Provisional Prophylactic Isolation Statement, until the confirmation of the PCR confirmation test result.
“One of the limitations to consider for any rapid test is the possibility of a false negative or false positive result”, also advance the health authorities, warning that a negative result does not eliminate the possibility of infection by SARS ‑ CoV ‑ 2 .
Although it is a less frequent event, there is also the possibility of a false positive result, particularly when the prevalence of infection in the population is low.
“For these reasons, the result obtained by the SARS-CoV-2 self-test does not dispense with the adoption of infection prevention and control measures established at national level in the context of COVID-19, nor the guidance of a health professional whenever necessary ”, stresses the circular.
The realization of self-tests, established in an exceptional and temporary regime and framed in the National Test Strategy for SARS-CoV-2, assumes “particular relevance for the control of transmission chains, namely in the context of the gradual and sustained reopening of certain sectors activity, establishments and services “, explains the document.
In order to be included in this exceptional regime, rapid antigen tests must have, among other characteristics, the CE marking, which shows compliance with the requirements legally provided for in the European Union.
In addition, they must present performance data for nasal samples, and the test must have at least a sensitivity equal to or greater than 80% and a specificity equal to or greater than 97%, according to the manufacturer’s information.
It must also contain instructions for use in Portuguese and adapted to the self-test, with an illustration of the test collection and execution process, including the following information: method of waste disposal, information on actions to be taken in view of the result obtained and procedure of communication of results.
The covid-19 pandemic caused at least 2,692,313 deaths worldwide, resulting from more than 121.7 million cases of infection, according to a report made by the French agency AFP.
In Portugal, 16,754 people died from 816,623 confirmed cases of infection, according to the most recent bulletin from the Directorate-General for Health.