QCOSTARICA – The health ministry on Friday authorized the import and use of rapid or home tests to detect covid-19, as a screening strategy at a time when the highly contagious omicron variant is present in the country.
Authorization for the sale of these products, also called self-tests, must be managed with the Customer Service Department (Dirección de Atención al Cliente) of the Ministry of Health, and comply with the requirements established by the Import Directive.
“Self-tests authorized for marketing and use are those which have a sanitary registration or temporary entry authorization from the Ministry of Health and apply only to those recommended by the World Health Organization / Pan American Organization (WHO / PAHO) or authorized by strict regulatory authorities for prequalification of in vitro tests, ”the statement said.
Tests imported and marketed in Costa Rica must have a sensitivity equal to or greater than 80% (probability that the test result for a disease is positive if you actually have the disease), and a specificity equal to or greater than 95% (chance that a test will be negative if you do not really have the disease).
“The person who obtains a positive result from this test must isolate himself, in the same way he must go to a health service to verify the result by RT-PCR, as well as to determine the health regulations. The self-tests may be marketed in establishments with current health operating authorization for an activity compatible with the sale of this type of product, ”specifies the Ministry of Health.
These tests measure the antigens, which are proteins of the virus, and determine if a person is showing symptoms. Some require a nasal sample which can be obtained with a swab (included in the kit in which the test is provided) and others work with a saliva sample. Results are in minutes.
Santiago Núñez Corrales, a Costa Rican complex systems researcher at the University of Illinois at Urbana-Champaign, United States, sees these tests as transcendent in the context of the pandemic and useful for people to make decisions about. the opportunity to attend work or social activities or isolate yourself if they are positive.