The National Health Surveillance Agency (Anvisa) determined the collection of two tests for Covid-19. The measure suspends the marketing, distribution, manufacture, import and advertising of the exams “Teste Covid meuDNA PCR-LAMP Autocoleta de Saliva”, by the company Empreendimentos Pague Menos S/A, and “Autotest Covid-19 Isa Lab”.
According to Anvisa, the product “Autotest Covid-19 Isa Lab” is not registered with the agency and was being marketed by a non-regularized company. The product “Teste Covid meuDNA PCR-LAMP Autocoleta de Saliva” is also not registered with Anvisa.
Anvisa received the complaint about the irregular tests on the 20th and forwarded the cases for investigation. The restrictive measure aims to reduce risks to the health of the population.
In notes sent to CNN, Isa Lab and Mendelics/myDNA stated that the products provided do not fit into the self-test category. According to the companies, although the collection is done by the user, the clinical analyzes are carried out in the laboratory. Isa Lab and Mendelics/meuDna also informed that the tests are registered with Anvisa (read the full notes below).
Self-test evaluation process in Brazil
So far, there is no product approved by Anvisa as a Covid-19 self-test. On January 19, Anvisa demanded additional information from the Ministry of Health to decide on the use of this type of test in Brazil.
The exams, which can be done at home, allow monitoring the conditions of the disease. However, the tests are not conclusive for the diagnosis according to Anvisa.
The decision of the agency’s Collegiate Board of Directors voted, in majority, for the collection of additional information, by the Ministry of Health, of public policy for the use of exams in the country. Directors proposed a period of 15 days for the folder to send the complementary data.
Anvisa and Health hold meeting
Anvisa specialists met with the Ministry of Health on Friday (21) to discuss the implementation of self-tests in the country.
The meeting was attended by the director of the Agency Rômison Mota and technicians from the Health Products Technology area, in addition to the executive secretary of the Ministry of Health, Rodrigo Cruz, the head of the Extraordinary Secretary to Combat Covid (Secovid), Rosana Leite, and folder technicians.
At the meeting, held by videoconference, details necessary for the implementation of self-tests were discussed, seeking to fill possible gaps in the construction of the public policy proposal.
Nota Isa Lab
Isa Lab informs that the kit mentioned in the content of the article is a Covid-19 detection test that uses the PCR-LAMP (Isothermal Loop-Mediated Amplification) technique as a basis for diagnosis, from a saliva sample, which is collected by the patient himself. Therefore, this is a self-collection test and not a self-test. This is a way of testing the active infection, touted by the World Health Organization (WHO) as the best tool to track the virus and prevent transmission. As with RT-PCR, the test considered the “gold standard”, the PCR-LAMP technique identifies the RNA of the virus in the cells of the infected person from an early stage. And, although the saliva sample is collected by the patient, it is sent to Mendelics, a clinical analysis laboratory, leader in genomics in Brazil, duly registered (CRM-SP 955.471) and accredited (PALC 32290508, CGCRE Inmetro – Norma 15189 :2015 – CLC 0007). It is in the laboratory that the analysis and release of results is performed.
Isa Lab emphasizes that the kit then marketed is duly registered with ANVISA under registration code No. 10237610236 (authorization: 1.02.376-1) and is in accordance with current legislation and regulations. The product packaging was developed when the self-test category was not yet a reality in the world.
Finally, until there is a reassessment of Anvisa’s understanding of the current suspension, Isa Lab withdrew the product from commercialization and reinforces its commitment to the safety and well-being of customers, who have a service attested by the ONA certificate – a accreditation methodology developed in 1999, based on regional certification methods from Latin America and other countries, such as the United States, Canada, Spain and England, which has the general objective of encouraging the development of a permanent process of quality assessment and certification of health services.
Note Mendelics / myDNA
Regarding ANVISA resolution (213/2022) dated 01/25/2022, we inform you:
1. The saliva collection kit sold in pharmacies is a product registered with ANVISA under registration code No. 10237610236 (authorization: 1.02.376-1) and is in accordance with current legislation and regulations. The saliva collection kit is used for self-collection, in the same way that urine, sputum and feces collection kits are used for home collection of samples subsequently analyzed in clinical analysis laboratories.
2. The meuDNA Covid test is not a self-test or a quick test. There is no testing performed by the patient or the pharmacist. The meuDNA Covid test is a laboratory test with a diagnostic purpose, performed at the Mendelics laboratory. Mendelics is a clinical analysis laboratory, leader in genomics in Brazil, duly registered (CRM-SP 955.471) and accredited (PALC 32290508, CGCRE Inmetro – Norma 15189:2015 – CLC 0007). The tests performed by Mendelics are governed by ANVISA’s RDC 302/2005.
3. The meuDNA test available in pharmacies and on the meudna.com website uses the PCR-LAMP (Isothermal Loop-Mediated Amplification) technique as the basis for diagnosis. Like RT-PCR, the test considered the “gold standard”, it identifies the RNA of the virus in the cells of the infected person at an early stage. In other words, it is a way of testing active infection, identified by the World Health Organization (WHO) as the best tool to track the virus and prevent transmission.
In the face of yet another wave of Covid plaguing the country and the lack of tests available in many places, we hope that ANVISA will reassess this misinterpretation and re-release the meuDNA saliva self-collection kits for sale at PagueMenos pharmacies as soon as possible.
We make ourselves available for clarifications through the contacts: [email protected] and telephone (11) 5096-6001.
Reference: CNN Brasil
