The National Health Surveillance Agency (Anvisa) determined again, this Monday (31), the collection of the exam “Covid test meuDNA PCR-LAMP Autocoleta de Saliva”. This time, the suspension of commercialization, distribution, manufacture, import and advertising of the exam is directed to Drogaria São Paulo, Drogaria Pacheco and Raia Drogasil.
On the 26th, Anvisa had already issued a statement suspending the sale and use of the test by Drogaria Pague Menos.
According to the agency, the product is not regulated by Anvisa, which prevents the sale in pharmacies and drugstores.
In a note sent to CNN Last week, Mendelics/myDNA stated that the product provided does not fit into the self-test category. According to the company, although the collection is done by the user, the clinical analyzes are carried out in the laboratory. Mendelics/meuDna also informed that the test is registered with Anvisa (read the full note below).
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 leading clinical analysis laboratory in genomics in Brazil, duly registered (CRM-SP 955.471) and accredited (PALC 32290508, CGCRE Inmetro – Norma 15189:2015 – CLC 0007). The tests carried out 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. That is, 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 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.
Note from Anvisa published this Monday (31)
Anvisa published, in the Official Gazette (DOU) this Monday (31/1), three more resolutions, this time against Drogaria São Paulo, Drogarias Pacheco and Raia Drogasil. The rules suspend the marketing, distribution, manufacture, import, advertising and use, and determine the recall of the product Test Covid meuDNA PCR-LAMP Autocoleta de Saliva.
Resolutions 280/2022, 281/2022 and 282/2022 are already in force and are valid throughout the national territory. It is noteworthy that the aforementioned product is not regulated by Anvisa, so it cannot be sold in pharmacies and drugstores, according to the Resolution of the Collegiate Board of Directors (RDC) 44/2009 and Normative Instruction (IN) 9/2009.
RDC 44/2009 and IN 9/2009 establish the criteria and minimum conditions for compliance with good pharmaceutical practices for the sanitary control of the operation, dispensing and marketing of products and the provision of pharmaceutical services in pharmacies and drugstores.
According to these rules, products for lay use, including material for self-collection and self-tests, must be regulated by Anvisa to be sold in pharmacies and drugstores.
Last Wednesday (26/1), RE 213/2022 had already been published, ordering Drogaria Pague Menos to suspend the sale and collect the same product.
Source: CNN Brasil
