O fornecedor de insumos da ECO Diagnóstica para o teste de Covid-19 IgG/IgM foi pré-submetido ao FDA

Com o aumento diário do número de casos de Covid- 19 no mundo, e sua rápida disseminação, os testes de diagnóstico rápido serão uma ferramenta importante no auxílio do manejo e controle dessa doença viral.

Desde o primeiro caso de transmissão local de Covid- 19 nos EUA, o uso emergencial de testes sorológicos de detecção de antígeno tem sido discutido. O Food and Drug Administration (FDA) anunciou que não faz objeção ao uso dos kits de diagnóstico rápido mesmo sem autorização de uso emergencial na condição de que o fabricante faça uma submissão dentro dos próximos 15 dias.

“Under the update published today, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances. The FDA is aware that numerous commercial manufacturers are developing tests for coronavirus with the intention of submitting an EUA to the FDA. During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. As noted in the guidance, the FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.” (Nota do comissário do FDA, Dr. Stephen M. Hahn)

A ECO Diagnóstica acredita que o teste rápido será uma ferramenta importante no programa de manejo de saúde quando combinados com outros testes confirmatórios e nos locais em que os insumos para o teste de RT-PCR não são suficientes. De acordo com o FDA:

“Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection. We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status”. (Nota do comissário do FDA, Dr. Stephen M. Hahn)

A nota do FDA na íntegra pode ser acessada clicando aqui.

Tags:

covid-19, ECO Diagnóstica, Food and Drug Administration (FDA), testes de diagnóstico rápido

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