Brazil awards ANVISA status to BioHit for its antigen and antibody Covid-19 test kits.
BioHit Healthcare’s antibody and antigen tests for Covid-19 have been awarded ANVISA status, the official stamp of approval from Brazil’s Ministry of Health. BioHit’s Sars-CoV-2 IgM/IgG antibody test and SARS-CoV-2 Antigen quantitative assay kit are now included in the select group of Covid-19 tests of allowed manufacturers of goods in Brazil.
“Our BioHit test kits had already earned the FDA’s coveted EUA (Emergency Use Authorization) and now this great news from Brazil. Very exciting,” says Dr. James Strader, CEO of Bio Testing Supplies, the pandemic division of Avrio Genetics. “
Anvisa certification is granted only to companies that have been proven to maintain good manufacturing practices for health products, so BioHit’s approval by ANVISA means it meets the standards of Brazilian Class III vitro diagnostic products across the board. “It adds up to a blanket approval from the Brazilian government,” says Strader.
“In their selection process, Brazil started with products already on the EUA authorization list and went from there, so selecting BioHit as only one of three companies to get the ANVISA is huge,” says Frederick M. Schaffer M.D., Board certified Immunologist, formerly an Associate Professor at the Medical University of South Carolina.
The Sars-Cov-2 Antigen test shows who has or does not have active Covid-19 while Biohit’s Sars-CoV-2 IgM/IgG Antibody Test Kit, a rapid laminar flow assay (LFA) that typically delivers results within 15 minutes, identifies those who have already had the virus and have thus acquired antibodies. When evaluated by the FDA, this test was shown to have a very high IgM and IgG sensitivity as well as a very high specificity. “This is important as it shows who may have possible immunity and thus a potential green light to resume their daily life,” explains Schaffer
With a population of close to 210 million—Brazil has about 2/3 the number of people in the U.S.—there is a lot of testing to be done. BioHit’s ANVISA status will make it possible for these tests to play an important role in combating Covid-19 in this country.
“Fortunately we have several million BioHit test kits in the pipeline ready to be shipped by Bio Testing Supplies, a ‘go-to’ company that also sells other diagnostic testing supplies including personal protective equipment (PPE),” adds Dr. Strader.
For more information and to order the BioHit test kit, click here.