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The agency said it strongly recommends the use of POC nucleic-acid testing to diagnose HIV in infants and children younger than 18 months.
Prequalification from the World Health Organization indicates that products meet high quality standards and are safe for their intended use.
The findings stem from a recent meeting of a WHO Guideline Development Group convened to address challenges with TB diagnosis and related drug-resistance.
Since August, Abbott said it has shipped 200 million Panbio tests to 120 countries globally, although it is not available in the US.
FIND said it will announce agreements that will enable the distribution of more than 250 million rapid antigen tests per year to low- and middle-income countries.
The company is drawing on its previous experience developing and commercializing its HIV self-test to make progress on a test that could be used for three different indications.
News items for the in vitro diagnostic industry for the week of Oct. 19, 2020.
Over six months, Abbott and SD Biosensor will provide rapid antigen tests to a variety of countries at a maximum price of $5 per test.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.