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October 18, 2021updated 22 Nov 2021 10:31am

Coronavirus company news summary – US FDA warns of potential false positives with Abbott Covid-19 test kits – Australia’s TGA approves Covid-19 rapid antigen self-tests

By Chloe Kent

The US Food and Drug Administration (FDA) has issued an alert regarding potential false-positive results with some Abbott Alinity Covid-19 test kits. The false-positive results are due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. Abbott has recalled the tests in order to correct the software issue, and the kits can continue to be used following the implementation of the software correction. The FDA advised caregivers to consider any positive result from tests using such kits to be presumptive and retest the patients using other authorised alternatives.

Australia’s medicine and therapeutic regulatory agency the Therapeutic Goods Administration (TGA) has approved five Covid-19 self-tests for use in the country. The approved rapid antigen self-tests include three products from China’s Hangzhou Alltest Biotech. Two of these tests are oral fluid tests, while the third one is a self-administered nasal swab. TGA also green-lighted a nasal swab test from Hangzhou Biotest Biotech and SD Biosensor’s self-testing kit. All these test kits will hit the shelves on 1 November.

LumiraDx has filed an Emergency Use Authorization (EUA) request with the FDA for its SARS-CoV-2 and Flu A/B rapid antigen test. The microfluidic immunofluorescence assay is developed to swiftly identify influenzas A and B as well as Covid-19, providing results in around 12 minutes.

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