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September 20, 2021

Coronavirus company news summary – FDA warns of potential false positives with Abbott tests – Burnet Institute and Doherty Institute develop test to check immunity

By Chloe Kent

The US Food and Drug Administration (FDA) has published a warning that two of Abbott‘s Covid-19 testing kits could deliver false-positive results. The possible false positives can occur with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. This is thought to be associated with the current mixing parameters of the polymerase chain reaction (PCR) reaction mixture, which may cause overflow into neighbouring wells in the assay reagent tray. This overflow into wells of true negative samples placed near positive samples in the tray could lead to false positives. The FDA has recommended retesting of positive samples with another authorised test.

Researchers at Burnet Institute and Doherty Institute in Australia have developed a finger prick test for fast analysis of an individual’s immunity against Covid-19 via measurement of neutralising antibodies to the infection. The COVID-19 NAb-Test, which delivers results within 20 minutes, can help determine if a person needs a vaccine booster. It can also predict immunity to new and emerging SARS-CoV-2 variants. The test is being funded by the Government of Victoria state.

Quadrant Biosciences is set to provide its saliva swab test, the Clarifi COVID-19 Test, to New York businesses with 100 or more employees. This is expected to help businesses reach new testing mandates announced by the US federal government last week. Developed in alliance with SUNY Upstate Medical University, the Clarifi test is designed for self-collection, enabling easy on-site testing. Results are provided in 24-48 hours.

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