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expert reaction to FDA approval of Abbott rapid antigen test for SARS-CoV-2

The US Food and Drug Administration (FDA) have approved the Abbott rapid antigen test for SARS-CoV-2.

 

Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said:

“The fact that the FDA say a negative test might need repeating speaks volumes.  If true, that would suggest that the rapid antigen test might lack the sensitivity of the gold-standard PCR tests.

“That’s not to say that such tests might not play a role in controlling future coronavirus outbreaks through rapid population surveillance and testing and tracing.  You don’t need to identify every infection to enable you to keep R below 1, and therefore stop an outbreak form growing.  But it would be less useful, when used alone, in the management of patients in a hospital setting or care home, where accurate and sensitivity tests are required to ensure that patients get the right care and are also isolated to prevent extensive onward chains of transmission.”

 

Prof Richard Tedder, Visiting Professor in Medical Virology, Imperial College London, said:

“This is a lateral flow test which detects viral antigens expressed by infected cells.  In trials it has a sensitivity when compared with PCR testing of 97.1%.  Though it is, as expected, of lower sensitivity than the molecular assays it would be anticipated to identify persons with a higher viral load in the respiratory tract, those who would be the individuals who pose the greatest risk of transmitting the infection to others. It has good specificity in the region of 98.5% in clinical trials.

“Such an approach will provide results in a far more timely fashion than is delivered by the current government sponsored systems and could contribute greatly to the control of transmission.  The company manufacturing this, Abbott, Chicago, US, have previously produced similar diagnostics of high quality for various infections including for example hepatitis B.”

 

 

https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-authorizes-first-diagnostic-test-where-results-can-be-read-directly-testing-card

 

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

 

Declared interests

Prof Richard Tedder: “No conflict other than I know Abbott well.”

None others received.

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