
Qorvo’s Covid-19 test sounds good to the US FDA
The Covid-19 pandemic has spurred healthcare innovation across the board, with the astonishing success of mRNA-based vaccines being perhaps the most obvious example. Sometimes, however, a new technology emerges that might cause industry watchers to wonder whether it was strictly necessary. The IT company Qorvo has obtained US emergency authorisation for a test for coronavirus antigens that uses sound waves. The sample is placed in a cartridge loaded into Qorvo’s Omnia benchtop analyser; if nucleocapsid antigens are present they bind to antibodies immobilised in the cartridge, forming a slightly heavier mass. The system then uses what Qorvo calls “bulk acoustic waves” to cause the molecules to resonate; the antibody-antigen complexes resonate at a different frequency from the unbound antibodies, allowing a sensor to detect whether Covid-19 antigens are present. Its accuracy is acceptable, but this technology has to be markedly more expensive than the much simpler lateral flow assays such as Abbott’s BinaxNow, which costs $5 per test. Still, Qorvo received the NIH’s backing in the form of a $24.4m contract to produce and launch the Omnia platform. It is nice to see innovation rewarded, but widespread uptake seems unlikely.
Accuracy of selected FDA-authorised antigen tests | |||
---|---|---|---|
Company | Test | PPA | NPA |
Lumiradx | LumiraDx Sars-Cov-2 Ag test | 97.6% | 96.6% |
Abbott Diagnostics | BinaxNow Covid-19 Ag card | 97.1% | 98.5% |
Quidel | Sofia Sars antigen FIA | 96.7% | 100% |
Quidel | Sofia 2 Flu + Sars antigen FIA | 95.2% | 100% |
Qorvo | Omnia Sars-Cov-2 Antigen Test | 89.5% | 100% |
Access Bio | CareStart Covid-19 antigen test | 88.4% | 100% |
Becton, Dickinson and Company | BD Veritor system for Sars-Cov-2 | 84.0% | 100% |
PPA and NPA = positive and negative percent agreement. Source: FDA. |