RE:RE:You Heard It Here First: Sona Will Not Get ApprovedHC considers Antigen test so bad that they have to be double checked with PCR.
SONA LOD is poor so the 5 day limit maybe worst.
The proposed framework includes a number of suggestions. For example, the framework suggests considering:
- positive results from RADTs as a "presumptive positive" case until a reference nucleic acid-based (PCR) method confirms the positive result
- the clinical context of the test (asymptomatic as opposed to symptomatic) and the pre-test probability of infection in the person tested when interpreting a negative RADT result
- further testing using a nucleic acid-based (PCR) reference method for patients with negative RADT results where the pre-test probability of COVID-19 remains high (for example, a known contact, high community transmission), to direct further management
- if the pre-test probability is low, then the person can be monitored and remain out of isolation
As the guidance indicates, these new tests are still being investigated, and their performance characteristics are not yet fully understood. Viral loads, which are generally high in early disease, are sufficiently above the limit of detection for some antigen tests for the first 5 days of symptoms. After this initial period, performance decreases rapidly as the viral load starts to decrease.
MikeyH wrote: I disagree - I think they are under high scrutiny, mainly because they have no track record in the sector. But I do believe the amount of back and forth between HC and the company is positive. However it has to be soon; every day that passes is another lost opportunity.
A lot of people are criticizing HC unfairly. It takes time to make sure a company's claims are legit, especially so a start-up with no track record. Be patient