Thursday, August 27, 2020

Fingers crossed

The Food and Drug Administration has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment.

[...]

Test-maker Abbott says it could soon manufacture 50 million of the rapid antigen tests per month, which could ease the country's testing bottleneck .

[...]

Health care providers still must administer the test but it can be done in point-of-care settings like offices.

[...]

Abbott CEO Robert Ford hinted that the test was on its way to market during the company’s July 16 earnings call, but declined to give specifics on when the company expected FDA to authorize the test.

  Politico
Perhaps because he knew it would be during the GOP convention?

Serious caveat:
The FDA said Monday that health providers can use antigen tests, which are less accurate than lab tests, to screen people without coronavirus symptoms on an “off-label” basis if lab turnaround times are too long.

The agency cautioned that negative results from such tests should be considered as presumptive negatives, and that different approaches, like repeated testing of the same person, should be considered.

[...]

Data that Abbott submitted to the FDA show that the test accurately detects 97.1 percent of positive samples and 98.5 percent of negative samples.
That seems pretty darned good.
The company says it plans to ship “tens of millions” of the tests to customers beginning in September, and is on track to manufacture 50 million tests a month from October on.

Abbott is also releasing a smartphone app that could allow people to display test results from their health care provider via a QR code when entering a public space.
So who's going to hack the app to allow people with positive results show they tested negative?

...but hey, do what you want...you will anyway.

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