With rapid antigen tests for SARS-CoV-2 slow to come to market, officials at the US Food and Drug Administration have tried to signal via a number of public comments that the agency would be flexible regarding test performance requirements and use models.
Ans: Slow to come to market because the FDA will not approve them
These indications of flexibility have largely failed to speed development and commercialization of rapid antigen tests, however, as test vendors, wary of falling short of agency requirements, have instead stuck to the more stringent specifications presented in the FDA's test templates.
Ans: The FDA specifications do not consider real world use. Wouldn't real world use be part of the flexibility they say they have? Where's the flexibilty in making home tests by prescription only so Doctors get paid to slow down the process?.
Early in the COVID-19 pandemic, rapid antigen tests were identified as a potentially key technology for slowing transmission of SARS-CoV-2 with calls for these tests growing as it became evident that molecular test capacity was not able to keep up with demand and was unlikely to ever reach a level where regular testing at population scale would be possible.
Ans: PCR tests cannot produce timely results and until WHO and the CDC changed the cycle turns to under 30x, they were producing many false positives which made antigen tests look bad in comparison, but in retrospect, antigen tests were probably more accurate than PCR at the time. A whole year wasted by relying on PCR tests whose continued use was motivated by the lab companies' greed. Whoever called them "the Gold Standard" was vastly mistaken.
Antigen tests have also been slow to scale, at least to the capacities deemed necessary by advocates of population screening. In particular, the US has yet to see the sort of cheap, relatively low sensitivity rapid antigen tests that researchers like Harvard University epidemiologist Michael Mina have advocated for use in serial screening models where frequent, repeated testing could compensate for such tests' lower sensitivity.
Ans: Innova said it will scale to 50 Million tests per day, and is at 10 million per day now. Why would the author, who spoke to Daniel Elliott, Innova CEO, leave that information out ot the article? There is hardly anything in this article about Dr Mina's views on the FDA, which would be scientific reasons for approving antigen tests and refutes what the unnamed FDA source says. I think the author is placating that source to curry favor because the website 360DX could use tips from the FDA.
The FDA has often been cited as the key roadblock to the availability of such tests, with supporters of serial testing models claiming that the agency's stated requirements of 80 percent sensitivity and 99 percent specificity for home tests available by prescription and for 90 percent sensitivity and 99 percent specificity for over-the-counter tests have added to product development times and prevented lower performing tests from entering the market.
Ans: OMG- A TRUE PARAGRAPH! ITS A MIRACLE!
Ans: Slow to come to market because the FDA will not approve them
These indications of flexibility have largely failed to speed development and commercialization of rapid antigen tests, however, as test vendors, wary of falling short of agency requirements, have instead stuck to the more stringent specifications presented in the FDA's test templates.
Ans: The FDA specifications do not consider real world use. Wouldn't real world use be part of the flexibility they say they have? Where's the flexibilty in making home tests by prescription only so Doctors get paid to slow down the process?.
Early in the COVID-19 pandemic, rapid antigen tests were identified as a potentially key technology for slowing transmission of SARS-CoV-2 with calls for these tests growing as it became evident that molecular test capacity was not able to keep up with demand and was unlikely to ever reach a level where regular testing at population scale would be possible.
Ans: PCR tests cannot produce timely results and until WHO and the CDC changed the cycle turns to under 30x, they were producing many false positives which made antigen tests look bad in comparison, but in retrospect, antigen tests were probably more accurate than PCR at the time. A whole year wasted by relying on PCR tests whose continued use was motivated by the lab companies' greed. Whoever called them "the Gold Standard" was vastly mistaken.
Antigen tests have also been slow to scale, at least to the capacities deemed necessary by advocates of population screening. In particular, the US has yet to see the sort of cheap, relatively low sensitivity rapid antigen tests that researchers like Harvard University epidemiologist Michael Mina have advocated for use in serial screening models where frequent, repeated testing could compensate for such tests' lower sensitivity.
Ans: Innova said it will scale to 50 Million tests per day, and is at 10 million per day now. Why would the author, who spoke to Daniel Elliott, Innova CEO, leave that information out ot the article? There is hardly anything in this article about Dr Mina's views on the FDA, which would be scientific reasons for approving antigen tests and refutes what the unnamed FDA source says. I think the author is placating that source to curry favor because the website 360DX could use tips from the FDA.
The FDA has often been cited as the key roadblock to the availability of such tests, with supporters of serial testing models claiming that the agency's stated requirements of 80 percent sensitivity and 99 percent specificity for home tests available by prescription and for 90 percent sensitivity and 99 percent specificity for over-the-counter tests have added to product development times and prevented lower performing tests from entering the market.
Ans: OMG- A TRUE PARAGRAPH! ITS A MIRACLE!
