Which pharmaceutical co. will be the first to come up with an over the counter corvid 19 test kit as easy to use as a pregnancy test kit?
回答 (5)
The same one that came up with an OTC flu test kit.
The FDA has requirements set as to what is allowed OTC which must be simple to use, idiot proof, and yet accurate. The test needs to be classified as a low complexity test before that can be allowed to happen.
At present the most accurate way to test for the virus is through PCR technology which is classified as high complex testing because of the complexity of sampling and testing.
The only way to achieve a low complexity test is through the use of technology that does not use PCR but instead uses antigen testing technology which isn't as accurate. The collection of samples is also complex and not easy nor simple. If not collected properly then you will get poor results. For this reason I seriously doubt one will ever see an OTC version for coronavirus or the flu.
There's two major problems with the testing. One is the collection of the appropriate sample with the preferred sample being a nasopharyngeal sample through the use of a wired small swab shoved down your nose all the way to the back of your throat which is then placed in viral transport media. Most people can not collect their own samples. A sample of that fluid is then removed and tested via PCR or antigen testing. At present with the flu virus both technologies are possible. Antigen testing is more available with point of care kits with a little meter reader that gives positive or negative indicators. It is much more portable and less complex that can be used at doctors offices.
PCR technology is more costly and more complex with dedicated instruments that do the PCR reactions which are more accurate in detecting the flu. These are not point of care tests but are very rapid and compatible to the turnaround times that antigen testing. In short there isn't any advantage in doing antigen testing when a PCR test is more accurate and takes the same amount of time to do.
The same path is being generated with regards to the coronavirus.
How accurate will it be? That is the difference between what is being used globally, and what the CDC requirements are for the testing.
won't happen. You don't see a flu test kit do you? just not possible.
I don't think they're going to handle it that way, dear -- no OTC tests.
The Trump administration seems to think that a German pharmaceutical company is well on the way to a vaccine and is reportedly trying to hijack its efforts. The Germans are not pleased.
Let's hope that's not true, because if it is, Trump and his minions are going to look even worse than they already do.
收錄日期: 2021-04-24 07:47:32
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