What is your insight after viewing the video which explains the ones we were discussing (low sensitivity) are not the ones in the article. The issue now is diagnostic test criteria vs. public health criteria.
I had such high hopes when I thought that the ones that folks could do at home would be allowed, but the regulatory agencies saying too low sensitivity, and the makers of such tests must mirror and have a way so that all of the results are reported to a public health organization for the results. Test makers just don't have that internal expertise. MOO And that is what much of this video is about.
Therefore... test makers can't do, pandemic doesn't fit any of the US agencies seamlessly. CLIAA doesn't want, FDA doesn't want. Test folks cannot do unless under *investigation* criteria.. e.g. cannot roll out to millions to test at home as no precedent for ANY agency in the US
@Sundog MOO
It's a conundrum, and the government moves too slowly. Hopefully, we will learn much for the next pandemic/epidemic which now will be endemic MOO
It's gonna get real nasty with blame game as we move forward MOO as a public heath test that has low sensitivity, but works great in a pandemic, was not envisioned. Heck, most MSM and gov'mt officials still don't get it MOO. (Notwithstanding, high government doesn't get the easiest stuff.. this is third level critical thinking MOO)
ETA... This is a you tube channel called MEDCAM, did the MODS approve, cause I see it often in WS? Or do I need to self report? Just looked them up....sorry
Not sure the speakers have the same information I am reading and posting from MIT website. The FDA is clearly interesting in paper test, has already approved one, is working with MIT/3M/NIH on one that can be produced by the thousands quickly. Dr Birx spoke of these in many of her first WHTF PC...she was challenging, great minds at our great universities to a quickly develop a "finger stick/spit" type test.
As far as manufacturing the test 3M excels at this, it's their core business. MOO..we'll see Johnson and Johnson and others jump on these home test kits.
FDA is aware of low sensitivity in home test....examples home pregnancy, blood sugars. No blood sugar reading from a home test device ever matches a blood test. It's a 'tool" and warning system. So yes, the FDA will be approving test that meet standards and they already have standards for home test, which the speakers says they do not.
If you read any of the article from MIT/3M it clearly states paper test are in FDA review and 3M will manufacture.
Yes, the test not 100% reliable, the margin of error is great for a false positive. MOO...I'd rather have false positive and seek medical advice, than a negative test and walk around infecting people.
The "purpose" of the paper test, convenient, take in the comfort of your home, no doctor order require, distributed by pharmacies, big box stores, cheap to produce, and mass distribute.
Much like the "home pregnancy test" , home test for urinary tract infection, or test finger stick blood sugar and other home test.
This test is designed for rapid, mass testing and with any home test Covid, pregnancy, UTI, or elevated blood sugars we should seek medical advice from our physician or local health department, if we obtain certain results. Its never gonna be, nor is meant to be the only test a positive person would take. I'm sure there will be a warning....when to contact a medical professional.
I do see folks taking more than one test, just like with home pregnancy and blood glucose tests, some folks may suspect an incorrect reading or just not believe in the results. Some folks that won't go to a doctor or test site, are afraid to go for a nasal swab, illegal immigrants who fear ICE, or feel big brother would monitor them, will have a tool they can use to at least try to stop the spread.
It's a new type of test to add to our tool box.
Now we PCR, antibody, and home test.
Hopefully these test will be in the market within the next few months.
MOO...