RE:RE:RE:Q: what's with the "ethics review board"?Ethics review could refer to anything information that is filled in on the FDAEUA application.
Its a warning they are watching and checking.
All the bad Antobody tests they let through were Lateral flow tests . That is why the FDA is cracking down hard making sure everyone is crossing the Ts and dotting the i.
Here is what Siemens has to say. Siemens Healthineers nabs first FDA nod for semi-quantitative SARS-CoV-2 antibody test
The test has 100% sensitivity and 99.9% specificity. It is the fifth antibody test from Erlangen, Germany-based Siemens Healthineers that has secured an EUA, all of which have sensitivities and specificities that exceed 99%. These include various test iterations for specific equipment.
In addition to the new semi-quantitative SARS-CoV-2 antibody test, Siemens Healthineers also markets a total antibody test that is designed to detect all the antibodies from a COVID-19 infection, which makes it useful shortly after symptoms appear.
Siemens Healthineers has the largest installed base of equipment to conduct serology antibody tests, noted Nath. The COV2G antibody test is available on an installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. This includes the Atellica Solution and ADVIA Centaur XP and XPT families of analyzers. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems also are being pursued.
SARS-CoV-2 antibody tests have gotten something of a bad reputation for a lack of accuracy, generating several headlines in major mainstream publications. But Nath argued that this isn’t based on high-throughput, automated testing results, but rather on results from lateral flow, or rapid antibody, tests. These are strip-based tests, akin to pregnancy tests, that tend to have a much larger margin of error when it comes to results but offer a very fast turnaround time of 10 to 15 minutes.
Lateral flow tests tend to have significantly lower accuracy rates, particularly with specificity, which then is amplified since the population prevalence is so low. For example, if a lateral flow test has 90% sensitivity and 95% specificity – and it’s applied to a population with only 5% prevalence – then the positive predictive value is wrong more than half of the time.
“So, the reason there's a lot of confusion in this field right now is people use the words antibody test without specifically referring to whether the test is a serology-based antibody test or a lateral flow test,” summed up Nath. “That's one point of confusion. The second point of confusion is the market in the United States and other parts of the world is that we're flooded with a large number of lateral flow tests from manufacturers that were not necessarily present in the U.S. market prior to this pandemic. And there is quite a big variation in quality among these lateral flow tests.
Findingmoney wrote: I thought it was because if a normal person without training administered the test, many factors could skew the results if not done properly, and the Ethical Review Board had to expand the reporting of field testing to include these new parameters. Logical yet poorly timed for us, but if they were ever going to change the rules it should be now, since SONA may be producing in mass scale and though they may pass past rules, they can set bar higher for others attempting a similar test method and may now set the standard for the future. Now which companies need to take their product off the market right now, until reviewed to be deemed acceptable for minimal false readings because in order to get a handle on the people infected you must consider all of the factors including the training needed to perform the tests.IMO