[HN Gopher] EUA Authorized Serology Test Performance ___________________________________________________________________ EUA Authorized Serology Test Performance Author : wyndham Score : 23 points Date : 2020-06-11 23:29 UTC (23 hours ago) (HTM) web link (www.fda.gov) (TXT) w3m dump (www.fda.gov) | moose_ears wrote: | Related: https://open.fda.gov/apis/device/covid19serology/ | Animats wrote: | It looks like this technology is getting debugged. Some of the | tests are well above 99% for both specificity and sensitivity. | Some aren't, and they will probably be withdrawn from the market. | FuckButtons wrote: | So from what I heard the other day, those >99% Numbers were | from a subset of the actual sample, which they argued was | because of the requisite time lag for seroconversion but may | just be p-hacking. | Animats wrote: | Cite? | FuckButtons wrote: | Segment starts around 17 minutes: | https://www.bbc.co.uk/sounds/play/m000jw02 | [deleted] | Shank wrote: | For the uninitiated, the FDA faced criticism initially by being | too slow to authorize PCR tests for SARS-CoV-2 and issued a much | more broad EUA for serological tests. However, serological tests | need to be run on known positive and negative patients (already | tested) to validate their accuracy. Because infection with SARS- | CoV-2 is relatively uncommon, and because the EUA is broad, tests | that offer the statistical value of a coin flip have been | authorized and used. This is a problem if you're trying to make | health decisions. | | So, the FDA is trying to advise people on this risk by providing | tools to judge the performance of serological tests to help clear | up the confusion. This is because many tests have rated | performance based on a very small number of people and the error | bars are relatively large. | makomk wrote: | Even the worst tests here provide a lot more information than a | coin flip, as I understand it. A 50% PPV at a prevalance of 5% | means that if the odds of someone having had coronavirus were | 5% going into the test and they get a positive result, you can | immediately update your estimate of the odds of them having had | it to 50%, which isn't nothing. ___________________________________________________________________ (page generated 2020-06-12 23:00 UTC)