[HN Gopher] EUA Authorized Serology Test Performance
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       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       | Some aren't, and they will probably be withdrawn from the market.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.
        
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       (page generated 2020-06-12 23:00 UTC)