The document linked below shows (2 weeks ago) what guidance on the use of rapid point-of-care testing could look like. @ICMRDELHI conducted a 2-site eval of antigen test. Note recommendation of add'l PCR to establish negatives & paired testing in some settings too. h/t @avtansh https://twitter.com/avtansh/status/1276362070309646337
Of course the scientist in me wants to learn more about their experimental design, validation, sample size, and other protocols. :D But page 1 makes the argument, and page 2&3 shows recommendations for use. Very interesting. https://www.icmr.gov.in/pdf/covid/strategy/Advisory_for_rapid_antigen_test14062020.pdf
One point seems particularly interesting as a regulatory example: "ICMR encourages other manufacturers/developers who have antigen detection assays to come forward for validation." I don't have expertise in this area, but indep validation & reporting seems like a good idea?
Followup: Here's a nice thread on the @US_FDA guidance & regulation— https://twitter.com/Mglo/status/1276336577246044160?s=20
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