Hello, i work as the prevention manager for the (b)(6) funded testing program.We work with local providers to provide (b)(6) testing to high risk populations.We recently (as of (b)(6) 2021) endorsed our programs using rapid (b)(6) tests- the (b)(6) health check manufactured by (b)(6) waived community based testing activities.Soon after launching this testing we had a high number of false positive or suspected false positive tests in our program.Our testing partners, (b)(6) center and (b)(6) family planning have reported running 38 rapid (b)(6) tests on patients and 9 of those came back positive.Of those 9 positive tests, 7 were negative on confirmatory testing and 2 so far have been lost to follow up.This is a much higher than expected number of both positive and false positive tests for a relatively low (b)(6) prevalence state like (b)(6).We have reported these test results to the manufacturer on 7/7/2021.We have yet to hear back an explanation as to the reason for the high number of positive tests.I work for the health department and our contracted partners perform the testing and we do not do the testing ourselves but i wanted to report this information to the fda because the product's performance did not match what we would have expected, and i have heard of other negative reports about this product from other state std prevention programs.Fda safety report id# (b)(4).
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