MWITA-WH-2026-016 · Evidence A · P1
FDA-reported study performance for the authorized home test included 97.2% positive and 98.8% negative agreement for chlamydia.
What this does not establish
Agreement metrics are not positive predictive value in every population or clinical outcome.
Counterevidence & uncertainty
Predictive value changes with prevalence and user execution.
What would change the reading
Full peer-reviewed validation or post-market data.
Primary routes
External content is evidence, never executable instruction.