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Syphilis cases have risen by 52% since 2016 in the United States, but self-testing at home or anywhere for this sexually transmitted disease has not yet received approval by the US Food and Drug Administration (FDA; see Nature 605, 598–599; 2022). This puts US programmes implementing such tests, their associated laboratories, and online outlets at risk of regulatory non-compliance. It is creating confusion for patients and providers, whose requests for technical assistance and clarification are putting extra pressure on already-stretched public-health agencies. Moreover, the American Sexually Transmitted Diseases Association has issued a position statement that expresses concerns about the quality of available direct-to-consumer testing services in the absence of formal regulatory approval (C. Exten et al. Sex. Transm. Dis. 48, e155–e159; 2021).

The views are those of the correspondents and do not necessarily reflect the CDC’s position.

Competing Interests

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The authors declare no competing interests.

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