At-Home STI Test Pulled in Australia Over False Negatives 2026

The at-home STI test for chlamydia and gonorrhoea has been pulled from Australian shelves after failing to detect infections, raising serious health concerns. Australia’s only approved home test for these sexually transmitted infections was suspended by the Therapeutic Goods Administration (TGA) following a review that found the device unreliable and posing a high risk of false negative results. Consumers who purchased the $24 kit from pharmacies now face uncertainty about their health status.

Why Was the At-Home STI Test Suspended?

The TGA handed Touch Biotechnology a six-month suspension after a review of its self-testing kit. The regulator stated that the device is not reliable and poses a high risk for false negative results for users. The product first hit pharmacy shelves in December 2024, but by May 2025, a health service alerted the TGA about false negatives affecting an unspecified number of patients.

In its assessment, the TGA acknowledged it does not have a reliable estimate of how many users may have received incorrect results. Touch Biotechnology’s general manager, Mazz Gencer, said the company “acknowledges the TGA’s action and has ceased supply” while further verification and performance testing are completed.

What Were the Test’s Claims vs. Reality?

At the time of approval, Touch Biotechnology claimed the test correctly identified more than 99% of positive cases for both chlamydia and gonorrhoea when compared against urine PCR testing, and that it produced no false positives. However, the TGA’s review contradicted these claims, highlighting serious performance gaps.

Touch Biotechnology said it followed the established regulatory assessment process at the time of registration but declined to share non-public regulatory submissions or technical information. The company was required to maintain a post-market surveillance report, including adverse events like false results, but the extent of reported issues remains unclear.

Key Takeaways for Australian Consumers

This recall highlights the importance of relying on clinically validated testing methods. If you used the Touch Biotechnology STI test, consider retesting at a clinic or with a different approved method.

• The at-home STI test was the only approved home kit for chlamydia and gonorrhoea in Australia.
• False negative results can lead to untreated infections and further transmission.
• Consult your healthcare provider for accurate testing alternatives.
• The TGA urges consumers to report any adverse events from medical devices.

What’s Next for At-Home STI Testing?

Touch Biotechnology must complete further performance testing before the suspension ends. The TGA will review any new evidence before deciding on re-approval. In the meantime, Australians should use laboratory-based PCR tests offered by clinics or sexual health services. Home testing remains a convenient option but must meet strict reliability standards to protect public health.

This case also raises broader questions about regulatory oversight of rapid diagnostic tests. The TGA’s suspension sends a clear message that manufacturers must ensure their products meet safety and efficacy benchmarks, especially when used for conditions requiring prompt treatment.

FAQ

Stay informed about health product recalls by visiting the TGA’s website. Your health and safety are paramount – never hesitate to seek professional medical advice for STI screening.