Background
We have completed a review of the TouchBio Chlamydia & Gonorrhoea Test for self‑testing (for females). The review was undertaken to verify the performance of the device. During the review, we also received signals suggesting false negative results in individuals who had used the device, where subsequent testing using alternative methods identified infection.
Chlamydia and gonorrhoea are nationally notifiable sexually transmissible infections. Accurate detection of these infections is important to support timely diagnosis, treatment, and prevention of transmission.
Review findings
As part of the review, we initiated independent laboratory testing of the analytical performance of the device, including whether it reliably detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) at the concentrations claimed by the manufacturer.
We found that we could not reproduce the analytical performance claims for Limit of Detection. Until this issue is resolved with the manufacturer, we consider the device is not reliable for detecting CT and NG at the claimed concentrations. This raises concerns about the potential for false negative results for users of the device.
False negative results may lead to missed detection of infection, delays in diagnosis and treatment, and ongoing transmission.
Outcomes and actions
Following the review, the TouchBio Chlamydia & Gonorrhoea Test for self‑testing (for females) was suspended from the Australian Register of Therapeutic Goods (ARTG).
While the suspension is in place, the device cannot be lawfully supplied by the sponsor in Australia.
The sponsor is undertaking further work to address the issues identified in the review, including demonstrating that the device can reliably detect CT and NG at the claimed concentrations.
Information for healthcare professionals and consumers
As this the TouchBio Chlamydia & Gonorrhoea Test for self‑testing (for females) is intended for self‑testing, individuals using the test should be aware of its limitations.
Based on the above findings, a negative result from the device does not exclude infection. The device should not replace assessment by a medical practitioner and is best considered as an initial screening tool.
Individuals with ongoing risk of infection, recent exposure, or persistent symptoms should seek further evaluation, including confirmatory testing, through a healthcare professional or a sexual health clinic.
Healthcare professionals and services should be aware of the potential for false negative results associated with this device. Where relevant, consideration may be given to appropriate follow‑up and confirmatory testing in line with local clinical practice, particularly in individuals at risk of infection.
Reporting problems
We encourage consumers and healthcare professionals to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products.
For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.