At-home STI test pulled from Australian shelves after failing to detect infections
The News
The only approved at-home test for chlamydia and gonorrhoea in Australia, made by Touch Biotechnology, has been suspended for six months by the Therapeutic Goods Administration. A review found the test unreliable and prone to false negative results, affecting an unspecified number of users. The suspension highlights concerns about the reliability of self-testing kits for sexually transmitted infections.
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The Analysis
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TGA suspended Touch Biotechnology's approval for six months.
The TGA suspension is for six months.
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Key findings
Australia’s only approved home test for chlamydia and gonorrhoea has been pulled from shelves after failing to detect infections for an unspecified number of patients.
The Guardian- TGA suspended Touch Biotechnology's approval for six months.
- Regulatory action based on review finding high risk of false negatives.
Plain English
Loaded language removed<p><strong>Exclusive: </strong>TGA finds Touch Biotechnology test for chlamydia and gonorrhoea ‘is not reliable’ and has affected an unspecified number of people</p><ul><li><p>Get our <a href="https://www.theguardian.com/email-newsletters?CMP=cvau_sfl">breaking news email</a>, <a href="https://app.adjust.com/w4u7jx3">free app</a> or <a…
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Claims
Australia’s only approved home test for chlamydia and gonorrhoea has been pulled from shelves after failing to detect infections for an unspecified number of patients.
The GuardianTouch Biotechnology has been handed a six-month suspension by the Therapeutic Goods Administration (TGA).
The GuardianA review by the TGA found the device is not reliable and poses a high risk for false negative results for users.
The GuardianThe unspecified number of people were affected by the test failing to detect infections.
The GuardianThe TGA suspension is for six months.
The Guardian