The MHRA issued a warning in August about potentially unreliable HIV testing kits, manufactured by Qingdao Hightop Biotech Co Ltd. The regulator seized 114 of the Hightop HIV/AIDS Home Test Kits from 2 suppliers in the UK. All sales of these kits have been terminated in Britain.
The kits did not bear the CE mark meaning they did not meet regulatory requirements for test performance, labelling and instructions for use. Only kits which have been approved for performance labelling and instructions for use are awarded the CE mark. The MHRA recommends only kits bearing the CE mark and are clearly intended for self-testing should be used.
The MHRA further urges consumers to purchase kits online from pharmacies which are registered with the MHRA and which displays the European Common Logo on every page of its website. More information about buying HIV testing kits online are available from here: http://www.nat.org.uk/#
Any concerns about the kits should be discussed with a doctor or healthcare professional and any faults can be reported to the MHRA via the Yellow Card Scheme.
Consumers who believe they may have used a Hightop HIV/AIDS Home Test Kit are advised to seek a further HIV test at their local sexual health clinic or through their GP as the kits are unreliable and may give a false reading.
John Wilkinson, Director of the MHRA’s Devices Unit stated “People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable. Make sure that the kit has a CE mark and clearly states that it is intended for self-testing. Don’t use a test kit if it’s damaged or the seal is broken”.
“If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”.
“We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme”.