HIV Home-test Kits with False Result Risk Seized by UK Medicines Agency

UK Medicines Healthcare products Regulatory Agency (MHRA) has seized over 100 HIV home-testing kits in fear that they are unreliable. The agency was in a bid to seize all available stock of the Hightop HIV/Aids home-test kit being distributed by UK suppliers.

However, it cautions that there are kits still available online and therefore, warned people against buying the product online. The agency urged those who had already bought it not to use it due to the high potential getting false results.

It advised people to make sure that any HIV kit they purchase has a CE mark before using it. The CE mark shows that the product is in line with EU safety, health and environmental requirements.

The seized home kits produced by Qingdao Hightop Biotech, don’t carry an official CE mark. This then puts doubts to whether the manufacturer has met all the regulatory requirements regarding labelling, test performance and instructions for use.

Not Safe or Reliable

John Wilkinson, the director of MHRA asked people to be careful when buying a self-test kit from the high street or online and make sure that the kits they buy are safe and reliable.

He added that should anyone have doubts or suspect that they may have used an unreliable test kit, they should visit the nearest sexual health clinic, GP or other healthcare professionals for reliable and safe testing.

The MHRA managed to seize 114 of the Hightop HIV/Aids home-test kits from two suppliers based in the UK. The agency has since stopped the sale of the brand in the UK market.

The manufacturer of the kits specialises in medical tests and equipment. The company has since stopped supplying its HIV kit to the UK market after it was contacted by the MHRA.

MHRA now recommends that people buy self-test kits from reputable sources only, such as online pharmacies registered with MHRA. The UK laws require that all online pharmacies be registered with MHRA and always display the European common logo on all their web pages.

Huge Benefits of HIV Home Self-Test Kits

There are many benefits of home self-test kits for HIV and STIs. For instance, they offer more privacy encouraging more people to test themselves increasing early diagnosis of HIV and other STIs.

The earlier one is tested, the sooner that can be placed on treatment should they test positive. This can greatly increase chances of getting cured in cases of some STIs or allow for better management of the HIV virus prolonging life.

Statistics by the National Aids Trust show that the UK has over 100,000 people living with HIV. A quarter of these are not aware of their HIV positive status and therefore, are not receiving HIV treatment. Another 39% of HIV positive people are diagnosed late. This lowers their life expectancies and quality of life.

BioSure HIV Self Test was the first HIV self-testing kit to be legally approved in the UK. The kit was first introduced into the UK market in 2015. It’s accuracy rate is a whopping 99.7%. Such are the kits that the two agencies are encouraging people to use for HIV testing.