Testing For All highlights that previously withdrawn ‘finger prick’ antibody test is now MHRA-compliant – launches UK’s most affordable home test kit
Not-for-profit company brings Roche product back to market
Testing For All, the not-for-profit company committed to making Covid-19 tests accessible and affordable for everyone, has launched the UK’s most affordable,MHRA-compliant antibody home testing kit. Initially priced at £39 per test, it is a finger prick sampling kit – manufactured by Swiss healthcare company Roche – that is CE certified for use with capillary blood and can be easily administered at home.
Antibody test kits from Roche and Abbot were briefly available until the MHRA announced in June that further validation of capillary blood-based tests was needed and that their use was to be suspended. Testing For All is promoting the message that the Roche product it provides is now fully MHRA-compliant for capillary blood, and that such tests can now resume.
The kit is available from Testing For All at:
https://www.testingforall.org/product/covid-19-home-antibody-test/
The home test enables anybody to determine if Covid-19 antibodies are present in their bloodstream, and whether or not they have had the virus. Antibody testing has only previously been available to NHS staff and key workers, and has required an intravenous blood sample to be taken by a qualified nurse. Testing For All’s capillary sampling kit is based on simple finger-prick blood collection, with results available within 48hours.
“This is an important step forward in Covid-19 testing, as it empowers any member of the public to understand if they have had the virus or not, regardless of who they are,” says Kelly Klifa, co-founder of Testing For All. “We have rigorously trialled our antibody testing kit and met all MHRA compliance criteria in order for the results to be fully recognised. As an agile, not-for-profit company, this is a first step towards fulfilling our commitment to make affordable Covid-19 testing available to everyone.”
The UK Government has extensive stocks of a similar capillary testing kit from Roche, but has thus far not made them widely available. Furthermore, the Government’s official advice still cites a lack of validation of capillary blood-based tests,despite recent proof of their efficacy. By demonstrating that such tests can now be MHRA-compliant, Testing For All hopes to drive the uptake of capillary blood sampling and show that it is a convenient and efficient method of testing as part of the fight against Covid-19.
“We believe that it is right to bring this fully certified antibody test kit to market now, as it provides people with an option that isn’t currently available to them,” says James Monico, co-founder of Testing For All. “The only safe way out of this crisis is through large-scale, affordable testing. We’re here to support and complement the Government’s existing capability, providing testing across society and helping to restart the UK economy.”
The capillary sampling kit contains a special CE-marked ‘lancet’, similar to those used by diabetics, with which the user can draw blood from their fingertip. It also includesa sample receptacle, accessories such as wipes, plasters and transport packaging materials, and a link to a web application to enable the user to register the kit to themselves. Once taken, the user can arrange for the sample to be collected and sent to a testing laboratory. Results should be available within 48 hours.
Capillary blood test kits have been in the UK market for over 10 years and have been used to take millions of blood samples for analysis at remote pathology labs. However, as a result of Covid-19, the UK regulators have started enforcing a 2012 IVD regulation requiring that capillary blood test kits be CE marked (as a class II device under the IVDD) in order to be placed on the market. Testing For All underwent a rigorous validation process to CE certify their sampling kits, which are used together with the Roche Anti-SARS-CoV-2 assays, also fully certified.
About Testing For All
Testing For All is a not-for-profit UK company with a mission to make Covid-19 testing accessible and affordable to anyone who needs it. We make easy-to-use, fully-certified tests available to anybody wishing to understand whether they are currently infected or if they have been exposed to the virus in the past. We believe that the only safe way out of this crisis is through large-scale, affordable testing for all.https://www.testingforall.org/
