COVID19 home-testing kits misled customers

stethoscope and blood sample tube

Home-testing kits sold online in the UK and US in the midst of the coronavirus pandemic were provided with incomplete and in some cases, misleading information on how accurate they were.

Testing has been regarded as critical to managing the pandemic, the two main tests being molecular virus tests (to detect current infection) and antibody tests (to detect previous infection). Outside of national testing programmes, multiple websites were found  selling both types of test in kit form for personal home use. These tests have subsequently been banned in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

The study, which is the first research into the accuracy of the information provided by websites selling tests for the virus, analysed 27 sites in the UK and US which were selling tests in May 2020. The online information provided with each of the 41 tests (39 in the UK and 2 in the US) was reviewed for completeness, accuracy and how informative it was.

Of the 41 tests, only nine provided the name of the test manufacturer while only ten provided information on when to use the test.

Information on accuracy was only provided with 12 of the tests and just under half failed to provide information on how to interpret the results.

Sensitivity and specificity information ranging from 97.5% to 100% for molecular tests and 100% for antibodies was provided for 27 of the 41 tests. However, researchers were only able to link these figures to manufacturer’s documents or publications for four of the tests.

Only 12 out of the 18 antibodies tests being sold explained that a positive result does not necessarily imply immunity from future infection.

Researchers also found misleading information about regulatory approval with websites claiming endorsements from Public Health England, the NHS or the UK or other European governments. This is despite the fact that currently, no COVID-19 antibody tests have regulatory approval for home sampling or home testing.

Professor Jon Deeks, co-author from the Institute of Applied Health Research at BHP founder member the University of Birmingham said: “Our analysis has found that many of these third-party websites omitted trustworthy guidance on the timing of tests, the interpretation of results and the implications of results. It is crucial that all test users are given adequate and appropriate information to help them make safe and informed choices, and best practice guidance should be developed to ensure the safety of these users. The role of the regulator in enforcing complete and accurate information should also be reviewed.”

Dr Sian Taylor-Phillips, lead author from the Warwick Medical School at the University of Warwick said: “It is essential that people buying tests for COVID-19 are given complete and correct information. Our study shows this simply isn’t happening at the moment. This could put people at risk of becoming infected or infecting others.”

The full paper, ‘Information given by websites selling home self-sampling COVID-19 tests: An analysis of accuracy and completeness’ is available on medRxiv.