2022-03-28 10:42

Qlife study follow up - deviations in test execution explain incorrect results

In a Danish clinical evaluation of rapid tests for covid-19, conducted at Hvidovre Hospital and published on the hospital's website in February, the results for the Egoo SARS-CoV-2 test differed from another scientific study. The company therefore contacted Hvidovre Hospital and the Danish Medicines Agency to verify the methodology in the evaluation.  Deviations in the test execution from intended use and instructions account for incorrect results.

The study set-up was using Hvidovre Hospital best practice for covid-19 testing (RT-qPCR) as the comparator method. Thus, the test execution deviates from the Egoo.Health Intended Use and Instruction for Use by using another dilution factor than specified by Qlife.

"As a consequence of the deviations the Egoo.Health test results will be excluded from the study as well as further scientific review and future publication will exclude the Egoo.Health results”, says Thomas Warthoe, CEO of Qlife.

Previous scientific published study shows that Egoo covid-19 PCR test can deliver test results with almost the same sensitivity and specificity as laboratory tests (qRT-PCR) in 30 minutes without access to specialized laboratory equipment.