Evaluation of a new "all in one" SARS-CoV-2 antigen-detecting rapid diagnostic test and self-test: Diagnostic performance and usability in child and adult populations.

ABSTRACT

The control of the COVID-19 epidemics has been one global health priorities for the last 2 years. To that end, more reliable and easy-to-use, regardless of age, diagnostic tests are necessary. Considering that, we evaluated an innovative two-step self-test, the AAZ COVID-VIRO ALL IN®, switching from the classic nasal swab to a nasal sponge. We performed a multicenter study, on 124 adults and children, in a point-of-care setting. Sensitivity, specificity and overall acceptance of the COVID-VIRO ALL IN® self-test compared to reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal samples were of 93.0%, 100%, and 97.5%, respectively. We then performed a multicenter, usability study to evaluate the ease of use of COVID-VIRO ALL IN® on 68 laypersons adults. A vast majority of participants correctly executed and interpreted the test. The usability was then specifically investigated on 40 children and teenagers, comparing COVID-VIRO® first generation to the new COVID-VIRO ALL IN®. They all found COVID-VIRO ALL IN® more comfortable and easier to use. For young children, the new self-test seems safer (less risk of trauma and no liquid exposure), and faster than saliva-based RT-PCR. Moreover, the COVID-VIRO ALL IN® can easily be adapted as a multiplex self-test for other respiratory viruses, opening new perspectives of simultaneous, rapid and massive detection of respiratory infections, especially among vulnerable populations like children and elderly people.