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.
Keywords: COVID-19; SARS-CoV-2; antigen testing; children COVID testing; diagnostic testing; nasal sampling; self-test; usability.
【저자키워드】 COVID-19, SARS-CoV-2, Usability, antigen testing, diagnostic testing, Nasal sampling, Self-test, children COVID testing, 【초록키워드】 respiratory infections, Saliva, multicenter study, children, diagnostic test, Epidemics, diagnostic, risk, nasal, RT-PCR, Population, Antigen, COVID, respiratory viruses, polymerase chain reaction, point-of-care, specificity, Adults, Health, Reverse transcriptase polymerase chain reaction, Usability, diagnostic tests, diagnostic testing, age, multicenter, nasal swab, multiplex, trauma, Other respiratory viruses, switching, classic, reverse transcriptase, Chain Reaction, health priorities, Perspective, Nasopharyngeal samples, participant, transcriptase, nasopharyngeal sample, polymerase chain, performed, evaluate, investigated, evaluated, majority, less, faster, 【제목키워드】 Population, Rapid diagnostic test,