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Multicenter Study
. 2022 Sep;94(9):4097-4106.
doi: 10.1002/jmv.27812. Epub 2022 May 25.

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

Thierry Prazuck  1   2 , Anne Gravier  1 , Daniela Pires-Roteira  2 , Aurelie Theillay  2 , Sandra Pallay  2 , Mathilda Colin  2 , Raphael Serreau  3 , Laurent Hocqueloux  2 , Nino Guy Cassuto  4
Affiliations
Multicenter Study

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

Thierry Prazuck et al. J Med Virol. 2022 Sep.

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.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Visual appearance of the COVID‐VIRO ALL IN® test device and representation of the potential results.
See this image and copyright information in PMC

Comment in

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