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 two 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 multicentre 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 RT‐PCR on nasopharyngeal samples were of 93.0%, 100% and 97.5%, respectively. We then performed a multicentre, 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, 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. This article is protected by copyright. All rights reserved.

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

“…Among the 49 studies on nasal swabs containing 79,073 samples [ [2] , [3] , [4] , 6 , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] ], all of them were published between 2021 and 2022, and twenty-one studies were conducted in the USA [ 12 , 14 , 15 , 18 , 21 , 22 , [25] , [26] , [27] , [32] , [33] , [34] , [35] , 39 , 44 , 45 , [47] ...…”

“…In addition to eliminating the drawbacks of nasopharyngeal swabs in terms of causing discomfort and possibly even damage to the patient [ 56 ], nasal swabs offered the option of home testing. Questionnaires were conducted in several studies, resulting that nearly all patients reported no pain in the anterior nasal collection, and it was easy to understand how to perform self-testing and interpret the test results [ 3 , 4 , 6 , 47 , 53 , 57 ]. Previous experience with HIV self-testing demonstrated that self-testers could perform HIV rapid diagnostic tests with reliability and accuracy [ 58 ].…”

“…The drawbacks of PCR, such as delays in obtaining results, and the necessity for pricey laboratory equipment as well as trained healthcare personnel, make it unsuitable for application in large screening programs [ 2 ]. Therefore, the rapid antigen test (RAT), with its short turnaround time and low cost, offers a rapid and easy-to-perform alternative to SARS-CoV-2 detection [ 3 , 4 ].…”

“…Widespread use of self-testing for SARS-CoV-2 infection, which could help reduce the workload of healthcare workers, can be a useful supplement to point-of-care tests by enabling more wide-ranging testing. Self-testing, if reliable, enables individuals to get prompt results, facilitating the early identification and isolation of COVID-19 cases [ 2 , 4 , 6 ].…”

The acceptance of SARS‐CoV‐2 rapid antigen self‐testing: A cross‐sectional study in China

“…For example, a nasal sponge sampling for SARS‐CoV‐2 RAST showed a more comfortable experience in the child and adult populations. 28 Therefore, it is expected to increase the public's acceptance of SARS‐CoV‐2 RAST by using a new sampling approach in the future. Second, the economic level might play a considerable role in the intention to use SARS‐CoV‐2 RAST.…”