ABSTRACT
The control of the COVID-19 epidemics has been one of top global health priorities for the last eighteen months. To that end, more reliable and easy-to-use diagnostic tests are necessary. Young children are still not eligible to vaccination and it is important to find a way to easily test this key population regularly. With that in mind, we evaluated a new innovative easy two-step self-test named COVID-VIRO ALL IN(R) developed by AAZ that uses a sampling nasal sponge instead of a classic nasal swab. Mirroring the previous study conducted on the first generation of COVID-VIRO(R) antigenic self-test, we first performed a multicentre, prospective study on 124 adults and children, in a point-of-care setting. Sensitivity, specificity and overall acceptance of the COVID-VIRO ALL IN(R) antigen self-test compared to RT-PCR on nasopharyngeal samples were evaluated at 93.02%, 100% and 97,5%, respectively. We then performed a multicentre, prospective, usability study to evaluate the ease of use of COVID-VIRO ALL IN(R) in real life on 68 laypersons, all adults. Globally, 99% of them considered the instructions material good, 98% executed the procedure well, and all of them interpreted the results correctly. The usability was then specifically investigated on 40 children and teenagers participants, comparing both COVID-VIRO(R) first generation and the new COVID-VIRO ALL IN(R). All of them found COVID-VIRO ALL IN(R) much easier to use and much more comfortable. For young children, the COVID-VIRO ALL IN(R) self-test appears to be safer (less risk of trauma compare to nasal swabs and no liquid exposure) easier to use than classic COVID self-tests and giving immediate result which is not the case for RT-PCR done on saliva samples (currently done in routine for kids in French schools). It could be an adapted tool for future mass screening campaigns in schools or at home under adult supervision for kids from the age of 3.
Subject(s)
COVID-19 , Precursor Cell Lymphoblastic Leukemia-Lymphoma , Wounds and InjuriesABSTRACT
Background The SARS-CoV-2 virus is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease). In response to the growing COVID-19 pandemic, Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a real-life study to evaluate the performance of two RDTs, COVID-PRESTO and COVID-DUO, compared to the gold standard, RT-PCR. Methods RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orleans, France). Fingertip whole blood samples taken at different time points after onset of the disease were tested with RDTs. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated. Results Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with RDTs were all negative for these patients, indicating a specificity of 100% for both RDTs. In the RT-PCR positive subgroup (n=238), 133 patients were tested with COVID-PRESTO and 129 patients were tested with COVID-DUO (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days). Conclusion COVID-PRESTO and DUO RDTs turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with capillary blood sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.