| Popis: |
For the last two years, the SARS-CoV-2 virus spread all around the world and led to the COVID-19 pandemic. The need of methods to control the pandemic and to propose rapid and efficient diagnostic tools has emerged. In this perspective, SARS-CoV-2 rapid antigen detection tests (RADT) have been developed. We performed a retrospective study on 638 collected nasopharyngeal samples used for reference RT-qPCR diagnosis to compare the AQ+ COVID-19 Ag Rapid Test” from InTec (AQ+ InTec test) performance with other commercially available RADT. We analysed the sensitivity and specificity of the different tests and showed a better overall performance of the AQ+ InTec test, which was confirmed on the SARS-Cov-2 Omicron variant. We then conducted a prospective study on 1428 patients, to evaluate the sensitivity and specificity of the AQ+ InTec test on nasal and nasopharyngeal samples in a point of care setting. We showed that sensitivity and specificity reach acceptable criteria regarding the official recommendations of the MDCG 2021-21 in both symptomatic and asymptomatic patients. Overall, the results of these two studies confirm that the AQ+ InTec test is a valuable tool for testing in a pandemic context with a high proportion of asymptomatic patients who are potential carriers for the SARS-CoV-2 virus and is performant on the most current circulating variant Omicron.HighlightsThe sensitivity of the AQ+ COVID-19 Ag Rapid Test from InTec reaches 94.4% on nasal samples and 97.4% on nasopharyngeal samples.The performance of the test remains high on asymptomatic patients with a sensitivity of 89.2% on nasal samples and 97.0% on nasopharyngeal samples.Prospective study in a point of care setting revealed a better sensitivity compared with other commercially available rapid antigen detection tests |
