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RESEARCH PRODUCT
Point-of-care evaluation of a rapid antigen test (CLINITESTⓇ Rapid COVID-19 Antigen Test) for diagnosis of SARS-CoV-2 infection in symptomatic and asymptomatic individuals
Sandrine PoujoisJavier ColominaDavid NavarroGabriella AlvarezEliseo AlbertIgnacio Torressubject
0301 basic medicineMicrobiology (medical)medicine.medical_specialtyCopper SulfateCoronavirus disease 2019 (COVID-19)Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Point-of-Care Systems030106 microbiologyPopulationAsymptomaticSensitivity and SpecificityCitric Acid03 medical and health sciences0302 clinical medicineInternal medicineAntigen assaysmedicineHumans030212 general & internal medicineeducationLetter to the EditorPoint of careeducation.field_of_studybusiness.industrySARS-CoV-2COVID-19Antigen testInfectious DiseasesSodium BicarbonateRapid antigen testmedicine.symptombusinessdescription
AbstractRapid antigen assays (RAD) based on lateral flow immunochromatography (LFIC) technology have emerged as a valuable tool for the control of COVID-19 pandemic. Manufacturer□independent, real□world evaluation of these assays is crucial given the considerable heterogeneity reported in their clinical and analytical performances. Here, we report for the first time on the point-of-care performance of the CLINITEST® Rapid COVID-19 Antigen Test (Siemens, Healthineers, Erlangen, Germany) to detect SARS-CoV-2 infection in presumptive COVID-19 cases or asymptomatic close contacts of COVID-19 patients. When compared to RT-PCR, the overall sensitivity of the assay was 80.2 (95% CI, 70.9-87.1) for symptomatic patients sampled (nasopharyngeal specimens) within five days after the onset of symptoms and 60% (95% CI, 40.7-76.6%) for asymptomatic participants. The overall specificity was 100% in both population groups.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-05-01 | The Journal of Infection |