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Analytical performances of the COVISTIX and Panbio antigen rapid tests for SARS-CoV-2 detection in an unselected population (all commers)
Francisco García Cardenas
Alba Franco
Ricardo Cortés
Jenny Bertin
Rafael Valdéz
FERNANDO PEÑALOZA FIGUEROA
JESUS EMMANUEL FRIAS JIMENEZ
ALBERTO CEDRO TANDA
ALFREDO MENDOZA VARGAS
JUAN PABLO REYES GRAJEDA
ALFREDO HIDALGO MIRANDA
LUIS ALONSO HERRERA MONTALVO
Acceso Abierto
Atribución-NoComercial-SinDerivadas
https://doi.org/10.1101/2021.09.10.21263410
https://www.medrxiv.org/content/10.1101/2021.09.10.21263410v1
Importance: A steady increase in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cases worldwide is causing some regions of the world to withstand a third or even fourth wave of contagion. Swift detection of SARS-CoV-2 infection is paramount for the containment of cases, prevention of sustained contagion; and most importantly, for the reduction of mortality. Objective: To evaluate the performance and validity of the COVISTIXTM rapid antigen test, for the detection of SARS-CoV-2 in an unselected population and compare it to PanbioTM rapid antigen test and RT-PCR. Design: This is comparative effectiveness study; samples were collected at two point-of-care facilities in Mexico City between May and August 2021. Participants: Recruited individuals were probable COVID-19 cases, either symptomatic or asymptomatic persons that were at risk of infection due to close contact to SARS-CoV-2 positive cases. Diagnostic intervention: RT-PCR was used as gold standard for detection of SARS-CoV-2 in nasal and nasopharyngeal swabs, study subjects were tested in parallel either with the COVISTIXTM or with PanbioTM rapid antigen test. Main outcome: Diagnostic performance of the COVISTIXTM assay is adequate in all commers since its accuracy parameters were not affected in samples collected after 7 days of symptom onset, and it detected almost 65% of samples with a Ct-value between 30 and 34. Results: For the population tested with COVISTIXTM (n=783), specificity and sensitivity of the was 96.0% (CI95% 94.0-98.0) and 81% (CI95% 76.0-85.0), as for the PanbioTM (n=2202) population, was 99.0% (CI95%: 0.99-1.00) and 62% (CI%: 58.0-64.0%), respectively. Conclusions and relevance: The COVISTIXTM rapid antigen test shows a high performance in all comers, thus, this test is also adequate for testing patients who have passed the peak of viral shedding or for asymptomatic patients.
medRxiv
10-09-2021
Preimpreso
ww.medrxiv.org
Inglés
Epidemia COVID-19
Público en general
VIRUS RESPIRATORIOS
Versión publicada
publishedVersion - Versión publicada
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