Analytical Performances of the COVISTIX (TM) Antigen Rapid Test for SARS-CoV-2 Detection in an Unselected Population (All-Comers)
Por:
Garcia-Cardenas, Francisco, Peñaloza F., Bertin-Montoya, Jennifer, Valdez-Vazquez, Rafael, Franco, Alba, Cortes, Ricardo, Frias-Jimenez, Emmanuel, Cedro-Tanda, Alberto, Mendoza-Vargas, Alfredo, Reyes-Grajeda J.P., Hidalgo-Miranda, Alfredo, Herrera, Luis A.
Publicada:
1 jun 2022
Resumen:
The performance and validity of the COVISTIX (TM) rapid antigen test for
the detection of SARS-CoV-2 were evaluated in an unselected population.
Additionally, we assessed the influence of the Omicron SARS-CoV-2
variant in the performance of this antigen rapid test. Swab samples were
collected at two point-of-care facilities in Mexico City from
individuals that were probable COVID-19 cases, as they were either
symptomatic or asymptomatic persons at risk of infection due to close
contact with SARS-CoV-2 positive cases. Detection of the Omicron
SARS-CoV-2 variant was performed in 91 positive cases by Illumina
sequencing. Specificity and sensitivity of the COVISTIX (TM) rapid
antigen test was 96% (CI 95% 94-98) and 81% (CI 95% 76-85),
respectively. The accuracy parameters were not affected in samples
collected after 7 days of symptom onset, and it was possible to detect
almost 65% of samples with a Ct-value between 30 and 34. The COVISTIX
(TM) antigen rapid test is highly sensitive (93%; CI 95% 88-98) and
specific (98%; CI 95% 97-99) for detecting Omicron SARS-CoV-2 variant
carriers. The COVISTIX (TM) rapid antigen test is adequate for examining
asymptomatic and symptomatic individuals, including those who have
passed the peak of viral shedding, as well as carriers of the highly
prevalent Omicron SARS-CoV-2 variant.
Filiaciones:
Garcia-Cardenas, Francisco:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Peñaloza F.:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Bertin-Montoya, Jennifer:
Centro Citibanamex COVID, Mexico City, 11200, Mexico
Ctr Citibanamex COVID, Mexico City 11200, DF, Mexico
Valdez-Vazquez, Rafael:
Centro Citibanamex COVID, Mexico City, 11200, Mexico
Ctr Citibanamex COVID, Mexico City 11200, DF, Mexico
Franco, Alba:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Cortes, Ricardo:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Frias-Jimenez, Emmanuel:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Cedro-Tanda, Alberto:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Mendoza-Vargas, Alfredo:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Reyes-Grajeda J.P.:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Hidalgo-Miranda, Alfredo:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Herrera, Luis A.:
Instituto Nacional de Medicina Genómica, Periférico Sur 4809, Arenal Tepepan, Tlalpan, Mexico City, 14610, Mexico
Unidad de Investigación Biomédica en Cáncer, Instituto Nacional de Cancerología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, 04510, Mexico
Inst Nacl Med Genom, Periferico Sur 4809, Mexico City 14610, DF, Mexico
Univ Nacl Autonoma Mexico, Inst Invest Biomed, Inst Nacl Cancerol, Unidad Invest Biomed Canc, Mexico City 04510, DF, Mexico
gold, Green Published, All Open Access, Gold, Green
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