Universidad Peruana Cayetano Heredia

Diagnostic performance of four lateral flow immunoassays for COVID-19 antibodies in Peruvian population.

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dc.contributor.author Calderón Flores, Rodrigo Alonso
dc.contributor.author Caceres Cardenas, Guillermo Ernesto
dc.contributor.author Alí Francia, Karla Giannina
dc.contributor.author De Vos, Margaretha
dc.contributor.author Emperador, Devy
dc.contributor.author Cáceres Nakiche, Tatiana
dc.contributor.author Eca Ávila, Anika Guadalupe
dc.contributor.author Villa Castillo, Luz Estefania
dc.contributor.author Albertini, Audrey
dc.contributor.author Sacks, Jilian A.
dc.contributor.author Ugarte Gil, Cesar Augusto
dc.coverage.spatial Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Perú
dc.date.accessioned 2023-07-18T16:18:56Z
dc.date.available 2023-07-18T16:18:56Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/20.500.12866/13924
dc.description.abstract Serological assays have been used in seroprevalence studies to inform the dynamics of COVID-19. Lateral flow immunoassay (LFIA) tests are a very practical technology to use for this objective; however, one of their challenges may be variable diagnostic performance. Given the numerous available LFIA tests, evaluation of their accuracy is critical before real-world implementation. We performed a retrospective diagnostic evaluation study to independently determine the diagnostic accuracy of 4 different antibody-detection LFIA tests: Now Check (Bionote), CareStart (Access bio), Covid-19 BSS (Biosynex) and OnSite (CTK Biotech). The sample panel was comprised of specimens collected and stored in biobanks; specifically, specimens that were RT-PCR positive for SARS-CoV-2 collected at various times throughout the COVID-19 disease course and those that were collected before the pandemic, during 2018 or earlier, from individuals with upper respiratory symptoms but were negative for tuberculosis. Clinical performance (sensitivity and specificity) was analyzed overall, and subset across individual antibody isotypes, and days from symptoms onset. A very high specificity (98% - 100%) was found for all four tests. Overall sensitivity was variable, ranging from 29% [95% CI: 21%-39%] to 64% [95% CI: 54%-73%]. When considering detection of IgM only, the highest sensitivity was 42% [95% CI: 32%-52%], compared to 57% [95% CI: 47%-66%] for IgG only. When the analysis was restricted to at least 15 days since symptom onset, across any isotype, the sensitivity reached 90% for all four brands. All four LFIA tests proved effective for identifying COVID-19 antibodies when two conditions were met: 1) at least 15 days have elapsed since symptom onset and 2) a sample is considered positive when either IgM or IgG is present. With these considerations, the use of this assays could help in seroprevalence studies or further exploration of its potential uses. en_US
dc.language.iso eng
dc.publisher Public Library of Science
dc.relation.ispartofseries PLOS Global Public Health
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Virus testing en_US
dc.subject Antibodies en_US
dc.subject Enzyme-linked immunoassays en_US
dc.subject COVID 19 en_US
dc.subject SARS CoV 2 en_US
dc.subject Reverse transcriptase-polymerase chain reaction en_US
dc.subject Viral vaccines en_US
dc.subject Respiratory infections en_US
dc.subject.mesh Prueba de COVID-19
dc.subject.mesh Anticuerpos
dc.subject.mesh Técnicas para Inmunoenzimas
dc.subject.mesh COVID-19
dc.subject.mesh SARS-CoV-2
dc.subject.mesh Reacción en Cadena de la Polimerasa de Transcriptasa Inversa
dc.subject.mesh Vacunas Virales
dc.subject.mesh Infecciones del Sistema Respiratorio
dc.title Diagnostic performance of four lateral flow immunoassays for COVID-19 antibodies in Peruvian population. en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1371/journal.pgph.0001555
dc.relation.issn 2767-3375


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