Performance of UMELISA SARS-CoV-2 antigen and STANDARD F COVID-19 in the diagnosis of COVID-19 in Villa Clara, Cuba

Adrian Fernández García 1, Yamila González Bermudez 1, David del Valle Laveaga 2, Daniela Andreu Alvarez 1, Liss Mariam Rodríguez Rodríguez 1, María de Lourdes Sánchez Alvarez 1, Noira Durán Morera 3 and Rigoberto Fimia-Duarte 4, 5, *

1 Provincial Laboratory of Microbiology and Sanitary Chemistry, Provincial Center of Hygiene, Epidemiology and Microbiology (CPHEM), Villa Clara, Cuba.
2 Academic Area of Health, Maya World University, México.
3 Mariana Grajales" Obstetrics and Gynecology Hospital, Villa Clara, Cuba.
4 Faculty of Health Technology and Nursing (FTSE), University of Medical Sciences of Villa Clara (UCM-VC), Cuba.
5 Central University "Marta Abreu" of Las Villas, Villa Clara, Cuba.
 
Research Article
GSC Biological and Pharmaceutical Sciences, 2022, 19(03), 279–286.
Article DOI: 10.30574/gscbps.2022.19.3.0251
Publication history: 
Received on 19 May 2022; revised on 23 June 2022; accepted on 25 June 2022
 
Abstract: 
A cross-sectional descriptive study was carried out with the objective of describing the performance of UMELISA SARS-CoV-2 Antigen and STANDARD F COVID-19 Ag FIA in the diagnosis of COVID-19, at the Provincial Laboratory of Microbiology and Sanitary Chemistry of Villa Clara, during the month of February 2022. 1056 patients who underwent Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) using the QIAcube HT genome extraction technique, UMELISA SARS-CoV-2 Antigen and STANDARD F COVID-19 Ag FIA were included. Sensitivity, specificity, positive and negative predictive value were calculated as efficacy indicators and Spearman's Rho coefficient for the correlation between variables. The result was that 29.3% were sick, of which 189 were female, with a median age of 46 years. 74.8% had symptoms, most often fever, cough and runny nose. UMELISA SARS-CoV-2 Antigen showed higher specificity with 97.45%; while STANDARD F COVID-19 Ag FIA had higher sensitivity with 99.35%. It was shown that there is a significant inverse correlation between the RT-PCR cycle threshold and the fluorescence values ​​of both techniques studied (p=0.000). About a third of the patients studied were sick with symptoms, with a predominance of females. UMELISA SARS-CoV-2 Antigen turned out to be more useful in confirming the presence of the disease, while STANDARD F COVID-19 Ag FIA showed better performance in ruling out the presence of the disease.
 
Keywords: 
Performance; UMELISA SARS-Cov-2 Antigen; STANDARD F COVID-19 Ag FIA; RT; PCR; COVID-19
 
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