Concordancia entre la prueba de antígenos rápida para SARS-CoV-2 y la prueba diagnóstica de RT-qPCR

Main Article Content

Antonio Barrios-Pérez
Ivette Cid-Oros
Carlos Becerril-Gutiérrez
Oswaldo S. Medina-Gómez

Abstract

Objective: to assess the agreement between the rapid antigen testing (RATS) for SARS-CoV-2 and quantitative reverse transcription polymerase chain reaction (RT-qPCR). Methods: analytical cross-sectional study, conducted in three medical units from January 1, 2021, to June 30, 2022, in Mexico City, Mexico. Non-probabilistic sampling was performed using data from the Online Notification System for Epidemiological Surveillance. Data analysis was performed using frequency measures, Cohen’s kappa index, and maximum likelihood estimation. Results: Of 2173 participants with both diagnostic tests: 565 respiratory samples were concordant with a positive result (26.09% CI95% 24.25 - 27.99%), and 1229 with a negative result (56.55% CI95% 54.44 - 58.65%). The sensitivity of RAT versus RT-qPCR was estimated to be 65.17% (95%CI 61.99 - 68.33%), while the specificity was 94.10% (95%CI 92.82 - 95.38%); a positive predictive value of 88.01% (95% CI 85.23 - 90.41%), and a negative predictive value of 80.27% (95%CI 78.19 - 82.24%). The Cohen’s kappa index was 0.62 (substantial agreement), and a calculated likelihood ratio of 40% at pre-test prevalence, a post-test probability of 88.3% was observed for a positive result with RAT in case of having COVID-19. Conclusion: The present study demonstrated substantial concordance between RAT and RT-qPCR, supporting the feasibility of using both tests. This provides clinicians with a valuable tool for informed decision making in the diagnostic context of COVID-19.

Downloads

Download data is not yet available.

Article Details

How to Cite
Barrios-Pérez, A., Cid-Oros, I., Becerril-Gutiérrez, C., & Medina-Gómez, O. S. (2024). Concordancia entre la prueba de antígenos rápida para SARS-CoV-2 y la prueba diagnóstica de RT-qPCR. Atención Familiar, 25(2), 62–67. https://doi.org/10.22201/fm.14058871p.2024.287946

References

The Lancet editorial board. COVID-19 in Latin America—emergency and opportunity. The Lancet. 2021;398(10295):93.

Remes‐Troche JM, Velarde‐Ruiz Velasco JA. The Liver and COVID‐19 in Mexico. Clin Liver Dis. 2022;19(2):49-52.

Garduño-Orbe B, Sánchez-Rebolledo JM, Cortés-Rafael M, García-Jiménez Y, Perez-Ortiz M, Mendiola-Pastrana IR, et al. SARS-CoV-2 Reinfection among Healthcare Workers in Mexico: Case Report and Literature Review. Medicina (Kaunas). 2021 May 3;57(5):442.

Miller TE, Garcia Beltran WF, Bard AZ, Gogakos T, Anahtar MN, Astudillo MG, et al. Clinical sensitivity and interpretation of PCR and serological COVID‐19 diagnostics for patients presenting to the hospital. FASEB J. 2020;34(10):13877-13884.

Kumar A, Singh R, Kaur J, Pandey S, Sharma V, Thakur L, et al. Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. 2021;11:596201.

Sule WF, Oluwayelu DO. Real-time RT-PCR for COVID-19 diagnosis: challenges and prospects. Pan Afr Med J. 2020;35(Suppl 2):121.

Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Araos R, et al. Comparative evaluation of four rapid SARS-CoV-2 antigen detection tests using universal transport medium. Travel Med Infect Dis. 2021;39:101942.

Gohl DM, Garbe J, Grady P, Daniel J, Watson RHB, Auch B, et al. A rapid, cost-effective tailed amplicon method for sequencing SARS-CoV-2. BMC Genomics. 2020;21(1):863.

Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernández-Fuentes MÁ, et al. Field evaluation of a rapid antigen test (PanbioTM COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres. Clin Microbiol Infect. 2021;27(3):472.e7-472.e10.

Osterman A, Badell I, Basara E, Stern M, Kriesel F, Eletreby M, et al. Impaired detection of omicron by SARS-CoV-2 rapid antigen tests. Med Microbiol Immunol (Berl). 2022;211(2-3):105-117.

Yamayoshi S, Sakai-Tagawa Y, Koga M, Akasaka O, Nakachi I, Koh H, et al. Comparison of Rapid Antigen Tests for COVID-19. Viruses. 2020;12(12):1420.

Landis JR, Koch GG. The Measurement of Observer Agreement for Categorical Data. Biometrics. 1977;33(1):159-174.

Deeks JJ, Altman DG. Diagnostic tests 4: likelihood ratios. BMJ. 2004;329(7458):168-169.

Peckham H, De Gruijter NM, Raine C, Radziszewska A, Ciurtin C, Wedderburn LR, et al. Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission. Nat Commun. 2020;11(1):6317.

COVID-19 Tablero México. COVID - 19 Tablero México. [Internet]. [Citado 2024 Ene 15]. Disponible en: https://datos.covid-19.conacyt.mx/

Bongolan VP, Minoza JMA, De Castro R, Sevilleja JE. Age-Stratified Infection Probabilities Combined With a Quarantine-Modified Model for COVID-19 Needs Assessments: Model Development Study. J Med Internet Res. 2021;23(5):e19544.

Ren SY, Wang WB, Gao RD, Zhou AM. Omicron variant (B.1.1.529) of SARS-CoV-2: Mutation, infectivity, transmission, and vaccine resistance. World J Clin Cases. 2022;10(1):1-11.

Chams N, Chams S, Badran R, Shams A, Araji A, Raad M, Mukhopadhyay S, et al. COVID-19: A Multidisciplinary Review. Front Public Health. 2020;8:383.

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. The Lancet. 2020;395(10223):497-506.

Iser BPM, Sliva I, Raymundo VT, Poleto MB, Schuelter-Trevisol F, Bobinski F. Definição de caso suspeito da COVID-19: uma revisão narrativa dos sinais e sintomas mais frequentes entre os casos confirmados. Epidemiol E Serviços Saúde. 2020;29(3).

Khalid MF, Selvam K, Jeffry AJN, Salmi MF, Najib MA, Norhayati MN, et al. Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis. Diagnostics. 2022;12(1):110.

Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020;99:328-333.

Berger A, Nsoga MTN, Perez-Rodriguez FJ, Aad YA, Sattonnet-Roche P, Gayet-Ageron A, et al. Diagnostic accuracy of two commercial SARSCoV- 2 antigen-detecting rapid tests at the point of care in community-based testing centers. PLoS ONE. 2021;16(3 March 2021):1-12.

Lippi G, Henry BM, Plebani M. LumiraDX SARS-CoV-2 Antigen Test for Diagnosing Acute SARS-CoV-2 Infection: Critical Literature Review and Meta-Analysis. Diagnostics. 2022;12(4):947.

Pandey AK, Mohanty A, Hada V, Rath RS, Kumar S, Kishore S, et al. Comparison of the Rapid Antigen Testing Method With RT-qPCR for the Diagnosis of COVID-19. Cureus. 2021;13(8).

Dinnes J, Deeks JJ, Berhane S, van Wyk SS, Nyaaba N, Domen J, et al. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane Infectious Diseases Group, ed. Cochrane Database Syst Rev. 2021;2022(7).