Concordance between two rapid diagnostic tests for the detection of antibodies against SARS-CoV-2

  1. Jaime de la Iglesia 1
  2. Tania Fernández-Villa 2
  3. Juan M. Fegeneda-Grandes 3
  4. Manuel Gómez-García 3
  5. Raúl Majo García 4
  6. Silvia López Sanz 5
  7. Patricia Mendez da Cuña 6
  8. Marta Llaneza García 7
  9. Alicia Marcos Sádaba 8
  10. José Pedro Fernández Vázquez 9
  1. 1 Centro de salud Condesa, León
  2. 2 Instituto de Biomedicina (IBIOMED). Universidad de León, León
  3. 3 Facultad de Veterinaria, Universidad de León, León
  4. 4 Centro de Salud Eras de Renueva, Gerencia de Atención Primaria del Área de Salud de León, León
  5. 5 Centro de salud Ribera del Esla, Gerencia de Atención Primaria del Área de Salud de León, León
  6. 6 Centro de salud La Palomera, León
  7. 7 Centro de salud Trobajo del Camino, León
  8. 8 Centro de salud Eras de Renueva, León
  9. 9 Gerencia de Atención Primaria del Área de Salud de León, León
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Journal:
Semergen: revista española de medicina de familia

ISSN: 1138-3593

Year of publication: 2020

Issue Title: COVID19 en Atención Primaria

Issue: 1

Pages: 28-32

Type: Article

DOI: 10.1016/J.SEMERG.2020.06.009 DIALNET GOOGLE SCHOLAR

More publications in: Semergen: revista española de medicina de familia

Abstract

Objective To assess the agreement between two rapid detection tests (RDT) for antibodies against SARS-CoV-2 infection. Materials and methods This was a cross-sectional study that used a random sample of non-hospitalized patients from the primary care management division of the Healthcare Area of Leon (58 RT-PCR-positive cases and 52 RT-PCR-negative cases). Information regarding symptoms was collected and all patients were simultaneously tested using two RDTs (Combined - cRDT and Differentiated - dRDT). The results of both tests were evaluated using the chi-square test and, for degree of agreement, the kappa coefficient. Results About 52% of the participants were women (mean age: 48.2 ± 11.0 years). A total of 58.2% were positive for d-RDT and 41.2% were positive for c-RDT. In the subjects who were RT-PCR-positive, d-RDT was positive in 72.4% and c-RDT in 55.2%; in those who were RT-PCR-negative, the percentages were 42.3% and 26.9%, respectively. The kappa coefficient observed between the two RDTs was 0.644, and was higher in patients without a fever or anosmia (0.725) and lower in those with a fever or anosmia (0.524). Conclusions There is good agreement between the tests used in this study. Given the sensitivity observed, they can be very useful as a complement to RT-PCR.

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Funding information

The authors would like to thank all patients for their participation in this study who have voluntarily agreed to collaborate in the evaluation of diagnostic techniques against COVID-19. Thank you to the primary care management division of the Healthcare Area of Leon and the University of Leon also, because their collaboration has been crucial in developing this study.

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Bibliographic References

  • Ministerio de Sanidad. Información científico – técnica. Enfermedad por coronavirus, covid-19. Available at: https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/20200417ITCoronavirus.pdf.(accessed 09-05-2020). Google Scholar
  • Sociedad Española de Enfermedades Infecciosas y Microbiología Clinica. Recomendaciones institucionales. Documento de posicionamiento de la SEIMC sobre el diagnóstico microbiológico del COVID-19. Available at: https://seimc.org/contenidos/documentoscientificos/recomendaciones/seimc-rc-2020-PosicionamientoSEIMCdiagnosticomicrobiologicoCOVID19.pdf. (accessed 10-05-2020). Google Scholar
  • Instituto de Salud Carlos III. Informe sobre estrategia de diagnóstico microbiológico del COVID-19 (Actualización) Madrid 19 de abril de 2020. Available at: https://www.semergen.es/files/docs/COVID-19/Documentos/informe-Iestrategia-microbiologico.pdf.(accessed 10-05-2020). Google Scholar
  • StataCorp. 2017. Stata: Release 15. Statistical Software. College Station, TX: StataCorp LLC. Google Scholar
  • Ministerio de Sanidad. INTERPRETACIÓN DE LAS PRUEBAS DIAGNÓSTICAS FRENTE A SARS-CoV-2. 24 de abril de 2020. Versión 2. Available at: https://www.mscbs.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/INTERPRETACION_DE_LAS_PRUEBAS.pdf.(accessed 12-05-2020). Google Scholar
  • J.L. Fleiss The design and analysis of clinical experiments Wiley, New York (1986) Google Scholar
  • N. Sethuraman, S. Stanleyraj Jeremiah, A. Ryo Interpreting Diagnostic Tests for SARS-CoV-2 JAMA (2020), 10.1001/jama.2020.8259 Google Scholar
  • L. Quan-Xin, L. Bai-Zhong, D. Hai-Jun, Gui-Cheng Wu, D. Kun, Yao-Kai Chen, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19 Nature Medicine (2020), 10.1038/s41591-020-0897-1 Google Scholar
  • Ministerio de Sanidad. Informe sobre la situación de COVID-19 en España. Informe COVID-19 n° 25. 23 de abril de 2020. Available at: https://www.isciii.es/QueHacemos/Servicios/VigilanciaSaludPublicaRENAVE/EnfermedadesTransmisibles/Paginas/InformesCOVID-19.aspx (accessed 25-04-2020). Google Scholar
  • J.R. Lechien, C.M. Chiesa-Estomba, D.R. De Siati, M. Horoi, S.D. Le Bon, A. Rodriguz, et al. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study Eur Arch Otorhinolaryngol. (2020), 10.1007/s00405-020-05965-1 Google Scholar
  • Ilustre Colegio de Médicos de Madrid. Informe, recomendaciones y propuestas del Ilustre Colegio de Médicos de Madrid (ICOMEM) sobre pruebas diagnósticas en las distintas situaciones de infección por el Coronavirus SARS-CoV-2. Available at: https://www.icomem.es/adjuntos/adjunto_2682.1588921631.pdf.(accessed 12-05-2020). Google Scholar
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