Validación clínica de un test serológico rápido semicuantitativo para pacientes infectados de covid-19 y determinación de la seroprevalencia en una población sanitaria

  1. J.G. Soto Campos 1
  2. A. Cebolla Ramírez 2
  3. I. Mendia Azkoaga 2
  4. J.C. Alados Arboleda 3
  5. S. Pérez Cortés 4
  6. J.A. Córdoba 4
  1. 1 Unidad de Gestión Clínica de Neumología y Alergia. Hospital Universitario de Jerez. Cádiz, España.
  2. 2 Biomedal S.L. Sevilla, España.
  3. 3 Unidad de Gestión Clínica Infecciones de Hospital Universitario de Jerez. Cádiz, España.
  4. 4 Unidad de Gestión Clínica de prevención, promoción y vigilancia de la Salud. Hospital Universitario de Jerez. Cádiz, España.
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Journal:
Revista española de patología torácica

ISSN: 1889-7347

Year of publication: 2021

Volume: 33

Issue: 4

Pages: 217-223

Type: Article

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More publications in: Revista española de patología torácica

Abstract

Objective: The objective of this study was two-fold. On one hand, the diagnostic validity of a semiquantitative rapid time resolved fluorescence immunochromatography method (LFIA-TRF) to determine IgM and IgG levels was evaluated and, on the other hand, a seroprevalence study was carried out among healthcare workers. Methods: To validate the diagnosis, a volunteer sample (n=75) was analyzed with LFIA-TRF after previously undergoing an RT-PCR test to confirm or rule out a possible SARS-CoV-2 infection. Finally, a sample of healthcare professionals directly involved in caring for patients infected with SARS-CoV-2 was randomly selected to determine IgM/IgG using LFIA-TRF. Results: The relative fluorescence levels considered positive ranged from 0.85-707 U/L for IgG and 0.75-64.5 U/L for IgM. The sensitivity was 100%, the specificity 95.4%, the positive predictive value (PPV) 76.9% and the negative predictive value (NPV) 100%. Of the 77 healthcare workers, 4 had positive serology, with 5.2% exceeding the seroprevalence in the community population. Conclusions: LFIA-TRF, especially the IgG result, showed good sensitivity and clinical utility both in determining the course of SARS-CoV-2 infection and to carry out seroprevalence studies.

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