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. 2020 Nov 16;10(1):19893.
doi: 10.1038/s41598-020-76914-5.

Detection of SARS-CoV-2 antibodies is insufficient for the diagnosis of active or cured COVID-19

Pilar Escribano  1   2 , Ana Álvarez-Uría  1   2 , Roberto Alonso  1   2   3 , Pilar Catalán  1   2 , Luis Alcalá  1   2 , Patricia Muñoz  1   2   3   4 , Jesús Guinea  5   6   7
Affiliations

Detection of SARS-CoV-2 antibodies is insufficient for the diagnosis of active or cured COVID-19

Pilar Escribano et al. Sci Rep. .

Abstract

We assessed the performance of Abbott's SARS-CoV-2 IgG assay and the PanbioTM COVID-19 IgG/IgM rapid test device for the diagnosis of either active or cured COVID-19. Three cohorts of patients were chosen. Cohort 1, patients (n = 65) who attended the emergency department on March 30, 2020 with clinical suspicion of active COVID-19 (n = 56 with proven/probable COVID-19). Cohort 2, hospital workers (n = 92) who had either been (n = 40) or not (n = 52) diagnosed with proven/probable COVID-19 and were asymptomatic at the time of the sampling. Cohort 3, patients (n = 38) cared at the hospital before the start of the COVID-19 pandemic. Detection of serum antibodies was done using Abbott´s SARS-CoV-2 IgG assay and the PanbioTM COVID-19 IgG/IgM device. Both methods showed 98% agreement for IgG detection. No antibodies were detected in the 38 samples from hospitalized pre-COVID subjects. The diagnostic performance of IgGs detected by Abbott´s SARS-CoV-2 assay in Cohorts 1/2 was: sensitivity (60.7%/75%) and specificity (100%/84.6%). The diagnostic performance of IgM by PanbioTM COVID-19 in Cohorts 1/2 was: sensitivity (16%/17.5%) and specificity (100%/98.1%). We show that IgG detection alone is insufficient for the diagnosis of active or cured COVID-19. IgM detection has a limited diagnostic value.

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Conflict of interest statement

The authors declares no competing interest within the scope of this manuscript. This study did not receive any funding. PE (MS15/00115) is a recipient of a Miguel Servet contract supported by FIS (Fondo de Investigación Sanitaria, Instituto de Salud Carlos III). JG is a steady researcher contracted by Fundación para la Investigación Biomédica del Hospital Gregorio Marañón. AAU (CM18/0089) is supported by a Río Hortega contract supported by the FIS.

Figures

Figure 1
Figure 1
Scatter plots of index values obtained by Abbott´s SARS-CoV-2 IgG assay (Architect analyser) versus days from the onset of symptoms of all patients (a), and patients from Cohort 1 (b) and Cohort 2 (c). Dots in red indicate proven COVID-19 cases and dots in blue indicate probable COVID-19 cases.
See this image and copyright information in PMC

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