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. 2020 Dec;98(4):115181.
doi: 10.1016/j.diagmicrobio.2020.115181. Epub 2020 Aug 21.

Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies

Aurelie Velay  1 , Floriane Gallais  1 , Ilies Benotmane  1 , Marie Josée Wendling  2 , François Danion  3 , Olivier Collange  4 , Jérôme De Sèze  5 , Catherine Schmidt-Mutter  5 , Francis Schneider  6 , Pascal Bilbault  7 , Ferhat Meziani  8 , Samira Fafi-Kremer  9
Affiliations

Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies

Aurelie Velay et al. Diagn Microbiol Infect Dis. 2020 Dec.

Abstract

Rapid and accurate diagnosis is crucial for successful outbreak containment. During the current coronavirus disease 2019 (COVID-19) public health emergency, the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnosis is the detection of viral RNA. Additional diagnostic methods õenabling the detection of current or past SARS-CoV-2 infection would be highly beneficial. We assessed 2 immunochromatographic lateral flow assays (LFA-1, LFA-2) and 2 enzyme-linked immunosorbent assay kits (IgA/IgG ELISA-1, IgM/IgG ELISA-2) using 325 samples: serum samples from polymerase chain reaction-confirmed COVID-19 hospitalized patients (n = 55) and healthcare workers (n = 143) and 127 samples from negative controls. Diagnostic performances were assessed according to days after symptom onset (dso) and the antigenic format used by manufacturers. Clinical sensitivities varied greatly among the assays, showing poor mutual agreement. After 15 dso, ELISA-1 (Euroimmun) and LFA-1 (Biosynex) combining IgM and IgG detection showed the best performances. A thorough selection of serological assays for the detection of ongoing or past infections is advisable.

Keywords: COVID-19; Humoral response; SARS-CoV-2; Serological diagnosis.

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Figures

Fig. 1
Fig. 1
Study flowchart for LFA and ELISA evaluation. Panel 1 and panel 2 were used to determine the clinical sensitivity of the LFA and ELISA. RF corresponds to samples containing rheumatoid factor, and ANA refers to samples containing antinuclear antibodies.
Fig. 2
Fig. 2
Positive rates of virus-specific antibodies measured by LFA (combining IgG and IgM) and ELISA (combining IgA or IgM and IgG) versus days of symptom onset in COVID-19 patients and healthcare workers (panel 1 and panel 2). Sensitivity panel 1+ panel 2 (excluding the second serum sample in repeatedly sampled patients).
Fig. 3
Fig. 3
(A) Positive rates of virus-specific antibodies measured by LFA (combining IgG and IgM) and ELISA (combining IgA or IgM and IgG) versus days of symptom onset in COVID-19 patients (panel 1). (B) Positive rates of virus-specific antibodies measured by LFA (combining IgG and IgM) and ELISA (combining IgA or IgM and IgG) versus days of symptom onset in COVID-19 healthcare workers (panel 2). Sensitivity (excluding the second serum sample in repeatedly sampled patients).
Fig. 4
Fig. 4
Positive rates of virus-specific antibodies measured by LFA (combining IgG and IgM), ELISA (IgA), and ELISA (IgM) versus days of symptom onset in 50 COVID-19 patients (part of panel 1). Sensitivity (excluding the second serum sample in repeatedly sampled patients).
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