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. 2020 Sep-Oct;34(5):3039-3045.
doi: 10.21873/invivo.12138.

Preliminary Data of a Quantitative Point of Care Test for SARS-CoV-2 Antibodies From Greece

Paraskevi C Fragkou  1 , Vassiliki Papaevangelou  2 , Anastasia Antoniadou  1 , Dimitra Kavvatha  1 , Agapi Ploussi  3 , Nikos Pantazis  4 , Tamta Sirmpilantze  1 , Christos Psarrakis  1 , Spyridon A Pournaras  5 , Sotirios Tsiodras  1 , Alexis Kelekis  6
Affiliations

Preliminary Data of a Quantitative Point of Care Test for SARS-CoV-2 Antibodies From Greece

Paraskevi C Fragkou et al. In Vivo. 2020 Sep-Oct.

Abstract

Background: Antibody testing is necessary to identify immune individuals in the post-initial wave of the COVID-19 pandemic.

Patients and methods: We prospectively evaluated the performance of a quantitative point-of-care test (POCT) for SARS-CoV-2 antibodies. The patient group (PG) comprised of hospitalized confirmed COVID-19 cases. Asymptomatic healthcare volunteers with negative rRT-PCR were included in the control group (CG). Measurement of IgM and IgG was obtained by dry fluorescence immunoassay.

Results: Twenty-six PG (65.9±15.4 years old, male 57.7%) and 18 CG (45.6±10.1 years old, male 33.3%) were included. By manufacturer's cut-off (≥0.04 mIU/ml), sensitivity and specificity were 73.08% and 88.89% for IgM and 88.46% and 33.33% for IgG, respectively. Estimated areas under the ROC curve were 0.907 and 0.848 for IgM and IgG, respectively. Results were improved using a cut-off of IgM ≥0.05 mIU/ml and IgG ≥0.10 mIU/ml.

Conclusion: Using stringent cut-off values, SARS-CoV-2 antibody POCT detects immune people and can be used during socioeconomic normalization of communities.

Keywords: COVID-19; IgG; IgM; SARS-CoV-2; antibodies; diagnostics; novel coronavirus; point-of-care testing.

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Conflict of interest statement

The Authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Consumables, test strips and the reader were provided for free by Lansion Biotech.

Figures

Figure 1
Figure 1. Non-parametric ROC curves for IgM and IgG antibodies.
Figure 2
Figure 2. Quantitative analysis of anti-SARS-CoV-2 IgM and IgG antibodies by participant group [upper left, upper right] and by time of symptom onset [lower left, lower right]. Between participant groups differences [upper left, upper right]: p<0.001 for both IgM and IgG test. For time of symptom onset lower left, lower right]: p=0.083 for IgM, p=0.022 for IgG.
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