Clinical performance of SARS-CoV-2 IgG antibody tests and potential protective immunity
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Abstract
As the current SARS-CoV-2 pandemic continues, serological assays are urgently needed for rapid diagnosis, contact tracing and for epidemiological studies. So far, there is little data on how commercially available tests perform with real patient samples and if detected IgG antibodies provide protective immunity. Focusing on IgG antibodies, we demonstrate the performance of two ELISA assays (Euroimmun SARS-CoV-2 IgG & Vircell COVID-19 ELISA IgG) in comparison to one lateral flow assay ((LFA) FaStep COVID-19 IgG/IgM Rapid Test Device) and two in-house developed assays (immunofluorescence assay (IFA) and plaque reduction neutralization test (PRNT)). We tested follow up serum/plasma samples of individuals PCR-diagnosed with COVID-19. Most of the SARS-CoV-2 samples were from individuals with moderate to severe clinical course, who required an in-patient hospital stay.
For all examined assays, the sensitivity ranged from 58.8 to 76.5% for the early phase of infection (days 5-9) and from 93.8 to 100% for the later period (days 10-18) after PCR-diagnosed with COVID-19. With exception of one sample, all positive tested samples in the analysed cohort, using the commercially available assays examined (including the in-house developed IFA), demonstrated neutralizing (protective) properties in the PRNT, indicating a potential protective immunity to SARS-CoV-2. Regarding specificity, there was evidence that samples of endemic coronavirus (HCoV-OC43, HCoV-229E) and Epstein Barr virus (EBV) infected individuals cross-reacted in the ELISA assays and IFA, in one case generating a false positive result (may giving a false sense of security). This need to be further investigated.
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SciScore for 10.1101/2020.05.08.085506: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources 25 µl of goat-anti human fluorescein-labeled IgG conjugate was used as secondary antibody. human fluorescein-labeled IgGsuggested: NoneExperimental Models: Cell Lines Sentences Resources Immunofluorescence assay (IFA): For an immunofluorescence assay Vero cells (african green monkey, ATCC CCL-81 (American Type Culture Collection, Manassas, Virginia, USA)) were infected with SARS-CoV-2 and harvested two days post infection. Verosuggested: NonePlaque reduction … SciScore for 10.1101/2020.05.08.085506: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources 25 µl of goat-anti human fluorescein-labeled IgG conjugate was used as secondary antibody. human fluorescein-labeled IgGsuggested: NoneExperimental Models: Cell Lines Sentences Resources Immunofluorescence assay (IFA): For an immunofluorescence assay Vero cells (african green monkey, ATCC CCL-81 (American Type Culture Collection, Manassas, Virginia, USA)) were infected with SARS-CoV-2 and harvested two days post infection. Verosuggested: NonePlaque reduction neutralization test (PRNT): To test for neutralizing capacity of SARS-CoV-2 specific antibodies, Caco-2 cells (human colon carcinoma cells, ATCC DSMZ ACC-169 (American Type Culture Collection, Manassas, Virginia, USA)) were seeded on a 96-well plate 3-5 days prior infection. Caco-2suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- No conflict of interest statement was detected. If there are no conflicts, we encourage authors to explicit state so.
- No funding statement was detected.
- No protocol registration statement was detected.
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