A haemagglutination test for rapid detection of antibodies to SARS-CoV-2
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Abstract
Serological detection of antibodies to SARS-CoV-2 is essential for establishing rates of seroconversion in populations, and for seeking evidence for a level of antibody that may be protective against COVID-19 disease. Several high-performance commercial tests have been described, but these require centralised laboratory facilities that are comparatively expensive, and therefore not available universally. Red cell agglutination tests do not require special equipment, are read by eye, have short development times, low cost and can be applied at the Point of Care. Here we describe a quantitative Haemagglutination test (HAT) for the detection of antibodies to the receptor binding domain of the SARS-CoV-2 spike protein. The HAT has a sensitivity of 90% and specificity of 99% for detection of antibodies after a PCR diagnosed infection. We will supply aliquots of the test reagent sufficient for ten thousand test wells free of charge to qualified research groups anywhere in the world.
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SciScore for 10.1101/2020.10.02.20205831: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Sample Collection and Ethics: Figures 1,2: Control whole blood (K2EDTA) as a source of red cells was collected from a healthy donor after informed consent.
IRB: Figure 3: Pre-pandemic negative controls: these samples were collected from healthy adults in the Oxfordshire region of the UK between 2014 and 2016, ethics approval: Oxfordshire Clinical Research Ethics Committee 08/H0606/107+5Randomization 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 Lyophilisation of IH4-RBD and CR3022 monoclonal antibody: For … SciScore for 10.1101/2020.10.02.20205831: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Sample Collection and Ethics: Figures 1,2: Control whole blood (K2EDTA) as a source of red cells was collected from a healthy donor after informed consent.
IRB: Figure 3: Pre-pandemic negative controls: these samples were collected from healthy adults in the Oxfordshire region of the UK between 2014 and 2016, ethics approval: Oxfordshire Clinical Research Ethics Committee 08/H0606/107+5Randomization 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 Lyophilisation of IH4-RBD and CR3022 monoclonal antibody: For lyophilisation, 200 μL (1 mg) of IH4-RBD (5 mg/mL) and 100 μL (200 μg) CR3022 mAb (2 mg/mL) in PBS buffer prepared in Protein Lo-Bind microcentrifuge tube (Fisher Scientific) were frozen at −80 °C and further cooled down to - 196 °C using liquid nitrogen. CR3022suggested: (Imported from the IEDB Cat# CR3022, RRID:AB_2848080)Equipment and Reagents for HAT: Other Reagents: Monoclonal antibody to human IgG (Gamma chain specific) Clone GG-5 Sigma Cat. No. I5885 human IgGsuggested: (Sigma-Aldrich Cat# I5885, RRID:AB_260225)Experimental Models: Cell Lines Sentences Resources For large scale production, the protein was synthesized by Absolute Antibody Ltd, Oxford using the same plasmid construct in HEK293 cells. HEK293suggested: CLS Cat# 300192/p777_HEK293, RRID:CVCL_0045)Results 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:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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