Neutralizing antibodies develop in some patients to varying degrees following infection with SARS-CoV-2
Reagent preparation Prepare only the appropriate amount of required reagent on the day of use. Store all reagents as per instructions stated on the label.
Results calculation 1. Neutralizing antibodies will vary in terms of concentration and affinity, this assay provides a qualitative readout. As such the user should use the comparable positive controls inhibitory controls when comparing interassay results. The provided controls are tested for comparability between lots and can be traced. 2. The protein titers in the test samples will fall in the range of high, medium, low or negative. We recommend each lab develop their own statistical cutpoint using methodologies as described by G. Shankar, et al. (2008). (Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharmaceutical and Biomedical Analysis 48:12671281). 3. Any sample undiluted or diluted still reading greater than the highest standard should be diluted appropriately with assay buffer and retested. If the samples have been diluted, the concentration determined from the standard curve must be multiplied by the dilution factor.
Intra-assay coefficient of variation (CV) <10%. Inter-assay CV <10%.
Notes
This kit is compatible with EDTA-plasma, heparinplasma and serum samples. Samples can be stored at or below -20°C for up to 1 year.
Usage Notes
Quantification of neutralizing antibodies
Protocol
SARS-CoV-2 spike protein ligand binding assay allows rapid quantification of COIVD19 neutralizing antibodies in serum that block the interaction between the viral spike protein and its target the ACE2 receptor.
Applications
ELISA
Storage
-20C, 1 year
Reviews of SARS-CoV-2 surrogate Virus Neutralizing Test (sVNT) (spike protein/ ACE2 ligand binding assay) COVID-19 sVNT