AffinityImmuno Products

This is a competitive ELISA that measures COVID19 neutralizing antibodies in human sera and plasma that prevents the binding of viral spike protein to its ACE2 receptor target.

Prepare only the appropriate amount of required reagent on the day of use. Store all reagents as per instructions stated on the label.

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 48:1267–1281). 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.

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.

Samples are used neat.