Automated Disposable Enzyme-Linked Immunosorbent Assay For At Home Detection

Enzyme linked immunosorbent assays (ELISAs) are used to detect a wide range of analytes with tremendous sensitivity and specificity. These analytes include whole cells, proteins, antibodies, and small molecules. High sensitivity is enabled by using an enzyme label to amplify a signal, while the high specificity is enabled using a “sandwich” immunoassay that captures an analyte between two highly specific probe. The analyte can be a protein (including an antibody), peptide, small molecule, or intact virus or bacterial particle as examples. Both enzymatic detection and the sandwich assay format require multiple washing steps and sequential delivery of reagents. These washing and reagent addition steps yield robust analytical performance from ELISAs, but they are complicated to perform and relegate the assay to a centralized laboratory with expensive equipment and trained technicians. In many testing situations the time and financial resources needed for ELISAs are not available. There are more affordable point-of-care alternatives, but they often lack the analytical performance needed.

One of the most common alternatives to an ELISA is the lateral flow immunoassay (LFIA). Lateral flow strips are inexpensive and easy to use in comparison to the ELISA. They require only a sample addition step from the end user and the results are easy to interpret in most settings.