Third World Diagnostics--A One-Step Immunoassay for TSH

Our goal is to develop a self-performing, one-step, semi-quantitative, visual immunometric assayfor human TSH. This assay will use whole blood as a substrate and indicate whether serum levels ofTSH in excess of 5 IU/ml are present. It will contain a built-in control to indicate successful assaycompletion. This assay will be helpful as a screen for neonatal hypothyroidism, especially in populationsthat lack the technological infrastructure required to perform currently available TSH assays. It will alsobe used to screen samples in a cost-effective fashion for the presence of an elevated TSH and thusindicate whether a sample requires a more expensive quantitative TSH assay. By allowing TSHmeasurement to be performed outside of a laboratory and by providing a screening method o detect anelevation in TSH, this assay represents a significant technical innovation. Because of its low cost andease of use, it will have considerable commercial application as a replacement for more expensive andcumbersome radio-, enzyme-linked, fluorescent, and chemiluminescent immunoassays.