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

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1 R43 HD31379-1,
Agency Tracking Number: 24950
Amount: $73,520.00
Phase: Phase I
Program: SBIR
Awards Year: 1994
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
4242 U.S., Route 1, Monmouth Junction, NJ, 08852
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Jemo Kang
 (908) 274-1000
Business Contact
Phone: () -
Research Institution
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.

* Information listed above is at the time of submission. *

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