SBIR-STTR Award

There is a need for an HIV-1 antibody test that is specifically designed for field use with saliva and that is rapid, accurate, convenient, and inexpensive. Such a test would be especially valuable in work with i.v. drug abusers and prostitutes, where time with the patient is brief and followup is difficult. Use of saliva allows for a rapid "on the street" test, because the time, precautions, and equipment attendant with blood drawing and serum preparation are eliminated. The avoidance of needles makes the assay particularly valuable in testing prison populations.This project uses a saliva test with a column format to concentrate the antibodies from 1 to 5 ml of saliva onto a small amount of protein A-agarose gel. Having demonstrated the accuracy and speed of the test with serum and saliva samples, Epitope, Inc., now intends to embark on larger scale testing with several hundred matched saliva and serum samples from control and HIV-1-infected subjects. Further improvement of the formatting and sensitivity of the test will prepare it for commercialization.

Anticipated Results:
This product could be sold as a rapid, convenient assay for HIV-1 antibodies in saliva that could be used for field testing for AIDS and pre-AIDS conditions, as well as other infectious diseases.National Institute of Allergy And Infectious Diseases

There is a need for reliable antibody tests for infectious diseases which are based on saliva and which are rapid, convenient, and inexpensive. Such tests would be especially valuable in work with IV drug abusers and prostitutes, where time spent with the patient is brief and follow-up is difficult. Use of saliva allows for a rapid "on the street" test since time precautions and equipment attendant with blood drawing and serum preparation are eliminated. The avoidance of needles makes the assay particularly valuable in testing prison populations. A rapid saliva-based test in the physician's office would also have great advantages. The proposed device utilizes a probe containing a microporous membrane and protein A to capture antibodies from a saliva sample or directly from the mouth and give a diagnostic result in l5 minutes. Having completed Phase I work demonstrating the sensitivity and specificity of the materials and principle of the proposed test, the investigators plan to build a device based on this principle and test it in clinical trials in support of an IND submission to the FDA. They propose clinical trials with their test for HIV-l antibodies and preclinical studies in development of tests for hepatitis A and hepatitis B.

Thesaurus Terms:
AIDS test, antiviral antibody, diagnosis design /evaluation, human immunodeficiency virus 1, immunologic assay /test, saliva Staphylococcus aureus, bacterial protein, clinical study /trial, hepatitis A, hepatitis B, liver disorder diagnosis, membrane, tooth loss colorimetry, human clinical subject, minority group