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Ultra-sensitive method for HIV p24 antigen detection

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93428
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
AI083169
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
ALLIED INNOVATIVE SYSTEMS, LLC
1 JILL CT, BLDG 16, UNIT 2 HILLSBOROUGH, NJ 08844-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: Ultra-sensitive method for HIV p24 antigen detection
Agency: HHS
Contract: 1R44AI083169-01
Award Amount: $95,420.00
 

Abstract:

DESCRIPTION (provided by applicant): The objective of this proposal is to develop ultra-sensitive ELISA (Enzyme-Linked ImmunoSorbent Assay) methods for quantification of HIV p24 antigen. At present, the p24 antigen test is relatively insensitive, being abl e to detect only 5- 10 pg/ml. This quantity of antigen may not be present in the serum of infected individuals, even when the virus is actively replicating. In fact, only about 50-60% of AIDS patients, 30-40% of ARC patients, and 10% of asymptomatic patien ts will have p24 antigenemia that is detectable. Therefore, the development of more sensitive p24 antigen tests is of great importance. It is in this context that we are proposing to develop a highly sensitive p24 antigen assays that will be less expensive than RNA viral load tests and appropriate for use both in developed and developing countries in which the limitations of infrastructure and laboratory capability prohibit nucleic acid testing. The specific aims of the Phase I and Phase II, in part, includ e 1) analyzing and optimizing of all variables affecting the accuracy and functionality of the p24 tests; and 2) validation of the HIV-1 p24 detection assay. Advantages of the proposed assays such as the increased sensitivity, signal-to- noise ratio, and d ynamic range, reduced time and low cost of the analysis substantiates our belief that the proposed amplification method has a prominent commercial and scientific potential. PUBLIC HEALTH RELEVANCE: The development of the proposed method will allow using HI V p24 antigen tests for monitoring HIV infection, blood screening, identification of acute infection, to assist in the diagnosis of infection in the newborn, and in detecting antigen in supernatants from cultures. The performance of the developed tests wil l be improved significantly as compared with that for conventional assays. Successful completion of these studies will be beneficial for public health, and make available all of the technology needed for a substantial business opportunity to license the te chnology and manufacture commercial products.

Principal Investigator:

Simon Bystryak
9739195707
SBYSTRYAK@AOL.COM

Business Contact:

Simon Bystryak
sbystryak@aol.com
Small Business Information at Submission:

ALLIED INNOVATIVE SYSTEMS, LLC
1 Jill Ct., Bldg. 16, unit 2 Hillsborough, NJ 08844

EIN/Tax ID: 223711467
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No