Rapid Serological Diagnosis of Scrub Typhus Infections

Award Information
Agency: Department of Defense
Branch: Army
Contract: DAMD17-03-C-0029
Agency Tracking Number: A022-3162
Amount: $729,605.00
Phase: Phase II
Program: SBIR
Awards Year: 2004
Solicitation Year: 2002
Solicitation Topic Code: A02-183
Solicitation Number: 2002.2
Small Business Information
2033 Route 130, Monmouth Jct., NJ, 08852
DUNS: 116671434
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: Y
Principal Investigator
 Young Choi
 (732) 297-2222
Business Contact
 Thomas Saborine
Title: CBO
Phone: (732) 297-2222
Email: sabourin@springpharma.com
Research Institution
Scrub typhus, caused by Orientia tsutsugamushi poses a threat to U.S. forces deployed to the Asian/Australian/Pacific regions during contingency and peacekeeping operations. Development of an assay for the detection of O. tsutsugamushi that is rapid, accurate, field-usable and soldier-friendly is therefore a high priority for the DoD. In its Phase I effort, Access Bio demonstrated the feasibility in development of a prototype assay to detect scrub typhus employing immunochromatographic assay technology. The developed test system is field-deployable (blood assay, hand-held device, ten minutes assay, no equipment, no special facility, field storage, field-temperature operation), soldier-friendly (easy-to-operate, no special training), accurate and clinically useful (separate result for IgM and total antibodies, 100% agreement with the clinical samples). In Phase II research and development, Access Bio will further develop and deliver the test system for the confirmation of the project goal. This test system will be able to distinguish between the acute infection and chronic infection of scrub typhus. Four subsequent lots of the assay will be produced and delivered for evaluation by the COR. The same technology which showed satisfactory feasibility in Phase I will be employed. Target sensitivity and specificity is >95%.

* information listed above is at the time of submission.

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