Arrayed Lateral Flow Biosensor for Rapid Molecular Identification of UTI-Related

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$195,098.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43AI102357-01
Award Id:
n/a
Agency Tracking Number:
R43AI102357
Solicitation Year:
2012
Solicitation Topic Code:
NIAID
Solicitation Number:
PA11-096
Small Business Information
2501 Earl Rudder Freeway South, COLLEGE STATION, TX, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
184758308
Principal Investigator:
ANJALSHARMA
(979) 764-2200
renee.hisaw@lynntech.com
Business Contact:
RENEEHISAW
(979) 764-2218
renee.hisaw@lynntech.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): The aim of this application is to develop a rapid, easy-to-use, and inexpensive test for urinary tract infection diagnosis using an ultrasensitive arrayed lateral flow nucleic acid biosensor (LFNAB) to identify uropathogens. UTI is the most common urological disease in the United States and is a major cause of patient morbidity and health care expenditure for all age groups. It was estimated that over 7 million office visits and more than 1 million hospital admissions per year are UTI related. Up to 10% of UTIs result in serious complications such as gram-negative sepsis or chronic pyelonephritis with loss of renal function. According to information provided by the National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC), UTI was listed as the primary diagnosis for 8.27 million physician office and hospital outpatient visits (1.41 million men; 6.86 million women) in year 2000. The annual total cost of UTI (evaluation and treatment) to the United States health care system was 3.5 billion ( 1 billion for men; 2.5 billion for women) in year 2000. Because UTI is so common, large numbers of urine specimens are processed daily in most clinical microbiology laboratories and this comprises a significant component of these health care costs involve UTI. While empirical and rapid UTI screening tests (e.g., urine microscopy and chemical-based dipsticks analysis) are very fast, they are not very sensitive or do not have the ability to identiy the UTI causing pathogens.On the other hand, the culture-based method is accurate and reliable and allows bacterial identification but requires at least an overnight incubation of cultures before results are available. Thus it is very common to have a time lag of approximately 2 days between specimen collection and pathogen identification. To this end, Lynntech proposes to develop an affordable and accessible POC molecular assay for UTI diagnosis by improving the design of the lateral flow assay and the upfront sample preparation step needed for urine samples. The lateral flow strip will be designed to target bacterial 16S rRNA of major UTI-related pathogen groups and to allow species identification of bacteria by putting arrayed nucleic acid capturing lines on the strip. The abilityto quickly identify negative samples will eliminate the need to culture all the samples collected. A positive result with uropathogens identified will give physicians more information to avoid presumptive treatments and prescribe effective medication to patients for better outcomes. PUBLIC HEALTH RELEVANCE: A urinary tract infection (UTI) is an infection that can happen anywhere along the urinary tract (urethra, bladder, kidneys, and ureters). UTI is among the most common diseases of humans and isthe most common urological disease in the United States and is a major cause of patient morbidity and health care expenditure for all age groups. This project will advance the development of a molecular diagnostic device for the rapid and inexpensive detection of uropathogens. We expect our technology will lead to an assay that will allow clinicians to provide more than empirical UTI treatments initially. A rapid report of a negative result will eliminate the need for UTI-based treatment/therapy and the physicians can focus on the investigation of other possible reasons for the illness. Secondly, a positive result with uropathogens identified will give physicians more information to avoid presumptive treatments and prescribe effective medication to patients. Having the information on the identity of the pathogen(s) involved also allows physicians to better prescribe antibiotics without contributing to growing antimicrobial resistance.

* information listed above is at the time of submission.

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