Neonatal screening for sickle cell disease (SCD) and other hemoglobinopathies has been shown to reduce morbidity and mortality of affected individuals through early intervention, and to also reduce the healthcare burden of this common group of disorders. However, traditional screening methods are laborious and costly, and thereby often inappropriate for low-resource settings in areas of high prevalence of SCD. We propose the development of a rapid, simple, and inexpensive lateral-flow immunoassay (LFIA) test kit for the point-of-care detection of hemoglobin phenotypes directly in whole blood samples. This convenient and inexpensive assay format has proven to be an accurate and reliable diagnostic methodology for a variety of POC applications where a rapid assay is needed. The proposed LFIA for hemoglobin phenotypes will utilize highly specific monoclonal antibodies (MAbs) for HbA, HbS, and HbC, recently developed by Silver Lake Research using a proprietary antibody generation system. By using these MAbs in a single test, the proposed LFIA will be able to identify and distinguish between the most common SCD phenotypes including normal (HbAA), HbSS, HbAS, HbCC, HbSC, and HbS/boThal. The proposed test kit will also include an inexpensive, disposable sample preparation component, capable of rapidly preparing a whole blood sample or dried blood spot filter for analysis by the LFIA test strip. SLRC's existing LFIA formats, used in tests currently manufactured by the Company, share a low-cost production platform that will enable the delivery of tests to the end-user at <$2 per unit. SLRC has over 15 years of experience in LFIA development and production, with more than 20 marketed LFIA products originally designed, developed, and manufactured at SLRC.

Public Health Relevance

Newborn screening for sickle cell disease has proven to dramatically improve patient outcomes and reduce the healthcare burden of SCD, but available methods of screening are not practicable in low-resource settings - where most SCD cases occur. We propose the development of a rapid, simple, and inexpensive test kit to detect SCD by using novel specific antibodies to the mutant hemoglobins that define the disease. The proposed test kit promises to enable on-the-spot SCD diagnosis in low-resource settings, making possible immediate intervention and significant benefits to both patients and healthcare providers. (End of Abstract)

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HL123670-01
Application #
8755582
Study Section
Special Emphasis Panel (ZHL1-CSR-C (M1))
Program Officer
Hanspal, Manjit
Project Start
2014-08-01
Project End
2016-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
$221,510
Indirect Cost
Name
Silver Lake Research Corporation
Department
Type
DUNS #
874892821
City
Monrovia
State
CA
Country
United States
Zip Code
91016