The goal of this project is to develop a lateral flow assay for detecting complement levels and complement activation status in a patient. This assay will give results in seconds versus either hours or days that normal complement lab assays have. It also will give more accurate results than conventional assays. The complement system is a group of more than 30 serum and membrane proteins that comprise an important effector arm of the innate immune system. However, complement can also damage host tissue, leading to its being termed a """"""""double-edged sword."""""""" Complement plays a role in many, and diverse, diseases such as age- related macular degeneration (AMD), arthritis, stroke, trauma, and more. Altogether more than 30 million Americans suffer from complement-involved disorders. One problem facing detecting and treating these diseases are fast and reliable assays. For some indications such as trauma massive complement activation can occur within minutes of injury. This often proceeds a cytokine storm that can cause shock or organ failure. Knowing the cytokine storm is imminent allows preemptive treatment. In other cases the samples must be shipped for complement is very labile and does not store well at temperatures warmer than -80C. A lateral flow assay will allow immediate accurate results that are not available to most labs at present.

Public Health Relevance

We intend to develop a point of care, lateral flow assay for the detection and quantification of complement component 3 and its metabolites. This is to address the variability of other assay formats caused by the duration of the assay, and the test article handling and storage.

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 #
1R43HL103378-01
Application #
7928388
Study Section
Special Emphasis Panel (ZRG1-CVRS-B (53))
Program Officer
Mitchell, Phyllis
Project Start
2010-06-01
Project End
2012-05-31
Budget Start
2010-06-01
Budget End
2012-05-31
Support Year
1
Fiscal Year
2010
Total Cost
$199,998
Indirect Cost
Name
Kypha, Inc.
Department
Type
DUNS #
832251537
City
Saint Louis
State
MO
Country
United States
Zip Code
63108
Schramm, Elizabeth C; Staten, Nick R; Zhang, Zhouning et al. (2015) A quantitative lateral flow assay to detect complement activation in blood. Anal Biochem 477:78-85