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Atherosclerotic plaque rupture has been shown to be the primary cause for over 60% of the 725,000 deaths from cardiovascular disease each year in the United States. These plaques consist of a soft lipid-rich core and a hard collagen-rich cap. Inflammation resulting in plaque instability stimulates monocytes to produce chemical signals called interleukins. These interleukins stimulate the liver to produce acute-phase proteins, including CRP, into the circulatory system. However, the quantity of CRP released is very low. This is much lower than the quantities detectable by the most routinely used turbidimetric immunoassays (TIA). This need for a lower detection limit has brought about a number of “high sensitivity” CRP assays. Using these new assays, a number of studies have shown that slight elevations in CRP levels appear several years prior to the visible onset of coronary disease. Very low levels of CRP, undetectable by the traditional TIA test limits of 4-6 mg/dL, correlated with hypercholesterolemia indicate a 2.6 fold increase in possible coronary events.
MBC has developed a lateral flow test device to measure at low levels CRP in human serum. The device has been able to detect CRP in human serum as low as 0.002 mg/dL. In preliminary lab studies, the test device was not inhibited by sodium citrate or heparin. However, it was noted that EDTA did inhibit the test device.
This lateral flow device quickly measures CRP values to the levels that have been recently shown to be valuable indicators of future cardiac problems. This device is both economical and functional for clinical use and can be a valuable monitoring device for asymptomatic or otherwise healthy individuals.
MBC is presently looking for partners to clinically evaluate this device and market the product worldwide.
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