Rapid Heart Failure Diagnostic Kit

A new in vitro diagnostic test kit that allows emergency rooms and hospital laboratories to quickly diagnose congestive heart failure (CHF) has been approved for marketing in the United States and has received CE marking for sale in Europe.

The StatusFirst CHF NT-proBNP rapid test kit was developed by Nanogen, Inc. (San Diego, CA, USA) and is being manufactured for Nanogen by Princeton BioMeditech Corp. (Princeton, NJ, USA).

The StatusFirst CHF test measures circulating levels of NT-proBNP, a biomarker for heart disease, and provides a quantitative assessment of the biomarker's concentration in as little as 15 minutes via a small, low cost reader. NT-proBNP is a derivative of the brain hormone natriuretic peptide, which is released in response to cardiac stress and has been demonstrated in numerous clinical studies to be an accurate and reliable indicator of cardiac disease risk.

The test device utilizes biotin coupled anti-NT-proBNP antibody/streptavidin solid-phase chromatographic immunoassay technology. After a sample has been dispensed into the sample well, the test device is placed into a LifeSign DXpres reader. The reader displays the intensity of the NT-proBNP band 15 minutes after sample addition and converts the intensity into NT-proBNP concentration units automatically by using lot specific calibration factors supplied via a data chip in each box.

"With an aging population and more people surviving myocardial infarctions [MI], the market for cardiac diagnostics related to heart failure is expected to exceed [US]$500 million annually in the next five years,” said David Ludvigson, president and chief operating officer of Nanogen. "This product was developed by Nanogen and complements the rapid cardiac tests for MI we acquired last year. The StatusFirst CHF product is an important addition as we build our point-of-care rapid testing franchise.”


Related Links:
Nanogen, Incorporated
Princeton BioMeditech