ESA has announced that it has received FDA approval to market its Plasma Metanephrine Analysis Kit
ESA has announced that it has received FDA approval to market its Plasma Metanephrine Analysis Kit.
The kit will enable clinical laboratories to detect the presence of pheochromocytomas with far more specificity and sensitivity than traditional assays.
The new product extracts free metanephrine (MN) and normetanephrine (NMN) from plasma for HPLC-electrochemical detection analysis of the catecholamines' metabolites.
Pheochromocytomas are chromaffin cell tumors that generally arise in the adrenal glands and are characterised by excessive production of catecholamines that can lead to hypertension and to a fatal illness if left undiagnosed or untreated.
The significant advantages of the ESA technique stem from the more direct correlation of plasma free metanephrine concentration to the catecholamine and metanephrine production of adrenomedullary and pheochromocytoma cells than from other sources.
The new ESA method is sensitive enough to detect all but the smallest of pheochromcytomas, and yield fewer false positive results than traditional biochemical tests that would then require additional biochemical testing and imaging studies.
The ESA Plasma Metanephrine Analysis Kit provides reagents for the plasma metanephrine extraction procedure. Samples are then measured by HPLC and electrochemical detection. ESA's CoulArray electrochemical detector using patented coulometric electrodes allows for the detection of 100 percent of the analyte injected.
This improves both the sensitivity and selectivity when compared to amperometric electrochemical detectors.
