The Food and Drug Administra-tion has approved Abbott’s RealTime CMV molecular test. The assay uses polymerase chain reaction and homogenous real-time fluorescent detection to quantify cytomegalovirus (CMV) DNA in human plasma or whole blood. Its dual-target design makes it the only commercially available CMV test that amplifies two select regions of the CMV genome, which reduces the risk of under-quantitation or failure to detect
The RealTime CMV test is intended for use with Abbott’s m2000 RealTime automated molecular diagnostics platform. It was standardized against the 1st World Health Organization International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques. Abbott designed the assay as a tool to help manage hematopoietic stem cell transplant patients being treated for CMV infections.