In the US and Canada, there are three automated commercially available PCR systems that are approved for detection of MRSA: BD GeneOhm MRSA Assay, Xpert MRSA Assay, and Roche LightCycler MRSA Advanced.
The F.D.A. recently approved computer-assisted detection systems, known as C.A.D., on mammography, which are believed to improve the ability to interpret results.
However, disappointingly few biomarkers were approved for the detection of unrecognized disease, and even approved markers may lack a sound validation phase.
To date, several kinds of MNPs have also been approved for disease detection by intraperitoneal injection [26, 27] as well as intravenous injection [28].
However, there is currently lack of regulatory approved Exotoxin A detection methods for diagnosis purpose.
The Xpert MRSA/SA skin and soft tissue infection assay (GeneXpert, Cepheid® Inc., Sunnyvale, CA) is approved for rapid detection (within 1 h) of MRSA and MSSA in wounds.
Hybrid capture 2 (Qiagen, Gaithersburg, Maryland) using the threshold of ≥1 relative light units/cut off (rlu/co) is a clinically validated US Food and Drug Administration approved test for detection of human papillomavirus DNA, with a high sensitivity for high grade cervical intraepithelial neoplasia.
However, urine cytology, and many of the currently developed FDA approved urine biomarkers including detection of chromosomal aneuploidy and deletion using fluorescence in situ hybridization (UroVysion®) have limited sensitivity for detection of low stage and grade tumors that form the main group that recur [ 4, 5].
Such detection systems, approved by the Food and Drug Administration in 1998, are sold by several companies, including Hologic of Bedford, Mass.; iCAD of Nashua, N.H.; and Kodak.
Last week, the U.N. General Assembly approved measures to coordinate detection and response to asteroid strikes that could level cities and possibly destroy our civilization.
