Human papilloma virus (HPV) is estimated to be the most common sexually transmitted infection in the United States. Digene's hybrid capture assay for HPV received approval by the Food and Drug Administration (FDA) in 2003. Only recently have other manufacturers, such as Third Wave Technologies and Roche Diagnostics, added this virus to their testing capabilities.
Mycobacterium species represented another desirable target for molecular testing. Although some improvements in cultivation and staining techniques have been realized by incorporating broth media and fluorochrome staining, identification is still hampered by the organism's growth rate.
Gen-Probe first marketed probes that would allow the identification of tuberculosis, M. avium-intracellulare, and M. gordonae in culture-positive specimens. These probes significantly streamlined the workup of culture-positive specimens.
The direct detection of Mycobacterium in clinical specimens is of great interest to clinicians and infection control practitioners. In 1995, Gen-Probe received FDA approval for its Amplified Mycobacterium tuberculosis Direct (MTD) product for this specific application (in smear-positive specimens). This method employs isothermal transcription-mediated amplification; the amplicons are detected using the same hybridization as the culture confirmation tests.
