Infectious disease test kit GeneNav™

for cervical cancerbacteriaHPV

The GeneNav™ HPV One qPCR Kit is designed for quick initial screening of individuals for the presence of all 14 High Risk human papilloma virus (HPV) subtypes allowing physicians to identify those at risk for cervical cancer. This in vitro diagnostic kit allows for the specific detection and discrimination between HPV 16, HPV 18, and nonspecific pooled detection of the other 12 high risk HPV subtypes (HPV 31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 56, HPV 58, HPV 59, HPV 66, and HPV 68). A human β-Actin internal control is also used in the GeneNav™ HPV One qPCR Kit to assess specimen quality and ensure the reliability of the HPV detection results. DETECTION: Specific detection and discrimination between HPV 16, 18, and non-specific pooled detection of HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. INTERNAL CONTROL: β-Actin SPECIMEN COLLECTION: Cervical Swab KIT TYPE: Fluorescent Probe-based qPCR EQUIPMENT COMPATIBILITY: Compatible with all current qPCR machines ANALYTICAL SENSITIVITY: 130 copies/reaction ANALYTICAL SPECIFICITY: No cross-reactivity with the 14 HPV types or with a panel of bacteria, fungi or viruses commonly found in the female anogenital tract. See Datasheet for full test results. REGULATORY STATUS: CE-IVD