Infectious disease test kit GeneNav™

for genotypingHPVbacteria

The GeneNav™ HPV Genotyping qPCR Kit is designed for continuous monitoring of individuals who have been confirmed to be HPV positive with one of the 14 High Risk human papilloma virus (HPV) subtypes. This kit allows physicians to track patients who are at a greater risk of developing cervical cancer by identifying individuals who show persistent infection with the same HPV subtype. This in vitro diagnostic kit allows for the specific detection and discrimination of all 14 High Risk HPV subtypes: HPV 16, HPV 18, 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 β-Actin internal control is also used in the GeneNav™ HPV Genotyping qPCR Kit to assess specimen quality and ensure the reliability of the HPV detection results. DETECTION: Specific detection and discrimination between all 14 High Risk HPV Subtypes, including: HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. INTERNAL CONTROL: β-Actin SPECIMEN COLLECTION: Cervical Swab KIT TYPE: Fluorescent Probe-based qPCR EQUIPMENT COMPATIBILITY: Compatible with most 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