The GeneNav™ HPV Complete qPCR Kit utilizes quantitative PCR (qPCR) technology to detect all 14 High Risk human papilloma virus (HPV) subtypes, allowing physicians to identify those at risk for cervical cancer. In addition, HPV Complete enables detection of HPV types 6 and 11 which are considered low risk for cervical cancer, however they are the cause of 90% of all cases of genital warts as well as respiratory papillomatosis.  This in vitro diagnostic kit allows for simultaneous detection of HPV 16 or HPV 18, 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), and simultaneous detection of low-risk subtypes HPV 6 or 11. A human β-Actin internal control is also used in the GeneNav™ HPV Complete qPCR Kit to assess specimen quality and ensure the reliability of the HPV detection results.

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DETECTION:
Simultaneous detection of HPV 16 or HPV 18, 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), and simultaneous detection of low-risk subtypes HPV 6 or 11.

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