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Introduction

Over 130 HPV types have been documented in literature, approximately 40 of which infect the anogenital area and are sexually transmitted. Persistent anogenital high risk HPV infection is associated with the majority of cervical cancers. Cervical cancer is highly preventable when cytological and HPV screening programs are employed to facilitate early detection and treatment of pre-cancerous lesions. Of the sexually transmitted HPV genotypes, 14 (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are considered high risk as they lead to cervical cancer or anogenital warts. In addition, HPV types 6 and 11 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.
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Rapid and precise analysis - From collected samples to results in less than 2hr
Quick and easy setup procedure - 20min of hands on time for evaluating 96 patient samples
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No need for purchasing equipment - compatible with all current qPCR platforms (4 Fluorescent Channels)
Quality by Design - Flag samples with low cellularity through β-Actin internal control reducing false negative results


GeneNav™

HPV Complete qPCR Kit

Format:

48 reactions/kit

Cat. No.

E116

Quantity:

Inquire

Description

The GeneNav™ HPV Complete qPCR Kit is a single tube system which utilizes quantitative PCR (qPCR) technology to detect the 16 HPV types described. This kit is able to simultaneously detect the presence of HPV 16 or HPV 18, one of the other high risk HPV subtypes, and HPV 6 or 11.

Principle of Assay

The GeneNav™ HPV Complete qPCR Kit uses probe-based qPCR technology to detect HPV with high specificity. Each sequence-specific probe contains a 5’ fluorophore and a 3’ quencher. On its own, the probe’s 3’ quencher effectively absorbs the emission from the nearby 5’ fluorophore so that no net fluorescence is detected. During PCR amplifcation, the probe binds to its specific target template. While replicating the DNA sample, the PCR Taq Polymerase’s 5’ to 3’ exonuclease activity also hydrolyzes the probe, releasing a free-floating 5’ fluorophore that is detectable by the qPCR machine and can be translated into an amplification plot. This HPV Complete qPCR kit identifes 14 types of high risk HPV, 2 types of low risk HPV, and a human ACTIN control using 4 fluorescent channels in one tube: ROX, FAM, HEX and Cy5. As a result, this kit can not only detect the 14 high risk HPV types and 2 low risk HPV types, it is also capable of distinguishing HPV 16 and 18 from all the other types. The internal control, human ACTIN, indicates the quality of extracted DNA.

Intended Use

The GeneNav™ HPV Complete qPCR Kit is a qualitative in vitro diagnostic test that detects all 14 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) at clinically relevant infection levels from cervical swab specimens.

Performance Characteristics


Analytical Sensitivity:
130 copies/reaction
Analytical Specificity:
Cross reaction among these 16 HPV types was not observed. A panel of bacteria, fungi, and viruses commonly found in the female anogenital tract were tested with the GeneNav™ HPV Complete qPCR Kit to assess potential cross-reactivity. The pathogens tested include: Candida albicans, Proteus vulgaris, Corynebacterium pseudodiptheriticum, Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Escherichia coli, Streptococcus mitis, Lactobacillus acidophilus, Streptococcus pyogenes, Herpes simplex virus, type 1 and 2 (HSV-1 and 2), Chlamydia trachomatis, Neisseria gonorrhoeae, Human Immunodeficiency Virus type 1 (HIV-1 pol and env regions), and Mycoplasma hominis. Negative results were obtained from all above-mentioned organisms.
Reproducibility:
Reproducibility of the GeneNav™ HPV Complete qPCR Kit was assessed at two external sites using a panel of HPV positive and negative cultured cells and HPV positive and negative cervical specimens. DNA was extracted from 500 μl of cervical samples or cultured cells suspended in Specimen Transportation Medium. The DNA was extracted using the sample prep solution included in this Kit. DNA was extracted from sixteen samples and tested with GeneNav™ HPV Complete qPCR Kit at two sites on five non-consecutive days within a two-week time period. Two lots of GeneNav™ HPV Complete qPCR Kits were used across the two sites for the study. The total number of measurements for each sample was 20 (2 sites x 5 days x 2 lots x 1 run per day). The results showed that the coefficient of variation (CV) for the kit performance was less than 5% among different product lots and different operators.

Registration Status

CE-IVD Registered
Health Canada-IVD Clinical Testing
FDA-IVD Clinical Testing