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Introduction

Screen your patients for HPV 16, HPV 18, and a pool of 12 other high risk HPV subtypes with our GeneNav™ HPV One qPCR Kit. This simple one-tube system is designed for quick and accurate initial screening of patients who are HPV positive from those who are HPV negative so that you may identify those who require continuous monitoring.
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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 One qPCR Kit

Format:

48 reactions/kit

Cat. No.

E114

Quantity:

Inquire

Description

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.

Principle of Assay

The GeneNav™ HPV One 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 amplification, 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 One qPCR kit identifies 14 types of high risk HPV and a Human β-Actin control using 4 fluorescence channels in one tube: FAM, HEX, ROX and Cy5. As a result, this kit can not only detect the 14 high risk HPV types, it is capable of distinguishing HPV 16 and 18 from the other types. The internal control, Human β-Actin, indicates the quality of extracted DNA.

Intended Use

The GeneNav™ HPV One qPCR Kit is a qualitative in-vitro diagnostic test that detects HPV 16 and HPV 18 specifically, and the remaining 12 High Risk HPV subtypes non-specifically (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels from cervical swab specimens.

Performance Characteristics


Analytical Sensitivity:
130 copies/reaction
Analytical Specificity:
Cross reaction among these 14 HPV types was not observed. A panel of bacteria, fungi, and viruses commonly found in the female anogenital tract were tested with the GeneNavTM HPV One 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 One 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 One qPCR Kit at two sites on non-consecutive days within a two-week time period. Two lots of GeneNav™ HPV One 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