crb® HPV Genotyping qPCR

35,000$

The crb® HPV Genotyping qPCR  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 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 crb® HPV Genotyping qPCR Kit to assess specimen quality and ensure the reliability of the HPV detection results.

 

Format: 24 rxns/Kit (Pack of 600 Kits)

Description

Introduction

90% of HPV positive cases clear up naturally within 2 years. Our crb®  HPV Genotyping qPCR offers simultaneous detection and genotyping of all 14 high risk HPV subtypes, enabling you to monitor your patient for any persistent infection of the same HPV subtype that could lead to cervical cancer. Get the results you need to deliver the right care at the right time.

Principle of Assay

The crb® HPV Genotyping qPCR  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. In this HPV Genotyping qPCR kit, the 14 types of high risk HPV and a human β-Actin control are divided into 8 reaction tubes, with 2 fluorescent channels per tube: FAM and HEX. Detection of a positive signal in a particular channel can identify a specific genotype of HPV. An internal control, β-Actin, indicates the quality of extracted DNA.

 

The crb® HPV Genotyping qPCR  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.

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 crb® HPV Genotyping 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 crb® HPV Genotyping qPCR  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 crb® HPV Genotyping qPCR  at two sites on non-consecutive days within a two-week time period. Two lots of crb®  HPV Genotyping qPCR  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.

 

 

SKU MD018
Detection
  • HPV virus
Specimen
  • Whole blood
  • Serum
  • Plasma
Kit Content
  • Test device
  • Buffer
Test per kit 48

 

 

Registration Status

CE-IVD Registered
FDA-IVD Clinical Testing

IFU & SDS

Shelf life: 24 months