안국약품(주)

HPV(Human Papillo Virus) is 99% main cause of Cervical cancer.
HPV DNA kit is brand-new tech which enables customers to prevent from Cervical cancer.

1. General Principle


1.1 HPV(Hunman Papillomavirus) and Cervical cancer

HPVs, a group of circular double-stranded DNA virus with a size of about 8 Kb, are known to cause cervical cancers in women as well as various other malignant tumors in humans. Among over 70 genotypes of HPVs identified to date, the oncogenic high-risk HPVs(HPV-16, 18, 31, 33, 35, etc) are associated with invasive cervical carcinomas and their precursors, whereas the low-risk HPVs (HPV-6, 11, 34, 40, etc) cause genital warts and lesions rarely progress to malignancy. In fact, the high-risk HPVs are found in more than 90% of the cervical tissues of parients with cervical carcinoma or cervical intraepithelial neoplasia(CIN). In order to detect cervical cancer at an earlier stage, PAP(Papanicolaou) smear and several molecular biological methods for HPV detection have heen used. However, most of these methods either lack in accuracy or require laborious steps for diagnosis. Our introducing HPV denotyping chip(patent pending), a DNA microarray containing HPV type-specific oligonucleotide probes, enables more accurate and rapid HPV detection and genotyping with a simple procedure.

1.2 Biology of HPV

HPV consists of early genes(E1,E2,E4,E5,E6,E7), late genes(L1,L2), and LCR(long control region) , and most types of HPV L1 gene fragment (about 150bp) can be amplified by consensus primers. The functions of the genes are:

E1: replication of viral DNA

E2: initiation and repression of malignant progression

E4: protein synthesis for the growth of viruses and infected cells

E5: control and induction of EGF(Epidermal growth factor) and CFS(Colony stimulating factor) receptor

E6/E7: immortalization of cell, activation of oncogenes and progression to malignacy

L1: viral major capsid proteins

L2: minor capsid proteins

LCR: control of DNA replication and transcription


1.3 Therapy of Cervical cancer

It has been generally accepted that the detection of HPV DNA, the direct cause for cervical cancer, is more effective than the conventional PAP smear method.

Screening for HPV DNA is based on the fact that HPV is responsible for most of cervical cancer occurences. Recent reports reveal that direct screening for HPV DNA in human samples is 16% more effective in finding the disease compared to PAP smear.

Introduction of convenient HPV DNA screening method is considered to dramatically increase the early detection rate of cervical cancer in every nation, especially in developing countries where medical practices and facilities are lacking.

Cerbical cancer initiates and develops as follows: infection of cervix-cervical dyplasia=cervical intraepithelial neoplasia-cervical cancer grade 1-grade 2-grade 3-grade 4-grage. Table 1. shows the progression stages and the corresponding recovery rates.

Table 1. The progression stages and recovery rates of cervical cancer

Grade
Progression stage
Recovery (%)

0
Cervical intraepithelial neoplasia
100

1
Cervical cancer
80-90

2
Cervix and 2/3 of upper vagina
50-60

3
Invasion to pelvic wall, 1/3 of lower vagina
20-25

4
Invasion to bladder, rectum, metastasis to liver, lung
0-7

1.4 Principle of HPVDNAChip™

HPV genotyping chip is made by immobilizing 22 HPV type-specific oligonucleotide probes and control (β-globin probe) on an aldehyde-derivatized slide glass. The probes are as follows: 15 high risk HPV probes; 16,18,31,33,35,39,45,51,52,56,58,59,66,68,69,BG(β-globin), 7 low risk HPV probes; 6,11,34,40,42,43,44. A random Cyanine 5 labeled β-globin product is used as a marker to denote the position of each probe and as an internal control for hybridization reaction. Target DNA is being PCR amplified using primer sets and conditions provided in the following chapter and hybridized onto the chip, the position of which is subsequently detected. The target DNA randomly incorporates Cyanine 5 during PCR amplification, enabling visualization of the position of hybridization upon laser fluorescence scanning. In the case of multiple infections, multiple hybridization signals can be found.

1.5 Advantages of HPVDNAChip™

1)Optimally designed kit for HPVDNA microarray
2)Most-cost effective kit for HPV genotyping
3)Most convenient kit for HPVDNA microarray
4)Highly quality-controlled HPVDNAChip kit