Product

Human Papillomavirus Genotyping Real Time PCR Kit



Introduction

Cervical cancer is a life-threating disease in the women’s cervix, which is the fourth killer among cancers for females.

 

The human papillomavirus (HPV) is a group of DNA virus that only infect with human mucosal cells or epithelial cells and can cause to cancer. There are more than 100 types of HPV. Each type has specific preferred infected area. These HPV can be classified into two groups according to the potential risks to develop cancer, high-risk HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59, 66 and 68) and low-risk HPV (6, 11, 81).

 

Cervical cancer is a preventable cancer. To decrease morbidity and mortality of cervical cancer, encouraging women to take regular HPV screening is important. By the guideline published by WHO in 2021, WHO recommends using HPV DNA detection as the primary screening test for both of “screen-and-treat approach” and “screen, triage and treat approach”.

 

High-risk HPV DNA detecting for screening can more sensitively identify cervical intraepithelial neoplasia (CIN) than other methods. Screening high-risk HPV can avoid unnecessary colposcopy procedures and improve the clinical management. When certain type of HPV is identified more than once during 6 months, the patient can be considered as constant infection and further triage should be taken. It enables women to access to diagnosis at the early stage of HPV infection and to get treatment before development of precancerous lesions and cervical cancer. The quantity of high-risk HPV loads has positive correlation with the increased risk of cervical cancer and precancerous lesions. The value of HPV virus load also can predict development of residual lesions after treatment.

Features
  • Cost-saving: compatible for most mainstream real-time PCR instruments, no specific system required
  • Fulfillment of clinical use: respectively report 21 genotypes of HPV to address further triage and treatment
  • Strategic product: precisely identify different HPV infection after screening applied
  • Reliable performance: high sensitivity and specificity validated in clinical sites
  • Cytologic sample detectable (ThinPrep® and BD SurePathTM)

Parameters
LOD 1200 copies/mL
PPA 91.20%
NPA 98.20%
Sample Input Volume 2 μL*8
Sample Type

Cervical exfoliated cells

Cytologic samples (ThinPrep®and BD SurePathTM)

Cervical swab

Testing Time 90 mins (only for qualitative and genotyping)
Storage Temperature -20±5℃
Shelf-life 12 months

 

Catalog NO. Product Package ThinPrep® and BD SurePathTM sample extraction solution*
JC80301NW-24T Human Papillomavirus Genotyping Real Time PCR Kit 24 T/Kit

Compatible with Bioperfectus

DNA extraction kit (SDK80120) and automatic extractors (SSNP series, SMPE-960)

JC80301NW-48T 48 T/Kit
JC80301NWO-24T 24 T/Kit Compatible with other nucleic acid extraction products
JC80301NWO-48T 48 T/Kit

 

Certificates

CE, NMPA