Product

Human Papillomavirus Genotyping Real Time PCR Kit

CE-IVD


Introduction

The Human Papillomavirus Genotyping Real Time PCR Kit is an HPV genotyping test kit designed to identify 21 HPV genotypes individually. The assay supports detailed genotype reporting after or alongside HPV screening, including HPV genotype 16, HPV 18 and other high-risk or clinically relevant types covered by the kit.

 

The test can be used with cervical exfoliated cells, cytology specimens collected in ThinPrep® or BD SurePath media, and cervical swabs. Individual genotype results can support clinical follow-up, triage and assessment of genotype persistence .

Features

 Individual 21-genotype reporting: Identifies each HPV genotype covered by the assay and respectively reports 21 genotypes of HPV to support further assessment and triage.

• Cervical specimen compatibility: Supports cervical exfoliated cells, ThinPrep® and BD SurePath samples, and cervical swabs.

• 90-minute workflow: Delivers qualitative HPV genotyping results in approximately 90 minutes

• Broad instrument compatibility: Compatible with most mainstream real-time PCR instruments, no specific system required

Parameters

LOD 400 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

Applications

The assay is designed for professional HPV genotyping workflows. Applications include:

Genotype-level follow-up after HPV screening:Identification of individual HPV genotypes to support further assessment following a positive HPV screening result.

HPV 16/18 and other genotype assessment:Differentiation of HPV genotype 16, HPV 18 and other high-risk or clinically relevant genotypes included in the 21-genotype panel.

Longitudinal genotype comparison: Comparison of genotype results over time to support the assessment of repeated detection.

Molecular testing of cervical specimens: HPV genotyping of cervical exfoliated cells, liquid-based cytology specimens and cervical swabs in professional laboratory workflows.

Certificates

CE, NMPA