Women's Health
HPV Detection Kit
Multiplex real-time PCR for 14 high-risk HPV genotypes.
Format
Multiplex real-time PCR
Manufactured in
Jeddah · KSA
Quality system
ISO 13485 aligned
GMP
WHO GMP aligned
Overview
The Gene Matrix HPV Detection Kit is a multiplex real-time PCR assay designed to detect 14 high-risk HPV genotypes from cervical samples — supporting national cervical-cancer screening pathways with a fully in-Kingdom-manufactured solution.
Clinical Context
- Cervical cancer remains the fourth most common cancer in women globally; persistent infection with high-risk HPV genotypes is the principal cause.
- Genotype-aware HPV testing is recommended by major international guidelines as a primary screening tool, alongside or in place of cytology.
- Localised manufacturing reduces dependency on imported assays and supports national screening-programme resilience.
Target Panel — 14 High-Risk Genotypes
| Parameter | Detail |
|---|---|
| Genotypes detected | 16 · 18 · 31 · 33 · 35 · 39 · 45 · 51 · 52 · 56 · 58 · 59 · 66 · 68 |
| Internal control | Endogenous human gene control |
| Sample type | Cervical swab in transport medium |
| Format | Multiplex real-time PCR |
| Result reporting | Genotype-specific channels |
Workflow
From sample to result, in four steps
- 01
Sample collection
Validated transport medium and sample types per assay specification.
- 02
Nucleic acid extraction
Compatible with major automated and manual extraction workflows.
- 03
Real-time PCR
Multiplex amplification on standard 96-well thermocyclers.
- 04
Reporting
Genotype/serotype-specific channels for clear clinical reporting.
Performance
Validated to international references
Each assay is characterised for analytical sensitivity, specificity and limit of detection against established clinical references. Full validation packs and lot-specific data are shared with prospective customers under appropriate confidentiality.
Analytical sensitivity
Validated against international reference panels
Analytical specificity
No cross-reactivity with related pathogens
Limit of detection
Lot-specific data on request
Frequently asked
Does the kit differentiate HPV-16 and HPV-18 individually?
Yes. The assay reports genotype-specific signals — including HPV-16 and HPV-18 individually — enabling risk-stratified clinical management.
What sample volume is required?
Standard cervical-swab volumes in validated transport media are supported. Specific volumes are detailed in the kit's instructions for use.
Is the kit suitable for primary screening programmes?
Yes. The assay is designed for high-throughput primary screening workflows and is compatible with major laboratory PCR platforms.