What is in the HPV Detection Kit?

The TRUPCR® HPV 16 & 18 PCR Testing Kit is a molecular diagnostic assay developed for the detection of high-risk HPV types 16 and 18 from cervical specimens. These two genotypes are most strongly associated with progression to cervical cancer.

The kit includes:

• Primer and probe sets for HPV 16 (detected in FAM channel)

• Primer and probe sets for HPV 18 (detected in HEX channel)

• An endogenous internal control (detected in Texas Red channel)

• Master mix with hot-start polymerase

• Ready-to-use reagents and positive/negative controls

Each reaction runs in a two-tube format with three targets per test, allowing simultaneous amplification and detection of both HPV genotypes alongside internal validation.

Role of HPV 16 & 18 in Disease

Human Papillomavirus (HPV) is a double-stranded DNA virus that infects mucosal epithelial cells and is transmitted primarily through sexual contact. While many HPV-positive infections are asymptomatic and self-limiting, persistent infection with high-risk genotypes—especially HPV 16 and HPV 18—can lead to the development of high-grade cervical lesions and ultimately, invasive cancer.

These two types alone account for approximately 70% of all cervical cancer cases worldwide, making their detection a clinical priority. The presence of HPV 16 or HPV 18 DNA, particularly when integrated into host cell genomes, indicates a significantly higher risk of disease progression than other high-risk HPV types.

Routine identification of these genotypes allows:

• Early intervention and colposcopy referral

• Better risk stratification in women with abnormal cytology

• Improved patient follow-up post-treatment or surgery

About the TRUPCR® HPV 16 & 18 PCR Testing Kit

This kit is built around a TaqMan-based real-time PCR platform, designed to maximize analytical performance while simplifying lab workflows. By targeting the conserved genomic regions of HPV 16 and 18, and excluding cross-reactivity with low-risk types or other HPV genotypes, the assay delivers high confidence results for both diagnostic and screening applications.

Core attributes include:

• High-throughput friendly with easy interpretation of Ct values

• Optimized for DNA from cervical samples in liquid-based cytology media

• CE-IVD certified for clinical diagnostic use

• Designed for use in molecular diagnostics, gynecological oncology, and screening labs

The inclusion of an internal DNA control in every sample ensures that negative results are truly HPV-negative and not caused by PCR inhibition or extraction errors.

Principle and Workflow

The TRUPCR® HPV 16 & 18 PCR Testing Kit uses fluorescent hydrolysis probes to detect viral DNA targets through real-time PCR amplification. The assay workflow consists of:

1. DNA Extraction from cervical cells in liquid medium

2. Reaction Setup with pre-mixed primers, probes, and master mix

3. Real-Time Amplification and Detection:

   • FAM channel for HPV 16

   • HEX channel for HPV 18

   • TEXAS RED for the internal control

PCR cycling and data acquisition are completed in approximately 90 minutes. Results are interpreted using Ct thresholds, with genotype-specific amplification curves clearly differentiating HPV 16-positive, HPV 18-positive, and dual-infection samples.

Clinical Application

The kit provides targeted support for:

• Primary screening of women for high-risk HPV infection

• Reflex testing in patients with ASC-US or LSIL cytology

• Monitoring HPV status post-vaccination or post-treatment

• Triaging HPV-positive patients for colposcopy

• Supporting epidemiological studies of HPV prevalence

Its HPV-targeted approach enhances sensitivity and clinical relevance, particularly when compared to conventional cytology. By identifying the two genotypes most responsible for cervical cancer, labs can provide actionable results that improve patient care and program outcomes.

This makes the TRUPCR® HPV 16 & 18 kit a valuable addition to any cervical cancer screening strategy that includes molecular testing.