HPV-Q Real-Time PCR Kit

Product Overview

Human Papillomavirus (HPV) is one of the most common sexually transmitted infections worldwide and is recognized as the primary cause of cervical cancer. Persistent infection with high-risk HPV genotypes is responsible for nearly all cases of cervical cancer and contributes significantly to other anogenital malignancies, including cancers of the vulva, vagina, penis, and anus, as well as a growing proportion of head and neck cancers. Although HPV infections are common and often asymptomatic, persistent infection with oncogenic HPV types can lead to the development of precancerous lesions that may progress to invasive cancer if left undetected.

More than 100 HPV genotypes have been identified, with approximately 40 known to infect the anogenital tract. Among these, HPV16 and HPV18 are the most clinically significant, accounting for nearly 70% of cervical cancer cases globally. Because HPV infections often remain asymptomatic for extended periods, accurate molecular testing plays a critical role in identifying high-risk individuals before disease progression occurs.

The HPV-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific in vitro diagnostic assay for the qualitative detection of HPV16, HPV18, and 12 additional high-risk HPV genotypes in clinical specimens. By combining precise molecular targeting with robust quality controls, the assay enables reliable HPV screening, supports risk stratification, and contributes to improved patient outcomes through earlier clinical intervention.

Targets:

HPV-16, HPV-18, and 12 Other High-Risk HPV Genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 & 68)

Technology:

Real-Time PCR (TaqMan)

Detection:

Qualitative (Detected / Not Detected)

Sample Type:

Cervical Swabs, Cervical Canal Swabs, Urine

Certification:

CE-IVD

How the Assay Works

The HPV-Q kit is a CE-IVD-marked assay built on real-time PCR technology with primers and probes specifically designed to detect HPV16, HPV18, and 12 other clinically relevant high-risk HPV genotypes. The assay targets conserved regions of HPV DNA and utilizes multiplex fluorescent detection for simultaneous analysis of multiple targets within a single reaction.

Specific probes labeled with HEX and FAM enable differential detection of HPV16 and HPV18, respectively, while pooled high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are detected through the Texas Red channel. A human Beta-Actin Internal Control monitored through the Cy5 channel validates sample quality, DNA extraction efficiency, and PCR performance throughout the testing process.

Positive and negative controls are included to ensure workflow reliability and eliminate false positive or false negative results. Ready-to-use reagents and a streamlined workflow minimise hands-on time, reduce procedural complexity, and improve laboratory efficiency.

Why Molecular Testing Matters for HPV

HPV infections frequently occur without visible symptoms, making symptom-based diagnosis unreliable. While many infections resolve naturally, persistent infection with high-risk HPV genotypes remains the most important risk factor for the development of cervical cancer and several other HPV-associated malignancies.

Traditional cytology-based screening methods provide valuable clinical information but may not detect the presence of HPV before cellular abnormalities develop. Molecular detection of HPV DNA allows identification of infection at an earlier stage, enabling clinicians to assess cancer risk more effectively and implement appropriate follow-up strategies.

The ability to specifically identify HPV16 and HPV18 provides additional clinical value, as these genotypes are associated with the highest oncogenic potential. Early molecular detection supports cervical cancer prevention programmes, improves patient management, and facilitates evidence-based clinical decision-making.

Key Features & Benefits

High analytical accuracy

Analytical sensitivity and analytical specificity of 100%, with a Ct cut-off value of ≤28, ensuring reliable detection of clinically relevant HPV infections.

Comprehensive high-risk HPV screening

Simultaneously detects HPV16, HPV18, and 12 additional high-risk HPV genotypes associated with cervical cancer development.

Robust internal control

The Cy5-channel Beta-Actin Internal Control validates sample quality and PCR efficiency in every run, safeguarding against false-negative results arising from poor DNA quality or PCR inhibition.

Positive and negative controls included

Ensure workflow reliability and eliminate false positive or false negative results, confirming assay integrity in every run.

High clinical performance

Clinical sensitivity and clinical specificity of 99% provide confidence in patient screening and risk assessment programmes.

Cross-reactivity tested

No cross-reactivity observed with HSV-1, HSV-2, Cytomegalovirus (CMV), or Chlamydia trachomatis, ensuring highly specific HPV detection in clinically relevant differential diagnosis settings.

Reproducible results

Precision studies demonstrating repeatability below 4% CV and reproducibility below 3.5% CV ensure consistent performance across runs, operators, and testing sites.

Compatible with multiple leading PCR platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480 systems, enabling seamless integration into existing laboratory workflows.

Applications

Cervical Cancer Screening Programmes: Supports early identification of women at increased risk of developing cervical cancer through accurate detection of high-risk HPV genotypes.
Women's Health & Gynaecology Clinics: Enables comprehensive HPV testing to support patient risk assessment, monitoring, and follow-up strategies.
Clinical & Hospital Laboratories: Provides rapid and reliable molecular detection of high-risk HPV infections for routine diagnostic applications.
Immunocompromised Patients: Particularly valuable for women with compromised immune systems, including HIV-positive individuals, who face a significantly higher risk of HPV persistence and cervical cancer progression.
Public Health Screening Initiatives: Facilitates large-scale HPV screening programmes aimed at reducing the burden of cervical cancer through early intervention.
Differential Diagnosis & Preventive Oncology: Supports evidence-based clinical decision-making by identifying clinically significant HPV infections before progression to malignancy.

Analytical Performance

Analytical sensitivity of 100% and analytical specificity of 100%
Clinical sensitivity of 99% and clinical specificity of 99%
Ct cut-off value of ≤28 for positive detection
Accuracy of 99%
Limit of detection (LOD): 1000 copies/ml
Linearity demonstrated with R² = 0.999
Internal control (Cy5) validates sample quality and PCR efficiency in every run
Positive and negative controls included for complete assay integrity and contamination-free validation
No cross-reactivity with HSV-1, HSV-2, Cytomegalovirus (CMV), or Chlamydia trachomatis
12-month shelf life with stable performance under recommended storage conditions

Commercial Name	Old Cat No.	New Cat No.	Pack Size
HPV-Q Real-Time PCR Kit	G610013-1	G610013	50 Tests

Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

Product Overview

How the Assay Works

Why Molecular Testing Matters for HPV

Sample Type & Reporting Output