M.Pox(VZV)-Q Real-Time PCR Kit

Product Overview

Mpox (formerly known as Monkeypox) is a zoonotic viral disease caused by the Monkeypox virus, a double-stranded DNA virus belonging to the Orthopoxvirus genus of the Poxviridae family. Human infection may occur through direct contact with infected animals, contaminated materials, or close person-to-person transmission. Clinical manifestations typically include fever, headache, lymphadenopathy, muscle aches, fatigue, and a characteristic vesiculo-pustular rash.

The clinical presentation of Mpox can overlap with other rash-causing illnesses, particularly Varicella-Zoster Virus (VZV), making laboratory confirmation essential for accurate diagnosis and patient management.

The Mpox (VZV)-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific in vitro diagnostic assay designed for the qualitative detection and differentiation of Monkeypox Virus Clade I and Clade II DNA from human clinical specimens. The assay combines robust molecular detection with integrated quality controls to support reliable diagnosis, outbreak monitoring, and infection control measures.

Targets:

Monkeypox Virus (Mpox DNA – Clade I & Clade II)

Technology:

Real-Time PCR (TaqMan Chemistry)

Detection:

Qualitative (Detected / Not Detected)

Sample Type:

Lesion Swabs, Lesion Crusts, Vesicular Fluid Samples

Certification:

IVD

How the Assay Works

The Mpox (VZV)-Q kit is based on multiplex real-time PCR technology and utilizes target-specific primers and fluorescent probes for the simultaneous detection and differentiation of Monkeypox Virus Clade I and Clade II. The assay employs:

FAM Channel: Monkeypox Virus Clade I
Cy5 Channel: Monkeypox Virus Clade II
HEX Channel: Internal Control

The built-in Internal Control monitors sample quality, nucleic acid extraction efficiency, and PCR amplification performance throughout the workflow. Positive and No Template Controls (NTC) are included to ensure assay integrity and minimize the risk of false-positive or false-negative results. Ready-to-use reagents and a streamlined workflow help reduce hands-on time and simplify laboratory operations.

Why Molecular Testing Matters for Mpox

Accurate differentiation between Mpox and other vesicular rash illnesses is critical for effective patient management and outbreak containment. Clinical symptoms alone may not reliably distinguish Mpox from conditions such as chickenpox caused by Varicella-Zoster Virus.

Real-time PCR provides highly sensitive and specific detection of viral DNA directly from clinical specimens, enabling confirmation of active infection during the early stages of disease. Molecular testing supports timely isolation measures, contact tracing, and public health interventions while reducing the likelihood of misdiagnosis. The assay has been designed to specifically detect Monkeypox virus genomic targets while minimizing cross-reactivity with non-target pathogens, ensuring confidence in diagnostic results.

Key Features & Benefits

Dual-Clade Detection & Differentiation

Simultaneously detects and differentiates Monkeypox Virus Clade I and Clade II in a single reaction, supporting epidemiological surveillance and outbreak investigations.

High Analytical Performance

Clinical sensitivity of 98% and clinical specificity of 99%, enabling reliable detection even in challenging clinical samples.

Robust Internal Control

Integrated HEX-channel Internal Control validates extraction quality and amplification efficiency, reducing the risk of false-negative results.

Positive & Negative Control Validation

Includes Positive Control and No Template Control for comprehensive assay verification and contamination monitoring.

Sensitive Detection

Limit of Detection (LOD) of 200 copies/ml, enabling detection of low viral loads.

Highly Reproducible Results

Precision studies demonstrate excellent repeatability and reproducibility with coefficient of variation values below 3%.

Minimal Cross-Reactivity

No cross-reactivity observed during analytical specificity studies, ensuring highly specific Mpox detection.

Ready-to-Use Reagents with 12-Month Shelf Life

Pre-formulated reagents simplify workflow, reduce setup errors, and support efficient inventory management.

Applications

Clinical & Hospital Laboratories: Supports rapid and reliable diagnosis of suspected Mpox infections from lesion-based clinical specimens.
Public Health & Reference Laboratories: Facilitates surveillance, outbreak monitoring, and molecular confirmation of Mpox cases.
Infection Prevention & Control Programs: Provides actionable molecular results to support isolation measures and transmission control.
Differential Diagnosis of Vesicular Rash Illnesses: Assists in distinguishing Mpox from clinically similar diseases such as Varicella-Zoster Virus infections.
Travel & Border Health Screening: Supports testing of travelers returning from endemic or outbreak regions with suspected symptoms.
Research & Epidemiological Studies: Enables monitoring of circulating Mpox strains and supports molecular epidemiology initiatives.

Analytical Performance

Clinical Sensitivity: 98% & Specificity: 99%
Limit of Detection (LOD): 200 copies/ml
No Cross-Reactivity Observed
Internal Control (HEX) included in every reaction
Positive and No Template Controls included

Ct Cut-off: ≤35

Repeatability Within Run: CV <2.5%

Repeatability Between Days: CV <2.0%

Reproducibility Between Sites: CV <1%

Reproducibility Between Operators: CV <3%

Shelf Life: 12 Months under recommended storage conditions

Commercial Name	Old Cat No.	New Cat No.	Pack Size
M.Pox(VZV)-Q Real-Time PCR Kit	G2M705821	G610011	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 Mpox

Sample Type & Reporting Output