CMV-Q Real Time PCR Kit

Product Overview

Cytomegalovirus (CMV) is a prevalent virus within the herpesvirus family, capable of remaining latent and reactivating in the body. It spreads through various bodily fluids such as saliva, blood, urine, semen, and breast milk, and can also be transmitted via organ transplants and blood transfusions. Congenital transmission occurs when a pregnant woman passes the virus to her unborn child, potentially leading to significant health issues for the infant. Symptoms of CMV vary widely depending on the individual's immune status, ranging from mild or no symptoms in healthy individuals to severe disease including retinitis, pneumonia, hepatitis, and gastrointestinal disease in immunocompromised individuals.

To address this important research need, Genes2Me introduces the CMV-Q Real Time PCR Kit, an in vitro diagnostic test based on real time PCR technology for the detection and quantification of Cytomegalovirus specific DNA in human EDTA whole blood. Real time PCR offers higher sensitivity and specificity than serology-based methods, detecting CMV DNA directly and allowing earlier detection of active infection along with more accurate monitoring of viral load. The assay is intended to be performed by a laboratory professional in a research laboratory.

Targets:
Cytomegalovirus (CMV) DNA
Technology:
Real-Time PCR (Multiplex, Quantitative)
Detection:
Qualitative and Quantitative (Viral Load)
Sample Type:
Human EDTA Whole Blood
Certification:
RUO (For Research Use Only)
CMV-Q Real Time PCR Kit

How the Assay Works

The CMV-Q Kit uses real time quantitative PCR in a multiplex reaction to quantitatively detect CMV DNA and an Internal Control in the same tube. The assay includes CMV specific primers and a FAM labelled probe for CMV DNA detection, along with Internal Control primers and a Cy5 labelled probe. Fluorescence from FAM indicates CMV quantity, while Cy5 confirms sample integrity and PCR performance. The kit includes four Quantification Standards (QS1 to QS4, at 100000, 10000, 1000, and 100 copies per microliter respectively) to generate a standard curve, allowing for precise quantification of CMV DNA in clinical samples. This dual channel detection ensures accurate and reliable results by simultaneously assessing viral load and the quality of the PCR process.

Clinical Relevance

Close physical or sexual contact, breastfeeding, and occupational exposure, particularly among healthcare workers, are common transmission modes for CMV. Congenital CMV can result in jaundice, hepatosplenomegaly, low birth weight, microcephaly, seizures, and hearing loss. In immunocompromised individuals, such as those with HIV/AIDS or transplant recipients, CMV reactivation can cause more severe disease, making timely detection and viral load monitoring crucial for guiding treatment and management decisions. Real time PCR based viral load monitoring supports earlier detection of active infection compared to serology-based IgM and IgG antibody testing.

Sample Type & Reporting Output

Sample Type:
Human EDTA Whole Blood
Reporting Output:
Qualitative detection (Detected / Not Detected) and quantitative viral load (copies per ml) of CMV DNA
Targets Detected:
CMV specific DNA and Internal Control in a single multiplex reaction, with four Quantification Standards for standard curve generation

Key Features & Benefits

Single Tube Multiplex Detection

Simultaneous detection of Enterovirus (universal, FAM), Enterovirus 71 (Texas Red), Coxsackievirus A16 (HEX), and an Internal Control (Cy5) within a single reaction.

Dual Channel Quantitative Detection

Simultaneous detection of CMV DNA (FAM) and an Internal Control (Cy5) in a single multiplex reaction, enabling both qualitative result interpretation and precise viral load quantification.

Integrated Internal Control

An Internal Control confirms sample integrity and PCR performance in every run, supporting confidence in result interpretation.

Built In Quantification Standards

Four Quantification Standards (QS1 to QS4) are provided to generate a standard curve for accurate determination of CMV DNA concentration in copies per ml.

High Analytical Performance

100% analytical sensitivity and 100% analytical specificity, with a limit of detection of 50 copies per ml and a measuring range of 10 to 109 copies per reaction.

Flexible Compatibility

Validated on leading Real-Time PCR platforms including Thermo Fisher QuantStudio 5, Bio-Rad CFX96, Roche LightCycler 480, and Genes2Me RapiCycler 96.

Strong Clinical Performance

99% clinical sensitivity and 99% clinical specificity support dependable result interpretation.

Long Shelf Life

The kit has a shelf life of 12 months from the date of manufacture and remains stable until the labeled expiration date when stored as specified.

Applications

  • Monitoring CMV viral load in transplant recipients to guide pre-emptive antiviral therapy and detect early reactivation
  • Detection of active CMV infection in immunocompromised individuals, including those with HIV/AIDS, where serology-based testing has limited utility
  • Research into congenital CMV transmission and its association with infant health outcomes
  • Quantitative tracking of CMV DNA levels over time to support treatment response monitoring in research settings
  • Academic and public health research studying CMV epidemiology, transmission routes, and reactivation dynamics

Analytical Performance

  • Analytical sensitivity of 100% and analytical specificity of 100% for detection of CMV DNA
  • Trueness (bias) of 99% and accuracy (resulting from trueness and precision) of 99%
  • Precision with a coefficient of variation of less than 3.9% for repeatability and less than 3.5% for reproducibility
  • Limit of detection of 50 copies per ml, with a measuring range of 10 to 109 copies per reaction and linearity of R squared equals 0.999
  • Ct value cut off less than or equal to 35 for differentiating positive and negative results, with a calibrator slope of negative 3.31
  • Well controlled identification and control of known relevant endogenous and exogenous interfering substances, including human genomic DNA, NaCl, BSA, and hemoglobin
  • No cross reactivity observed against HIV, HCV, HBV, and HSV
  • Compatible with QuantStudio 5, CFX96, LightCycler 480, and RapiCycler 96 platforms
  • Manufactured under strict quality standards with reagent stability maintained under recommended storage conditions of negative 30 degrees Celsius to negative 10 degrees Celsius

With the CMV-Q Real Time PCR Kit, research laboratories can achieve sensitive, specific, and quantitatively precise detection of Cytomegalovirus DNA in whole blood. By supporting accurate viral load monitoring alongside qualitative detection, the kit helps researchers generate timely, informed insights for CMV related research, from transplant monitoring to congenital transmission studies. Empower your laboratory with the CMV-Q Real Time PCR Kit, because rapid molecular insights can make a lasting difference in research outcomes.

Data Analysis and Report

CMV-Q Real-Time PCR Kit

CMV-Q Real-Time PCR Kit specific amplification plot of Treponema pallidum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
CMV-Q Real-Time PCR Kit G2MBR4-0075 50 Tests

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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.

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