M. Pneumoniae-Q Real-Time PCR Kit

Product Overview


Mycoplasma pneumoniae is one of the most common and insidious causes of community-acquired pneumonia worldwide. The absence of cell wall structure makes it inherently resistant to many antibiotics, and its slow-growing nature renders traditional culture-based methods unreliable, often delaying diagnosis by days or weeks. The bacterium spreads readily through respiratory aerosols and can exacerbate serious conditions including asthma, COPD, ARDS, and cardiovascular complications, making timely detection critical, particularly in children, teenagers, and other vulnerable populations.

The M. Pneumoniae-Q Real-Time PCR Kit from Genes2Me delivers sensitive, specific detection of M. pneumoniae DNA directly from nasopharyngeal fluid, sputum, and throat swabs. It provides dependable results quickly, empowering clinicians to make informed treatment decisions and helping prevent further community spread.

Targets:
Mycoplasma pneumoniae (DNA)
Technology:
TaqMan-based Real-Time PCR
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Nasopharyngeal Fluid, Sputum, Throat Swab
Certification:
CE-IVD
Pneumoniae-Q

Genes2Me is a CE Marked molecular diagnostics company trusted by clinical laboratories across global markets. The M. Pneumoniae-Q Kit meets European conformity standards for in vitro diagnostic devices, validated to international benchmarks for accuracy, reliability, and safety.

How the Assay Works


The M. Pneumoniae-Q kit uses a single-tube real-time PCR design with highly specific primers and fluorescent probes for precise DNA amplification. M. pneumoniae DNA is detected in the FAM channel, while the HEX channel monitors an internal control to validate extraction and amplification in every run. Positive and negative controls are included to further ensure assay integrity and guard against contamination or procedural errors.

Why Multiplex Testing Matters


Atypical pneumonia caused by M. pneumoniae presents with non-specific symptoms that closely resemble viral respiratory infections, making clinical diagnosis unreliable on its own. Multiplex testing with a built-in internal control enables simultaneous pathogen detection and run validation, reducing the risk of false negatives and ensuring accurate, timely identification. This is especially important in outpatient and paediatric settings where rapid diagnosis directly influences antibiotic prescribing decisions.

Sample Type & Reporting Output


Sample Type:
Nasopharyngeal fluid, sputum, and throat swab samples
Reporting Output:
Qualitative detection of M. pneumoniae DNA (Detected / Not Detected)
Targets Detected:
Mycoplasma pneumoniae (DNA)

Key Features & Benefits


Multiplex assay with internal control

Simultaneously detects M. pneumoniae DNA (FAM) and validates the run via internal control (HEX), safeguarding against extraction and amplification errors.

High sensitivity with Ct cut-off of 38 or below

Detects low bacterial loads with confidence, enabling accurate identification even in early or subclinical infections.

Positive and negative controls included

Both controls are supplied in every kit, guaranteeing assay integrity and minimising the risk of contamination or experimental error.

Compatible with multiple leading PCR platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480.

Broad sample type compatibility

Accepts nasopharyngeal fluid, sputum, and throat swabs, offering flexibility to suit different clinical collection protocols.

Streamlined workflow with optimised reagent stability

Pre-formulated reagents and clear amplification protocols ensure consistent, reproducible results with minimal setup time.

Applications


  • Clinical & Hospital Laboratories: Enables rapid, sensitive detection of M. pneumoniae from multiple respiratory sample types, supporting timely antibiotic treatment decisions and reducing unnecessary broad-spectrum prescribing.
  • Paediatric & Neonatal Care: Critical diagnostic tool for children and teenagers, the populations most affected by M. pneumoniae, where delayed diagnosis can lead to prolonged illness and complications.
  • Outbreak Surveillance: Supports rapid identification and containment of M. pneumoniae clusters in hospitals, schools, and community settings where the pathogen spreads readily through respiratory aerosols.
  • Immunocompromised Patients: Essential for patients with asthma, COPD, or compromised immunity, where M. pneumoniae infection can trigger severe exacerbations and systemic complications including ARDS.
  • Travel & Occupational Health: Reliable screening in occupational health programmes and travel medicine settings, particularly where individuals are exposed to close-contact environments with elevated transmission risk.

Analytical Performance


  • High analytical sensitivity and specificity
  • Ct cut-off of 38 or below for positive detection, reliable even at low bacterial DNA concentrations
  • No cross-reactivity with common respiratory pathogens
  • Positive and negative controls included for full assay integrity validation

Ordering Information


Commercial Name Old Cat No. New Cat No. Pack Size
Adeno-Q Real-Time PCR Kit G2M707721R 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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