LP-MP Multiplex Real-Time PCR Kit

Product Overview

Respiratory tract infections caused by Legionella pneumophila and Mycoplasma pneumoniae remain significant causes of community-acquired and atypical pneumonia worldwide. Legionella pneumophila is a gram-negative, aerobic bacterium which is responsible for Legionnaires’ disease and Pontiac fever. While M. pneumoniae is a cell-wall lacking, gram negative, aerobic bacteria which is a major cause of mild to severe respiratory infections commonly referred to as walking pneumonia. Clinical symptoms often overlap with those of other bacterial and viral respiratory pathogens, making accurate laboratory diagnosis essential for timely treatment and infection control.

The LP-MP Multiplex Real-Time PCR Kit from Genes2Me is a highly sensitive and specific in vitro diagnostic assay designed for the simultaneous qualitative detection of Legionella pneumophila and Mycoplasma pneumoniae DNA in respiratory specimens. Based on multiplex PCR technology with robust internal controls, the assay delivers rapid, reliable, and accurate results from a single reaction tube, supporting improved patient management and laboratory efficiency.

Targets:

Legionella pneumophila (LP)/ Mycoplasma pneumoniae (MP) bacterial DNA

Technology:

Real-Time PCR (TaqMan)

Detection:

Qualitative (Detected / Not Detected)

Sample Type:

Nasopharyngeal fluid, sputum and throat swab

Certification:

CE-IVD

How the Assay Works

The LP-MP Multiplex Real-Time PCR Kit utilizes Real-Time PCR technology with pathogen-specific primers and probes targeting Legionella pneumophila and Mycoplasma pneumoniae. The assay enables simultaneous detection of both pathogens within a single reaction.

Target-specific fluorescent probes are detected through dedicated channels. The assay simultaneously detects Legionella pneumophila in the FAM channel, Mycoplasma pneumoniae in the HEX/VIC channel, and the Internal Control in the Cy5 channel, ensuring reliable and efficient multiplex analysis.

The integrated Internal Control validates nucleic acid extraction efficiency, sample quality, and PCR performance throughout the workflow. Positive and No Template Controls help ensure assay integrity, reliable amplification, and contamination monitoring.

Why Molecular Testing Matters for Respiratory Infections

Respiratory tract infections remain a significant cause of morbidity worldwide, and atypical bacterial pathogens are often underdiagnosed due to overlapping clinical symptoms. Mycoplasma pneumoniae is a common cause of walking pneumonia. Due to its atypical clinical presentation and lack of a cell wall, conventional diagnostic approaches may not provide timely identification. Molecular testing offers a rapid and highly sensitive alternative for accurate pathogen detection.

The LP-MP Multiplex Real-Time PCR Kit provides a reliable molecular approach for simultaneous detection of these clinically significant pathogens, enabling improved patient management and infection control measures.

Key Features & Benefits

Simultaneous Detection of Two Major Respiratory Pathogens

Multiplex assay design enables the detection of both Legionella pneumophila and Mycoplasma pneumoniae from a single sample and reaction, reducing turnaround time and reagent consumption.

Robust Internal Control Monitoring

The Cy5-channel Internal Control validates extraction quality and PCR performance, minimizing the risk of false-negative results caused by inhibition or extraction failure.

Reliable Detection at Low Target Levels

A limit of detection (LOD) of 100 copies/ml supports accurate detection even in samples containing low bacterial loads.

Cross-Reactivity Evaluated

No cross-reactivity observed with clinically relevant respiratory pathogens including Chlamydia pneumoniae, Neisseria meningitidis, HSV-1, HSV-2, and VZV, supporting high assay specificity.

Compatible with Leading PCR Platforms

Validated on RapiCycler 96, Bio-Rad CFX96, QuantStudio 5, and LightCycler 480 systems for seamless laboratory integration.

Applications

Clinical & Hospital Laboratories: Supports rapid and accurate diagnosis of atypical bacterial pneumonia, enabling timely therapeutic decisions and improved patient management
Respiratory Infection Screening Programs: Facilitates routine screening of respiratory specimens for common atypical bacterial pathogens in diagnostic laboratories.
Critical Care & High-Risk Patients: Provides reliable pathogen detection in immunocompromised individuals, elderly patients, and hospitalized cases where rapid diagnosis is crucial.
Differential Diagnosis of Pneumonia: Assists clinicians in distinguishing atypical bacterial pneumonia from viral and other respiratory infections, supporting targeted treatment strategies.

Analytical Performance

Limit of Detection (LoD) 100 copies/mL, enabling reliable detection of low bacterial loads.
Supporting clinical decision making in pediatric settings, particularly for children with asthma who face a heightened risk of severe illness .
Clinical sensitivity of 98% and clinical specificity of 98% for accurate identification of Legionella pneumophila and Mycoplasma pneumoniae.
Analytical specificity of 100%, ensuring precise target detection with no observed cross-reactivity against tested respiratory pathogens.
Ct cut-off of ≤35 for positive result interpretation, supporting consistent and standardized reporting.
No cross-reactivity observed with tested respiratory pathogens.
Internal Control (Cy5) validates extraction and amplification performance.
12-month shelf life under recommended storage conditions.

Commercial Name	Old Cat No.	New Cat No.	Pack Size
LP-MP Multiplex Real-Time PCR Kit	G2M707921	G610007	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 Respiratory Infections

Sample Type & Reporting Output