N.Gonorrhoeae-Q Real-Time PCR Kit

Product Overview

Neisseria gonorrhoeae is the causative agent of gonorrhoea, one of the most prevalent sexually transmitted infections (STIs) worldwide. The infection can affect the genitals, rectum, throat, and eyes, with many cases remaining asymptomatic in both men and women. Untreated infections may lead to severe complications including pelvic inflammatory disease (PID), infertility, septic arthritis, and increased susceptibility to HIV transmission.

The N. Gonorrhoeae-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific in vitro diagnostic assay designed for the qualitative detection of N. gonorrhoeae DNA in human clinical samples. The assay combines advanced molecular detection technology with robust internal controls to ensure accurate, reliable, and reproducible results for clinical diagnostics and STI screening programs.

Targets:
Neisseria gonorrhoeae DNA
Technology:
Real-Time PCR (TaqMan Chemistry)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Urine, Urethral Swab, Cervical Swab, Semen
Certification:
CE-IVD
Gonorrhoeae-Q

How the Assay Works

The N. Gonorrhoeae-Q Real-Time PCR Kit is based on single-tube real-time PCR technology using target-specific primers and fluorescent probes for the detection of N. gonorrhoeae DNA.

  • HEX channel: Detects N. gonorrhoeae target DNA
  • Cy5 channel: Detects Internal Control (RNaseP) to validate sample quality and amplification efficiency

The assay includes:

  • Target-specific primer and probe mix
  • Internal control primer and probe mix
  • Positive control template
  • qPCR master mix
  • RNase/DNase-free water

The integrated internal control safeguards against false-negative results caused by PCR inhibition or inadequate sample quality, while positive and negative controls ensure complete assay integrity and contamination-free performance.

Why Molecular Testing Matters for Gonorrhoea

Gonorrhoea frequently presents non-specific or asymptomatic infections, making clinical diagnosis unreliable. Delayed or missed diagnosis can contribute to continued transmission, chronic complications, and antimicrobial resistance.

Molecular detection using real-time PCR enables:

  • Early and accurate pathogen identification
  • Detection even in asymptomatic patients
  • High sensitivity and specificity compared to conventional methods
  • Faster turnaround time for timely clinical intervention
  • Reliable screening in high-risk populations and STI clinics

The assay provides rapid and dependable detection of N. gonorrhoeae DNA, supporting effective patient management and infection control strategies.

Sample Type & Reporting Output

Sample Type:
Urine, Urethral Swab, Cervical Swab, Semen
Reporting Output:
Qualitative detection of N. gonorrhoeae DNA (Detected / Not Detected)
Targets Detected:
Target Detected Neisseria gonorrhoeae DNA

Key Features & Benefits

High Sensitivity & Specificity

Reliable molecular detection of N. gonorrhoeae DNA with a Ct cut-off of ≤35 for accurate identification of positive samples.

Robust Internal Control

Built-in RNaseP internal control in the Cy5 channel validates sample quality and PCR efficiency in every run.

Positive & Negative Controls Included

Ensures assay integrity, contamination monitoring, and reliable workflow validation.

Rapid & Reliable Detection

Supports timely diagnosis and faster clinical decision-making in STI management.

Single-Tube Workflow

Simplified assay setup minimises hands-on time and reduces risk of procedural errors.

Ready-to-Use Reagents

Pre-formulated reagents streamline workflow and simplify laboratory operations.

Applications

  • Clinical & Diagnostic Laboratories: Enables sensitive and accurate detection of N. gonorrhoeae infections for routine diagnostic testing.
  • STI Screening Programs: Supports large-scale sexually transmitted infection screening and surveillance initiatives.
  • Hospital & Reference Laboratories: Facilitates rapid molecular confirmation of gonorrhoea infections for improved patient management.
  • Reproductive & Sexual Health Clinics: Provides dependable testing for symptomatic and asymptomatic individuals.
  • Public Health & Epidemiology: Supports infection surveillance and control strategies in high-risk populations.
  • High-Risk Patient Screening: Useful for screening immunocompromised individuals and patients with recurrent or persistent infections.

Analytical Performance

  • Qualitative detection of N. gonorrhoeae DNA
  • Ct cut-off of ≤35 for positive interpretation
  • Internal control validates sample quality and amplification efficiency
  • Positive and negative controls included for workflow validation
  • Compatible with multiple leading real-time PCR systems
  • 12-month shelf life under recommended storage conditions
  • Designed for accurate and reproducible molecular diagnostics

Data Analysis and Report

NG_Amplification

Neisseria Gonorrhoeae Real Time PCR specific amplification plot of N.Gonorrhoeae Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
N.Gonorrhoeae-Q Real-Time PCR Kit G2M706421 G2M706421R 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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