Syphilis-Q Real-Time PCR Kit

Product Overview


Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. It is primarily transmitted through sexual contact and may also be passed from mother to fetus during pregnancy, leading to congenital Syphilis. The disease progresses through multiple stages, beginning with painless sores (chancres), followed by rash, fever, swollen lymph nodes, and potentially severe complications affecting the heart, brain, and nervous system if left untreated. Early and accurate detection is essential for effective treatment and prevention of complications.

The Syphilis-Q Real-Time PCR Kit from Genes2Me is a highly sensitive and specific in vitro diagnostic assay designed for the qualitative detection of Treponema pallidum DNA from clinical samples. The assay supports rapid molecular diagnosis and helps laboratories deliver reliable results for timely patient management.

Targets:
Treponema pallidum (Syphilis DNA)
Technology:
Real-Time PCR (TaqMan)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Whole Blood, Cerebrospinal Fluid, Amniotic Fluid, Genito-Urinary Ulcers
Certification:
CE-IVD
Syphilis-Q

How the Assay Works


The Syphilis-Q kit utilizes advanced real-time PCR technology with primer and probe sets specifically targeting conserved genes of Treponema pallidum. The assay employs HEX-labeled probes for pathogen detection and a Cy5-labeled internal control to validate sample quality, nucleic acid extraction, and PCR efficiency in every run. Positive and negative controls ensure workflow integrity and reliable assay performance.

The ready-to-use reagents and optimized workflow minimize hands-on time while reducing the risk of contamination and procedural errors.

Why Molecular Testing Matters for Syphilis


Serological methods remain widely used for Syphilis screening; however, molecular detection offers enhanced sensitivity and specificity, particularly during early infection stages or in samples with low pathogen load. Real-time PCR enables direct detection of Treponema pallidum DNA, supporting earlier diagnosis and improved patient management.

The assay provides reliable results even in challenging clinical presentations and supports confirmation in cases where serological results may be inconclusive.

Sample Type & Reporting Output


Sample Type:
Whole Blood, Cerebrospinal Fluid, Amniotic Fluid, Genito-Urinary Ulcers
Reporting Output:
Qualitative detection of Treponema pallidum DNA (Detected / Not Detected)
Targets Detected:
Treponema pallidum DNA

Key Features & Benefits


High Sensitivity & Specificity

Advanced TaqMan-based real-time PCR technology enables highly sensitive and specific detection of Treponema pallidum DNA, ensuring reliable identification even in samples with low bacterial burden.

Early Molecular Confirmation of Active Infection

Direct detection of T. pallidum DNA supports diagnosis during early stages of infection when serological responses may be absent, delayed, or inconclusive, enabling timely clinical intervention.

Robust Internal Control System

A Cy5-labelled Internal Control validates nucleic acid extraction quality, sample integrity, and PCR amplification efficiency in every reaction, reducing the risk of false-negative results.

Positive & Negative Controls Included

Built-in Positive Control and No Template Control (NTC) reactions verify assay integrity, monitor contamination, and ensure confidence in result interpretation throughout the testing workflow.

Reliable Qualitative Detection

Provides clear qualitative reporting of Treponema pallidum DNA (Detected / Not Detected), simplifying result interpretation and supporting rapid clinical decision-making.

Ready-to-Use Reagents for Streamlined Workflow

Pre-formulated reagents minimise hands-on preparation, reduce operator variability, and improve laboratory efficiency while lowering the risk of procedural errors.

Compatible with Leading Real-Time PCR Platforms

Validated on Bio-Rad CFX96, QuantStudio™ 5, Roche LightCycler® 480, and RapiCycler 96 systems, allowing seamless integration into established molecular diagnostic workflows.

Supports Maternal & Prenatal Screening

Facilitates early detection of maternal infection and supports efforts to reduce the risk of congenital syphilis through timely diagnosis and treatment.

Applications


  • Clinical & Hospital Laboratories: Supports accurate molecular diagnosis of Syphilis from multiple clinical sample types.
  • Maternal & Prenatal Screening: Enables early detection to reduce the risk of congenital Syphilis.
  • Infectious Disease Laboratories: Supports rapid confirmation of Treponema pallidum infection.
  • Public Health & Screening Programs: Facilitates surveillance and disease monitoring initiatives.
  • Differential Diagnosis: Assists in distinguishing Syphilis from other sexually transmitted infections with overlapping clinical symptoms.

Analytical Performance


  • Qualitative detection of Treponema pallidum DNA with high analytical accuracy.
  • Ct cut-off of ≤35 for positive detection.
  • Internal control ensures sample integrity and PCR efficiency.
  • Positive and negative controls validate assay performance.
  • Stable reagents with a 12-month shelf life under recommended storage conditions.
  • Validated across multiple compatible real-time PCR platforms.

Data Analysis and Report


Syphilis_Amplification

Syphilis Real Time PCR 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
Syphilis-Q Real-Time PCR Kit G2M705521 G610048-1 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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