Rapid Tests > Treponema Pallidum Antigen Assay

Treponema Pallidum (Syphilis) Antigen Rapid Test – EZER™ Diagnostic Kit

Rapid Tests > Treponema Pallidum Antigen Assay

Treponema Pallidum (Syphilis) Antigen Rapid Test – EZER™ Diagnostic Kit

Product highlights

  • Syphilis-targeted — Detects Treponema pallidum antibodies in blood, serum, or plasma
  • Quick results — Visual interpretation within 15 minutes
  • High specificity — 99.8% vs. PCR, minimizing false positives
  • User-friendly — Requires no instrumentation or complex handling

Treponema Pallidum (Syphilis) Antigen Rapid Test – EZER™ Diagnostic Kit

About Treponema Pallidum (Syphilis) Antigen Rapid Test – EZER™ Diagnostic Kit

The EZER™ Treponema Pallidum Antibody Rapid Test provides fast and dependable detection of antibodies against Treponema pallidum, the causative agent of syphilis. Developed for professional use in clinical laboratories, this lateral flow immunoassay delivers clear, qualitative results from whole blood, serum, or plasma in just 15 minutes.

Syphilis often presents with vague symptoms, making early and accurate diagnosis critical. The EZER™ test detects total antibodies (IgG and IgM) against T. pallidum, supporting the identification of both recent and latent infections.

Requiring only a minimal sample volume, the test is simple to perform and includes all components for immediate use. With a specificity of 99.8% and 95% agreement with PCR-based reference methods, it offers a trusted solution for frontline screening in sexual health clinics, public health programs, and microbiology labs.

Ideal for use as a primary screening tool or as part of a diagnostic algorithm, the EZER™ Syphilis Rapid Test is a reliable choice for infectious disease diagnostics and clinical chemistry workflows.

Specifications of the Treponema Pallidum (Syphilis) Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Syphilis Rapid Test?

The EZER™ Treponema Pallidum Antibody Rapid Test is a qualitative immunochromatographic assay that detects antibodies to Treponema pallidum—the causative agent of syphilis. The test works with three sample types: whole blood, serum, or plasma, making it flexible for a variety of clinical settings.

Kit contents:

  • 40 test cassettes

  • 1 vial of sample buffer

  • 40 plastic droppers

  • 1 package insert

All components are ready to use. The test must be stored at 2–30°C and used immediately after opening. No equipment or specialized training is required to administer the test or interpret the results.

EZER™ Syphilis Rapid Test detecting Treponema pallidum antibodies in human blood sample

Role of Treponema pallidum in Syphilis

Treponema pallidum is a spiral-shaped bacterium responsible for syphilis, a systemic and potentially chronic infection. The disease progresses through distinct stages:

  • Primary syphilis: Painless ulcers and highly infectious lesions

  • Secondary syphilis: Skin rashes, mucocutaneous lesions, lymphadenopathy

  • Latent and tertiary stages: Can lead to organ damage including CNS, cardiovascular system, and bones

Congenital syphilis occurs when the bacterium crosses the placenta during pregnancy, leading to severe complications in neonates.

Due to its often asymptomatic nature in latent stages, syphilis is frequently underdiagnosed. Therefore, early syphilis-targeted serologic testing is critical in both clinical and screening contexts to prevent disease progression and transmission.

About the EZER™ Treponema Pallidum Antibody Rapid Test

Manufactured by Genesis Biotech, the EZER™ Syphilis Rapid Test has been clinically validated in a study comparing results with a leading PCR method. Key performance indicators include:

  • Sensitivity: 87.1%

  • Specificity: 99.8%

  • Overall agreement: 95.0%

The test uses Treponema pallidum antigens immobilized on a nitrocellulose strip, combined with colloidal gold-conjugated antigen particles for detection. Internal control lines ensure the validity of each test.

Cross-reactivity studies showed no false positives from specimens containing:

  • Anti-HIV

  • Anti-HCV

  • HBsAg

  • Influenza A/B

  • RSV

  • Adenovirus

Additionally, no interference was observed with bilirubin, hemoglobin, triglycerides, or high cholesterol levels.

Principle and Workflow

The test operates using a lateral flow format:

  1. Sample Application:

    • Serum/plasma: Add 1 drop sample + 1 drop buffer

    • Whole blood: Add 2 drops blood + 1 drop buffer

  2. Reaction Time: Wait 15 minutes before reading the result

  3. Interpretation:

    • Two lines (T + C): Syphilis-positive

    • One line at C: Syphilis-negative

    • No C line: Invalid test

The T line intensity may vary depending on the antibody concentration. Even a faint test line indicates a syphilis-positive result.

Clinical Application

The EZER™ Syphilis Rapid Test is an ideal tool for:

  • Sexual health clinics offering walk-in STI screening

  • Public health programs performing mass serologic testing

  • Emergency rooms needing quick results for symptomatic patients

  • Microbiology and molecular diagnostic labs verifying seroprevalence

The test helps identify syphilis-positive individuals quickly, facilitating timely treatment and contact tracing. It’s especially valuable in low-resource settings or when immediate answers are needed prior to confirmatory testing.

As a CE-marked in vitro diagnostic product, this test provides a robust frontline solution in both endemic and non-endemic regions where syphilis is a persistent threat.

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For any missing information or if you require additional details, please do not hesitate to contact us. 

 

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