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.

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.