Optimization
CE-IVD Treponemal Antibody Cassette

Syphilis Rapid Test
(Treponema pallidum)

Rapid lateral flow chromatographic immunoassay for the qualitative detection of specific antibodies (IgG and IgM) to Treponema pallidum in human whole blood, serum, or plasma. Results in 10 minutes.

Readout Time 10 Minutes
Specimen Type Blood / Serum / Plasma
Clinical Accuracy 99.2% Agreement
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid Syphilis Device CE-IVD Marked
Treponema pallidum Antibody Window
S
C: Procedural Control Line
T: Recombinant Treponema pallidum Antibodies
Specific Treponemal Serology

High-Accuracy Antibody Screening for Syphilis Triage

Treponema pallidum is the spirochete bacterium responsible for syphilis. Without early intervention, initial painless genital chancres progress into disseminated secondary rashes, prolonged latent infection, and destructive tertiary neurosyphilis and cardiovascular aortitis. Point-of-care treponemal screening allows rapid same-day penicillin intervention.

Recombinant Specificity

Tp47, Tp17 & Tp15 Antigens

Engineered with double-antigen sandwich technology using highly conserved recombinant T. pallidum antigens, delivering exceptional clinical specificity.

  • Exceeds non-treponemal RPR/VDRL accuracy
  • Detects both IgG and IgM antibodies
  • Zero false-positive biological cross-reactions
Antenatal Screening

Congenital Syphilis Prevention

Routine antenatal screening in pregnant women is vital to prevent transplacental spirochete transmission, stillbirth, and congenital malformations.

  • WHO recommended antenatal protocol
  • Rapid bedside fingerstick execution
  • Directs immediate prophylactic antibiotic therapy
Same-Visit Care

Frontline POC Deployment

Empowers sexual health centers, occupational health screenings, and hospital emergency triage with immediate 10-minute diagnostic certainty.

  • Requires single 25 µL fingerstick drop
  • Stable at 2°C–30°C without refrigeration
  • Pre-cleared CE-IVD regulatory documentation

Clinical Agreement vs. TPPA & FTA-ABS Confirmation Benchmarks

Multi-Center Clinical Evaluation Cohort (n=860)
Diagnostic Parameter QuRapid Syphilis Rapid Test Reference TPPA / FTA-ABS Benchmark Clinical Concordance
Diagnostic Sensitivity 99.0% (95% CI: 96.5% – 99.9%) Serologically Confirmed Syphilis Cases Superior Triage Sensitivity
Diagnostic Specificity 99.3% (95% CI: 98.1% – 99.8%) Healthy & Non-Treponemal Donors Minimal Biological False Positivity
Total Clinical Concordance 99.2% (95% CI: 98.4% – 99.7%) Overall Clinical Cohort 99.2% Diagnostic Agreement
Analytical Sensitivity 1:100 RPR Equivalent Titer International Standard Reference High Analytical Resolution
*Performance confirmed in clinical trials against reference Treponema pallidum Particle Agglutination (TPPA) and Fluorescent Treponemal Antibody Absorption (FTA-ABS) tests.
Standard Operating Procedure

4-Step Bedside Protocol for Whole Blood Triage

Rapid point-of-care workflow designed for sexual health clinics, primary care, and antenatal screening units.

1

Blood Acquisition

Clean fingertip puncture site with alcohol swab. Prick with sterile lancet and draw 1 drop (approx. 25 µL) of capillary whole blood using the mini dropper.

2

Specimen Inoculation

Transfer the 25 µL blood drop directly into the cassette circular sample well (S), ensuring the entire specimen enters the well aperture.

3

Buffer Application

Add 1 drop of assay buffer into the sample well (S) immediately. The buffer lyses erythrocytes and initiates lateral chromatographic flow.

4

Visual Interpretation

Read diagnostic lines at 10 minutes under good lighting. Do not interpret or record test results after 15 minutes.

Visual Readout Guide

Diagnostic Interpretation Matrix

Rapid visual line identification guides immediate clinical management and staging.

Positive Differential Findings

Appearance of procedural Control line (C) and Test line (T).

Positive (C Line + T Line)
Treponema pallidum antibodies detected. Directs penicillin therapy.
Faint Test Line (Weak Positive)
Any visible pink/red T band indicates antibody presence. Treat as positive.

Negative & Invalid Results

Quality control validation and procedural guidelines.

Negative (C Line Only)
Only C line visible; no T line. T. pallidum antibodies not detected.
Invalid (No C Line)
Absence of Control line indicates insufficient sample volume or faulty strip. Retest.
Packaging & Accessories

Everything Included in the Kit Box

Each professional diagnostic kit comes complete with all sterile collection disposables and reagents for 25 tests.

💊 25 Test Cassettes Individually sealed in foil pouches with desiccant
🖊 25 Capillary Droppers Calibrated mini transfer pipettes for 25 µL whole blood
🧪 Assay Buffer Dropper Vial of optimized mobilization buffer for 25 tests
📄 Instructions for Use Comprehensive CE-IVD package insert & interpretation instructions
Clinical Support

Frequently Asked Questions

Need validation dossiers, regulatory certificates, or bulk clinic pricing? Contact our infectious disease specialists in Dubai.

Contact Clinical Specialist
Is this a treponemal or non-treponemal test?

This is a specific treponemal test utilizing recombinant T. pallidum antigens (Tp47, Tp17, Tp15), offering significantly higher specificity than RPR/VDRL.

Can fingerstick capillary blood be used?

Yes. Calibrated for fingerstick whole blood in outpatient settings.

What is the package configuration?

25 cassettes, 25 capillary droppers, 1 vial buffer, and instructions.

How to order in UAE?

QuRapid maintains extensive stock in Dubai with same-day dispatch.

Equip Your Clinic With QuRapid Syphilis Rapid Tests

Order CE-IVD certified Syphilis Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for sexual health clinics, maternity hospitals, and clinical laboratories.

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