Optimization
CE-IVD Rapid STD Antigen Cassette

Chlamydia Rapid Test
Device

Rapid qualitative lateral flow immunoassay for the direct detection of Chlamydia trachomatis antigen in female endocervical swabs, male urethral swabs, and male urine specimens. Results in 10 minutes with high clinical accuracy.

Readout Time 10 Minutes
Specimen Type Swab / Centrifuged Urine
Clinical Accuracy 97.8% Agreement
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid Chlamydia Device CE-IVD Marked
Chlamydia Antigen Test Window
S
C: Procedural Control Line
T: Chlamydia trachomatis LPS Antigen
Direct Antigen Detection

Targeted Triage for Chlamydia trachomatis Infections

Chlamydia trachomatis is the world’s most widespread sexually transmitted bacterial pathogen. Because up to 80% of women and 50% of men remain completely asymptomatic, untreated infections can silently progress to pelvic inflammatory disease (PID), tubal infertility, and chronic urethritis. Direct on-site antigen detection enables immediate, single-visit antibiotic prescription.

Direct LPS Target

Lipopolysaccharide (LPS) Antigen

Utilizes monoclonal antibodies specific to chlamydial genus-specific LPS antigen, confirming active reproductive tract colonization.

  • Exquisite sensitivity: 1.0 x 10^4 IFU/swab
  • Detects active pathogen presence
  • Zero serological lag time
Urogenital Health

PID & Infertility Prevention

Early identification halts ascending upper genital tract infection, protecting female reproductive fertility and curbing community transmission.

  • Validated for endocervical & urethral swabs
  • Compatible with centrifuged male urine
  • Averts long-term tubal damage
Same-Visit Care

Point-of-Care Clinic Deployment

Empowers gynecology clinics, dermatology practices, and wellness centers across Dubai and the UAE with instant 10-minute diagnostic certainty.

  • Complete Reagents A & B included
  • No lab culturing or cold-chain reliance
  • CE-IVD and ISO 13485 compliant

Diagnostic Accuracy vs. Reference PCR / NAAT Standards

Multi-Center Clinical Evaluation Cohort (n=720)
Diagnostic Parameter QuRapid Chlamydia Rapid Test Reference PCR / NAAT Assay Clinical Performance Status
Diagnostic Sensitivity 94.2% (95% CI: 89.5% – 97.2%) Confirmed NAAT Positive Cohort Superior POC Sensitivity
Diagnostic Specificity 98.8% (95% CI: 96.9% – 99.7%) NAAT Negative Clinical Donors High Specificity (No Cross-Reactivity)
Total Clinical Agreement 97.8% (95% CI: 96.2% – 98.8%) Overall Swab/Urine Cohort 97.8% Concordance
Analytical Detection Limit 1.0 × 10^4 IFU / swab Gold Standard Benchmark High Analytical Resolution
*Performance validated against reference molecular NAAT/PCR assays. Demonstrated zero cross-reactivity with Neisseria gonorrhoeae, Trichomonas vaginalis, Candida albicans, or Gardnerella vaginalis.
Standard Operating Procedure

4-Step Bedside Protocol for Swab & Urine Extraction

Rapid chemical extraction lyses elementary bodies and neutralizes pH for seamless chromatographic migration.

1

Specimen Harvesting

Collect clinical specimen using the sterile endocervical or urethral swab. For male urine, centrifuge 10–15 mL of first-catch urine and harvest the pellet.

2

Reagent Extraction

Add 6 drops of Extraction Reagent A into the extraction tube. Insert the swab, rotate vigorously, and incubate for 2 minutes. Add 6 drops of Reagent B to neutralize.

3

Specimen Dispensing

Squeeze the tube sides against the swab, attach the dropper tip, and apply exactly 3 drops (approx. 80 µL) into the cassette sample well (S).

4

10-Minute Readout

Interpret visual diagnostic bands at 10 minutes under bright lighting. Do not interpret or record test results after 15 minutes.

Visual Readout Guide

Diagnostic Interpretation Matrix

Clear visual line interpretation guides immediate on-site therapeutic decision-making.

Positive Differential Findings

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

Positive (C Line + T Line)
Chlamydia trachomatis antigen detected. Directs immediate antibiotic therapy.
Faint Test Line (Weak Positive)
Any visible pink/red T band indicates low bacterial load. Treat as positive.

Negative & Invalid Results

Quality control validation and procedural guidelines.

Negative (C Line Only)
Only C line visible; no T line. Chlamydia antigen not detected.
Invalid (No C Line)
Absence of Control line indicates incomplete extraction or faulty strip. Retest.
Packaging & Accessories

Everything Included in the Kit Box

Supplied with all necessary extraction reagents and sterile collection swabs for 25 tests.

💊 25 Test Cassettes Individually sealed in foil pouches with desiccant
🧪 Extraction Reagents A & B Pre-measured dropper bottles for cell lysis and pH neutralization
🧹 Sterile Swabs & Tubes 25 sterile collection swabs and 25 extraction tubes with dropper caps
📄 Instructions for Use Comprehensive CE-IVD package insert & protocol 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
Can male urine be tested?

Yes. First-catch urine (10-15 mL) is centrifuged, and the cellular pellet is extracted using Reagents A and B.

Does it cross-react with other STDs?

Extensive studies demonstrate zero cross-reactivity with Neisseria gonorrhoeae, Trichomonas vaginalis, Candida albicans, or Gardnerella vaginalis.

What is included in the kit?

25 cassettes, Extraction Reagent A, Extraction Reagent B, sterile swabs, extraction tubes, and instructions.

How to order in UAE?

Contact QuRapid for rapid UAE delivery with full regulatory documentation.

Equip Your Clinic With QuRapid Chlamydia Rapid Tests

Order CE-IVD certified Chlamydia Rapid Test Devices with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for gynecology clinics, urology practices, and diagnostic laboratories.

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