Optimization
CE-IVD Certified Point-of-Care Diagnostic Assay

COVID-19 Antigen
Rapid Test (Professional)

High-sensitivity lateral flow chromatographic immunoassay for the rapid, qualitative identification of SARS-CoV-2 nucleocapsid (N) antigen directly from anterior nasal or nasopharyngeal swabs. Delivers definitive visual clinical results in 15 minutes to facilitate immediate infection control and clinical triaging.

Readout Time 15 Minutes
Specimen Type Nasal / NP Swab
Clinical Accuracy 97.1% Sens | 99.5% Spec
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid COVID-19 Ag Cassette CE-IVD Marked
SARS-CoV-2 Reading Window
S
C — Internal Control Line
T — SARS-CoV-2 Antigen (Positive)
Clinical Overview

Point-of-Care Diagnostics for Rapid Infection Containment

Rapid point-of-care antigen screening enables immediate clinical decision-making, patient isolation, and treatment initiation at first point of healthcare contact across UAE clinics and hospitals.

SARS-CoV-2 Antigen

Conserved Nucleoprotein Target

Detects the highly conserved structural nucleocapsid (N) protein of SARS-CoV-2 rather than the hypermutable spike protein, guaranteeing diagnostic fidelity across all current and evolving lineages.

  • Omicron JN.1, KP.2 & KP.3 Lineage Detection
  • No loss of sensitivity from spike mutations
  • Calibrated for high viral load transmission risks
Emergency Triage

Immediate Bedside Action

Delivers conclusive visual readouts in 15 minutes, empowering clinicians to make on-the-spot triage decisions without waiting for central laboratory turnaround times.

  • Emergency department acute screening
  • Inpatient admission transmission control
  • Occupational health & day surgery clearances
UAE Healthcare Ready

Zero Cold-Chain Logistics

Formulated for robust temperature stability up to 30°C, eliminating delicate refrigeration logistics and ensuring dependable performance across clinics in Dubai and the UAE.

  • Room temperature storage (2°C – 30°C)
  • 24-Month manufacturer shelf life
  • Supplied complete with pre-dispensed buffer tubes

Multi-Center Clinical Evaluation (vs. RT-PCR Reference)

CE-IVD Validation Cohort (n = 620)
Diagnostic Parameter Clinical Result 95% Confidence Interval (CI) Clinical Significance
Clinical Sensitivity 97.10% 93.8% – 98.9% High positive agreement during acute symptomatic phase (Ct < 30)
Clinical Specificity 99.50% 98.4% – 99.9% Extremely low false-positive rate prevents unnecessary patient quarantine
Overall Diagnostic Accuracy 98.80% 97.5% – 99.5% Concordance across symptomatic and high-risk exposed cohorts
Limit of Detection (LoD) 100 TCID50/mL Analytical LoD Study Reliably detects low-titer viral concentrations in nasal secretions
Cross-Reactivity 0.0% Non-Reactive Panel of 24 Pathogens No cross-reactivity with Flu A, Flu B, RSV, Adenovirus, or MERS-CoV
Validation conducted in multi-center clinical trials evaluating confirmed symptomatic patients within 7 days of symptom onset compared directly to gold-standard RT-PCR assays.
Standard Operating Protocol

4-Step Standard Operating Procedure

Standardized clinical workflow requiring no specialized instrumentation or dedicated laboratory infrastructure.

1

Specimen Collection

Collect mucosal secretions via anterior nasal swab (insert 2–3 cm into both nostrils and rotate 5 times) or standard nasopharyngeal swab using the sterile flocked swab supplied.

2

Lysis & Extraction

Immerse the swab into the pre-filled extraction buffer tube. Rotate the swab head against the inner tube wall for 15 seconds while squeezing the flexible tube sides.

3

Sample Inoculation

Fit the dropper nozzle securely onto the tube. Invert vertically and dispense exactly 3 full drops of processed extract into sample well (S) of the cassette.

4

Result Readout

Observe the result window at exactly 15 minutes. Strong positives may appear within 3–5 minutes, but negative results must be confirmed at 15 minutes. Do not interpret past 20 minutes.

Result Interpretation

Visual Result Interpretation Guide

Clear lateral flow colorimetric bands provide unequivocal diagnostic answers in point-of-care settings.

Definitive Test Outcomes

Evaluation of bands formed across the reading zone:

Positive Result (C + T Lines)
Both Control (C) and Test (T) lines appear. Indicates presence of SARS-CoV-2 nucleocapsid antigen. Even a faint T line represents a positive finding.
Negative Result (C Line Only)
Only the Control (C) band appears. No visible line in the T zone. Indicates SARS-CoV-2 antigen is absent or below detection limit.
Invalid Result (No C Line)
Control line fails to appear, regardless of whether a T line is visible. Insufficient volume or procedural error. Retest with a new device.

Clinical Diagnostic Best Practices

Essential operational rules for healthcare staff:

Window of Sensitivity
Optimal diagnostic yield occurs during days 1 to 5 following clinical symptom onset when mucosal viral titers are at their highest.
Negative In High Suspicion
In symptomatic patients with negative rapid antigen results, secondary confirmation via RT-PCR is recommended per UAE clinical guidelines.
Built-In Quality Control
The internal procedural C line confirms adequate sample volume and proper lateral flow capillary migration along the membrane.
Complete Kit Configuration

Everything Required for Point-of-Care Testing

Supplied in self-contained clinical cartons of 25 tests, ready for immediate deployment without ancillary laboratory equipment.

🧪 25 Test Devices Individually sealed in moisture-barrier foil pouches with silica desiccant
🧴 25 Pre-Filled Tubes Pre-dispensed extraction lysis buffer with integrated dropper caps
🪪 25 Sterile Swabs Individually wrapped medical flocked swabs for nasal / NP sampling
📜 Workstation & IFU Tube holding rack and comprehensive clinical instructions for use insert
Clinical Support

Frequently Asked Questions

Need technical dossiers, batch release certificates, or wholesale pricing? Contact our clinical diagnostic team in Dubai.

Contact Clinical Specialist
Does this test detect circulating Omicron variants and sublineages?

Yes. The assay specifically targets the conserved SARS-CoV-2 nucleocapsid (N) protein rather than the variable spike protein, ensuring consistent diagnostic sensitivity across all Omicron sublineages including BA.1, BA.5, XBB, JN.1, KP.2, and KP.3.

How quickly can results be reliably interpreted?

Results are definitively read at 15 minutes. Strongly positive samples with high viral load may display a distinct test line earlier (within 3 to 5 minutes), but negative results must be verified at the full 15-minute incubation period.

What clinical specimen types are validated for this test?

The assay is CE-IVD validated for human anterior nasal swabs and nasopharyngeal swabs collected using the supplied medical flocked swabs.

What is the analytical Limit of Detection (LoD)?

The calibrated analytical Limit of Detection is 100 TCID50/mL, providing superior sensitivity for detecting acute viral shedding during early symptom onset.

Is this kit intended for self-testing or clinical professional use?

This product is CE-IVD certified strictly for professional in vitro diagnostic use by trained healthcare personnel in hospitals, clinics, diagnostic centers, and point-of-care medical facilities.

Equip Your Clinic With QuRapid COVID-19 Rapid Antigen Tests

Order CE-IVD professional COVID-19 Antigen Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the Northern Emirates. B2B bulk pricing available for clinics, hospitals, and corporate healthcare providers.

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