Optimization
CE-IVD Certified Point-of-Care Pediatric Immunoassay

Respiratory Syncytial Virus
(RSV) Antigen Rapid Test

Rapid chromatographic immunoassay for the direct qualitative identification of Respiratory Syncytial Virus (RSV) viral nucleoproteins in human nasopharyngeal swabs or aspirates. Delivers reliable, visually distinct clinical results in 15 minutes to expedite triage in infants, children, and high-risk elderly populations.

Readout Time 15 Minutes
Specimen Type NP Swab / Aspirate
Clinical Specificity 99.50% (High CI)
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid RSV Ag Cassette CE-IVD Marked
RSV Antigen Reading Window
S
C — Internal Control Line
T — RSV Viral Antigen (Positive)
Clinical Overview

Critical Point-of-Care Differentiation for Pediatric & Geriatric Care

Respiratory Syncytial Virus is the single most common cause of bronchiolitis and lower respiratory infections in infants and elderly adults, presenting symptoms virtually indistinguishable from Influenza or COVID-19.

Dual Subgroup Coverage

RSV Subgroups A & B

Features cross-reactive monoclonal antibodies targeting conserved structural proteins, ensuring dependable detection of both Subgroup A and Subgroup B seasonal variants without loss of analytical sensitivity.

  • Detects both active viral subgroups
  • Calibrated for pediatric mucosal loads
  • No false-positive cross-binding
Pediatric Triage

Prevent Unnecessary Antibiotics

Rapid 15-minute diagnosis allows pediatricians and emergency physicians to definitively identify viral etiology, preventing inappropriate antibiotic administration and guiding supportive care immediately.

  • Vital in infant bronchiolitis screening
  • Reduces pediatric hospital admission stays
  • Enables immediate cohorting in PICU / NICU
Clinic Optimized

Room Temperature Stability

Requires no cold-chain storage or specialized refrigeration equipment. Hermetically sealed foil packaging ensures stable 24-month shelf life across clinical settings in Dubai, Abu Dhabi, and the UAE.

  • Ambient storage: 2°C to 30°C
  • Individually pouched with desiccant
  • Supplied with pediatric-friendly flexible swabs

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

CE-IVD Clinical Trial Cohort (n = 540)
Diagnostic Parameter Clinical Result 95% Confidence Interval (CI) Clinical Significance
Clinical Sensitivity 93.30% 87.8% – 96.5% High diagnostic accuracy in active mucosal viral shedding phase
Clinical Specificity 99.50% 98.1% – 99.9% Virtually zero false positives eliminates misdiagnosis and improper cohorting
Overall Accuracy 98.00% 96.4% – 99.1% High concordance across pediatric and geriatric clinical sample cohorts
Limit of Detection (LoD) 1.0 x 10³ TCID50/mL Analytical LoD Protocol Reliably detects low-titer viral concentrations in nasopharyngeal secretions
Cross-Reactivity 0.0% Non-Reactive Panel of 22 Respiratory Pathogens Zero cross-reactivity with SARS-CoV-2, Flu A, Flu B, Adenovirus, or Rhinovirus
Clinical trials conducted in multi-center pediatric and hospital emergency cohorts evaluating suspected acute respiratory infection against gold-standard RT-PCR.
Standard Operating Protocol

4-Step Standard Operating Procedure

Simple, instrument-free clinical workflow designed for fast execution in outpatient clinics and emergency departments.

1

Specimen Collection

Collect nasopharyngeal secretions using the sterile flocked pediatric swab or obtain a nasal aspirate specimen from the patient.

2

Lysis & Extraction

Insert swab into the pre-filled buffer tube. Swirl vigorously 10–15 times while compressing the flexible tube walls against the swab tip.

3

Sample Inoculation

Secure the dropper nozzle onto the tube. Invert vertically and dispense exactly 3 full drops (80 µL) of extract into sample well (S).

4

Result Readout

Read chromatographic lines at exactly 15 minutes. Strong positive lines may appear earlier, but negative results must be confirmed at 15 minutes.

Result Interpretation

Visual Result Interpretation Guide

Rapid, intuitive colorimetric line reading provides unambiguous answers at bedside.

Definitive Test Outcomes

Evaluation of colored bands formed in the reading window:

Positive Result (C + T Lines)
Both Control (C) and Test (T) lines appear. Indicates presence of RSV antigen. Even a faint T line denotes a positive diagnostic finding.
Negative Result (C Line Only)
Only the Control (C) band appears. No line in the T zone. Indicates RSV antigen is absent or below assay detection limit.
Invalid Result (No C Line)
Control line fails to appear. Test is invalid regardless of test line appearance. Retest immediately with a new cassette device.

Clinical Diagnostic Best Practices

Key considerations for healthcare practitioners:

Pediatric Peak Window
Testing is most sensitive within the first 3 to 5 days of respiratory distress when mucosal viral shedding is highest.
Adult Low Viral Shedding
In older adults or immunocompromised individuals with lower viral loads, consider RT-PCR follow-up if clinical suspicion persists.
Internal Quality Control
Appearance of the procedural C line verifies adequate specimen volume and correct capillary wicking action.
Complete Kit Configuration

Everything Required for Bedside RSV Testing

Supplied in clinical boxes of 25 tests, fully equipped for point-of-care operation without additional consumables.

🧪 25 Test Devices Individually sealed in foil pouches with silica moisture absorber
🧴 25 Buffer Tubes Pre-filled extraction lysis buffer with integrated dropper tips
🪪 25 Sterile Swabs Flexible flocked swabs specifically designed for comfortable pediatric sampling
📜 Workstation & IFU Convenient tube rack and comprehensive step-by-step clinical package insert
Clinical Support

Frequently Asked Questions

Need validation dossiers, regulatory certificates, or bulk clinic pricing? Contact our clinical team in Dubai.

Contact Clinical Specialist
Does this test detect both RSV Subgroup A and Subgroup B?

Yes. The QuRapid RSV Antigen Rapid Test utilizes specific monoclonal antibodies capable of capturing conserved nucleoprotein antigens from both RSV Subgroup A and RSV Subgroup B strains.

Why is rapid point-of-care RSV testing critical in pediatrics?

RSV is the primary cause of acute bronchiolitis and viral pneumonia in infants under 2 years of age. Rapid 15-minute diagnosis enables prompt isolation, prevents inappropriate antibiotic prescriptions, and guides supportive clinical care.

What specimens are validated for the test?

The assay is CE-IVD validated for human nasopharyngeal swab specimens collected with supplied flexible flocked swabs, as well as nasal aspirate and wash fluids.

What is the analytical limit of detection (LoD)?

The analytical limit of detection is 1.0 x 10³ TCID50/mL, providing dependable sensitivity during the peak acute mucosal shedding window.

What are the temperature storage specifications?

Store unopened at 2°C to 30°C. No refrigeration is required, ensuring convenient shelf life of 24 months in clinics, pharmacies, and emergency rooms across the UAE.

Equip Your Clinic With QuRapid RSV Rapid Antigen Tests

Order CE-IVD certified Respiratory Syncytial Virus (RSV) Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for pediatric clinics, hospitals, and medical centers.

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