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CE-IVD Certified Point-of-Care Multiplex Immunoassay

COVID-19 & Influenza A+B
Ag Combo Rapid Test

Simultaneous qualitative differential detection of SARS-CoV-2, Influenza Type A, and Influenza Type B nucleoprotein antigens from a single patient swab. Delivers clear, visual clinical results in 15 minutes to initiate targeted antiviral treatment immediately.

Readout Time 15 Minutes
Specimen Type Nasal / NP Swab
Clinical Sensitivity 96.8% (COVID) | 95.9% (Flu)
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid Dual-Channel Device CE-IVD Marked
COVID-19
S
Flu A + B
S
Differential POC Diagnosis

Why Rapid Tri-Analyte Triage Matters

SARS-CoV-2 and seasonal Influenza viruses share almost identical early symptoms: sudden acute fever, cough, fatigue, chills, and cephalalgia. Because physical presentation alone cannot differentiate them, rapid point-of-care discrimination is essential to guide clinical prescription windows.

Target 1

SARS-CoV-2 Ag

Detects the highly conserved nucleocapsid (N) protein across circulating SARS-CoV-2 variants, including Omicron sub-lineages.

  • Clinical Sensitivity: 96.8%
  • Clinical Specificity: 99.4%
  • Guiding antiviral therapy (Paxlovid) within 5 days
Target 2

Influenza Type A

Identifies seasonal and avian influenza A subtypes, including predominant H1N1 and H3N2 strains circulating in community epidemics.

  • Clinical Sensitivity: 95.9%
  • Clinical Specificity: 99.8%
  • Early Oseltamivir / Zanamivir therapy within 48h
Target 3

Influenza Type B

Discriminates seasonal influenza B lineages (Yamagata and Victoria) with zero cross-reactivity against secondary respiratory pathogens.

  • Clinical Sensitivity: 94.2%
  • Clinical Specificity: 99.8%
  • Immediate isolation in clinics, schools, and hospitals

Clinical Performance vs. RT-PCR Reference Method

Multicenter Trial Validated
Analyte / Virus Clinical Sensitivity (95% CI) Clinical Specificity (95% CI) Total Agreement Limit of Detection (LoD)
SARS-CoV-2 (COVID-19) 96.8% (92.4% – 98.9%) 99.4% (98.2% – 99.8%) 98.9% 100 TCID50/mL
Influenza Type A 95.9% (90.7% – 98.2%) 99.8% (98.7% – 100%) 99.1% 1.5 × 103 TCID50/mL
Influenza Type B 94.2% (87.9% – 97.3%) 99.8% (98.7% – 100%) 99.0% 2.0 × 103 TCID50/mL
* Analytical specificity confirmed: Zero cross-reactivity with RSV, Human Adenovirus, Rhinovirus, Parainfluenza 1-4, Human Metapneumovirus, Streptococcus pneumoniae, and Mycoplasma pneumoniae.
Standard Operating Procedure

Simple 4-Step Clinic Protocol

Engineered for busy outpatient triage, urgent care centers, and clinical laboratories with no specialized instrumentation required.

1

Collect Swab

Collect a nasopharyngeal or anterior nasal specimen using the sterile flocked swab supplied with the test kit.

2

Extract Antigen

Insert swab into the pre-filled buffer tube. Rotate 10-12 times against tube wall. Squeeze tube sides while withdrawing.

3

Dispense Drops

Attach dropper tip to the tube. Invert and dispense exactly 3 drops (80 µL) into each cassette sample well (S).

4

Read at 15 Min

Interpret visual bands at 15 minutes. Results must not be read after 20 minutes to prevent chromatographic false readings.

Band Interpretation Guide

How to Read Test Cassette Lines

Dual reading windows physically separate the COVID-19 channel from the Influenza A+B channel to prevent any band misinterpretation.

Channel 1: COVID-19 Window

Evaluates SARS-CoV-2 nucleoprotein antigen presence.

Negative Result
Red line at (C) only. No line at (T).
COVID-19 Positive
Red lines at both (C) and (T).
Invalid Test
No line at (C). Discard & retest with new kit.

Channel 2: Flu A+B Window

Evaluates Influenza Type A and Type B nucleoproteins.

Flu A Positive
Red lines at (C) and line (A).
Flu B Positive
Red lines at (C) and line (B).
Flu Negative
Red line at (C) only. Neither A nor B appears.
Invalid Test
No line at (C). Discard & retest with new kit.
Kit Specifications

What’s Included in Each Kit (25 Tests/Box)

📦 25 Test Cassettes Individually sealed foil pouches with desiccant
🧪 25 Pre-filled Tubes Pre-dispensed extraction buffer with dropper nozzles
🥢 25 Sterile Swabs Flocked nasal/nasopharyngeal swabs
📄 Package Insert (IFU) Complete instructions & quality control protocol
Clinical Support

Frequently Asked Questions

Need technical information, validation dossiers, or regulatory certificates? Contact our clinical diagnostic team in Dubai.

Contact Clinical Specialist
Can this test differentiate between Influenza A and B?

Yes. The test features distinct, physically separated test lines for Influenza A and Influenza B in the right reading window, allowing clear, unequivocal differentiation between the two seasonal viral strains.

How early after symptom onset should the test be performed?

Testing is optimal within the first 1 to 5 days after symptom onset when viral shedding in upper respiratory secretions is at its peak. Beyond day 7, viral shedding may decrease below the limit of detection.

Does this test cross-react with other common respiratory viruses?

Extensive multicenter validation has confirmed zero cross-reactivity with RSV, Human Adenovirus, Rhinovirus, Parainfluenza types 1-4, Human Metapneumovirus, Streptococcus pneumoniae, and Mycoplasma pneumoniae.

What is the recommended storage temperature and shelf life?

Store sealed in the original packaging at room temperature or refrigerated between 2°C and 30°C. Kits do not require cold chain logistics, provided ambient temperatures remain strictly below 30°C. Shelf life is 24 months from manufacture.

What regulatory quality certifications does this rapid test possess?

The kit is manufactured under ISO 13485 quality management standards and carries CE-IVD certification for professional in vitro diagnostic use across UAE clinics, hospital laboratories, and government healthcare facilities.

Equip Your Clinic With Rapid 3-in-1 Diagnostics

Order CE-IVD COVID-19 & Influenza A+B Combo Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE.

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