DYONMED FluCoV2 Covid-19/Influenza A+B

The DyonMed FluCov2® test uses advanced indirect immunoassay technology to detect the SARS-CoV-2 nucleocapsid protein antigen, as well as the nucleoproteins of Influenza Type A and Type B. Because COVID-19 and the seasonal flu share nearly identical clinical symptoms, this multiplex test is an essential tool for accurate diagnosis during the winter months.

This Point of Care in-vitro diagnostic product offers exceptionally high reliability that is directly comparable to molecular testing (RT-PCR). It maintains its diagnostic accuracy even if the patient is taking medication or if other viruses and bacteria are present.

Key Advantages:

• 3 Diagnoses, 1 Sample: Simultaneously tests for COVID-19, Flu A, and Flu B using only one swab.
• High Accuracy: Demonstrates an overall accuracy rate of up to 98.63% (100% specificity and >91-96% sensitivity compared to PCR tests).
• Fast Results: Delivers clear, visual results within 10 to 15 minutes.
• Greek Manufacturing: A high-quality medical device proudly manufactured in Greece by DyonMed A.E.

How to Use the FluCov2® Test:

1. Collect a sample using the provided sterile swab from the nasopharynx or pharynx.
2. Place the swab into the extraction buffer tube, rotate it to mix thoroughly, and squeeze the tube walls to extract the liquid from the swab.
3. Attach the dropper tip and add exactly 3 drops of the extracted sample into the sample well of the test cassette.
4. Read the results between 10 and 15 minutes.

Interpretation of Results:

• POSITIVE COVID-19: Two distinct lines appear: one in the Control area (C) and one in the Test area (T).
• POSITIVE INFLUENZA A/B: Distinct lines appear in the Control area (C) and in the (A) and/or (B) test areas for the respective flu types.
• NEGATIVE: Only one colored line appears in the Control area (C). No lines appear in the T, A, or B areas.
• INVALID: The Control line (C) does not appear. The test must be repeated.

Package Contents:

• FluCov2® Test Cassettes
• Extraction buffer tubes (sample diluent)
• Sterile nasopharyngeal/pharyngeal swabs
• Detailed Instructions for Use (IFU) leaflet

This product is an in-vitro diagnostic medical device. A negative result does not completely rule out SARS-CoV-2 or Influenza A/B infections and should not be used as the sole basis for treatment or patient management decisions. Proper sample collection is critical; inadequate sampling may lead to false-negative results. Store the kit in a dry place between 4°C and 30°C and avoid direct sunlight and heat. Do not freeze. Keep out of reach of children.

• Fully complies with the requirements of Law 5198/2020 for the diagnostic adequacy of rapid antigen tests.
• Individually packaged to prevent cross-contamination of reagents and ensure maximum reliability.
• Strictly intended for use by healthcare professionals for accurate differential diagnosis.