ComboRSV®

“innovation in Point of Care Testing”

from DYONMED SA

ComboRSV® COVID-19/Influenza A+B/RSV Combo Rapid Test logo
COVID-19/Influenza A+B/RSV Combo Rapid Test (Colloidal Gold)

  • Management of respiratory infections at the doctor’s office or in home visits, wherever the patient is.

  • From one nasal or nasopharyngeal sample 4 different diagnoses.

  • ΑImmediate diagnosis and targeted treatment for infants, children and adults.

  • High reliability compared to RT-PCR.

  • Special receiving swab for infants and children.

  • Unique packages for home visits.

ComboRSV® COVID-19/Influenza A+B/RSV Combo Rapid Test

Special fast flow test cassette

(Fast Flow Technology)

Immediate result in 10 minutes

Combo RSV is not affected by the simultaneous use of medicinal substances

Decongestants, Antibiotics, Antibiotics, Nasal washes, etc

COMBO-RSV Chemtrue® COVID-19/Influenza A+B/RSV Combo Rapid Test (Colloidal Gold) is a rapid and direct combination test for the qualitative detection of the nucleocapsid protein antigen of SARS-COV-2, the influenza antigen type A (H1NI, H3N2, H7N9), influenza type B antigen (Victoria, Yamagata) and RSV virus antigen to aid in the diagnosis of COVID-19, influenza A/B and RSV infections. Intended for use by healthcare professionals.

Sensitivity and specialty

Diagnostic accuracy

Nasal swab sample results

Analysis of the Concordance Rate of the ComboRSV® Rapid Test and PCR Test in Nasal Swab Specimens:

      • Positive rate (95%CL) ( sensitivity ) = 93,98%
      • Adverse event rate (95%CL) ( specificity ) = 100%
      • Overall Coincidence ( Accuracy ) = 95,85%

Analysis of the Concordance Rate of the ComboRSV® Rapid Test and PCR Test in Nasal Swab Specimens:

      • Rate of positive cases (95%CL) (sensitivity) = 96.23%
      • Adverse event rate (95%CL) (specificity) = 100%
      •  Total match rate (accuracy) = 97.51%

Analysis of the Concordance Rate of the ComboRSV® Rapid Test and PCR Test in Nasal Swab Specimens:

      • Rate of positive cases (95%CL) (sensitivity) = 97.33%
      • Adverse event rate (95%CL) (specificity) = 100%
      • Total coincidence rate (accuracy) = 98.34%.

Analysis of the Concordance Rate of the ComboRSV® Rapid Test and PCR Test in Nasal Swab Specimens:

      • Rate of positive cases (95%CL) (sensitivity) = 97.33%
      • Adverse event rate (95%CL) (specificity) = 100%
      • Total coincidence rate (accuracy) = 98.34%.

The application of the test fully covers the requirements of law 5198/24-11-2020 for the specification of the necessary diagnostic adequacy characteristics of the medical technological products of rapid tests of SARSCoV-2 antigens (rapid test).

INTERPRETATION OF THE RESULTS

POSITIVE: Control lines (C line) of all three lanes are red and at least one of the COV line, influenza A line, influenza B line, and RSV line is red.

NEGATIVE: All three control lines (C line) are red and COV line, Flu A line, Flu B line and RSV line are absent.

INVALIDThe test is invalid when one of the control lines (C line) is absent after five minutes whether or not the COV line, FluA line, FluB line, or RSV line is red. 

Verify the procedure and repeat the test with a new ComboRSV® device.

NOTE:

  1. The intensity of the COV red line, FluA line, FluB line, and RSV line can vary depending on the concentration of antigen present in the sample. Therefore, ANY SHADE OF RED SHOULD BE CONSIDERED POSITIVE.

  2. A negative test result in this test means that an amount of antigen from COVID-19, Flu A/B, or RSV was not present in the sample greater than the limit of detection. However, a negative result does not rule out COVID-19, influenza A/B, or RSV and should not be used as the sole basis for diagnosis. The possibility of a false-negative result should be considered based on the patient’s recent viral exposure and the presence of clinical signs and symptoms, consistent with COVID-19, influenza A/B, and RSV, and confirmed by molecular testing if necessary.

  3. The amount of COVID-19 antigen in the nose may decrease during the disease. Specimens collected 7 days after the onset of symptoms are likely to be negative.

  4. The packaging and device prints should be legible.

Contact us for further information.

Customer service call center +30 210 6655494

     

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