FluCov2 from DyonMed S.A.

Influenza A/B & SARS CoV-2 Antigen rapid test immunochromatographic test (ICT) kit


 

With one sampling high reliability differential diagnosis!


SARS-CoV-2 & Influenza A/B Antigen Rapid Test

FluCov2® Antigen combo rapid test

  • With a sampling take reliable differential diagnosis Flu A / B and Covid19

  • Reliability is maintained while taking medication.

  • Reliability is maintained with the simultaneous presence of viruses-bacteria.

  • Comparative reliability results with molecular test (RT-PCR).

FluCov2

DyonCovidAg® Antigen Rapid test

1 sampling, 3 drops,

3 diagnoses

with specialty 100%

FluCov2® is a rapid immunochromatography assay for the simultaneous qualitative detection of coronavirus antigen (SARS-CoV-2) and influenza A and type B virus antigens in human nasopharyngeal and pharyngeal swab samples for diagnosis of both coronavirus infection (SARS-CoV-2 COVID-19) and the diagnosis of influenza A and type B virus infection and their differential diagnosis.

Sensitivity and specialty

In samples of nasopharyngeal smear

Analysis of the rate of FluCov2 και rapid test and PCR test in nasopharyngeal smear samples:

      • Percentage of positive coincidences (95%CL) (sensitivity) = 92.96%
      • Percentage of negative coincidences (95%CL) (specialty) = 100%
      • Overall coincidence rate (accuracy) = 95.19%.
Analysis of the rate of FluCov2 και rapid test and PCR test in nasopharyngeal smear samples:

      • Percentage of positive coincidences (95%CL) (sensitivity) = 91.67%
      • Percentage of negative coincidences (95%CL) (specialty) = 100%
      • Overall coincidence rate (accuracy) = 96.15%.
Analysis of the rate of FluCov2 και rapid test and PCR test in nasopharyngeal smear samples:

      • Percentage of positive coincidences (95%CL) (sensitivity) = 96.77%
      • Percentage of negative coincidences (95%CL) (specialty) = 100%
      • Overall coincidence rate (accuracy) = 98.63%.

In pharyngeal smear samples

Analysis of the rate of FluCov2 και rapid test and PCR test in pharyngeal smear samples:

      • Percentage of positive coincidences (95%CL) (sensitivity) = 92.25%
      • Percentage of negative coincidences (95%CL) (specialty) = 100%
      • Overall coincidence rate (accuracy) = 94.71%.

Analysis of the rate of FluCov2 και rapid test and PCR test in pharyngeal smear samples:

      • Percentage of positive coincidences (95%CL) (sensitivity) = 91.67%
      • Percentage of negative coincidences (95%CL) (specialty) = 100%
      • Overall coincidence rate (accuracy) = 96.15%.

Analysis of the rate of FluCov2 και rapid test and PCR test in pharyngeal smear samples:

      • Percentage of positive coincidences (95%CL) (sensitivity) = 93.75%
      • Percentage of negative coincidences (95%CL) (specialty) = 100%
      • Overall coincidence rate (accuracy) = 97.30%.

The implementation of the test fully covers the requirements of law 5198 / 24-11-2020 for the specialization of the necessary diagnostic adequacy characteristics of the medical devices of rapid antigen SARSCoV-2 (rapid test).

Use Instructions


INTERPRETATION OF RESULTS

POSITIVE: At least two distinct lines appear. One line must be in the control area (C) and the other line in the test area (T) for COVID19 or in (A) and (B) for influenza types

POSITIVE: At least two distinct lines appear. One line must be in the control area (C) and the other line in the test area (T) for COVID19 or in (A) and (B) for influenza types.

 

NEGATIVE: A line definitely appears in the control area (C). There is no line in the test area (T) or in (A) and (B) for the types of flu.

 

INVALID: No lines appear or the control line (C) does not appear, indicating user error or reagent failure. Verify the test procedure and repeat the test with a new FluCov2® device.

FluCov2




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