Genedia W / Covid – 19 Ag

Rapid nasopharyngeal swab useful for obtaining the Green Pass

GENEDIA W COVID-19 Ag device is a chromatographic immunoassay for the qualitative detection of specific antigens to COVID-19 present in human nasopharyngeal swab and sputum.

EImmediate on-site Antigen testing

• Allow wider testing with fast test time (10 minutes)
• Various type of specimen are available (Nasopharyngeal swab and sputum)
• Clinically proven data of asymptomatic patients available (Sensitivity in asymptomatic patients: 85%)

 

  • Specifications

    Method: Immunochromatography

    Packing unit: 20Tests / kit

    Certification: CE-IVD

    Specimen: Nasopharyngeal swab and sputum

    LOD: 7.50X102 TCID50/mL

    Running time: 10 minutes

    Expiry date: 24 months from the date of manufacture

    Storage condition: 2 ~ 30℃

  • Materials provided:

    ① Test device : 20 EA

    ② Extraction solution : 20 EA(10X2)

    ③ Sample developing filter cap : 20 EA

    ④ Sterilized swabs for sample collection : 20 EA

    ⑤ Instructions for use : 1 EA

  • Documentation to download

  • Sensitivity

    Clinical sensitivity: 90.1% (95% CI : 85.1% - 93.9%)
  • Specificity

    Clinical specificity: 100% (95% CI : 98.4% - 100%)
  • Total Agreement Ratio

    Total Agreement Ratio: 95.3%
Scientific information:
Licia Vitale
+39 0577 1521219
licia.vitale@vismederipharma.com


Commercial information:
Simone Paletti
+39 0577 1521063
simone.paletti@vismederipharma.com