Genedia W / Covid – 19 Ag

Rapid salivary swab – has no European and Italian validation for obtaining the green pass

COVICHEK™ COVID-19 Ag Kit is an in vitro diagnostic medical device that diagnoses COVID-19 by qualitatively testing the SARS-CoV-2 antigen in patients with symptoms of respiratory infections through immunochromatographic analysis (ICA).

 

PRINCIPLE OF THE TEST

The COVICHEK™ COVID-19 Ag is an immunoassay kit for rapid and qualitative determination of SARS-CoV-2 antigen in saliva specimen from human. Test kit contains a membrane strip, which is immobilized with the anti-SARS-CoV-2 monoclonal anti-body on the test line (T) and Goat-anti mouse IgG on the control line (C) respectively. And the strip is assembled in the test device. When the sample and the extraction solution are applied to the sample well, the sample is moved to the gold conjugated pad and reacts with anti-SARS-CoV-2 monoclonal antibody-coupled gold conjugate followed by reaction with anti-SARS-CoV-2 monoclenal antibody immobilized in the test line. When the sample contains SARS-CoV-2 antigens, avisibleline appears in the test region on the membrane.The solution continues to migrate to encounter acontrol reagent that binds a control conjugate, thereby producing another band in the control region. The COVICHEK™ COVID-19 Ag is also very useful to directly detect SARS-CoV-2 antigens from human saliva samples.

SPECIMEN PREPARATION AND STORAGE

1) Specimens: Saliva specimen from human

(1) Collect saliva using the saliva mini funnel included in the kit.

(2) Rinse your mouth with clean water 30 min prior to the Saliva collection. Do Not eat, drink, smoke or chew gum after that.

(3) Collected sample should be considered as potential infectious and should be handled strictly according to the applicable regulation

2) Specimen storage

It is recommended to use the specimen immediately after collection, if possible.

If it cannot be tested immediately after collection, put it in a lidded storage container. Specimens contained in Viral Transport Media can be stored for up to 72 hours when stored refrigerated (2~8℃) or frozen (-20℃).

INTERPRETATION OF THE RESULT

This product may or may not have a color band on the test line depending on the presence of SARS-CoV-2 antigen in the specimen.
1) Negative : The presence of only control line (C) within the result window indi -cates a negative result.
2) Positive : The presence of two control line (C) and test line (T) within the result window, no matter which band appears first indicates a positive result.
3) Invalid : If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are due to not having followed the instructions correctly. It is recommended that the specimen be re-tested using a new test.

Components of the product

- Test device : 25 EA
- Extraction solution tube : 25 EA
- Sample developing filter cap : 25 EA
- Saliva Funnel for sample collection : 25 EA
- Instructions for use : 1 EA
  • Specifications

    Method: Immunochromatography
    Target Protein: Nucleocapsid Protein of SARS-CoV-2
    Packing Unit: 1 Test / Kit, 25 Test / Kit
    Certification: CE-IVD
    Specimen: Nasopharyngeal, Oropharyngeal, and Saliva, Sputum
    LOD: 2 X 102 TCID50/mL
    Running Time: 15 minutes
    Expiry Date: 24 months from the date of Manufacture
    Storage Temp.:2 ~ 30℃
  • Materials provided:

    Test device individually foil-pouched with a desiccant
    Extraction Buffer, Tube & Dropper
    Self-test : Anterior Nasal / Throat swab
    Self-test : Saliva collection Funnel
    Clinical Operator : Nasopharyngeal / Oropharyngeal swab
    Instructions for Use
  • Documentation to download:

  • Sensitivity

    Clinical sensitivity: 99 / (99+4) x 100% = 96.11%
  • Specificity

    Clinical specificity: 448 / (1+448) x 100% = 99.78%
  • Total compliance rate (Accuracy)

    (99+448) / 552 x 100% = 99.09%
Scientific information:
Licia Vitale
+39 0577 1521219
licia.vitale@vismederipharma.com


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