Hotgene Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)(anteriornasal).

Description

Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)(anteriornasal).

This test is based on the immuno-chromatographic technology of colloidal gold and uses the double antibody sandwich method to detect COVID-19 antigen in human throat or nasal swab.

– Listed by the German Federal Institute for Drugs and Medical Devices (BfArM) –

– Special approval according to §11 paragraph 1 of the Medical Devices Act (MPG) of antigen tests for self-administration by laypersons (self-tests) –

This kit is used for the in vitro qualitative determination of Covid 19 antigen using a human nasal or throat swab. The test is used as a rapid test in individuals with suspected covid-19 and can be used for repeat nucleic acid detection in patients after discharge. A positive test result indicates that the sample contains coronavirus antigen. A negative test result does not rule out the possibility of infection.

This kit is based on the colloidal gold immunochromatographic method and uses the double antibody sandwich method to detect the novel coronavirus antigen in human throat or nasal swab. In the so-called Double-Antibody-Sandwich ELISA (DAS-ELISA), the enzyme is not bound to the antigen-specific antibody. Instead, another enzyme-coupled antibody directed against the specific antibody is added. The test is intended as an aid in the diagnosis of infection with SARS-CoV-2.

Components:

1. Coronavirus Antigen Test Cassette.
2. Sampling tube with sealing cap and included extraction buffer.
3. Sterile swabs.
4. Disposable pressure bags for disposal.
5. Directions for use.

Storage and shelf life:

1. The kit should be stored at 4 – 30 °C, shelf life is 18 months.
2. After opening the foil pouch (temperature 10 – 30 °C, humidity ≤ 70%), the test should be used within 30 minutes and at temperatures > 30 °C immediately.
3. The sample extraction buffer should be used within 18 months after opening (temperature 10 – 30 °C,humidity ≤ 70 %).
4. See label for date of manufacture and expiration date.

Your advantages at a glance:

• High specificity: 99.76%.
• High sensitivity 96.62%.
• Easy to use.
• Quick result in 15 minutes.
• Test specimens: throat swab or nasal swab. Anteriornasal.
• All test components are included.
• No cross-reactivity with HKU1, OC43, NL63, 229E, SARS coronavirus (inactive virus), MERS, influenza A/B, RVS.
• CE certified