Hotgen Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Anterior Nasal)

 

Packung: 40 Tests pro Packung
Preis pro Stück ab € 4,30

Features of the test:

  • High specificity: 99.76%.
  • High sensitivity 96.62%.
  • Easy to use.
  • Special approval according to Section 11, Paragraph 1 of the Medical Devices Act (MPG) for antigen tests for self-use by laypeople (self-tests).
  • Professional self-test for personal use in accordance with § 323c Para. 18 of the Federal Tax Code.
  • Quick result in 15 minutes.
  • Test samples: throat swab or nasal swab. Anterior nasal.
  • All test components are included.
  • No cross-reactivity with HKU1, OC43, NL63, 229E, SARS coronavirus (inactive virus), MERS, influenza A / B, RVS.
  • CE certified

How many packs are you interested in?

Out of stock

Description

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

Dieser Test basiert auf der immuno-chromatographischen Technologie von kolloidalem Gold und verwendet die Doppel-Antikörper-Sandwich-Methode zum Nachweis des COVID-19-Antigens im menschlichen Rachen- oder Nasenabstrich.

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

– Special approval according to Section 11, Paragraph 1 of the Medical Devices Act (MPG) for antigen tests for self-use by laypeople (self-tests) –

Dieses Testkit wird zur qualitativen In-vitro-Bestimmung des Covid-19-Antigens mittels eines menschlichen Nasen- oder Rachenabstrichs verwendet. The test is used as a rapid test for people with suspected Covid-19 and can be used for renewed nucleic acid detection in patients after their discharge. A positive test result indicates that the sample contains a coronavirus antigen. A negative test result does not rule out the possibility of infection.

This kit is based on the immunochromatographic method with colloidal gold and uses the double antibody sandwich method to detect the new coronavirus antigen in the 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-linked antibody directed against the specific antibody is added. The test is intended as an aid in diagnosing SARS-CoV-2 infections.

Components:

  1. Coronavirus antigen test cassette.
  2. Sampling tube with cap and included extraction buffer.
  3. Sterile swabs.
  4. Disposable pressure bags for disposal.
  5. Instructions for use.

Storage and shelf life:

  1. The kit should be stored at 4 – 30 ° C and the 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 immediately at temperatures > 30 ° C.
  3. The sample extraction buffer should be used within 18 months after opening (temperature 10 – 30 ° C, humidity ≤ 70%).
  4. Manufacturing date and expiry date see label.

Your advantages at a glance:

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

 

Additional information

product

Hotgen Novel Coronavirus 2019-nCoV Antigen Test

Certification

CE

Sample material

Naso- and oropharyngeal specimens – anteriornasal.

sensitivity

99,76 %

Specificity

99,76 %

storage

At room temperature

Pack size

40 tests per pack

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