VivaDiag ™ SARS-CoV-2 Ag rapid test

 

Packung: 25 Tests pro Packung
Preis pro Test ab € 3,50

Features of the test:

  • Easy to use
  • Diagnostic sensitivity (SARS-CoV-2): 90.90 percent.
  • Diagnostic specificity (SARS-CoV-2): 100 percent.
  • Storage at room temperature (2-30 ℃)
  • Quick result in just 15 minutes.
  • BfArM listed.
  • Can also be used by untrained people.

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Description

VivaDiag ™ SARS-CoV-2 Ag rapid test.

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

The VivaDiagTM SARS-CoV-2 Ag rapid test is used for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV 2 in human nasal, oropharyngeal or nasopharyngeal swab samples. The test is only intended for in vitro diagnostics. For professional use only. It is intended for clinical laboratories and healthcare professionals as a point-of-care test. Not for personal use.

The VivaDiag ™ SARS-CoV-2 Ag rapid test is based on immunoassay technology. Each test card has anti-SARS-CoV-2 monoclonal antibodies on the detection line (T line) and anti-mouse IgG polyclonal antibodies on the control line (C line). When the extracted sample is added to the sample well, it reacts with the labeled antibody to form a complex, the mixture then migrates through the membrane by capillary action and interacts with the coated anti-SARS-CoV-2 monoclonal antibody on the T-line. If the sample contains SARS-CoV-2-Ag, the T-line will appear purple, indicating that the SARS-CoV-2 Ag is positive. Otherwise the test result is negative. The test card also contains a control line C, which should appear purple for all valid tests. If the C-line does not appear, the test result is invalid even if the T-line is displayed.

Features of the test:

  • Easy to use
  • Diagnostic sensitivity (SARS-CoV-2): 90.90 percent.
  • Diagnostic specificity (SARS-CoV-2): 100 percent.
  • Storage at room temperature (2-30 ℃)
  • Quick result in just 15 minutes.
  • BfArM listed.
  • Can also be used by untrained people.

Clinical sensitivity / clinical specificity

A total of 497 samples were tested with the VivaDiagTM SARS-CoV-2 Ag rapid test. These specimens consisted of nasopharyngeal swabs from symptomatic patients. The performance of the VivaDiagTM SARS-CoV-2 Ag Rapid Test was compared to a commercial molecular assay.

Additional information

product

VivaDiag SARS-CoV-2 Ag Rapid Test

Certification

CE

Sample material

Nasal swab specimen, oropharyngeal swab specimen, nasopharyngeal swab specimen

sensitivity

90,90 %

Specificity

100 %

Pack size

25 tests per pack

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