The NCSCOV2J Rapid Antigen Test

The COVID-19 Antigen Rapid Test (anterior-nasal swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 virus antigens. In individuals with suspected SARS-CoV-2 infection and clinical presentation, a swab specimen is taken from the human (nasal) pharyngeal cavity.

This medical device is used for direct pathogen detection of the coronavirus and is approved by the Federal Institute for Drugs and Medical Devices.

Just like the classic laboratory tests, the rapid tests have the same goal: to diagnose an infection in order to subsequently isolate the infected person and to contain the spread of the virus as quickly as possible.

How does the test work?

Following swabbing with the swab from the (nasal) pharynx, the sample is prepared in the extraction buffer with the integrated extraction tube. The extracted sample is then applied to the sample wells of the test cassette.

The test cassettes are coated with SARS-CoV-2 antibodies in the test line area. During the test, the sample reacts with the SARS-CoV-2 antibody coated particles. The mixture migrates up the membrane by capillary action and reacts with the SARS-CoV-2 antibodies in the test line region.

If the sample contains SARS-CoV-2 antigens, a colored line appears in the test line area. If the specimen does not contain antigens to SARS-CoV-2, no colored line appears in the test line area, indicating a negative result. For procedural control, a colored line always appears in the control line area indicating that the correct volume of sample has been added and wicking of the membrane has occurred.

NCSCOV2J Scope of delivery

The NCSCOV2J rapid test is available in a packaging unit of 5 pieces per pack. Included are:

  • test cassette
  • extraction buffer
  • sterile swabs (for sample extraction)
  • instructions for use

 

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