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GENnow

GENnow

GENnow™ ANTIGEN RAPID TEST

For professional use only

 Published in November 2021 

 

How does it work? 

GENnowAntigen Rapid Test for human nasopharyngeal specimens, is a rapid test for the qualitative detection of SARS-CoV-2 antigens.

COVID-19-20P_BOX_052021_08_3D

As a lateral flow immunochromatographic test, the GENnow™ Antigen Rapid Test is designed to detect SARS-CoV-2 antigens in human nasopharyngeal specimens. During the test, anti-SARS-CoV-2 antibody-coated nanoparticles present in the test strip react with the SARS-Cov-2 antigens. The mixture then flows chromatographically along the test strip by capillarity.

 

A coloured line is generated as soon as a sample contains SARS-CoV-2 antigens and the anti-SARS-CoV-2 antibodies present in the (T) test area indicate a positive result. However, if no antigens are present in the sample, no coloured line is visible in the test area indicating a negative result. A coloured line should always appear in the control line area (C) indicating the correct procedure and the correct function of all components.

GENnow™ Antigen Rapid Test is intended for healthcare professionals only:

  •  high standards for sensitivity and specificity compared to a PCR method
  •  accurate and precise results in only 10 minutes
  •  Results are very easy to read

WHY A COVID-19 ANTIGEN TEST?

The use of a COVID-19 antigen device allows identification of any SARS-CoV-2 antigens present in our bodies and allows precautionary isolation measures to be taken to reduce the spread of the virus. Due to the steady and significant number of COVID-19 cases worldwide, there continues to be a high demand for accurate and reliable diagnostic tools that are simple and rapid. Only in this way can frequent testing be made possible, as Mina et al. explain in an article in the New England Journal of Medicine. Rapid tests with the above-mentioned characteristics have been developed to facilitate the diagnosis and traceability of infected individuals, which are very similar to the PCR method.

 

To slow the spread of the pandemic, as shown in Figure 1, the frequency of testing is becoming increasingly important. Transmission of the SARS-CoV-2 virus only occurs a few days after exposure, i.e. when the viral load has reached its peak.

The criteria shown in Figure 1 could be defined as a surveillance method aimed at reducing the number of SARS-CoV-2 affected individuals and providing accurate results quickly to limit the asymptomatic spread of the virus. Such a surveillance method cannot be performed using a standard PCR method, as PCR samples usually need to be tested by experts in specialised laboratories after collection. This mainly increases costs, reduces testing frequency and can delay results up to several days.

HOW TO APPLY THE TEST?

  1.  collect the nasopharyngeal sample by pushing the swab into the nasal cavity and holding it parallel to the palate. Turn and rub the swab about 5 times and then pull it out. 
  2.  Insert the swab into the extraction buffer and rotate it back and forth for about 10 seconds. Remove the swab while squeezing the sides of the tube to extract as much liquid as possible. 
  3.  add 2 drops of the previously obtained liquid to the sample collection container of the test cassette. Wait 10 minutes and read the results.

EVALUATION OF RESULTS

A Positive Result: Show two coloured bands at the C (control) and T (test) markings indicating the presence of SARS-CoV-2 antigens in the sample. In this case, call your country’s COVID-19 emergency reference number and follow the instructions.

Negative result: A coloured stripe appears at the C-mark (control) and none at the T-mark (test).

 

Invalid result: Nothing appears on the control line (C). Insufficient sample volume or incorrect application are the most likely reasons for the control line (C) being missing. Contact your local dealer if the problem persists.

 

GENnowAntigen Rapid Test only indicates the presence of SARS-CoV-2 antigens in the sample and should not be used as the sole criterion for diagnosis of SARS-CoV-2 infection. The results of the test should be considered in conjunction with other clinical results from other laboratory tests and assessments.

 

If you are interested in the GENnowAntigen Rapid Test, please contact us for more information at info@geniuspharma.ch.

REFERENCES

  1. European Centre for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov-background-disease)

  2. WHO Director-General’s opening remarks at the media briefing on COVID-19 – March 11th 2020 (https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—11-march-2020)

  3. Centers for Disease Control and Prevention, Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html)

  4. https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostictests-for-covid-19

  5. European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostic-testing. Accessed July 2020

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