- 20 Test cassettes
- 20 Sterile swabs
- 20 Extraction tubes and dropper tip
- 1 Workstation
- 2 Buffers
- 1 Package insert
Healgen Coronavirus Antigen Rapid Test Cassette (CE Marked 15min Covid-19 Nasal Swab) x 20 Test Kit
- 20 tests in a box
- Qualitative, visually read results in 15 minutes
- No instrument required
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- Procedural internal control included
- Sterile Swabs, Extraction Buffer and Extraction Tubes included
Each kit contains all the components required to run 20 tests:
- 20 Individually sealed test cassettes
- 20 Sterile swabs
- 20 Extraction Tubes and Tips
- 2 Extraction Buffer Vials
- 1 Workstation
- 1 Instruction manual (IFU)
Who can run these tests?
The test should be only be used in accordance with the instructions supplied and results interpreted by or under the supervision of a Medical Healthcare Professional. The test is not for home use.
What does it do?
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhoea are found in a few cases. This test is for the detection of SARS-CoV-2 nucleocapsid protein antigen. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
The Healgen Coronavirus Antigen Rapid Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Currently, individuals infected by SARS-CoV-2 are the main source of transmission; asymptomatic carriers are also known as a source of transmission. Based on the current epidemiological information, the incubation period can last from 1 to 14 days, where the average time before symptoms occur is about 5 days.
|Who can run these tests?||The test should be only be used in accordance with the instructions supplied by a Medical Healthcare Professional. The test is not for home use.|
|What does the test do?||This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection.|
|What samples are required to run the test?||Nasopharyngeal swab (Nasal Swab)|
|What is the difference between Antigen testing and Antibody testing?||
A new form of testing for Covid-19, rapid antigen testing represents a major advance in bringing the pandemic under control.
Antigen tests look for pieces of proteins that make up the SARS-CoV-2 virus, helping to determine if the person has an active Covid-19 infection.Antibody testing determines if a person has had the infection in the past. This is done by detecting the presence of antibodies produced by the immune system against Covid-19
|What is the testing time?||The test result should be read between 15 to 20 minutes. Do not interpret the result after 20 minutes.|
|What are the possible results?||
POSITIVE:* The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
*NOTE: The intensity of the colour in the test line region will vary depending on the concentration of antigen in the specimen. Therefore, any visible line in the test area either strong or weak (even much weaker than the control line) should be interpreted as positive.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid
|Is the test CE-marked?||Yes. The test is CE-marked for Medical Professional Use only in accordance with EU IVD regulations (IVDD 98/79/EC). A copy of the Manufacturers Declaration of Confirmity is available upon request.|
|Are these tests approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA)?|| Our Helgen antigen tests are one of the few that have been evaluated and validated by the UK’s DHSC to meet their standards for lateral flow testing. They are 1 of only 3 approved tests for use by schools, hospitals and the army. They are also used by the NHS in the UK.
More details on the MHRA/DHSC protocols for antigen test evaluations can be found here:
|Are these tests registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA)?|| In accordance to the IVD directive, manufacturers or are only required to register a CE marked product for professional use with a single competent authority within the EU. As these tests are manufactured in Germany they are registered with the German Federal Institute for Drugs and Medical Devices (BfArM) who are the German equivalent of the MHRA. Evidence of this registration is openly available on the BfArM website:
Therefore there is no requirement or need for an additional registration with the MHRA and it is fully authorised to be sold in the UK in accordance with IVD directive (IVDD 98/79/EC).
|Does the test need any additional components?||No. The tests are supplied with all required components to perform 20 tests.|
|Who can buy these tests?||These tests are only available to customers who can demonstrate that they are buying on behalf of a business or charity and not for home use. Customers may be asked to confirm that the test will only be used in accordance with the instructions supplied by a Medical Healthcare Professional.|