Healgen Rapid COVID-19 Antigen Self-Test Single Cassette (CE Marked 15min Nasal Swab)
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Healgen Rapid COVID-19 Antigen Self-Test Single Cassette (CE Marked 15min Nasal Swab) GCCOV-502a-H1 is a rapid in vitro immunochromatographic lateral flow test assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. Manufactured by Healgen Scientific.
Please note there is a minimum order quantity of 20 tests
- CE Marked: For Self-Testing
- Evaluated and Validated by the UK’s MHRA/DHSC: Approved test for use by schools, hospitals, and the army. Used by the NHS in the UK. More details HERE.
- French Government Validation: Full compliance with the Ministry of Solidarity and Health requirements for COVID-19 testing.
- German Government Validation: Full compliance with the Federal Institute for Drugs and Medical Devices COVID-19 testing requirements.
- Detects COVID-19 Variants including Omicron: Study by PHE and University of Oxford confirms variants, including Delta, are detectable. More details HERE.
- EU Approved Test: One of the few tests approved for use across all member states of the EU.
- Easy to Use: No special equipment needed, intuitive visual interpretation
- Rapid: Quick sampling with results in 15 min
- Convenient: All necessary reagents provided & no other equipment needed
- Accurate: 100% Specificity, 97.25% Sensitivity & 98.73% Accuracy
- ISO13485: Healgen manufacture in accordance with their ISO13485 Quality Management accreditation. They also hold many additional ISO accreditations.
Each kit contains all the components required to run a single test:
- 1 Individually sealed test cassette
- 1 Sterile swabs
- 1 Extraction Tube and Tip
- 1 Extraction Buffer Vials
- 1 Instruction manual (IFU)
Who can run these tests?
The test should be only be used in accordance with the instructions supplied and is CE-marked for self-testing.
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 diarrhea are found in a few cases. This test is for the detection of SARS-CoV-2 nucleocapsid protein antigen. 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.
Healgen Rapid COVID-19 Antigen Test Video Tutorial
Video tutorial for performing the Healgen Rapid COVID-19 Antigen Test.
GCCOV-502a-H1 - Healgen Rapid COVID-19 Antigen Self-Test - Brochure
Our brochure explaining the benefits for COVID-19 lateral flow testing.
GCCOV-502a-H1 - Healgen Rapid COVID-19 Antigen Self-Test - Instructions For Use (IFU)
Instructions For Use (IFU) for the Healgen Rapid COVID-19 Antigen Self-Test GCCOV-502a-H1 covering both Nasal sample collection.
GCCOV-502a - Coronavirus Ag Rapid Test Cassette - Healgen - Clinical Evaluation Report
Clinical evaluation report from the USA evaluation of the Healgen Coronavirus Ag Rapid Test Cassette GCCOV-502a covering both Nasal and Nasopharyngeal sample collection.
GCCOV-502a-H1 - Healgen Rapid COVID-19 Antigen Self-Test - EC Certificate for Self-Testing
EC Certificate for Self-Testing document of the Healgen Rapid COVID-19 Antigen Self-Test GCCOV-502a-H1.
- Does the test detect COVID-19 variants including Omicron?
Yes. The nucleocapsid phosphoprotein of SARS-CoV-2 was used as the main detected target in the Healgen Coronavirus Ag Rapid Test Cassettes (Swab) and Rapid COVID-19 Antigen Self-tests. This antigen test can therefore be used to detect both wild and mutant SARS-CoV-2 including the Alpha, Beta, Delta, Gamma, Lamda and Omicron Variants.
A statement from the manufacturer Helagen can be viewed HERE.
- Who can run these tests?
- Is there a minimum order quantity (MOQ)?
- What does the test do?
- What samples are required to run the test?
- What is the difference between Antigen testing and Antibody testing?
- What is the testing time?
- What are the possible results?
- Is the test CE-marked?
- Are these tests approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA)?
- Does this test meet any other Government standards?
- Are these tests registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA)?
- Does the test need any additional components?
- Who can buy these tests?
- How do the Healgen and Innova tests compare?