Healgen Coronavirus AG Rapid Test Cassette (CE Marked 15min Covid-19 Nasal Swab) x 20 Test Kit
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COVID-19 Rapid Antigen Test (CE Marked 15min Nasopharyngeal or Nasal Swab) 20 Test Kit (GCCOV-502a) is a rapid in vitro immunochromatographic lateral flow test assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. Manufactured by Healgen for medical healthcare professional in vitro diagnostic use only.
For medical healthcare professional in vitro diagnostic use only
- Evaluated and Validated by the UK’s MHRA/DHSC: 1 of only 3 approved tests 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 Kent and South African Variant: Study by PHE and University of Oxford confirms both variants are detectable. More details HERE.
- EU Approved Test: One of the few tests approved for use across all member states of the EU. More details HERE.
- 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
- CE Marked: For professional use
- Accurate: 99.60% 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 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 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 Coronavirus AG Rapid Test Cassette Video Tutorial
Video tutorial for performing the Healgen Coronavirus (Covid-19) Ag Rapid Test Cassette.
GCCOV-502a - Coronavirus Ag Rapid Test Cassette - Healgen - Instructions For Use (IFU)
Instructions For Use (IFU) for the Healgen Coronavirus Ag Rapid Test Cassette GCCOV-502a covering both Nasal and Nasopharyngeal sample collection.
GCCOV-502a - Coronavirus Ag Rapid Test Cassette - Healgen - Quick Start Guide
A useful quick start guide from Quadratech Diagnostics for the Healgen Coronavirus Ag Rapid Test Cassette GCCOV-502a.
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.
- 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. The full Instructions for Use (IFU) document can be found HERE.
- 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 detect the South African and Kent variant of COVID-19?
- Does the test need any additional components?
- Who can buy these tests?