Product Code: GCCOV-502a
Size: 20 Tests
For medical healthcare professional in vitro diagnostic use only
Quadratech are very happy to announce that we have become a distributor of the Healgen Coronavirus AG Rapid Test Cassette. The Healgen lateral flow test (LFT) is a quick, reliable and cost-effective way of detecting active Covid-19 infections in both symptomatic and asymptomatic patients. It is ideal for employers wanting to diagnose potential infections within their workforce. The 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 lateral flow test evaluations including the Healgen result publication can be found HERE
More details on the MHRA/DHSC protocols for antigen test evaluations can be found HERE
- 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.
- 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: 99.22% Specificity, 96.72% Sensitivity & 98.74% Accuracy
- ISO13485: Healgen manufacture in accordance with their ISO13485 Quality Management accreditation. They also hold many additional ISO accreditations.
KEY ADVANTAGES OF COVID-19 RAPID TESTING
- Helps prevent outbreaks in the workplace ensuring continuity of service, manufacturing and trading.
- The test detects active infections so it helps to determine if a person has the virus right now.
- Point-Of-Care testiing is cost-effective – eliminating the need for expensive lab-based testing.
- Testing has become a key part of corporate social responsibility policy — it’s hugely beneficial for the mental wellbeing of employers, staff and customers.
- Rapid antigen tests will detect Covid-19 proteins in both asymptomatic and symptomatic patients.
- Test results are delivered on-site in 15 mins. No need to send samples away for analysis.
- Unlike other antigen tests, our tests look for nucleocapsid protein making it the gold standard for rapid antigen testing.
- The tests were evaluated in the USA and highly accurate with 99.2% Specificity, 96.7% Sensitivity & 98.7% Accuracy.
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 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.