COVID-19 Rapid Antigen Test (CE Marked 15min Nasal Swab) 10 Test Kit
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COVID-19 Rapid Antigen Test (CE Marked 15min Nasal Swab) 10 Test Kit (M200969) is a rapid in vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. For medical healthcare professional in vitro diagnostic use only.
For medical healthcare professional in vitro diagnostic use only
- Easy to use: No special equipment needed, intuitive visual interpretation
- Rapid: Quick sampling with results in 15 min
- All necessary reagents provided & no other equipment needed
- Manufactured and evaluated in Germany
- CE Marked for professional use
- Accurate: 99.9% Specificity, 86.7% Sensitivity & 96.3% Accuracy
The box includes 10 individually sealed cartridges, along with:
- 10 sterile swabs
- 10 extraction Tubes
- 10 dropper tips for extraction tubes
- 1 buffer solution (0,09 % sodium azide), sufficient for 10 tests
- 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.
- 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?
- 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?
- What are the limitations of the test?
- How accurate are the tests?
- Is the test CE-marked?
- Are these tests registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA)?
- Are these tests approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA)?
- Who is the manufacturer and what quality standards are they adhering to?
- Does the test need any additional components?
- Who can buy these tests?