MöLab COVID-19 Rapid Antigen Test (CE Marked 15min Nasal Swab) x 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. These lateral flow tests are 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
- Convenient: All necessary reagents provided & no other equipment needed
- German Registration: Registered with the German equivalent of the MHRA – the Federal Institue for Drugs and Medical Devices. More info HERE
- EU Manufactured: Manufactured and evaluated in Germany by MöLab
- CE Marked: For professional use
- Accurate: >99.9% Specificity, 97.3% Sensitivity & 99.0% Accuracy
- ISO13485: Healgen manufacture in accordance with their ISO13485 Quality Management accreditation. They also hold many additional ISO accreditations.
Each lateral flow kit contains all the components required to run 20 tests:
- 10 Individually sealed test cassettes
- 10 Sterile swabs
- 10 Extraction Tubes
- 10 Dropper tips for extraction tubes
- 1 Buffer solution (0,09 % sodium azide)
- 1 Workstation
- 1 Instruction manual (IFU)
Who can run these tests?
The lateral flow 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.
M200969 - COVID-19 Rapid Antigen Test - Brochure
Our brochure providing an overview of the COVID-19 Rapid Antigen Test which is available to buy now.
M200969 - COVID-19 Rapid Antigen Test - IFU
Instructions for Use (IFU) document for the MoLab COVID-19 Rapid Antigen Test.
M200969 - COVID-19 Rapid Antigen Test - CE Declaration of Conformity
MoLab Declaration of Conformity for the MoLab COVID-19 Rapid Antigen Test.
M200969 - COVID-19 Rapid Antigen Test - German Clinical Study Report & Line Data
German Clinical Study Report & Line Data for the MoLab COVID-19 Rapid Antigen Test.
- 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?
- 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?