Rapid COVID-19 Antigen Test Kit
Rapid detection of COVID-19 antigen in nasal samples
The kit is ready to use and contains all the materials required to perform a test. The following components are included in the kit:
25 test strips (individually in a foil pouch with desiccant)
1 extraction buffer container
25 dispenser cap
1 instruction sheet
The COVID-19 Antigen Test Kit for Nasal Swab Samples is intended for in vitro diagnostic use only. The test is used to detect the antigen of the novel corona virus 2019 (SARS-CoV-2) in nasal samples that are infected with the novel corona virus 2019 (SARS-CoV-2).
The novel corona virus of 2019 (SARS-CoV-2) belongs to the group of corona viruses, which are transmitted as respiratory infections via air droplets from infected patients and are distributed worldwide. The novel corona virus infection (SARS-CoV-2) of 2019 is associated with mild to high fever, headache, loss of taste, mild to severe cough, shortness of breath, difficulty breathing and, in severe cases, leads to pneumonia, severe acute respiratory syndrome and even to death.
The COVID-19 antigen test kit is based on the principle of the lateral flow immunoassay. It is a rapid membrane-based screening test to detect the presence of antigen against the novel coronavirus 2019 (SARS-CoV-2). The test uses the two virus-specific monoclonal antibodies, one antibody conjugated to colloidal gold particles and another antibody immobilized on the membrane. Once the sample has been added to the sample well together with the buffer diluent, the antigen will bind to the colloidal gold particles coated with monoclonal antibodies. If an antigen against the Novel Corona Virus 2019 (SARS-CoV-2) is present in the sample, a pink color band will appear in the test area, followed by the control area, ensuring that the test was performed correctly.
Storage & STABILITY
The test device should be stored in the sealed pouch between 2 ° C and 30 ° C. The test kit is stable until the expiration date stated on the pouch. Do not use the tester if the pouch is damaged or the seal is broken. Store the tester in the sealed pouch until you are ready to use it.
SAMPLE COLLECTION & PREPARATION
Test procedure (step 1)
Take the virus swab extraction tube and add 10-12 drops of extraction buffer to the tube.
Open the nasopharyngeal swab included in the kit.
Take the swab and remove the clinical specimen. To avoid the risk of contamination: Make sure that the swab tip only comes into contact with the nasopharyngeal area.
After the clinical specimen is collected, insert the swab into the virus swab extraction tubes with extraction buffer.
Gently swirl the swab clockwise and counterclockwise into the tube 8-10 times while pressing down on the bottom of the tube.
After extraction, the buffer can become cloudy. Remove and discard the swab.
Seal the extracted sample with a nozzle cap. Now the KIT is ready to carry out the COVID-19 antigen test
Test procedure (step 2)
Open the pouch and remove the device.
Place the card on a flat surface and dispense two drops of the extracted sample into the sample well (S).
Interpret the results after 15 minutes, but before 20 minutes.
Results that are displayed after 30 minutes should be ignored.