SARS-CoV-2 Antigen Test Kit (LFIA)
BioMedomics has launched the SARS-CoV-2 Antigen Test Kit (LFIA) to aid in the diagnosis of an active coronavirus infection. The test detects the presence of the novel coronavirus antigens via nasal or throat secretion and provides diagnostic results within 15 minutes via a rapid lateral flow immunoassay (LFIA).
To view our Instructions for Use, please click here.
COVID-19 is a highly contagious and acute respiratory disease that has affected millions across the globe. Individuals infected by the novel coronavirus are the main source of infection, but asymptomatically infected individuals are also sources of incognito infection spreading. Based on the current epidemiological investigations, the incubation period of the virus is most commonly 3 to 7 days. The most common symptoms include fever, fatigue, and dry cough.
In March of 2020, BioMedomics successfully created one of the most reliable, accurate, and fastest COVID-19 antibody tests in the world: the COVID-19 IgM/IgG Rapid Antibody Test. BioMedomics has continued to put their passion of developing fast, accurate, and reliable COVID-19 testing methods into the new SARS-CoV-2 Antigen Test Kit (LFIA). While PCR tests take days to reveal results and require complex and expensive equipment, our antigen test enables early detection in an acute coronavirus infection, enabling healthcare providers to administer faster and more accurate treatment methods. Knowledge of active infection in the fastest time possible is epidemiologically important and is crucial in controlling the spread and management of the COVID-19 pandemic.
Features & Benefits
BioMedomics’s SARS-CoV-2 Antigen Test (LFIA) is used to qualitatively detect antigens of the novel coronavirus via nasal or throat secretion collection.
- Tests for active coronavirus infection
- Quick & comfortable sample collection
- Validated using PCR
- Results in 15 minutes
- Intuitive visual representative
- No special equipment needed
How It Works
1. Have patient tilt head back to an approximate 70° angle.
2. Insert the swab into the nasal cavity where there is the most secretion, gently spin and push the swab forward until blocked by the turbinate (about 2.0cm-2.5cm from the nostril).
3. Rotate swab and rub the swab on the cavity wall 3 times before taking it out.
4. Vertically add 8 drops of lysis buffer into the sampling tube. Insert the swab (after collection) into the solution.
5. Rotate the swab against the inner tube wall about 10 times.
6. Break swab handle and cover tube with dropper.
7. Place 2-3 drops of buffer in sample well. Read results after 15 minutes and no more than 20 minutes.
The COVID-19 Antigen Test (LFIA) is an antigen test used to aid in the diagnosis of an active coronavirus infection via a lateral flow immunoassay (LFIA). The test detects the presence of the novel coronavirus antigens via nasal or throat secretion and provides diagnostic results within 15 minutes.
The test cassette contains (1) colloidal gold-labeled anti-SARS-CoV-2 antibody and quality control antibody colloidal gold marker, (2) one detection line (T line) and one quality control line(C) fixed on a nitrocellulose membrane. T is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the C line. When the appropriate amount of test sample treated with lysis buffer is added to the sample well of the test cassette, the sample will move forward along the test strip via capillary action. If the sample contains the novel coronavirus antigens and concentration of antigens is higher than the limit of detection, the antigen will bind to the colloidal gold-labeled anti-SARS-CoV-2 antibody. The immune complex will be captured by the anti-SARS-CoV-2 antibody immobilized on the membrane, forming a red T line and indicating a positive result for the novel coronavirus. If the sample contains no novel coronavirus antigens or the antigens concentration is lower than the limit of detection, a negative result is displayed.
Results are valid 15 minutes after sample and buffer are combined in the cassette sample well.
A total of three detection lines are possible, with the control (C) line appearing when sample has flowed through the cassette.
1 | Invalid Result: If the quality control line (C) does not appear, then the test result is invalid and sample must be retested with a new cassette.
2 | Negative Result: If only the quality control line (C) appears and the detection T line is not visible, the sample contains no novel coronavirus antigens or the antigens concentration is lower than the limit of detection and the result is negative.
3 | Positive Result: If both the quality control line (C) and the detection line T appears, then the novel coronavirus has been detected and the result is positive. Result should be determined by whether the T-line is colored or not regardless of the color intensity.
For best results, use a combination of the BioMedomics’ s COVID-19 IgM/IgG Rapid Test to test for the detection of antibodies in human serum, plasma, or whole blood along with the SARS-CoV-2 Antigen Test Kit (LFIA) for the detection of active infection. By combining the results of both a rapid COVID Antigen and a rapid COVID Antibody test, it will give both the patient and healthcare provider the most accurate understanding of the patient’s health.
NOTE: BioMedomics SARS-CoV-2 Antigen Test Kit (LFIA) is not currently available for in vitro diagnostic use in the USA.