CoV-SCAN Rapid Antigen Test
BioMedomics has launched the CoV-SCAN Rapid Antigen Test (CoV-SCAN) to aid in the diagnosis of active coronavirus infection. The test detects the N-protein antigen of SARS-CoV-2 using a novel double antibody sandwich assay format. It uses a panel of antibodies, targeting multiple antigenic sites on SARS-CoV-2 N-protein antigen, that can detect many new variants of concern at equivalent (or up to eight-fold) improved sensitivity compared to original isolate.
To view our Instructions for Use, please click here.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a novel beta coronavirus and is the causative agent of Coronavirus Disease 2019 (COVID-19) and the pandemic. SARS-CoV-2 is mainly transmitted through droplets and contact routes, and people who are infected with SARS-CoV-2 may express signs and symptoms of acute respiratory illness, such as fever, cough, shortness of breath, etc., but can also be asymptomatic.
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 CoV-SCAN Rapid Antigen Test. While PCR tests take days to reveal results and require complex and expensive equipment, antigen test enables early detection in an acute coronavirus infection, enabling healthcare providers to administer faster and 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 CoV-SCAN helps in detection of extracted nucleocapsid protein (N-protein) antigens specific to SARS-CoV-2 in nasal swab specimens directly collected from individuals who are suspected of COVID-19 by a healthcare provider within the first five (5) days of symptom onset.
Given the worldwide surge of variant infections, it is particularly significant that CoV-SCAN is able to detect SARS-CoV-2 variants that pose a threat to the resurgence of COVID-19 infections. Variants of concern detected include Alpha (B.1.1.7) and Delta (B.1.617.2, AY.2) and variants of interest detected include Iota (B.1.526) and Mu (B.1.621). It was observed that not only were all variants of concerns detected by CoV-SCAN, but all they were detected at equal or up to 8-fold better sensitivity than the original, isolate virus (WA1).
Sensitivity of CoV-SCAN to SARS- CoV-2 variants
* A lower concentration on swab represents a higher sensitivity of the test
- Tests for active coronavirus infection
- Quick & comfortable sample collection
- Validated using PCR
- Detects variants
- Results in 15 minutes
- Intuitive visual representative
- No special equipment needed
How It Works
- Collect nasal sample with the given sterile swab.
- Vertically add 10 drops of lysis buffer into the sampling tube.
- Rotate the swab against the inner tube wall about 10 times. Squeeze swab from outer tube wall to dissolve sample in solution.
- Remove & discard swab and cover tube with dropper.
- Place 3 drops of buffer in sample well. Read results after 15 minutes and no more than 20 minutes
CoV-SCAN is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein (N-protein) antigens specific to SARS-CoV-2 in nasal swab specimens directly collected from individuals who are suspected of COVID-19 by a healthcare provider within the first five (5) days of symptom onset.
Nasal swab specimens require a sample preparation step (extraction) in which the sample is eluted into the lysis buffer solution. Extracted sample is added to the sample well of the test cassette to initiate the test. When the sample migrates in the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 N-protein antibodies conjugated to indicator and capture particles in the test strip, forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip.
Test results are interpreted at fifteen (15) minutes after sample addition. The presence of two (2) colored lines in the control line region (C-Line) and test line region (T-line) indicates the sample is SARS-CoV-2 positive. The presence of one (1) colored line, C-line, indicates the sample is SARS-CoV-2 negative. The absence of the C-line indicates an invalid test, and the sample must be retested.
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 does not contain novel coronavirus antigens or the antigen 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 CoV-SCAN Rapid Antigen Test for the detection of active infection. Combining the results of both a rapid COVID-19 Antigen and a rapid COVID-19 Antibody test, will give both the patient and healthcare provider the most accurate understanding of the patient’s health.
NOTE: BioMedomics CoV-SCAN Antigen Test is not currently available for in vitro diagnostic use in the United States of America.