COVID-19 antibody
COVID-19 IgG/IgM Antibody Rapid Test
Atlas Link Group has launched the rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. The test has been used widely by the Chinese CDC to combat infections and is now available globally. This test detects both early marker and later marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples.
It can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat.
This product has CE-IVD registration. You can download the EU Certificate
here.
This products has TGA-IVD Class 3 registration. You can download the TGA Certificate
here.
Brochure COVID-19 IgG IgM Antibody Rapid Test
Certificate of EU Product Notification
COVID-19 IgM IgG Antibody Test (Colloidal Gold) Clinical trial report (IVDC, China CDC)
Contents
20 cassettes in single pouch with desiccant
Assay buffer (5ml per bottle) for 20 tests
Lancets (20 pcs)
Alcohol Wipes (20 pcs)
10ul capillary pipette (20 pcs)
Instruction for use
How it works?
Steps
1. Collect blood/serum/plasma sample.
2. Add blood/serum/plasma sample to sample well.
3. Place 2-3 drops of buffer in sample well.
4. Read results after 10 minutes and no more than 15 minutes.
Results
FAQs
What is COVID-19 IgG/IgM Rapid Test?
NOVAtest Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.
How does COVID-19 Rapid Test Work?
The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.
How quickly can COVID-19 Rapid Test results?
Results are valid 15 minutes after sample and buffer are combined in the cassette sample well.
How accurate is the COVID-19 Rapid Test?
Comparing 300 samples with similar methodological detection
kits, the diagnostic sensitivity of IgM test is 96.3% -97.7%; the
diagnostic specificity is 97.6%; the t otal compliance is 97.0-97.7%.
The diagnostic sensitivity of IgG test is 95.8%; diagnostic
specificity is 96.2% -96.8%; total compliance is 96.0% -96.3%.
What do the results tell me?
A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
1 Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
2 Positive Result, M only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
3 Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
4 Positive Result, G and M: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.
What are the alternatives?
The COVID-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.
What factors can cause a false reading?
- Negative results do not rule out SARS-CoV-2 infection, particularly in the test searches for antibodies rather than the virus itself, meaning it can miss positive cases, especially early in the course of the disease, when a patient’s immune system has not yet created antibodies. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-rs-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.