GENERAL INFORMATION
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is the name given to the 2019 novel coronavirus. COVID-19 is the name given to the disease associated with the virus. SARS-CoV-2 is a new strain of coronavirus that has not been previously identified in humans. The 2019-Novel Coronavirus belongs to the genus β. It has a capsule, and its particles are round or oval, often polymorphous, with a diameter of 60-140nm. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV.
Artron COVID-19 IgM/IgG Antibody Test is a rapid, qualitative and convenient immunochromatographic in vitro assay for the differential detection of IgM & IgG antibodies to SARS-COV-2 in human serum, plasma or whole blood samples.
REAGENTS AND MATERIALS SUPPLIED
- Pouch contents: Test Cassette, Desiccant.
- 25 Capillary tubes for 25 tests.
- Sample buffer 3ml per bottle for 25 tests.
- Instructions for Use
PRINCIPLE OF THE TEST
The principle of Artron COVID-19 IgM/IgG Antibody Test is an antibody-capture immunochromatographic assay for the simultaneous detection and differentiation of IgM & IgG antibodies to SARS-COV-2 virus in human serum, plasma, or whole blood samples. SARS-COV-2 -specific antigens are conjugated to a colloidal gold and deposited on the conjugate pad. Monoclonal anti-human IgM and monoclonal anti-human IgG are immobilized on two individual test lines (T line 2 and T line 1) of the nitrocellulose membrane. The IgM line (T2) is closer to the sample well and followed by the IgG line (T1). When the sample is added, the gold-antigen conjugate is rehydrated and the SARS-COV-2 IgM and/or IgG antibodies, if any in the sample, will interact with the gold conjugated antigen. The immunocomplex will migrate towards the test window until the test zone (T1 & T2) where they will be captured by the relevant anti-human IgM (T2) and/or anti-human IgG (T1), forming a visible pink line, indicating positive results. If SARS-COV-2 antibodies are absent in the sample, no pink line will appear in the test lines (T1 & T2), indicating a negative result.
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. Absence of a pink control line in the Control Zone is an indication of an invalid result.
RESULTS
Performance characteristics:
- Sensitivity: 97.88% (with 95% confidence interval of 96.88% – 98.62%)
- Specificity: 97.22% (with 95% confidence interval of 95.20% – 98.56%)
- CE-IVD certificated