COVID -19 IgG/IgM Antibody Test (POCT)
Catalog Number: A03-51-322 ( 25 cassettes / box)
INTENDED USE:
Artron COVID-19 1gM/IgG Antibody Test is a rapid and qualitative immunochromatographic in-vitro assay for the differential detection of IgM &/or IgG antibodies to SARS-CoV-2 in human serum plasma, venous whole blood or fingerstick whole blood samples obtained from patients with suspected SARS-CoV-2 Infection. The device is designed to aid in the determination of recent or previous exposure to the SARS-CoV-2 virus, assessing the development of an immune response to the Virus after SARS-CoV-2 infection. The test may also detect a response to vaccination but is unable to distinguish between previously infected individuals and vaccinated individuals
DESCRIPTION:
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 colloidal gold and deposited on the conjugate pad. Monoclonal anti-human IgM and monoclonal anti-human IgG are immobilized on two individual test lines (M line and G line) of the nitrocellulose membrane. The M line is closer to the sample well and is followed by the G line. When the sample is loaded, the gold-antigen conjugate is rehydrated and the SARS-COV-21gM and/or IgG antibodies, if any in the sample, will interact with the gold conjugated antigen. The immunocomplex will migrate towards the test window reaching the test zone (G line & M line) where they will be captured by the relevant anti-human IgM (M line) and/or anti-human IgG (G line), 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 (G line & M line), indicating a negative result.
SAMPLE TYPE:
Serum/ plasma/ venous whole blood/ fingerstick whole blood
Time to Results:
15 – 30 min (Strong positive specimens may produce positive results in as little time as 1 minute. Confirm negatives in 10-20 minutes.)
Analytical Sensitivity:
n/a
Analytical Specificity:
One test gave a very equivocal signal on IgM with one anti-CHIKV plasma; No cross reactions were observed from all other 142 tested analytes
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
Serum/ Plasma/ Venous whole blood : 84.55% (IgM), 83.09% (IgG), 91.40% (combined) ; Fingerstick Whole Blood: 84.29% (IgM), 72.86% (IgG), 100% (combined)
Diagnostic Specificity:
Serum/ Plasma/ Venous whole blood : 98.05% (IgM), 99.75% (IgG), 97.88% (combined) ; Fingerstick Whole Blood: 98.33% (IgM), 100% (IgG), 98.33% (combined)
Accuracy:
Serum/ Plasma/ Venous whole blood : 93.08% (IgM), 93.61% (IgG), 95.44% (combined) ; Fingerstick Whole Blood: n/a
Precision
The precision was determined by replicate assays of both positive and negative samples with devices from three different production lots. The resultant data indicated no appreciable between lot variation when testing both positive and negative samples across three different lots.
Storage condition:
Store at 2-30°C, avoid direct sunlight and freezing.
Shelf life:
18 months; opened cassette should be used within 4 hours
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WARNINGS AND PRECAUTIONS
- For professional in-vitro diagnostic use only.
- Do not reuse. Do not use it if the product seal or its packaging is compromised.
- Do not use it after the expiration date shown on the pouch.
- Do not mix and interchange different specimens.
- This test should be performed at 2 to 30°C (17 to 86°F).
- If stored refrigerated, ensure that the Test Units are brought to operating temperature before performing testing.
- Wear protective clothing such as laboratory coats, disposable gloves, and eye protection while handling potentially infectious materials or performing the assay.
- Wash hands thoroughly after finishing the tests. Do not eat, drink, or smoke in the area where the specimens or tests are handled.
- Clean up spills thoroughly with appropriate disinfectants. Handle all specimens as if they contain infectious agents.
- Observe established precautions against microbiological hazards throughout testing procedures.
- Dispose of all specimens and used devices in a proper bio-hazard container.
- The handling and disposal of hazardous materials should follow local, regional, or national regulations.
- Keep out of children’s reach.
- For additional information on COVID-19 antibody (serology) testing: Information for patients, please refer to Health Canada for COVID-19 antibody (serology) testing: Information for patients:https://www.canada.ca/en/health-canada/services/drugs-health- products/covid19-industry/medical-devices/testing/serological/information-for- patients.html