(855) 678-7768 Option 3
How It Works
***This test should be performed by a healthcare professional following regular clinical laboratory procedures. Follow Instructions for Use.***
Add to Specimen Well (s):
1. One drop of whole blood/plasma/serum
(~10 ul) using the dropper (provided)
2. Two drops of buffer (provided)
3. Read Results in 15 minutes.
Interpreting Results
***Results should not be read after 20 minutes***
Negative
One colored line appears in the Control (C) region. Indicates that SARS-CoV-2 specific antibodies are not present or are present at undetectable levels.
Positive
Colored lines appear in the Control (C) region and the IgM region. This indicates the presence of SARS-CoV-2 specific IgM antibodies.
Positive
Colored lines appear in Control (C) region and the IgG region. This indicates the presence of SARS-CoV-2 specific IgG antibodies.
Positive
Colored lines appear in the Control (C) region, the IgG region and the IgM region. This indicates the presence of SARS-CoV-2 specific IgM and IgG antibodies.
Invalid
Colored line fails to appear in the Control (C) region, most likely indicating insufficient specimen volume or incorrect procedure. Repeat the test with a new test cassette.
More questions? Contact us.
*Note: The Clungene SARS-CoV-2 IgG/IgM Rapid Serology Test has been provided through guidance set forth by the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. It has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been exposed to the virus. Follow-up testing with molecular diagnostics should be considered 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-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
[WARNINGS AND PRECAUTIONS]
- For in vitro diagnostic use only.
- For healthcare professionals and professionals at point of care sites.
- Do not use after the expiration date.
- Please read all the information in this leaflet before performing the test.
- The test cassette should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
- The used test cassette should be discarded according to federal, state and local regulations.