ZEUS Rapid SARS-CoV-2 IgM/IgG Assay Procedure

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Assay Procedure:

  1. The ZEUS Rapid SARS-CoV-2 IgM/IgG Test Cassette contains the following features:
  2. Read the instructions carefully before beginning.
  3. Allow the Test Cassette and Specimen Diluent to equilibrate to room temperature (15 – 30°C ) before use. Do NOT warm these components to speed the process.
  4. Obtain the venuous blood, capillary blood, serum or plasma using standard protocols.
  5. Open the pouch and remove the Test Cassette. Place it on a clean and level surface. Discard the pouch and the desiccant.
  6. Using a calibrated pipette, add 65µL of blood, serum or plasma to a tube containing 450µL of the Specimen Diluent.
  7. Mix the contents of the tube by gently inverting the tube repeatedly.
  8. Transfer 65µL of the diluted specimen to the sample addition well of the test cassette.
  9. Set a laboratory timer.  
  10. Read the results after 15 minutes.
  11. After 18 minutes, the results are invalid.

Interpretation of Results:

When the 15 minute incubation has been completed, results may be interpreted as follows:

  1. Possible Anti-SARS-CoV-2 Positive Result:
    • A visible M-line (#1 line) in conjunction with a visible C-line. This indicates that the patient has IgM antibody to the SARS-CoV-2 virus.
    • A visible G-line (#2 line) in conjunction with a visible C-line. This indicates that the patient has IgG antibody to the SARS-CoV-2 virus.
    • A visible M-line and a visible G-line in conjunction with a visible C-line. This indicates that the patient has both IgM and IgG antibody to the SARS-CoV-2 virus.

    • Figure 1: Sample IgM Positive, IgG Positive and IgM + IgG Positive Reactions

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  2. Anti-SARS-CoV-2 Negative Result:
    • If there is no visible M-line (#1 line) and no visible G-line (#2 line); however, there is a visible C-line. That means the test is valid; however, the patient did not have any detectable IgM or IgG antibody to the SARS-CoV-2 virus. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow up testing with a molecular diagnostic should be considered to rule out infection on these individuals. Figure 2 depicts a negative result.

    • Figure 2: Negative Test Result Example

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  3. Invalid Test Results:
    • Regardless of the results of the M-line and the G-line (#1 line and #2 line), if there is no visible line at the C-line, the test is considered invalid and the test should be repeated. Examples of invalid test results are depicted in Figure 3 below.

    • Figure 3: Invalid Test Result Examples

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  4. When reporting test results, please consider the following:
    • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus. Follow up testing with a molecular diagnostic should be considered to rule out infection on 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.

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