ZEUS Rapid SARS-CoV-2 IgM/IgG Performance Summary

Test with Confidence. Test with ZEUS.

Clinical Correlation:  USA Cohort of 95 clinically characterized samples

Method:

ZEUS Scientific assembled a USA cohort of clinically characterized specimens consisting of the following:

  • We acquired serum from 70 normal healthy blood donors that were collected in the Northeastern US in the fall of 2019, prior to the pandemic reaching the US.
  • We acquired 25 different serum/plasma samples from 16 different COVID-19 patients who had symptoms consistent with COVID-19 and who were confirmed as PCR positive using an EUA-approved PCR assay.  The days between PCR test and specimen draw ranged from 7 to 40 days with an average of 17.7 days and a median of 14 days.

Results:

  • Of the 70 healthy donors, one specimen was positive on the IgM line.  The remainder were IgM negative.    All 70 of the specimens were negative on the IgG line.  Qualitative Specificity is 98.6% (69/70)
  • Of the 25 clinically positive specimens, 21/25 were positive on the IgM line and 25/25 were positive on the IgG line.    Therefore, all 25 were positive on the test.  Qualative Sensitivity is 100% (25/25).

Wuhan, China Cohort of 225 Samples
  • Specificity testing included samples from 95 normal healthy individuals.  Reported Specificity in this group was 98.9% (94/95)
  • Sensitivity testing of samples from 130 clinically diagnosed, PCR positive COVID-19 positive patients ranging from 4-24 days of infection duration.   Reported Sensitivity in this group was 86.9% (113/130)

Device Performance Characteristics:


Clinical Study: USA Cohort of 126 samples from an affected population
  • 40 reactive patients tested with an in-house immunoassay containing varying levels of antibody, 10 PCR positive patients, 10 reference negative patients and 66 potential cross-reactive samples from a variety of other disease states were tested. Results demonstrate the ZEUS Rapid SARS-CoV2 device’s ability to detect SARs-CoV-2 antibodies as patients seroconvert post SARS-CoV-2 infection while maintaining specificity.
  • Testing Summary
    • 10 High Reactive (10/10) tested ZEUS positive
    • 10 Medium Reactive (9/10) tested ZEUS positive
    • 10 Low Reactive (7/10) tested ZEUS positive
    • 10 Borderline Reactive (5/10) tested ZEUS positive
    • 10 PCR Positive (3/10) tested ZEUS positive, the earliest was 9 days post symptoms
    • 10 Negative (9/10) tested ZEUS negative, the ZEUS positive specimen is being repeated on the reference method.
    • 66 Cross Reactive (65/66) positive samples from over 20 different disease states tested ZEUS negative

Comparative Testing:

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