ZEUS ELISA SARS-CoV-2 IgG Performance Summary

Test with Confidence. Test with ZEUS.

Clinical Performance Studies

Four separate cohorts of clinically characterized specimens were tested:

  1. COVID-19 RT-PCR Positive Patient Specimens (n=35).  The date between EUA-approved PCR test result and specimen draw was 3 to 37 days, with an average of 15.97 days and a median of 14 days.
  2. COVID-19 RT-PCR Negative Patient Specimens (n=34)
  3. COVID-19 Serology Positive Patient Specimens (n=50)
  4. COVID-19 Serology Negative Patient Specimens (n=77)

Using PCR as the reference:

  • The ZEUS ELISA SARS-CoV-2 IgG Test System performed as follows:
  • Clinical Sensitivity = 35/35 = 100% (95% CI = 100% to 100%)
  • Clinical Specificity = 34/34 = 100% (95% CI = 100% to 100%)

Using Serology as the reference:

  • The ZEUS ELISA SARS-CoV-2 IgG Test System performed as follows:
  • PPA = 47/50 = 94% (95% CI = 87.4% to 100%)
  • NPA = 77/77 = 100% (95% CI = 100% to 100%)

Combining both PCR and Serology as “Clinical Truth”:

  • The ZEUS ELISA SARS-CoV-2 IgG Test System performed as follows:
  • Sensitivity = 82/85 = 96.5% (95% CI = 92.5% to 100%)
  • Specificity = 111/111 = 100% (95% CI = 100% to 100%)
Non-Clinical Performance Studies

Specificity – Pre-pandemic healthy blood donors

Ninety normal healthy blood donors collected in the North Eastern US prior to November of 2019 were tested on the ZEUS ELISA SARS-CoV-2 IgG Test System.   One specimen was equivocal and the remaining 89 specimens were negative. 

The specificity was determined to be 89/90 = 98.9%

Specificity – Pre-pandemic patients with various respiratory illnesses

Ninety specimens were evaluated on the ZEUS ELISA SARS-CoV-2 IgG Test System that were collected from patients with a variety of respiratory illnesses.  These specimens were tested for the following infectious agents;  MERS, RSV, FluA, FluB, Parainfluenza, Adenovirus, Enterovirus, Mycoplasma pneumonia, Legionella, B. pertussis, and C. pneumonia.  Many specimens were positive for antibody to multiple agents.  One of the ninety specimens was positive and the remaining 89 specimens were negative.  

The specificity in this cohort was determined to be 89/90 = 98.9%

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