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. 2021 Jan 17;90:23–27. doi: 10.1016/j.clinbiochem.2021.01.004

Table 1.

Validation Studies.

SARS-CoV-2 PCR Positive SARS-CoV-2 PCR Negative
  • A)

    Ortho Vitros Test Clinical Agreement: Clinical agreement of the UMMC ELISA using samples from SARS-CoV-2 PCR positive patients (>6 days from date of PCR positivity), samples from healthy individuals pre-2019, and samples from patients with other viruses.

Ortho Vitros Test Positive 73 1
Ortho Vitros Test Negative 0 152
Total 73 153
Sensitivity 73/73; 100% (CI: 93.8–100)
Specificity 152/153; 99.3 (CI: 95.9–100)
SARS-CoV-2 Positive SARS-CoV-2 Negative
  • B)

    UMMC ELISA Clinical Agreement: Clinical agreement of the UMMC ELISA using samples from SARS-CoV-2 PCR positive patients (> 6 days from date of PCR positivity), SARS- CoV-2 PCR negative patients, samples from healthy individuals pre-2019, and samples from patients with other viruses.

UMMC ELISA Positive 204 0
UMMC ELISA Negative 5 288
Total Samples 209 288
Sensitivity 204/209; 97.6% (CI: 94.2–99.1)
Specificity 288/288; 100% (CI: 98.4–100)