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. 2020 Jul 23;58(8):e01243-20. doi: 10.1128/JCM.01243-20

TABLE 1.

Attributes for the evaluated anti-SARS-CoV-2 IgG serologic assaysa

Attribute Data for:
Abbott Epitope Euroimmun Ortho-Clinical
Assay principleb CMIA ELISA ELISA CLIA
Solid-phase antigen Nucleocapsid Nucleocapsid Spike S1 Spike
Specimen type Serum, plasma Serum Serum Serum
Sample volume 25 μl 10 μl 10 μl 20 μl
EUA status Granted Submitted Granted Granted
Result calculation Index (S/Co) Index (S/Co) Index (S/Co) Index (S/Co)
Positive cutoff threshold ≥1.4 ≥1.21c ≥1.1 ≥1.00
Indeterminate cutoff range NA ≥1.01 to <1.21c ≥0.8 to <1.1 NA
Operational type Continuous, random access Batch Batch Continuous, random access
Time to first result 29 min 80 min 120 min 48 min
Test throughput per 8 h 1,600 630c 630d 1,040 to 1,200
a

Abbreviations: CMIA, chemiluminescent microparticle immunoassay; ELISA, enzyme-linked immunosorbent assay; CLIA, chemiluminescence immunoassay; EUA, emergency use authorization; S/Co, signal-to-cutoff; NA, not applicable.

b

All assays are indirect in format.

c

Laboratory-determined cutoff threshold.

d

Testing performed on the Dynex Agility automated ELISA processor (Chantilly, VA).