TABLE 1.
Summary of serological assays with emergency use authorization for detection of antibodies to ZIKV and performance characteristics in serum according to instructions for use
| Assay name and manufacturer | Date EUA issued | Specimen sourcea | Method | ZIKV antigen(s) | Positive agreement (% [95% CI]) | Negative agreement (% [95% CI]) | Peer-reviewed positive agreement (%) | Peer-reviewed negative agreement (%) | Interpretive categories |
|---|---|---|---|---|---|---|---|---|---|
| ZIKV MAC-ELISA (CDC) | 26 February 2016 | S | MAC-ELISA (colorimetric) | Recombinant, noninfectious, ZIKV-like particles | 94 (89.3–96.7)b | 30.9 (26.7–35.5)b | 83.3–100c | 47.1c | Presumptive ZIKV positive, equivocal, inconclusive, or negative |
| ZIKV Detect IgM capture ELISA (InBios International, Inc.) | 17 August 2016 | S | MAC-ELISA (colorimetric) | Envelope | 100 (90.6–100)d | 92.5 (85.8–96.1)d | 100e | 20–74e | Presumptive ZIKV positive, possible ZIKV positive, presumptive another flavivirus positive, or negative |
| Liaison XL Zika capture IgM assay (DiaSorin Incorporated) | 5 April 2017 | S | Microparticle IgM capture immunoassay (chemiluminescence) | NS1 | 94.2 (88.7–97.2)f | 99.3 (97.5–99.9)f | 85g | 56g | Presumptive ZIKV IgM positive, presumptive recent ZIKV positive, presumptive recent ZIKV negative, or negative |
| ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.) | 18 September 2017 | S, P | Microparticle IgM capture immunoassay (chemiluminescence) | NS1 | 90.2 (87.5–94)f | 95.9 (91.6–98.2)f | NA | NA | Presumptive ZIKV positive or negative |
| DPP Zika IgM system (Chembio Diagnostic Systems, Inc.) | 27 September 2017 | Fingerstick or venous WB, S, P | Immunochromatographic | NS1 | 95.1 (83.9–98.2)f | 98.2 (96.7–99)f | NA | NA | IgM reactive or nonreactive |
a
S, serum; P, plasma; WB, whole blood; NA, not available.
b
Agreement determined in comparison to ZIKV PRNT.
d
Agreement determined in comparison to CDC ZIKV PRNT and Trioplex RT-PCR results.
f
Agreement determined in comparison to unspecified comparator ZIKV IgM serological assay with FDA EUA, with specimens collected ≥8 days PSO.
g
Performance compared to ZIKV and DENV PRNT results (48).