TABLE 2.
Summary of molecular assays with emergency use authorization for detection of ZIKV RNA and performance characteristics according to instructions for use and peer-reviewed literature (as available)
| Assay name and manufacturer | Date EUA issued | Specimen sourcea | Method | Gene target(s) | Positive agreement in serum (% [95% CI]) | Negative agreement in serum (% [95% CI]) | Limit of detection in serum (95% CI) | Peer-reviewed positive agreement (% [95% CI]) | Peer-reviewed negative agreement (% [95% CI]) |
|---|---|---|---|---|---|---|---|---|---|
| Trioplex rRT-PCR (CDC)b | 17 March 2016 | WB, S, CSF, U, AF | RT-PCR (TaqMan) | Envelope (ZIKV) | 100 (92.6–100) | 99.1 (95.5–100) | 1.93 × 104 GCE/ml | NA | NA |
| Zika virus RNA qualitative real-time RT-PCR (Quest Diagnostics Infectious Disease, Inc.)c | 28 April 2016 | S, U | RT-PCR (TaqMan) | Envelope and membrane | 94.6 (85.4–98.2) | 100 (93.4–100) | 250 copies/ml | NA | NA |
| RealStar Zika virus RT-PCR kit (Altona Diagnostics, GmbH) | 13 May 2016 | S, U | RT-PCR (TaqMan) | NS1 | 96.8 (89.0–99.1) | 95.1 (83.9–98.7) | 0.61 copies/μl (0.39–1.27 copies/μl) (56); 0.015 PFU/ml (0.004–0.982 PFU/ml) (57) | 91.4–95.5 (56, 57) | 91.8–97.1 (56, 57) |
| Aptima Zika virus assay (Hologic Inc.) | 17 June 2016 | S, P, U | Transcription-mediated amplification | NS1, NS4/NS5 | 100 (96.7–100) | 97.2 (90.4–99.2) | 11.5 copies/ml (7.9–20.2 copies/ml) (55) | 94.7 (73.5–99.9) (55) | 94.8 (88.9–97.8) (55) |
| Zika virus real-time RT-PCR test (Viracor Eurofins)d | 19 July 2016 | S, P, U | RT-PCR (TaqMan) | Not specified | 100 (69.8–100) | 96.4 (86.6–99.4) | 97 copies/ml (plasma) | NA | NA |
| Versant Zika RNA 1.0 assay (kPCR) (Siemens Healthcare Diagnostics Inc.) | 29 July 2016 | S, P, U | RT-PCR | Not specified | 90.6 (83.1–95.0) | 85.2 (73.4–92.3) | 721 GCE/ml | NA | NA |
| xMAP MultiFLEX Zika RNA assay (Luminex Corp.) | 4 August 2016 | S, P, U | RT-PCR | Not specified | 95.8 (85.1–99.5) | 98.1 (93.4–99.5) | 687 copies/ml | NA | NA |
| Sentosa SA ZIKV RT-PCR test (Vela Diagnostics USA, Inc.) | 23 September 2016 | S, P, U | RT-PCR | NS4A | 94.9 (87.5–98.0) | 100 (93.6–100) | 6.0 × 103 copies/ml | NA | NA |
| Zika virus detection by RT-PCR (ARUP Laboratories)e | 28 September 2016 | S, P, U | RT-PCR | Not specified | 98 (89.5–99.7) | 100 (79.6–100) | 160 copies/ml | NA | NA |
| RealTime Zika (Abbott Molecular) | 11 November 2016 | WB, S, P, U | RT-PCR | Premembrane, NS3 | 92.6 (82.1–97.9) | 97.0 (89.6–99.6) | 30 copies/ml (12.2–30.89 copies/ml) (58) | 96.5 (80.0–99) (58) | 71.4 (35.2–94.4) (58) |
| Zika ELITe MGB kit U.S. (ELITechGroup) | 9 December 2016 | S, P | RT-PCR | NS3 | 94.7 (88.1–97.7) | 90.9 (82.4–95.5) | 270 copies/ml (plasma) | NA | NA |
| Gene-RADAR Zika virus test (Nanobiosym Diagnostics) | 20 March 2017 | S | RT-PCR | Not specified | 100 (92.9–100) | 100 (92.9–100) | 200 PFU/ml | NA | NA |
| CII-ArboViroPlex rRT-PCR (Columbia University) | 11 July 2017 | S, U | RT-PCR | 3′ untranslated region | 97.0 (89.8–99.2) | 100 (93.5–100) | 5.16 × 103 GEQ/ml | NA | NA |
| TaqPath zika virus kit (Thermo Fisher Scientific) | 2 August 2017 | S, U | RT-PCR (TaqMan) | Not specified | 94.9 (90.8–98.9) | 100 (95.3–100) | 50 genomic copies/ml | NA | NA |
a
WB, whole blood; S, serum; P, plasma; U, urine; CSF, cerebrospinal fluid; AF, amniotic fluid; GCE, genome copy equivalents; GEQ, genomic equivalent quantity; NA, not available.
b
Multiplex assay for ZIKV, DENV, and chikungunya virus.
c
Use limited to Quest Diagnostics Infectious Disease, Inc.
d
Use limited to Viracor Eurofins Laboratories.
e
Use limited to ARUP Laboratories.