Table 1.
Zika Virus Tests Approved by the FDA for Temporary Emergency Use144
| EUA Date (2016) | Test | Developer/Manufacturer | Description |
|---|---|---|---|
| February 26 | Zika MAC-ELISA | CDC | For detection of Zika virus-specific IgM in human sera or cerebrospinal fluid submitted with patient-matched serum specimen |
| March 17 | Trioplex Real-Time RT-PCR Assay | CDC | For detection and differentiation of RNA from Zika virus, dengue virus, and chikungunya virus in human sera or cerebrospinal fluid collected with patient-matched serum specimen; for detection of Zika virus RNA in urine and amniotic fluid, each collected with patient-matched serum specimen |
| April 28 | Zika Virus RNA Qualitative Real-Time RT-PCR Test | Quest Diagnostics | For detection of Zika virus RNA in human serum specimens |
| May 13 | RealStar Zika Virus RT-PCR Kit | Altona Diagnostics | For detection of Zika virus RNA in serum or urine collected with patient-matched serum specimen |
| June 17 | Aptima Zika Virus Assay | Hologic, Inc. | For detection of Zika virus RNA in human serum and plasma specimens |
| July 19 | Zika Virus Real-Time RT-PCR Test | Viracor-IBT Laboratories | For detection of Zika virus RNA in human serum, plasma, or urine collected with patient-matched serum or plasma specimen |
| July 29 | Versant Zika RNA 1.0 Assay (kPCR) Kit | Siemens Healthcare Diagnostics | For detection of Zika virus RNA in human serum, EDTA plasma, and urine collected with patient-matched serum or plasma specimen |
| August 4 | xMAP MultiFLEX Zika RNA Assay | Luminex Corporation | For detection of Zika virus RNA in human serum, plasma, and urine collected with patient-matched serum or plasma specimen |
| August 17 | ZIKV Detect IgM Capture ELISA | InBios International | For detection of Zika virus IgM antibodies in human serum |
| August 26 | LightMix Zika Real-Time RT-PCR Test | Roche Molecular Systems | For detection of Zika virus RNA in human serum and EDTA plasma; Zika virus RNA generally detectable approximately seven days after onset of symptoms |
| September 23 | Sentosa SA ZIKV RT-PCR Test | Vela Diagnostics | For detection of Zika virus in human serum, EDTA plasma, and urine collected with patient-matched serum or EDTA plasma specimen |
| September 28 | Zika Virus Detection by RT-PCR Test | Arup Laboratories | For detection of Zika virus in human serum, EDTA plasma, and urine collected with patient-matched serum or EDTA plasma specimen |
CDC = Centers for Disease Control and Prevention; EDTA = ethylenediaminetetraacetic acid; ELISA = enzyme-linked immunosorbent assay; EUA = emergency use authorization; FDA = Food and Drug Administration; IgM = immunoglobulin M; kPCR = kappa polymerase chain reaction; MAC-ELISA = IgM antibody capture enzyme-linked immunosorbent assay; RT-PCR = reverse transcriptase polymerase chain reaction; ZIKV = Zika virus.