The Abbott RealTime Zika assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories, using RT-PCR technology for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria. No need to send samples out or experience delays in reporting results. Abbott RealTime Zika lets you meet your testing needs in real time.
Leading Science: RT-PCR detection of Zika virus RNA in serum, plasma, whole blood (EDTA), and urine specimens (whole blood and urine collected alongside a patient-matched serum or plasma specimen) with excellent analytical accuracy.
Enabling Solutions: Full specimen extraction-to- amplification with the m2000 system enables reduced hands-on time vs. other nucleic acid testing options.
Trusted Partner: Ensuring access to this important test to meet a public health need, from a proven and dedicated molecular testing source.
Meet a real public health need with Abbott RealTime Zika Virus—molecular sensitivity as recommended by the CDC.1
Amplification and Detection: m2000rt
|Sample Type||Serum, EDTA plasma, whole blood (EDTA) and urine (whole blood and urine when collected alongside a patient-matched serum or plasma specimen)|
|Limit of Detection (LOD)||30 copies/mL (serum)
40 copies/mL (plasma)
40 copies/mL (urine)
120 copies/mL (whole blood)
|Internal Control||Processed with each sample|
|Abbott RealTime Zika Amplification Kit||09N27-090||00884999046771||96 assay (4 x 24)|
|Abbott RealTime Zika Control Kit||09N27-080||00884999046757||8 vials negative control
8 vials positive control
|Abbott RealTime Zika Combined
Intended Use: The Abbott RealTime ZIKA assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the qualitative detection of RNA from the Zika virus in serum, EDTA plasma, whole blood (EDTA), and urine (whole blood and urine collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
Specimens are tested using the m2000sp for automated specimen processing and the m2000rt for amplification and detection.
Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum, plasma, whole blood, and urine during the acute phase of infection and up to 14 days following onset of symptoms, if present. Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Abbott RealTime ZIKA assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of nucleic acid amplification and in vitro diagnostic procedures. This assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
For In Vitro Diagnostic Use. For use under an Emergency Use Authorization (EUA) only.
1. Centers for Disease Control and Prevention. All countries & territories with active Zika virus transmission. Available at wwwnc.cdc.gov/travel/page/world-map-areas-with-zika. Accessed September 29, 2016
For Use Under An Emergency Use Authorization Only.
CAUTION: United States federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by or on the order of a physician.
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