Abbott RealTime Zika

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. 

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.

References:

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

LIMITATIONS OF THE PROCEDURE

For Use Under An Emergency Use Authorization Only.

• This assay is for in vitro diagnostic use under the FDA Emergency Use Authorization only.
• Laboratories are required to report all positive results to the appropriate public health authorities.
• Specimen collection conducted prior to symptom onset or after the acute phase ofi nfection (approximately 7 days post-onset of symptoms) may lead to false negative results.
• Negative results do not preclude infection with Zika virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.
• A patient-matched serum specimen is currently required for serological follow up testing of negative RT-PCR results per the CDC testing algorithm (found at http://www.cdc.gov/zika/index.html).
• The impact of the administration of Zika virus vaccines and/or therapeutics on the ability to detect Zika Virus RNA in patient specimens has not been evaluated.
• This test has not been FDA cleared or approved.
• This test has been authorized by FDA under an EUA for use by authorized laboratories.
• This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens;
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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.

To learn more about RealTime ZIKA please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-zika

To access Fact Sheet for Patients please visit: https://www.molecular.abbott/sal/5-Abbott-Zika---FS-Patients-Final.pdf

To access Fact Sheet for Healthcare Providers please visit: https://www.molecular.abbott/sal/4-Abbott-Zika---FS-HCP-Final.pdf