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ADVIA Centaur Zika TestDetect IgM Antibodies to Zika Virus

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The ADVIA Centaur® Zika test* is intended for in vitro diagnostic use in the presumptive qualitative detection of IgM antibodies to the Zika virus in human serum and plasma using the ADVIA Centaur® XP and ADVIA Centaur® XPT Systems.

 

Importance of Zika IgM Diagnosis

Importance of Zika IgM Diagnosis:

  • Zika virus (ZIKV) infection in pregnant women increases the risk of having a baby with congenital Zika syndrome, which includes features such as microcephaly.1-3
  • Detection of ZIKV-specific IgM antibodies is used for diagnosis and appropriate clinical management of patients.3
  • Accurate diagnosis of ZIKV assists in public-health surveillance by tracking the spread of infection and aids in controlling the epidemic.4
ADVIA Centaur Zika Test Benefits

ADVIA Centaur Zika Test Benefits

  • Detect positive infections with limited cross-reactivity to other flaviviruses 8 days after onset of symptoms or risk of exposure.
  • Consolidate infectious-disease testing on one automated platform (ADVIA Centaur XP and ADVIA Centaur XPT).
  • Improve lab efficiency by using an automated test that can be used with serum and plasma samples and has good onboard stability and a long calibration interval.
Test Interpretation

Test Interpretation:

The ADVIA Centaur Zika Test requires the use of two assays.

  • The detection of IgM antibodies to the Zika virus is determined by combining in an algorithm the measurements of the ADVIA Centaur Zika Ab (ZikaAb) Assay and, as applicable, the ADVIA Centaur Zika IgM (ZikaM) Assay.
  • All patient samples must be tested initially with the ADVIA Centaur ZikaAb assay.
  • All ADVIA Centaur ZikaAb equivocal samples must be tested with the ADVIA Centaur ZikaM assay.
Molecular Zika Virus Testing

Molecular Zika Virus Testing

  • Real-time reverse transcription-polymerase chain reaction (rRT-PCR) should be performed during the first two weeks after symptom onset, and on urine samples collected less than 14 days after symptom onset.
  • A negative rRT-PCR result does not exclude ZIKV infection and serum should be analyzed by IgM antibody (serological) testing.
*The ADVIA Centaur Zika Test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories, only for the diagnosis for Zika virus infection and 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.

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.

1.Musso D, Gubler DJ. Zika Virus. Clin Microbiol Rev. 2016 Jul;29(3):487-524.

2.Centers for Disease Control. Zika: The Basics of the Virus and How to Protect Against It. CDC's Response to Zika. CDC August 12, 2016.

3. Ingrid B. Rabe, MBChB1; J. Erin Staples et. al. Interim Guidance for Interpretation of Zika Virus Antibody Test Results MMWR / June 3, 2016 / Vol. 65 / No. 21.

4. Petersen LR, Jamieson DJ, Powers AM, Honein MA. N Engl J Med. 2016 Apr 21;374(16):1552-63.