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xMAP® MultiFLEX® Zika RNA Assay

For Use Under the Emergency Use Authorization (EUA) Only

xMAP® MultiFLEX® Zika RNA Assay

Now FDA Authorized for Emergency Use

Luminex® xMAP® MultiFLEX® Zika RNA Assay is FDA Emergency Use Authorized nucleic acid test for the qualitative detection and identification of the Zika virus in human serum, plasma or urine (alongside matched serum or plasma) samples from individuals meeting CDC virus clinical criteria and/or CDC Zika virus epidemiological criteria.


Researchers estimate that approximately 2.2 billion individuals are currently at risk of Zika infection. Zika virus is a major public health concern due to potential links to birth defects (microcephaly) in cases of infections during pregnancy, and Guillain-Barre Syndrome (GBS), a neurodegenerative disease.1 xMAP® MultiFLEX® Zika RNA Assay is FDA authorized to detect Zika virus in human serum, plasma and urine (matched to serum or plasma) samples.


Features of the xMAP MultiFLEX Zika RNA Assay


  • Scalable—Ability to run 1-96 samples in a single run without wastage of reagents gives users the flexibility to accommodate variations in testing volumes
  • Performance—The assay has been tested on clinical samples from the 2016 Zika outbreak and has excellent NPA and PPA
  • Broader Capabilities—The authorization of the xMAP MultiFLEX Zika RNA Assay adds to the ever-increasing menu of IVD assays that are approved for use on the Luminex® 200™ and MAGPIX® systems
  • Approved Sample Types—The xMAP MultiFLEX Zika RNA Assay is authorized for use on serum, plasma, and/or matched urine samples, allowing customers to pick the sample type that is most relevant to their clinical needs


This test has been validated on both the Luminex® 100/200™ and the MAGPIX® systems.



The xMAP MultiFLEX Zika RNA Assay has an easy to perform workflow that allows users to process up to 96 samples/run.


xMAP® MultiFLEX® BioAssay Workflow

Ordering Information


Luminex Online Order Management
Email: [email protected]
Phone: 1.512.336.3550
Toll Free: 1.866.401.5450
Fax: 1.512.219.0544
Fax (Europe, Middle East, India, Asia): +31 (0)73 800 1998
Product Name Kit Size Registration Status Part Number
xMAP MultiFLEX Zika RNA Assay 100 Tests In Vitro Diagnostic use under Emergency Use Authorization Only MBP-EUA-01
  1. Messina JP, Kraemer MU, Brady OJ, et al. Mapping global environmental suitability for Zika virus. Jit M, ed. eLife. 2016;5:e15272. doi:10.7554/eLife.15272


EUA – In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization 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.

MultiFLEX is a trademark of GenArraytion Inc.

Intended Use (US-IVD):

The xMAP® MultiFLEX® Zika RNA Assay test is a RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (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 transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to qualified laboratories that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Test results are for the identification of Zika viral RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current Zika virus 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 xMAP® MultiFLEX® Zika RNA Assay test is intended for use by trained clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the xMAP® MultiFLEX® Zika RNA Assay. The test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The xMAP® MultiFLEX® Zika RNA Assay is indicated for use on Luminex® IVD xMAP® instruments (MAGPIX® or Luminex® 200™).