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The page below is a sample from the LabCE course Zika Virus: Overview and Laboratory Testing. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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CDC-Approved Zika Assays and Qualified Laboratories

For qualified laboratories within the United States, the CDC has made available two types of tests for use in the identification of the Zika virus.
CDC Trioplex rRT-PCR
This is a NAT that uses a real-time reverse transcriptase polymerase chain reaction (rRT-PCR) methodology for the qualitative detection and differentiation of RNA from dengue, chikungunya and Zika viruses in serum, cerebrospinal fluid (CSF), and for the detection of Zika virus RNA in urine and amniotic fluid. This test is designed for the simultaneous testing for the presence of dengue, chikungunya, and Zika viruses using a single sample. In the case of urine or CSF specimens, the CDC requires that the specimen be collected alongside a patient-matched serum specimen. Testing should be done on individuals meeting the CDC's Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel).
The CDC IgM antibody capture enzyme-linked immunosorbent assay (MAC-ELISA) is used for the qualitative detection of Zika virus IgM antibodies in human sera or CSF (submitted alongside a patient-matched serum specimen) collected from individuals meeting CDC's Zika virus clinical criteria and/or epidemiological criteria for the presumptive detection of antibodies to Zika virus in persons meeting CDC's clinical and/or epidemiological criteria for Zika virus testing.
Qualified laboratories
Both assays are intended for use in qualified laboratories, designated by the CDC as a part of a multi-test algorithm. Qualified laboratories include both public health laboratories, as well as other laboratories that have demonstrated proficiency with ELISA-based serological methods (for CDC Zika MAC-ELISA) or with rRT-PCR (for CDC Trioplex rRT-PCR) and who have facilities, personnel, and equipment appropriate to the safe handling of specimens suspected of containing Zika, dengue, or chikungunya viruses. CDC-designated laboratories who perform the CDC Zika MAC-ELISA and/or Trioplex rRT-PCR are first required to demonstrate proficiency with the assay(s) by successfully testing verification panels for each assay. Only laboratories that have been notified by the CDC that they have successfully completed the verification testing are authorized to use the CDC assays for diagnostic testing.
In addition, the FDA maintains a list of all Emergency Use Authorization (EUA) tests for Zika virus, discussed on the next content page.
Note: Additional information on these assays and multi-test algorithms will be presented later in this course.