There are no commercially available diagnostic tests cleared by FDA for the detection of Zika virus. FDA encourages commercial diagnostic developers and researchers developing laboratory developed tests (LDTs) for Zika virus to submit an Emergency Use Authorization (EUA) request. FDA will work interactively with developers to support such requests.
FDA has rapidly granted Emergency Use Authorizations for several in vitro diagnostic (IVD) devices. See Emergency Use Authorization for information about Zika virus diagnostics available under EUA.
Two types of diagnostic tests are needed for Zika virus: (1) tests to diagnose acute infection; and (2) tests to assess whether individuals, especially pregnant women, who were potentially exposed to Zika virus were actually infected. More: Diagnostic Testing information for health care providers, from CDC
There are no commercially available diagnostic tests cleared by FDA for the detection of Zika virus. See Emergency Use Authorization (EUA) for information about Zika virus diagnostics available under EUA.
FDA is working interactively with Zika virus diagnostic developers to help accelerate development programs and requests for EUAs. Draft EUA review templates delineating data requirements for a Zika virus diagnostic EUA are available by sending a request to: CDRH-ZIKA-Templates@fda.hhs.gov.
Nucleic acid (NAT)-based IVD devices for viral RNA are the most sensitive method available to detect acute Zika virus infection. However, the sensitivity of NAT-based methods may vary considerably across assays, and standardized reference materials are needed to facilitate product development. One of the conditions of authorization for a ZIKV NAT-based IVD device under an EUA, is for the EUA holder to assess traceability of their device with an FDA-recommended reference material. Traceability refers to tracing analytical sensitivity/reactivity back to a FDA recommended reference material.
To support fulfillment of an EUA condition of authorization to assess traceability, FDA has created the FDA Zika Virus Reference Materials for NAT-based IVD devices, which contains RNA from two current Zika virus strains in human plasma and three controls for blind testing. The FDA Zika Virus Reference Materials are available upon request to Zika device developers who have a pre-EUA submission with the agency and have established the analytical and clinical performance of their assay. FDA will consider requests for material to be used solely for research purposes on a case-by-case basis. The reference material is made available without cost.
To request the FDA Zika Virus Reference Materials for NAT-based IVD devices, email CDRH-ZIKA-Templates@fda.hhs.gov.
As a courtesy only, FDA is providing a list of potential sources of Zika-positive controls and/or verification/validation panels:
- Heat-inactivated virus in plasma available from European Virus Archive goes Global (EVAg)
- Freeze-dried, quantified virus available from European Virus Archive goes Global (EVAg)
- Purified, quantified virus RNA available from Vircell
- Quantified recombinant virus in human plasma available from SeraCare Life Sciences
Three of the above entities are in Europe, so there may be some steps required to bring materials into the United States. For information on importing reference biological material into the U.S. for use with the Zika NAT-based IVD devices, please visit the following links or contact email@example.com.
- Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research
- U.S. Customs and Border Protection: Importing Biological Materials
Laboratory developed tests are a subset of in vitro diagnostic devices that are intended for clinical use and designed, manufactured, and used within a single laboratory. Historically, FDA has generally not enforced premarket review and other applicable FDA requirements for LDTs because such tests were relatively simple lab tests and generally available on a limited basis. However, due to advances in technology and changes in business models, LDTs have evolved and proliferated significantly since the FDA first obtained comprehensive authority to regulate all in vitro diagnostics as devices in 1976. Some LDTs are now more complex, have a nation-wide reach and present higher risk.
Patients, as well as their physicians, depend on FDA to assure the tests they use to make medical decisions are accurate, reliable, and clinically meaningful. Recently, several developers announced they would be developing and making LDTs for Zika virus available to patients.
Zika virus may have serious implications for certain populations. For example, given the potential association of microcephaly and other poor pregnancy outcomes and Zika virus, a positive Zika test results poses a serious and challenging situation for pregnant women. Thus it is essential that in vitro diagnostic tests for Zika virus provide accurate and reliable results.
As such, FDA has requested developers of LDTs for Zika virus to submit information about their tests to help FDA better understand their design, validation, and performance characteristics. While FDA recognizes the need for expanding laboratory testing capacity for Zika virus, and encourages laboratories to develop Zika in vitro diagnostic tests, these tests should not be used for clinical diagnoses without FDA’s approval, clearance, or authorization. FDA is encouraging developers of LDTs for Zika virus to submit a request for an EUA; FDA will work interactively with LDT developers to support such requests.
Diagnostic Product Sponsors/Manufacturers
Draft EUA review templates for Zika, and Zika virus reference materials are available by email request to:
For questions regarding importing reference biological material into the U.S. for use with the Zika NAT-based IVD devices, contact firstname.lastname@example.org.