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Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.
The RealStar® Zika Virus RT-PCR Kit U.S. is a product of altona Diagnostics GmbH.
Under the EUA, the test can be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine (collected alongside a patient-matched serum specimen).
The RealStar® Zika Virus RT-PCR Kit U.S. is intended for use in individuals meeting US Centers for Disease Control and Prevention (CDC) 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 virus transmission at the time of travel).
The test is authorized for use only under the EUA in CLIA-certified High Complexity Laboratories in the US or by similarly qualified non-US laboratories, by clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.
The RealStar® Zika Virus RT-PCR Kit U.S. is authorized for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN), followed by the amplification and detection of Zika-virus-specific RNA using the RealStar® Zika Virus RT-PCR Kit U.S. on an ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from BIO-RAD), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research), or Rotor-Gene® Q 5/6 plex/MDxPlatform (QIAGEN).
About the EUA
The RealStar® Zika Virus RT-PCR Kit U.S. has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The RealStar® Zika Virus RT-PCR Kit U.S. is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Zika testing
The FDA has granted EUAs for 3 other tests designed to detect Zika virus:
- Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
- Trioplex Real-time RT-PCR Assay (CDC)
- Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (CDC).
The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus. 
Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.
The RealStar® Zika Virus RT-PCR Kit U.S. is a product of altona Diagnostics GmbH.
Under the EUA, the test can be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine (collected alongside a patient-matched serum specimen).
The RealStar® Zika Virus RT-PCR Kit U.S. is intended for use in individuals meeting US Centers for Disease Control and Prevention (CDC) 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 virus transmission at the time of travel).
The test is authorized for use only under the EUA in CLIA-certified High Complexity Laboratories in the US or by similarly qualified non-US laboratories, by clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.
The RealStar® Zika Virus RT-PCR Kit U.S. is authorized for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN), followed by the amplification and detection of Zika-virus-specific RNA using the RealStar® Zika Virus RT-PCR Kit U.S. on an ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from BIO-RAD), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research), or Rotor-Gene® Q 5/6 plex/MDxPlatform (QIAGEN).
About the EUA
The RealStar® Zika Virus RT-PCR Kit U.S. has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The RealStar® Zika Virus RT-PCR Kit U.S. is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Zika testing
The FDA has granted EUAs for 3 other tests designed to detect Zika virus:
- Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
- Trioplex Real-time RT-PCR Assay (CDC)
- Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (CDC).
The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus.
Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.
The RealStar® Zika Virus RT-PCR Kit U.S. is a product of altona Diagnostics GmbH.
Under the EUA, the test can be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine (collected alongside a patient-matched serum specimen).
The RealStar® Zika Virus RT-PCR Kit U.S. is intended for use in individuals meeting US Centers for Disease Control and Prevention (CDC) 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 virus transmission at the time of travel).
The test is authorized for use only under the EUA in CLIA-certified High Complexity Laboratories in the US or by similarly qualified non-US laboratories, by clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.
The RealStar® Zika Virus RT-PCR Kit U.S. is authorized for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN), followed by the amplification and detection of Zika-virus-specific RNA using the RealStar® Zika Virus RT-PCR Kit U.S. on an ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from BIO-RAD), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research), or Rotor-Gene® Q 5/6 plex/MDxPlatform (QIAGEN).
About the EUA
The RealStar® Zika Virus RT-PCR Kit U.S. has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The RealStar® Zika Virus RT-PCR Kit U.S. is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Zika testing
The FDA has granted EUAs for 3 other tests designed to detect Zika virus:
- Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
- Trioplex Real-time RT-PCR Assay (CDC)
- Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (CDC).
The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus.