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The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for DiaSorin Incorporated’s LIAISON® XL Zika Capture IgM assay, the first fully automated serology assay for the detection of Zika virus infection.
The LIAISON® XL Zika Capture IgM assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera.
The FDA’s decision to grant an EUA means the LIAISON® XL Zika Capture IgM assay can be used to test serum samples collected from individuals meeting criteria for Zika virus testing set forth by the US Centers for Disease Control and Prevention.
This includes clinical criteria—such as a history of clinical signs and symptoms associated with Zika virus infection—and/or epidemiological criteria—such as a history of residence in or travel to a geographic region with active Zika transmission.
Specimens used with the LIAISON® XL Zika Capture IgM assay should be collected between 8 days and 10 weeks after the onset of symptoms or risk of exposure to Zika.
The assay is intended for use in US laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).
Where there are presumptive Zika IgM positive and presumptive recent Zika positive results from the LIAISON® XL Zika Capture IgM assay, confirmation of the presence of anti-Zika IgM antibodies requires additional testing and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
More information on the LIAISON® XL Zika Capture IgM assay and other Zika assays granted EUAs can be found on the FDA’s EUA page.
Funding for the LIAISON® XL Zika Capture IgM assay was provided by the US Department of Health and Human Services, which granted DiaSorin a $2.6 million contract in the fall of 2016.
About the EUA
The EUA does not mean the LIAISON® XL Zika Capture IgM assay is 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.
This means the LIAISON® XL Zika Capture IgM assay is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner. 
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for DiaSorin Incorporated’s LIAISON® XL Zika Capture IgM assay, the first fully automated serology assay for the detection of Zika virus infection.
The LIAISON® XL Zika Capture IgM assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera.
The FDA’s decision to grant an EUA means the LIAISON® XL Zika Capture IgM assay can be used to test serum samples collected from individuals meeting criteria for Zika virus testing set forth by the US Centers for Disease Control and Prevention.
This includes clinical criteria—such as a history of clinical signs and symptoms associated with Zika virus infection—and/or epidemiological criteria—such as a history of residence in or travel to a geographic region with active Zika transmission.
Specimens used with the LIAISON® XL Zika Capture IgM assay should be collected between 8 days and 10 weeks after the onset of symptoms or risk of exposure to Zika.
The assay is intended for use in US laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).
Where there are presumptive Zika IgM positive and presumptive recent Zika positive results from the LIAISON® XL Zika Capture IgM assay, confirmation of the presence of anti-Zika IgM antibodies requires additional testing and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
More information on the LIAISON® XL Zika Capture IgM assay and other Zika assays granted EUAs can be found on the FDA’s EUA page.
Funding for the LIAISON® XL Zika Capture IgM assay was provided by the US Department of Health and Human Services, which granted DiaSorin a $2.6 million contract in the fall of 2016.
About the EUA
The EUA does not mean the LIAISON® XL Zika Capture IgM assay is 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.
This means the LIAISON® XL Zika Capture IgM assay is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for DiaSorin Incorporated’s LIAISON® XL Zika Capture IgM assay, the first fully automated serology assay for the detection of Zika virus infection.
The LIAISON® XL Zika Capture IgM assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera.
The FDA’s decision to grant an EUA means the LIAISON® XL Zika Capture IgM assay can be used to test serum samples collected from individuals meeting criteria for Zika virus testing set forth by the US Centers for Disease Control and Prevention.
This includes clinical criteria—such as a history of clinical signs and symptoms associated with Zika virus infection—and/or epidemiological criteria—such as a history of residence in or travel to a geographic region with active Zika transmission.
Specimens used with the LIAISON® XL Zika Capture IgM assay should be collected between 8 days and 10 weeks after the onset of symptoms or risk of exposure to Zika.
The assay is intended for use in US laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).
Where there are presumptive Zika IgM positive and presumptive recent Zika positive results from the LIAISON® XL Zika Capture IgM assay, confirmation of the presence of anti-Zika IgM antibodies requires additional testing and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
More information on the LIAISON® XL Zika Capture IgM assay and other Zika assays granted EUAs can be found on the FDA’s EUA page.
Funding for the LIAISON® XL Zika Capture IgM assay was provided by the US Department of Health and Human Services, which granted DiaSorin a $2.6 million contract in the fall of 2016.
About the EUA
The EUA does not mean the LIAISON® XL Zika Capture IgM assay is 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.
This means the LIAISON® XL Zika Capture IgM assay is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.