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Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Abbott Molecular Inc.’s RealTime ZIKA assay.
The EUA means the assay can be used by certified laboratories for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen).
Zika virus RNA is generally detectable in these specimens during the acute phase of infection.
According to updated guidance from the US Centers for Disease Control and Prevention (CDC), Zika virus RNA is detectable up to 14 days in serum and urine (possibly longer in urine), following the onset of symptoms, if present. Positive results are indicative of current infection.
The FDA’s decision to grant an EUA means Abbott’s RealTime ZIKA assay can be used in individuals who meet 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 transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).
The assay can be used by laboratories in the US 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).
The EUA does not mean Abbott’s RealTime ZIKA 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 Abbott’s RealTime ZIKA 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. 
Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Abbott Molecular Inc.’s RealTime ZIKA assay.
The EUA means the assay can be used by certified laboratories for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen).
Zika virus RNA is generally detectable in these specimens during the acute phase of infection.
According to updated guidance from the US Centers for Disease Control and Prevention (CDC), Zika virus RNA is detectable up to 14 days in serum and urine (possibly longer in urine), following the onset of symptoms, if present. Positive results are indicative of current infection.
The FDA’s decision to grant an EUA means Abbott’s RealTime ZIKA assay can be used in individuals who meet 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 transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).
The assay can be used by laboratories in the US 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).
The EUA does not mean Abbott’s RealTime ZIKA 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 Abbott’s RealTime ZIKA 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.
Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Abbott Molecular Inc.’s RealTime ZIKA assay.
The EUA means the assay can be used by certified laboratories for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen).
Zika virus RNA is generally detectable in these specimens during the acute phase of infection.
According to updated guidance from the US Centers for Disease Control and Prevention (CDC), Zika virus RNA is detectable up to 14 days in serum and urine (possibly longer in urine), following the onset of symptoms, if present. Positive results are indicative of current infection.
The FDA’s decision to grant an EUA means Abbott’s RealTime ZIKA assay can be used in individuals who meet 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 transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).
The assay can be used by laboratories in the US 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).
The EUA does not mean Abbott’s RealTime ZIKA 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 Abbott’s RealTime ZIKA 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.