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Applied Biosystems™ TaqPath™ Zika Virus Kit (ZIKV) Non-distribution product as customer accommodation.

A simple-to-use, real-time PCR solution for Zika virus RNA detection:

just add RNA. Now with FDA-issued emergency use authorization

Manufacturer:  Applied Biosystems™ A31745

Catalog No. A31745


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Description

Description

The kit also detects human endogenous control PPIA (Cyclophilin A) sequences, to monitor nucleic acid recovery and to serve as a process control for the RT-PCR. The kit includes primers and probes for Zika virus and PPIA targets, and other reagents for RT-PCR, in a lyophilized format. After addition of RNA sample, the reconstituted reagents are ready for standard real-time RT-PCR.

Emergency Use Authorization 
 
This test has been issued Emergency Use Authorization (EUA) for TaqPath Zika Virus (ZIKV) Kit, 0.1 mL Format, by the USA FDA.
 
  • This test has been authorized by the FDA under an EUA for use by authorized laboratories.
  • This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.
Intended Use

The TaqPath Zika Virus Kit (ZIKV) is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum and urine (collected alongside a patient-matched serum specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States 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-U.S. laboratories.
 
Results are for the identification of Zika virus RNA, which is generally detectable in serum and/or urine during the acute phase of infection and up to 14 days following onset of symptoms, if present. Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities.
 
Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
 
The TaqPath Zika Virus Kit (ZIKV) is intended for use by trained clinical laboratory personnel who have received specific training on the use of the TaqPath Zika Virus Kit (ZIKV) on the Applied Biosystems QuantStudio Dx Real-time PCR instrument and software system. The assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Features
  • Lyophilized with one-step RT-PCR master mix; simply add RNA
  • One-step qRT-PCR reaction runs in fast or standard mode
  • Optimized for the Applied Biosystems™ QuantStudio™ Dx Real-time PCR System
  • Simple workflow for  Zika virus RNA detection
  • Easy to use, environmentally friendly, no cold-chain management required, ship and store at room temperature

Order Info

Ambient Temperature

Specifications

Specifications

Singleplex fast strip (0.1mL, 12 x 8-well strip tubes)
0.1mL
96 Reactions
Block
Fast
Safety and Handling

Safety and Handling

Recommended Storage : No cold-chain management required, ship and store at room temperature.

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For Use Under the Emergency Use Authorization (EUA) Only