Zika ELITe MGB® Kit U.S. – EUA

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Easier and faster molecular solution for Zika testing

Zika infections are considered as a significant public health challenge at the international level. In the US and its territories, up to 40,000 travel associated and locally acquired mosquito-borne cases have been reported.1

Zika ELITe MGB® Kit U.S. is a real-time PCR assay for the detection of Zika virus in plasma and serum samples. In combination with ELITe InGenius®, a fully automated sample-to-result system, the Zika ELITe MGB® Kit U.S. offers unique benefits in terms of ease-of-use and time-to-result in comparison to other Emergency Use Authorization assays.

 

Catalogue Number

M800552

Product Description: Zika ELITe MGB® Kit U.S. contains all necessary PCR reagents and controls for Zika testing

Number of reactions: 48 per kit

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Accurate Zika detection

  • One-step, reverse transcription and real-time PCR amplification assay
  • Proprietary industry leading-leading Minor Groove Binder (MGB) technology
  • Excellent clinical performance
  • 100% of concordance on Certified Reference Material obtained during External Quality Assessment Programme

Simplified Zika testing workflow

  • Fully automated, cassette based, sample-to-result solution
  • Single benchtop solution performing all the steps of Zika Molecular Diagnostics
  • Simplified Zika testing workflow

Faster result & reduced hands-on time

  • Shorter turn-around time: 10 samples analyzed in less than 3 hours
  • Limited hands-on-time: less than 2 minutes per sample
  • Flexible batch-size and adapted throughput
  • Cost-effective solution: limited risk of errors, and labor-cost savings

 

 

 

Zika ELITe MGB® Kit U.S.:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

1 Case counts in the US as of January 4, 2017 https://www.cdc.gov/zika/geo/united-states.html

Sample type: serum and plasma

Kit Content:

  • 20x Zika PreMix : 1 x 98 µL
  • PCR master Mix : 1 x 972 µL
  • RT Enzyme Mix :1 x 20 µL
  • PCR Grade Water : 1 x 208 µL
  • Negative Control : 1 X 1600 µL
  • Positive Control : 2 X 800 µL
  • Internal Control : 4 X 180 µL

Maximum Shelf-life: 24 months

Storage Temperature: -20°C

Instrumentation: automated extraction and amplification with ELITe InGenius