Zika /Dengue/CHIK Real-Time PCR Test CE

The Aridia Zika/Dengue/CHIK Real-Time PCR Test is based on the real time amplification and detection of Zika virus (ZIKV), dengue virus (DENV), and/or chikungunya virus (CHIKV) RNA in a one-step format.

The test is designed for specific and qualitative detection of ZIKV, DENV, and/or CHIKV RNA in clinical specimens as an aid in the diagnosis of acute ZIKV, DENV, and/or CHIKV infection alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.

Recommended for use:

  • Symptomatic individuals that:
  • live in/have recently traveled to areas with active ZIKV/DENV/CHIKV transmission
  • have had unprotected sex with someone who lives in/has traveled to areas with active ZIKV transmission
  • Pregnant women, or those who plan to become pregnant, that have been exposed to ZIKV or live in/have traveled to areas with active ZIKV transmission

ZIKV RNA is detectable in serum approximately one week after infection and may persist up to 2 weeks in urine. DENV or CHIKV RNA is detectable in serum up to 7 days post symptom onset.

A positive PCR test during this detection window is confirmatory of virus infection. A negative PCR test does not exclude infection as viremia decreases over time and must be followed up with serological testing.

  • Real-time PCR technology
  • Dry formulation in an easy-to-use format for stable system
  • Room temperature shipment and storage for up to 24 months
  • Lyophilized components in each reaction well for stability, integrity and convenience
  • Pre-mixed reagents for less test steps and less human errors
  • Open system suitable for most real-time PCR thermocyclers and nucleic acid extraction kits on the market

Clinical performance:

  • Relative sensitivity: 100%, Relative specificity: 100% (test with clinical specimens and/or EQA panels, and compare with a commercial real-time PCR kit)
  • Limit of Detection: ≥ 10 copies as positive≥ 60% of the time; ≥ 50 copies as positive ≥ 95% of the time

Cross-Reactivity:

  • No cross-reactivity to ZIKV with chikungunya, dengue, St Louis encephalitis, West Nile, and yellow fever viruses
  • No cross-reactivity to DENV with chikungunya, Zika, St Louis encephalitis, West Nile, and yellow fever viruses
  • No cross-reactivity to CHIKV with dengue, Zika, St Louis encephalitis, West Nile, and yellow fever viruses

Analytical reactivity: the reactivity was confirmed by real time amplication for

  • ZIKV with Zika virus strain MR 766
  • DENV with dengue 1 virus strain Hawaii, dengue 2 virus strain New Guinea C, dengue 3 virus strain H87, and dengue 4 virus strain H241
  • CHIKV with chikungunya virus strain S27 Petersfield
  • Zika /Dengue/CHIK Real-Time RCR Test Strips
  • Optical Caps
  • Positive Control
  • Negative Control
  • PCR-Grade Water
  • Resuspension Solution

Catalog #

Product

Quantity

P0071H/L

Zika/Dengue/Chikungunya Real-Time PCR Test

96/kit

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FOR EXPORT ONLY