Prueba de PCR en tiempo real de Zika CE

PRUEBA DE PCR EN TIEMPO REAL DE ZIKA CE

The Aridia Zika Real-Time PCR Test is based on the real time amplification and detection of Zika virus (ZIKV) RNA in a one-step format.

The test is designed for specific and qualitative detection of ZIKV RNA in clinical specimens as an aid in the diagnosis of acute ZIKV 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 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. A positive PCR test during this detection window is confirmatory of ZIKV infection. A negative PCR test does not exclude infection as viremia decreases over time and must be followed up with serological testing.

Product features

Product specifications

Product features

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

Performance:

Sensitivity: 100%
Specificity: 100%
Limit of Detection: ≥ 10 copies as positive≥ 60% of the time; ≥ 50 copies as positive ≥ 95% of the time
Cross-Reactivity: no cross-reactivity with chikungunya, dengue, St Louis encephalitis, West Nile, and yellow fever viruses

Product specifications