Zika/Dengue/Chikungunya Virus Real-Time PCR Test CE | CTK-P0071

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.