Dengue Virus Real-Time PCR Test CE | CTK-P0060

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

The test is designed for specific and qualitative detection of DENV RNA in clinical specimens as an aid in the diagnosis of acute DENV 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:

Any person presenting with clinical signs or symptoms within a week consistent with acute dengue infection or dengue fever including: high fever, severe headaches, severe pain behind the eyes, severe joint and muscle pain, fatigue, nausea, vomiting, and/or skin rash.

DENV RNA is detectable in serum up to 7 days post symptom onset. A positive PCR test during this detection window is confirmatory of DENV infection. A negative PCR test does not exclude infection as viremia decreases over time and must be followed up with serological testing.

As mild dengue fever symptoms can overlap with acute clinical manifestations of other arbovirus infections, such as Zika virus and chikungunya virus infections, correct diagnosis of dengue infection during early disease onset is critical for guiding clinical patient management.