Dengue Serotyping Real-Time PCR Test CE

The Aridia Dengue Serotyping Real-Time PCR Test is based on the real-time amplification and detection of dengue virus (DENV) serotypes 1-4 in a one-step format.

The test is designed for specific and qualitative detection and differentiation of dengue virus (DENV) serotypes 1-4 RNA in clinical specimens as an aid in the diagnosis of acute DENV infections alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. Detection of DENV serotyping infections is crucial for patient management decisions and epidemiological surveillance that shape public health policies.  The product is intended for use by professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.

Any person presenting with clinical signs or symptoms 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, within a week after symptom onset.

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 diagnostic testing.