Dengue serotyping en tiempo real prueba de PCR CE

DENGUE SEROTYPING EN TIEMPO REAL PRUEBA DE PCR 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.

Product features

Product specifications

Product features

Real-time PCR technology
Dry formulation in an easy-to-use format provides a 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:

97% of DENV RNA-positive samples were serotyped using the Aridia Dengue Serotyping Real-Time PCR Test, 95% confidence interval (CI) [83%, >99%]
Limit of Detection: ≥50 DEN1, ≥10 DEN2, ≥50 DEN3, and ≥100 DEN4 RNA copies detected as positive ≥ 95% of the time
Cross-Reactivity: no cross-reactivity with Chikungunya virus strain S27 Petersfield, Zika virus strain MR 766, St Louis encephalitis virus strain 17D, West Nile virus strain H160/99, West Nile virus Heja, West Nile virus Ug37, Yellow fever virus strain 17D

Product specifications

DEN1 & DEN4 Test Strips (High Profile/Low Profile)
DEN2 & DEN3 Test Strips (High Profile/Low Profile)
Positive Control
Negative Control
PCR-Grade Water
Resuspension Solution (for Reconstitution of the Stabilized Reaction Mix)
Optical Caps