Dengue Ag 30 Test Per Box. CTK BIOTECH

The OnSite Dengue Ag rapid Test CE is a lateral flow chromatographic immunoassay for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood.

The test is designed to be used by professionals as a screening test and provides an initial test result to help diagnose dengue infection.

Any use or interpretation of this primary test result should also be based on other clinical findings and the judgment of health professionals. Alternative test methods should be considered to confirm the test result obtained with this device.

Recommended for use:

Anyone who develops clinical signs or symptoms within 9 days consistent with acute dengue infection or dengue fever including: high fever, severe headache, severe pain behind the eyes, severe joint and muscle pain, fatigue, nausea, vomiting, and/or rash My skin.

Dengue NS1 antigen can be detected in human blood from the first day after the onset of fever up to 9 days, allowing early detection and prompt treatment of dengue virus infection.

Because mild dengue symptoms can overlap with severe clinical symptoms of infections with other arboviruses, such as Zika virus and chikungunya virus infections, correct diagnosis of dengue infection during early disease onset is crucial to guide clinical management of patients.

PRODUCT FEATURES

In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection

Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen

Simple assay procedure yields results within 20-25 minutes

Clinical performance:

Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)

Sensitivity: 100%

Specificity: 98.8% comparing to a commercial ELISA

Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others

No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), Creatinine (442 µmol/L), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)

Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 200 μg/mL during the study.

Product Specification

Individually sealed foil pouches containing:

One cassette device

One desiccant

Plastic droppers

Sample diluent (REF SB-R0063, 5 mL/bottle)

One package insert (instruction for use)