Dengue Ag (NS1) Rapid Test
CTK Biotech, USA Dengue Ag (NS1) Rapid 10 Test
The OnSite Dengue Ag Rapid Test4.0 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.
- 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: 98.75% 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), 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)
- 24 month shelf life at 2-30 °C storage
Each kit contains :
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample diluent (5 mL/bottle)
- One package insert (instruction for use)
TEST PRINCIPLE :
The OnSite Dengue Ag Rapid Test4.0 is a lateral flow chromatographic immunoassay. The test strip in cassette device consists of: 1) a burgundy colored conjugate pad containing antibodies to dengue NS1 antigen conjugated with colloidal gold (dengue Ab conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with antibodies to dengue NS1 antigen, and the C line is pre-coated with a control line antibody. The antibodies to dengue NS1 recognize the antigens from all four dengue virus serotypes.
When an adequate volume of specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Dengue NS1 antigens, if present in the specimen, will bind to the Dengue Ab conjugates. The immunocomplex is then captured on the membrane by the pre-coated antibodies to dengue NS1 antigens forming a burgundy colored T line, indicating a dengue Ag positive test result and suggesting an early acute primary or secondary infection.
Absence of the T line suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies, regardless of color development on the test line (T line). If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.
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