Description

Dengue Ns1 Ag Elisa 96T pack

Dengue Antigen Elisa

ELISA INTENDED USE

The RecombiLISA Dengue Ag NS1 ELISA Kit is a solid-phase, enzyme linked immunosorbent assay that was developed using the antibody sandwich technique. The two main kit components are:

1) A 96 breakable well plate with the solid microwells pre-coated with rabbit anti- Pan Dengue NS1 antibody

2) A conjugate solution composed of antibodies against Dengue NS1 antigen conjugated with horseradish peroxidase (HRP-anti-dengue NS1 conjugates)

This test is intended for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum or plasma. It is intended to be used by professionals as an aid in the early detection of dengue virus infection . Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of healthcare providers.

Recommended for use:

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

Dengue NS1 antigen is released into the blood during viral replication in an infected patient, and is detectable from the first day after the onset of fever up to Day 9. NS1 antigen can be identified before the formation of antibodies, thus making it a beneficial biomarker for early detection of dengue infection, allowing for prompt management of dengue fever.

Analytic sensitivity: Detects recombinant Dengue type 2 NS1 at a level as low as 0.3 ng/mL.
Sensitivity: 100%
Specificity: 97.8%
Dengue Early Infection AccuSet Performance Panel: 100% agreement with PanBio Dengue Early ELISA
Cross Reactivity: No cross reaction with HCV, Syphilis, HBsAg, ANA, HIV, HAMA, H. pylori, RF, Malaria
Hook Effect: No hook effect up to 0.1 mg/mL
Interference: No interference with Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 1.3 %;Heparin: 3,000 U/L; Creatinine: 5 mmol/L; Bilirubin: 10 mg/dL; EDTA: 3.4 ?mol/L
Intra Assay Precision: CV < 10%
Inter Assay Precision: CV < 7%
Shelf life: 18 months
Open vial stability: 8 weeks at 2-8°C, or until the expiration date

Kit Components:

Microwells coated with monoclonal anti-dengue Ab, 8 wells x 12 strips
Dengue Ag positive control 0.5 mL
Dengue Ag negative control 0.5 mL
HRP–anti-dengue Conjugate 6mL
Wash buffer (30 x concentrate) 20 mL
TMB substrate A 6 mL
TMB substrate B 6 mL
Stop solution 6 mL
ELISA Working Sheet 2 sets
Product insert 1 set

Dengue Ns1 Ag Elisa 96T pack