Dengue Ag (NS1) ELISA Kit

The TRUSTwell 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.

Features of Dengue Ag (NS1) ELISA Kit:

• Analytic sensitivity: Detects recombinant Dengue type 2 NS1 at a level as low as 0.3 ng/mL.
• Sensitivity: 100%
• Specificity: 97.8%
• SeraCare 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
• 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
• The product inserts 1 set

Intended use of Dengue Ag (NS1) ELISA Kit:

The TRUSTwell Dengue Ag (NS1) ELISA Kit is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of an acute infection with dengue viruses.

Introduction of TRUSTwell Dengue Ag (NS1) ELISA Kit:

Dengue virus is an enveloped, single-stranded, positive-sense RNA virus that comprises four related but distinct serotypes (DEN1, 2, 3, and 4). The virus is transmitted by mosquitoes of the daytime-biting Stegomyia family, principally Aedes aegypti and Aedes albopictus. Almost 4 billion people are at risk for dengue infection1. It has been estimated that 100-400 million cases of dengue infections can occur annually on a worldwide basis.

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 fever5,6. Immune responses to a dengue infection vary depending on the immune status of the patient. During primary infection, IgM anti-dengue virus starts to appear approximately 4-6 days after the onset of fever, peaks after approximately two weeks, and remains in circulation for about 2-3 months.

IgG anti-dengue virus levels begin to increase slowly, peak around 14-21 days, and then decrease to low levels, persisting for the duration of life. During secondary infection, NS1 antigen can be detected in patients for up to 9 days after the onset of illness. However, it was reported that NS1 detection could be compromised by pre-existing anti-dengue IgG antibodies.

The TRUSTwell Dengue Ag (NS1) ELISA Kit utilizes pairs of specific polyclonal and monoclonal anti-dengue antibodies for the detection of all four serotypes of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum or plasma.

TRUSTwell Dengue Ag (NS1) ELISA Kit: