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TRUSTline Dengue Ag (NS1) Rapid Test:

The TRUSTline Dengue Ag (NS1) Rapid Test 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. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with dengue virus.

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The test kit is not automated and does not require any additional instruments. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

Salient Features of Dengue Ag (NS1) Rapid Test:

• Detection of NS1 antigen.
• Early detection facilitates faster treatment.
• A simple assay procedure yields results within 20 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% compared to a commercial ELISA
• Cross-Reactivity: no cross-reactivity was 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)

Intended use of Dengue Ag (NS1) Rapid Test:

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. More than 2.5 billion people living in the areas of tropical Asia, Africa, Australia, and the Americas are at risk for dengue infection. An estimated 100 million cases of dengue fever and 250,000 cases of life-threatening dengue hemorrhagic fever occur annually on a worldwide basis.

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Serological detection of IgM antibody is the most common method for the diagnosis of acute dengue virus infection. Lately, detection of antigens, such as dengue NS1, released during virus replication in the infected patient showed very promising results; it enables diagnosis from the first day after the onset of fever up to day 9 once the clinical phase of the disease is over, thus, allowing early detection and prompt treatment.
The TRUSTline Dengue Ag Rapid Test detects all four serotype dengue NS1 antigens in human serum, plasma, or whole blood. The Dengue Ag (NS1) Rapid Test is a diagnostic tool used for detecting dengue virus infection. It can be performed within 20 minutes by minimally skilled personnel and without the use of laboratory equipment.

Sensitivity and Timing:

• NS1 tests can be as sensitive as molecular tests during the first 0-7 days of symptoms.
• After day 7, NS1 tests are not recommended.
• A positive NS1 test result confirms dengue virus infection but does not provide serotype information.

Combined Testing:

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• Combining NS1 and IgM antibody tests can usually provide a diagnostic result during the first 1-7 days of illness.
• If both antigen and antibody tests are negative, a second, convalescent phase specimen should be obtained and tested for IgM.

Each Kit Contains: