Dengue NS1 Ag Self Test

Intended Use

Dengue NS1 Antigen self-test is a rapid solid phase immune-chromatographic test for the qualitative detection of Dengue NS1 Ag in human whole blood/serum/plasma. This test is intended to be for home use with self-collected whole blood specimens from individuals aged 18 years or above( or collected by adults for individuals below 18 years of age) as well as for professional use with venous Whole blood/Serum/Plasma samples. This test is for in-vitro diagnostic use only & is designed as an aid in the early diagnosis of dengue infection patients with clinical symptoms.

Salient Features

• Rapid, Visual, Home test for qualitative detection of Dengue NS1 antigen detection in human whole blood/serum/plasma.
• Finger prick sample can be used.
• Single test pack.
• All material to perform the test & its disposal are provided with the kit.
• Based on Sandwich principle.\
• Detection of Dengue in Seronegative stage i.e. from Day 1 of fever.
• Detection of all 4 serotypes of dengue virus.
• Reliable diagnosis of both primary and secondary infection.
• 100% Sensitivity & 100 % Specificity.
• Shelf life: 30 month at 2-30 °C.

Principle

Dengue NS1 Antigen Self-test is an immunoassay based on the “sandwich” principle. Dengue NS1 antigen device contains two lines, “C” (Control line) & “T” (Dengue NS1 Antigen detection Test line). Test line is coated with anti-dengue NS1 Antibodies. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloidal conjugate making antigen antibodies complex. On addition of assay buffer, this complex migrates along the membrane to the test region & forms the visible pink line “T” as antibody-antigen-antibody gold conjugate complex.

The intensity of the test band in the device will vary depending upon the amount of antigen present in the sample. The appearance of any purple/pink colour in test region should be considered as reactive for Dengue NS1 antigen. A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

Ordering Information

Performance Characteristics

In-house Evaluation: The performance of the test is evaluated in- house and compared with a licensed commercially available rapid test kit by using a known panel of Serum, Plasma, and Whole blood samples.

Sensitivity–100% and Specificity– 100%.

External Evaluation (from NABL Referral Lab)

Specificity-100% and Sensitivity-100%