Nulife Rapid Test Kit (Dengue Combo NS1 + IgG/IgM)

Overview

An immuno-chromatographic (lateral-flow) assay for the qualitative detection of Dengue non-structural protein 1 (NS1) antigen and IgG/IgM antibodies to Dengue virus in human whole blood, serum or plasma.

Intended Use

Intended as an aid in the diagnosis of Dengue infection through qualitative detection of NS1 antigen and IgG/IgM antibodies. Reactive results should be confirmed with alternative methods and clinical findings.

Directions for Use

Allow the test device, assay buffer and sample to reach room temperature (20-30°C) before opening the foil pouch.

NS1 Antigen test: add 2 drops (about 90 µL) of whole blood, serum or plasma to well ‘S’; start the timer; read at 15 minutes and do not read after 20 minutes.

IgG/IgM test – serum or plasma: add 1 drop (10 µL) to well ‘S’; whole blood: add 2 drops (20 µL) to well ‘S’.

Then add 2 drops (about 60 µL) of assay buffer to well ‘S’ and start the timer.

Read the IgG/IgM result at 15 minutes; do not read after 20 minutes.

Reading the Result

•  NS1 Antigen Negative – only one colored line at the control region (C).
• NS1 Antigen Positive – colored lines appear at both the control (C) and test (T) regions.
• IgG/IgM Negative – only the control line (C) appears.
• IgG/IgM Positive (IgG and IgM) – in addition to the control band, colored bands appear at both the IgG and IgM regions.
• IgG/IgM Positive (IgM) – in addition to the control band, a colored band appears only at the IgM region.
• Invalid – the control line (C) fails to appear; repeat with a new test.