Nulife Rapid Test Kit (Chikungunya IgG/IgM)

Overview

A rapid chromatographic (lateral-flow) immunoassay for the qualitative detection of IgG and IgM antibodies to Chikungunya (CHIK) in human whole blood, serum or plasma.

Intended Use

Intended as a screening test and as an aid in the diagnosis of infection with Chikungunya. Any reactive specimen must be confirmed with alternative testing method(s) and clinical findings.

Directions for Use

1. Allow the test cassette and specimen to equilibrate to room temperature (15-30°C), then place the cassette on a clean, level surface.

For serum or plasma: add 1 drop of serum or plasma (approx. 40 µL) to the specimen area, then add 2 drops of buffer (approx. 80 µL) and start the timer.

For venipuncture whole blood: add 1 drop of whole blood (approx. 40 µL) to the specimen area, then add 2 drops of buffer (approx. 80 µL) and start the timer.

For fingerstick whole blood: transfer approx. 40 µL of specimen (via capillary tube or 1 hanging drop) to the specimen area, then add 2 drops of buffer (approx. 80 µL) and start the timer.

Read the result at 15 minutes; do not interpret the result after 20 minutes.

Reading the Result

• IgG Positive – a colored line in the control region (C) and a colored line in the IgG region.
• IgM Positive – a colored line in the control region (C) and a colored line in the IgM region.
• IgG and IgM Positive – a colored line in the control region (C) plus colored lines in both the IgG and IgM regions.
• Negative – only one colored line appears in the control region (C); no line in the IgG or IgM region.
• Invalid – the control line fails to appear; review the procedure and repeat with a new test cassette.