Nulife Rapid Test Kit (Typhoid IgG/IgM)

Overview

The Nulife Rapid Test Kit (Typhoid) is a lateral-flow immunoassay for the simultaneous detection and differentiation of anti–Salmonella typhi (S. typhi) IgG and IgM antibodies in human serum, plasma or whole blood.

Intended Use

Intended as a screening test and an aid in the diagnosis of infection with S. typhi, for in-vitro diagnostic (IVD) use only. Any reactive (positive) specimen should be confirmed with an alternative method such as ELISA or PCR, together with clinical findings, before a diagnostic decision is made.

What’s in the Kit

Each pack contains everything needed for a single test: the test cassette, a sample diluent (buffer) bottle, a disposable dropper/pipette, a sterile lancet, an alcohol swab and the instructions for use.

Directions for Use

1. Bring the specimen and all test components to room temperature. If refrigerated or frozen, mix the specimen well before testing.

2. Open the pouch at the notch, remove the test device and place it on a clean, flat surface. Label the device with the specimen’s ID number.

3. Add the sample:

• Whole blood – add 1 drop (about 20 µL) into the sample well, then immediately add 2 drops (about 60–70 µL) of sample diluent (buffer).

• Serum or plasma – holding the dropper vertically, add 1 drop (about 30–35 µL) into the sample well, avoiding air bubbles, then immediately add 2 drops of sample diluent.

4. Start a timer. Read the result at 20 minutes; strong positives may appear in as little as 1 minute. Do not read the result after 30 minutes, and discard the device after interpreting the result.

Reading the Result (C = Control, G = IgG, M = IgM)

• Negative – only the C band appears (no anti–S. typhi antibody detected).

• IgG positive – the C band plus the G band appear.

• IgM positive – the C band plus the M band appear.

• IgG & IgM positive – the C band plus both the G and M bands appear.

• Invalid – if the C band does not appear, the test is invalid; repeat with a new device.

Storage & Handling

Store the kit at 2–40°C, protected from sunlight. Single use only — do not reuse. Treat all specimens as potentially infectious and handle using standard bio-safety procedures.