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Typhoid Rapid Test

Description

Intended Use

Typhoid Rapid Test is an immunochromatographic assay designed for the qualitative detection of specific IgG and IgM andodies against a specific Salmonella typhi antigen（1-3） in human serum, plasma. Typhoid Rapid Test is intended to be used as in vitro diagnostic of typhoid fever. The results obtained should not be the sole determinant for clinical decision.

The facts We should know about Typhoid fever

Typhoid fever is an infectious disease caused by a bacterium, Salmonella typhi. It continues to be a major health problem especially in the Asia Pacific region, the Indian subcontinent, Central Asia, Africa and South America (4). Definitive clinical diagnosis of typhoid is unreliable because typhoid fever symptoms mimic other diseases with fever that are common in this part of the world. Clinical presentations vary tremendously among patients and cover a wide spectrum, hence the need for a good laboratory test (5). In additional, an accurate diagnosis of typhoid at an early stage is important not only for an aetiological diagnosis for the patient but also to identify individuals that might serve as a source of infection6. Thus all cases of fever should be tested for typhoid and a rapid laboratory tests will be required. Typhoid Rapid Test offers early and specific diagnosis of typhoid.

Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15 30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.

2. Using the provided disposable pipette, transfer 2 drops of serum/plasma (approximately 50 µl) to the sample well, and then start the timer.

3. If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

4. The result should be read in 15 minutes. Do not interpret the result after 15 minutes.

Interpretation of Results

Result	Test Line (T) Intensity	Possible Interpretation
POSITIVE	Three distinct red lines appear.
	Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (IgM).	A Test Line (IgM) appears that means IgM is positive.
	Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (IgG).	A Test Line (IgG) appears that means IgG is positive.
	Three colored bands appear on the membrane	IgM, IgG both appear mean IgM, IgG both are positive.
NEGATIVE	Only one colored band appears, in the control region (C), and no apparent red or pink line appears in the test region (T).
	No Test Line (T)	A No Test Line result could be interpreted as IgM, IgG both are negative.
INVALID
	Control line fail(s) to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for failure of reference lines to develop. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.