A rapid test for the qualitative detection of IgG and IgM antibodies to Salmonella typhi (S. typhi) in human whole blood, serum or plasma. For professional in vitro diagnostic use only.
Typhoid fever is caused by S. typhi, a Gram-negative bacterium. World-wide an estimated 17 million cases and 600,000 associated deaths occur annually. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi2. Evidence of h. pylori infection also presents an increase risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gallbladder. The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion in the facilities that cannot afford to perform this complicated and time consuming procedure, Widal Test (also referred as Weil-Felix Test) is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test 3, 4. In contrast, the Typhoid Rapid Test Cassette is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen5 in whole blood, serum or plasma thus aid in the determination of current or previous exposure the S. typhi.
For the serum or plasma sample: Hold the dropper vertically and transfer 1 drop of serum or plasma (about 20μL) to the sample in the test window, then add 1 drop to the buffer (approximately 40μL) and start the stopwatch. Avoid trapping air bubbles in the sample.
For the complete venipuncture blood sample: Hold the dropper vertically and transfer 1 drop of whole blood (μL about 20) to the sample, then add 2 drops to the buffer (about 80 μL), and start the stopwatch. See illustration below.
For the complete blood sample of the fingertip: To use a capillary tube: Fill a capillary tube and transfer approximately 20 μL of whole blood from the fingertip to the sample area of the test window, then add 2 Drops on the pad (approx. 80 μL) and start the stopwatch.
Wait for the colored strips to appear. The result should be interpreted after 15 minutes. Do not interpret results after 15 minutes.
Positive: Two or three lines appear. One colored line should be in the control line region (C) and another apparent colored line should be test region 1 or 2 or both (1 & 2 printed on the test device)
Negative: One coloured line appears in the control line region(C). No line appears in the test line region (T).
Invalid:No visible band at all or test band without control band.