Typhoid Rapid Test Dipstick/Strips (Whole Blood/Serum/Plasma)

A rapid test for the qualitative detection of IgG and IgM antibodies to Salmonella typhi (S. typhi) in human whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.

Applications:

The Typhoid Rapid Test Dipstick is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM types of antibodies against Salmonella typhi (S. typhi) in human whole blood, serum or plasma. It is intended to be used as a screening test as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid rapid test dipstick needs to be confirmed with alternative testing method.

Description:

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 1 . Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi 2 . 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 . In contrast, the Typhoid Rapid Test Dipstick is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen in whole blood, serum or plasma thus aid in the determination of current or previous exposure the S.typhi.

How to use?

Allow test dipstick, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test cards on a clean and level desk, then peel off the strip label of the test cards, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 ul) to the specimen area of the test dipstick, then add 3 drops of buffer (approximately 120 ul),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 40 ul ) to the specimen area of the test dipstick, then add 3 drops of
buffer (approximately 120 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 40 ul of fingerstick whole blood specimen to the specimen area of test dipstick, then add 3 drops of buffer (approximately 120 ul) and start the timer. See illustration below.
·To use hanging drops: Allow 1 hanging drop of fingerstick whole blood specimen (approximately 40 ul) to fall into the specimen area of test dipstick, then add 3 drops of buffer (approximately 120 ul) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. The test result should be read at 15 minutes. Do not interpret the result after 20 minutes.
 

INTERPRETATION OF RESULTS 
(Please refer to the illustration above)
POSITIVE:* Two or three lines appear. One colored line should always appear in the control line region (C) and another one or two apparent colored line(s) should be in the test line region(s) (IgM and/or IgG).
IgM Positive: One colored line should be in Control region (C), another line appears in IgM region. It indicates a positive Test result for antibodies to S. typhi (Isotype IgM)
IgG Positive: One colored line should be in Control region (C), another line appears in IgG region. It indicates a positive Test result for antibodies to S. typhi (Isotype IgG)
*NOTE: The intensity of the color in the test line regions (IgM and IgG) may vary depending on the concentration of Typhoid antibodies present in the specimen. Therefore, any shade of color in the test line region (IgM and/or IgG) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions (IgM and IgG).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.