Typhoid IgG/IgM Rapid Test
For the qualitative detection of Typhoid IgG/IgM Antibody in serum/
plasma/whole blood
Typhoid IgG/IgM Combo Rapid Test Kit High Accurate Home Use
Infectious Disease Typhoid Fever Fast Diagnostsic Cassette
Intended Use
The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for
the simultaneous detection and differentiation of anti-Salmonella
typhi (S. typhi) IgG and IgM in human serum or plasma. It is
intended to be used as a screening test and as an aid in the
diagnosis of infection with S. typhi. Any reactive specimen with
the Typhoid IgG/IgM Rapid Test must be confirmed with alternative
testing method(s).
Principle
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. typhi.
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 can not afford to perform this complicated and
time-consuming procedure, Filix-Widal test is used to facilitate
the diagnosis. However, many limitations lead to difficulties in
the interpretation of the Widal test3,4.
In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid
laboratory test. The test simultaneously detects and differentiates
the IgG and the IgM antibodies to S. typhi specific antigen5 thus
to aid in the determination of current or previous exposure to the
S. typhi.
Assay Procedure
1. Bring the specimen and test components to room temperature if
refrigerated or frozen. Mix the specimen well prior to assay once
thawed.
2. When ready to test, open the pouch at the notch and remove
device. Place the test device on a clean, flat surface.
3. Fill the pipette dropper with the specimen. Holding the dropper
vertically, dispense 1 drop (about 30-45 µL) of specimen into the
sample well making sure that there are no air bubbles. Then add 1
drop (about 35-50 µL) of Sample Diluent immediately.
4. Results can be read in 15 minutes. Positive results can be
visible in as short as 1 minute.
Interpretation of Result
Negative: If only the C band presents, the absence of any burgundy color in
the both test bands (M and G) indicates that no anti-S. typhi
antibody is detected in the specimen. The result is negative or
non-reactive.
IgG Positive: In addition to the presence of C band, if only G band is
developed, the test indicates for the presence of anti- S. typhi
IgG in the specimen. The result is IgG positive or reactive.
IgM Positive: In addition to the presence of C band, if only M band is
developed, the test indicates for the presence of anti- S. typhi
IgM in the specimen. The result is IgM positive or reactive.
IgM and IgG Positive: In addition to the presence of C band, both M and G bands are
developed, the test indicates for the presence of anti-S. typhi IgG
and IgM in the specimen. The result is both IgG and IgM positive or
reactive.
Invalid: The test results are INVALID, if no control line is visible,
regardless of the presence or absence of lines in the IgG or IgM
test zone of the strip. Repeat the test using a new cassette.
