Infection Disease Typhoid Antibody Rapid Test with CE certificate
Test Device
| Product Name | Typhoid Antibody Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Typhoid Antibody Rapid Test Device is a lateral flow
immunoassay for the simultaneous detection and differentiation of
anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood,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 Antibody Rapid Test must be
confirmed with alternative testing method(s).
1. Clinical Performance For IgM Test
A total of 334 samples from susceptible subjects were tested by the
Typhoid Antibody Rapid Test and by a commercial S. typhi IgM EIA. Comparison for all subjects is showed in the following
table.
| Method | IgM EIA | Total Results |
| Typhoid Antibody Rapid Test | Results | Positive | Negative |
| Positive | 31 | 2 | 33 |
| Negative | 3 | 298 | 301 |
| Total Results | 34 | 300 | 334 |
Relative Sensitivity:91.2% (76.3% - 98.1%)*
Relative Specificity: 99.3% (97.6% - 99.9%)*
Relative Accuracy: 98.5% (96.5% - 99.5%)*
* 95% Confidence Intervals
2. Clinical Performance For IgG Test
A total of 314 samples from susceptible subjects were tested by the
Typhoid Antibody Rapid Test and by a commercial S. typhi IgG EIA kit. Comparison for all subjects is showed in the
following table.
| Method | IgG EIA | Total Results |
| Typhoid Antibody Rapid Test | Results | Positive | Negative |
| Positive | 13 | 2 | 15 |
| Negative | 1 | 298 | 299 |
| Total Results | 14 | 300 | 314 |
Relative Sensitivity:92.9% (66.1% - 99.8%)*
Relative Specificity: 99.3% (97.6% - 99.9%)*
Relative Accuracy: 99.0% (97.2% - 99.8%)*
* 95% Confidence Intervals
SUMMARY
Typhoid fever is caused by S. typhi, a Gram-negative bacterium. World-wide an estimated 17 million
cases and 600,000 associated deaths occur annually1. 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 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 Antibody Rapid Test Device 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.
