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
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
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).
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