Infection Disease Typhoid Antibody Rapid Test with CE certificate uncut sheet

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).

TEST PRINCIPLE

The Typhoid Ab Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant S. typhoid H antigen and O antigen conjugated with colloid gold (Typhoid conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi, T2 band is pre-coated with reagents for the detection of IgG anti-S. typhi , and the C band is pre-coated with goat anti rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. Anti-S. typhi IgM if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored T2 band, indicating a S. typhi IgM positive test result.

Anti-S. typhi IgG if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored T1 band, indicating a S. typhi IgG positive test result.

Absence of any test bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device

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.

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.

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 test^3,4.

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.