Typhoid lgG/lgM Rapid Test
Typhoid lgG/IgMRapid Test is a lateral flow chromatographic immunoassay.The test consists of:1) a burgundy colored conjugate pad containing recombinant S. typhoid H antigen and O antigenconjugated with colloid gold (Typhoid conjugates) and rabbit lgG-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 IgG for the detection of IgG anti-S. typhi, T2band is pre-coated with reagents for the detection of lgM anti-S.typhi, and the C band is pre-coatedwith goat anti rabbit lgG.
When an adequate volume of test specimen is dispensed into the sample well of the test, the testspecimen migrates by capillary action across the test.Anti-S. typhi lgM if present in the patientspecimen will bind to the Typhoid conjugates.
1.Clinical Performance For lgM Test
Atotal of 334 samples from susceptible subjects were tested by the Typhoid Ab Rapid Test and by
a commercial S. typhi lgMEIA.Comparison for all subjects is showed in the following table.
| Typhoid Ab Rapid Test | |||
| lgM EIA | Positive | Negative | Total |
| Positive | 31 | 3 | 34 |
| Negative | 2 | 298 | 300 |
| Total | 33 | 302 | 334 |
| Relative Sensitivity | 91% | ||
| Relative Specificity | 99.3% | ||
| Overall Agreement | 98.5% | ||
2.Clinical Performance For lgG Test
Atotal of 314 samples from susceptible subjects were tested by the Typhoid Ab Rapid Test and by
a commercial S. typhi lgG EIA kit. Comparison for all subjects is showed in the following table.
| Dengue lgG/lgM Rapid Test | |||
| lgG samples | Positive | Negative | Total |
| Positive | 117 | 1 | 118 |
| Negative | 2 | 185 | 187 |
| Total | 119 | 186 | 305 |
| Relative Sensitivity | 99.0% | ||
| Relative Specificity | 98.3% | ||
| Overall Agreement | 99.0% | ||
When ready to test, open the pouchat the notch and remove device.Placethe test device on a clean, flat surface.
Fill the pipette dropper with the specimen. Holding thedropper vertically, dispense 1 drop (about 30-45 uL) ofspecimen into the sample well making sure that thereare no air bubbles.Then add 1 drop (about 35-50 uL)of Sample Diluent immediately.
Results can be read in 15 minutes.
Don't read results after 30 minutes.
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