Typhoid Antigen Rapid Test

A 15 - minute, lateral flow immunoassay for the simultaneous detection and differentiation of Salmonella typhi (S. typhi) and Salmonella paratyphi  (S. paratyphi) antigens human fecal specimen, serum, plasma, whole blood or blood culture specimen.

INTENDED USE The S. Typhi/Paratyphi Ag Repid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of salmonella typhi (S. typhi) and salmonella paratyphi (S. paratyphi) antigens in human fecal specimen, serum, plasma, whole blood or blood culture specimen. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with S. typhi and or S. paratyphi.

TEST PROCEDURE Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Once the specimen is thawed, mix well prior to performing the assay. Step 2: When ready to test, open the pouch at the notch and remove the test device. Place the test device on a clean, Flat surface. Step 3: Be sure to label the device with the specimen ID number. Step 4:

For solid/watery fecal specimen 4.1   Shake the stool collection device vigorously to ensure a homogenous liquid suspension. 4.2   Hold the stool collection device vertically. Twist off the cap. Dispense 2 drops (70-90ul) of the solution into the center of the sample well of the cassette, making sure that there are no air  bubbles. Do not overload the solution.

For serum /plasma/whole blood specimen                                                                                               

Fill the plastic dropper with specimen. Holding the dropper vertically, dispense 1 drop (about 30-40ul) of serum/plasma or 1 drop of whole blood (about 40/50ul)into the sample well making sure that there are no air bubbles. 4.2   Immediately add 1 drop (about 30-45ul) of sample diluent to the sample well with bottle Positioned  Vertically.

For blood culture specimen   4.1  At the end of culture period, the red blood cells will settle to the bottom of tube. Fill the plastic dropper with the supernatant, do not disturb the blood cells. 4.2 Hold the dropper vertically, dispense 2 drops (80-90ul) of culture supernatant into The center of the sample well, sure that there are not air bubbles Step 5: Set up the timer. Step 6: Results can be read at 15 minutes. Positive results can be visible in as 1 minute. Negative results   must be confirmed at the end of the 20 minute only. 

However, any results  Interpreted outside of the 15-20 minute window should be considered invalid and must be  repeated. Discard used device after interpreting the result following local requirements  governing the disposal of device.  

Clinical Performance Sensitivity: 92.3% (95% Cl:74.9-99.1%) Specificity: 97.1% (95% Cl:90.0-99.7%) Overall agreement: 95.8%(95% Cl:89.7-98.9%)  

Contains : 25 - Individually packed cassette devices 25 - Stool Collection Devices 25- Patient ID Stickers 1 - Sample diluent (5mL) 1- Package Insert Typhoid, Typhidot, Typidot,