INTENDED USE

The  Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human 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 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

REAGENTS AND MATERIALS PROVIDED

1.Each kit contains 25 or 30 test devices, each sealed in a foil pouch with three items inside:
    a. One cassette device.      
    b. One plastic dropper.
    c. One desiccant.
2.Sample Diluent (1 bottle, 5 mL)
3.One package insert (instruction for use).

REAGENT PREPARATION AND STORAGE INSTRUCTIONS

All reagents are ready to use as supplied. Store unused test devices unopened at 2°C-30°C.  The positive and negative controls should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.

ASSAY PROCEDURE

Step 1:     Bring the specimen and test components to room temperature if refrigerated or frozen.  Mix the specimen well prior to assay once thawed.
Step 2:     When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3:     Be sure to label the device with specimen’s ID number.
Step 4:     Fill the pipette dropper with the specimen. 
                Holding the dropper vertically, dispense 1 drop (about 30-45 L) of specimen into the sample
                well making sure that there are no air bubbles.
                Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.

Step 5:    Set up timer.

Step 6:     Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.

Don’t read result after 15  minutes. To avoid confusion, discard the test device after interpreting the result.

INTERPRETATION OF ASSAY RESULT

1.NEGATIVE OR NON-REACTIVE RESULT: If only the C band is present, the absence of any burgundy color in the both test bands (M and G) indicates that no anti-S. typhi antibody is detected in the specimen.  The result is negative or non-reactive.

2.  POSITIVE OR REACTIVE RESULT: 
　　2.1In addition to the presence of C band, if only M band is developed, the test indicates for the presence of anti- S. typhi IgM in the specimen. The result is IgM positive or reactive.

　　2.2In addition to the presence of C band, if only G band is developed, the test indicates for the presence of anti- S. typhi IgG in the specimen. The result is IgG positive or reactive.

　　2.３In addition to the presence of C band, both M and G bands are developed, the test indicates for the presence of anti-S. typhi IgG and IgM in the specimen. The result is both IgG and IgM positive or reactive.

　　Samples with positive or reactive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

3.INVALID: If no C band is developed, the assay is invalid regardless of any burgundy color in the test bands as indicated below. Repeat the assay with a new device.