The Chagas Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with T. cruzi. Any reactive specimen with the Chagas Ab Combo Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
REAGENTS AND MATERIALS PROVIDED
1.Each kit contains 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).
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: For whole blood test
- Dispense 1 drop (about 40-50 µL) of the whole blood specimen into the sample well
- Then add 1 drop (about 35 -50 µL) of Sample Diluent immediately
Storage
Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry place, valid for 24 months.
DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.
