The Filariasis IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial parasites (W. Bancrofti and B. Malayi) in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of infection with lymphatic filarial parasites. Any reactive specimen with theFilariasis IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
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. One package insert (instruction for instruction).
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 2-3 drops (about 60- 90 µL) of specimen into the sample well making sure that there are no air bubbles.
Note: Add 1 drop of Saline or Phosphate-Saline buffer (common buffers used in clinic, not provided in the kit) into the sample well if flow migration is not observed within 30 seconds in the result window, which could occur with a highly viscous specimen.
Step 5: Set up timer.
Step 6: Results can be read in 10 minutes. Positive results can be visible in as short as 1 minute.
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.
