INTENDED USE
The  Filariasis IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antilymphatic filarial parasites (W. Bancrofti and B. Malayi) in human serum, plasma or whole blood. 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 the  Filariasis IgG/IgM Combo Rapid Test must be confirmed with alternative testing method(s).

INTRODUCTION
The lymphatic filariasis known as Elephantiasis, mainly caused by W. bancrofti and  B. malayi,  affects about 120 million people over 80 countries1,2.  The disease is transmitted to humans by the bites of infected mosquitoes within which the microflariae sucked from an infected human subject develops into third-stage larvae. Generally, repeated and prolonged exposure to infected larvae is required for establishment of human infection.

The definitive parasitologic diagnosis is the demonstration of microflariae in blood samples3. However, this gold standard test is restricted by the requirement for nocturnal blood collection and lack of adequate sensitivity. Detection of circulating antigens is commercially available. Its usefulness is limited for W. bancrofti4. In addition, microfilaremia and antigenemia develop from months to years after exposure. 

Antibody detection provides an early means to detect filarial parasite infection. Presence of IgM to the parasite antigens suggest current infection, whereas, IgG corresponds to late stage of infection or past infection5.  Furthermore, identification of conserved antigens allows ‘pan-filaria’ test to be applicable. Utilization of recombinant proteins eliminates cross-reaction with individuals having other parasitic diseases6.  The  Filariasis IgG/IgM Combo Rapid Test uses conserved recombinant antigens to simultaneously detect IgG and IgM to the W. bancrofti and  B. malayi parasites without the restriction on specimen collection. 

KIT COMPONENTS
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).

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

Apply 1 drop of whole blood (about 40-50 µL) into the sample well.

Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.

1 drop of specimen              1 drop of sample diluent      15 minutes

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.

PERFORMANCE CHARACTERISTICS