INTENDED USE
The Malaria Gold Rapid Test is a lateral flow chromatographic
immunoassay for the simultaneous detection and differentiation of
antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf)
and vivax, ovale, and malariea (Pv.o.m) in whole blood. This device is
intended to be used as a screening test and as an aid in the diagnosis of
infection with Plasmodium. Any reactive specimen with the Malaria
Gold Rapid Test must be confirmed with alternative testing method(s)
and clinical findings.

REAGENTS AND MATERIALS PROVIDED
1. Each kit contains 25 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 vial, 5 ml)
3. One package insert (instruction for use).

MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or Timer
2. Lancing device for whole blood test