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. 

SUMMARY AND EXPLANATION OF THE TEST 
Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 
200 million people and kills more than 1 million people per year. It is 
caused by four species of Plasmodium: P. falciparum, P. vivax, P.ovale, 
and P. malariae. These plasmodia all infect and destroy human 
erythrocytes, producing chills, fever, anemia, and splenomegaly. P. 
falciparum causes more sever disease than the other plasmodial species 
and accounts for most malaria deaths. P. falciparum and P. vivax are 
the most common pathogens, however, there is considerable 
geographic variation in species distribution1. 
Traditionally, malaria is diagnosed by the demonstration of the 
organisms on Giemsa stained smears of peripheral blood, and the 
different species of plasmodium are distinguished by their appearance 
in infected erythrocytes1. The technique is capable of accurate and 
reliable diagnosis, but only when performed by skilled microscopists 
using defined protocols2, which presents major obstacles for the 
remote and poor areas of the world. 
The Malaria Gold Rapid Test is developed for solving these above 
obstacles. It detects the antibodies generated in serum or plasma in 
response to the infection of plasmodium. Utilizing the Pf. specific 
antigen (HRP-II) and pan-malaria antigen (aldolase),the test enables 
simultaneous detection and differentiation of the infection of 
P.falciparum and or P. vivax, ovale,and malariae3-5, by untrained or 
minimally skilled personnel, without laboratory equipment.

TEST PRINCIPLE 
The  Malaria Gold Rapid Test is a lateral flow chromatographic 
immunoassay. The test cassette consists of: 1) a burgundy colored 
conjugate pad containing recombinant HRP-II and aldolase conjugated 
with colloid gold (Pf conjugates and Pan-malariaconjugates) and 
rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip 
containing two test bands (T1 and T2 bands) and a control band (C 
band). The T1 band is pre-coated with recombinant HRP-II antigen for 
the detection of antibodies to Pf only, T2 band is pre-coated with 
aldolase for the detection of antibodies to Pan-malaria protozoa, and 
the C band is precoated with goat anti rabbit IgG. 
When an adequate volume of test specimen is dispensed into the 
sample well of the test cassette, the specimen migrates by capillary 
action across the cassette. Antibodies including IgG, IgM and IgA 
against HRP-II antigen, only found in P. falciparum infection, if 
present in the specimen will bind to the Pf conjugates. The 
immunocomplex is then captured on the membrane by the pre-coated 
HRP-II antigen, forming a burgundy colored T1 band, indicating a 
Pf positive test result. 
Alternatively, antibodies including IgG, IgM and IgA against aldolase, 
generated following the infection by the either form of malaria 
protozoa if present in the specimen will bind to the Panmalaria
conjugates. The immunocomplex is then captured by the pre-coated 
aldolase antigen on the membrane, forming a burgundy colored T2 
band, indicating a plasmodium antibody positive result. 
Absence of any T bands (T1 and T2) suggests a negative result. The 
test contains an internal control (C band) which should exhibit a 
burgundy colored band of the immunocomplex of goat anti-rabbit 
IgG/rabbit IgG-gold conjugate regardless of the color development on 
any of the T bands. Otherwise, the test result is invalid and the 
specimen must be retested with another device. 

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 

WARNINGS AND PRECAUTIONS 
For in Vitro Diagnostic Use 
1.   This package insert must be read completely before performing the 
test. Failure to follow the insert gives inaccurate test results. 
2.   Do not open the sealed pouch, unless ready to conduct the assay. 
3.   Do not use expired devices. 
4.   Bring all reagents to room temperature (15-30 °Ċ) before use. 
5. Do not use the components in any other type of test kit as a 
substitute for the components in this kit. 
6.   Do not use hemolized blood for the testing. 
7.   Wear protective clothing and disposable gloves while handling the 
kit reagents and clinical specimens. Wash hands thoroughly after 
performing the test. 
8.   Users of this test should follow the US CDC Universal Precautions 
for prevention of transmission of HIV, HBV and other 
blood-borne pathogens. 
9. Do not smoke, drink, or eat in areas where specimens or kit 
reagents are being handled. 
10. Dispose of all specimens and materials used to perform the test as 
biohazardous waste. 
11. Handle the Negative and Positive Control in the same manner as 
patient specimens. 
12. The testing results should be read within 15 minutes after a 
specimen is applied to the sample well or sample pad of the device. 
Read result after 15 minutes may give erroneous results. 
13. Do not perform the test in a room with strong air flow, ie. an 
electric fan or strong airconditioning. 

REAGENT PREPARATION AND STORAGE INSTRUCTIONS 
All reagents are ready to use as supplied. Store unused test device 
unopened at 4-30℃. The positive and negative controls should be kept 
at 2-8℃. If stored at 2-8℃, 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℃. 

SPECIMEN COLLECTION AND HANDLING 
Consider any materials of human origin as infectious and handle them 
using standard biosafety procedures. 
Plasma 
1. Collect blood specimen into a lavender, blue or green top 
collection tube (containing EDTA, citrate or heparin, respectively 
in Vacutainer®) by veinpuncture. 
2.   Separate the plasma by centrifugation. 
3.   Carefully withdraw the serum into a new pre-labeled tube. 
Serum 
1.   Collect blood specimen into a red top collection tube (containing 
no anticoagulants inVacutainer®) by veinpuncture. 
2.   Allow the blood to clot. 
3.   Separate the serum by centrifugation. 
4.   Carefully withdraw the serum into a new pre-labeled tube. 
Test specimens as soon as possible after collecting. Store specimens at 
2 to 8 °Ċif not testedimmediately. 
Store specimens at 2 to 8 °Ċup to 5 days. The specimens should be 
frozen at -20 °Ċfor longer storage. 
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen 
specimens to room temperature slowly and mix gently. Specimens 
containing visible particulate matter should be clarified by 
centrifugation before testing. 
Blood 
Drops of whole blood can be obtained by either finger tip puncture or 
veinpuncture. Do not use any hemolized blood for testing. 
Whole blood specimens should be stored in refrigeration (2°Ċ-8 °Ċ) if 
not tested immediately. The specimens must be tested within 24 hours 
of collection.