A rapid test for the detection of Malaria in human blood (for in vitro test use only).

For the rapid qualitative determination of Malaria P.falciparum specific histidine rich protein-2 (Pf HRP-2) and Malaria P.vivax specific lactate dehydrogenase (pLDH) in human blood as an aid in the diagnosis of Malaria infection.

Malaria is a serious parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: Plasmodium falciparum, P. vivax, P. ovale, and P. malariae. In humans, the parasites (called sporozoites) migrate to the liver where they mature and release another form, the merozoites. The disease is now occurs in more than 90 countries worldwide, and it is estimated that there are over 500 million clinical cases and 2.7 million malaria-caused deaths per year. At the present, malaria is diagnosed by looking for the parasites in a drop of blood. Blood will be put onto a microscope slide and stained so that the parasites will be visible under a microscope.

The Genomix Malaria Antigen Test contains a membrane strip, which is pre-coated with two monoclonal antibodies as two separate lines across a test strip. One monoclonal antibody (test line 1) is specific to the P. falciparum histidine rich protein-2(Pf HRP-2) and another monoclonal antibody (test line 2) is pan specific to the lactate dehydrogenase of Plasmodium species (P. falciparum, vivax, malariae, ovale). Conjugate pad is dispensed with monoclonal antibodies conjugated to colloidal gold, which are pan specific to the P. falciparum histidine rich protein-2(Pf HRP-2) and lactate dehydrogenase of Plasmodium species.

So the Genomix Malaria Antigen Test is designed for the differential diagnosis between Plasmodium Falcifarum and the other Plasmodium species.

Genomix Malaria Antigen Test Kit contains following items to perform the assay:

1. Test devices
2. Instruction Card
3. Assay Buffer
4. Dropper (Optional)
5. Lancet(optional)
6. Silica Gel Pouch (Optional)

In order to obtain reproducible results, the following rules must be observed:

1. For in vitro diagnostic use only.
2. Use disposable gloves while handling potentially infectious material and performing the assay. Wash hands thoroughly afterwards.
3. Do not use it beyond the expiration date.
4. Do not eat or smoke while handling specimens.
5. Clean up spills thoroughly using an appropriate disinfectant.

1. Collect the whole blood into the collection tube (containing EDTA, citrate or heparin) by venipuncture.
2. If specimens are not immediately tested, they should be refrigerated at 2 ~ 8°C. For storage periods greater than three days, freezing is recommended. They should be brought to room temperature prior to use. Using the specimen in the long-term keeping more than three days can cause non-specific reaction.
3. When storage at 2 ~ 8°C, the whole blood sample should be used within three days.

1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce with a sterile lancet provided.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Using a pipette, gently squeeze the tube and immerse the open end in the blood drop. Then, gently release pressure to draw blood into the dropper.

1. Add 5μl of whole blood into Sample Well (small well).
2. Add two drops (60 μl) of assay buffer into buffer well.
3. Read the test result in 20 min.

1. Gently squeeze the tube.
2. Gently release to draw blood.
3. Immerse open end in blood.

P. falciparum Positive reaction

The presence of three color bands (three bands in all C, 1 and 2 areas) or two bands (one band in C area and another band in 1 area) indicates a positive result for P. falciparum. The Pf HRP-2 present in the sample reacts with the Pf HRP-2 conjugate and move through the test strip where the Pf HRP-2 is captured by the anti- P. falciparum specific histidine rich protein-2(Pf HRP-2).

P. vivax or other Plasmodium sp. Positive reaction

The presence of two color bands (one band in C area and another band in 2 area) indicates a positive result for P.vivax, P .malariae, or P. ovale. The pLDH present in the sample reacts with the pan anti-pLDH conjugate and move through the test strip where the pLDH is captured by pan specific anti-pLDH.

Negative reaction

The presence of only one band in C area within the result window indicates a negative result.

Invalid

The test is invalid if the line in C area does not appear. If this occurs, the test should be repeated using a new strip.

1. The test procedure, precautions and interpretation of results for this test must be followed when testing.
2. Anti-coagulants such as heparin, EDTA, and citrate do not affect the test result.
3. This test kit detects Plasmodium lactate dehydrogenase in patient whole blood and is useful as a screening procedure of malaria diagnosis.
4. Do not mix reagent of different lots.
5. The test is limited to the detection of antigen to Malaria Plasmodium sp.. Although the test is very accurate in detecting HRP-2 and pLDH, a low incidence of false results can occur. Other clinically available tests are required if Questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.