Malaria P.f./Pan Test Cassette

HENSOtest Malaria P.f. /Pan Test Cassette  is a rapid chromatographic immunoassay for the qualitative detection of four kinds of circulating plasmodium falciparum (P. falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.)) in whole blood.

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 migrate to the liver where they mature and release another form, the merozoites.

Features

• Result read in 20 minutes
• High accuracy 99.9%
• Sensitivity 99.9%
• Specificity 99.9%

Packaging

Box of 25T, Ctn of 1000T

One Step Malaria pf (HRPⅡ)/PANLDH Antigen Detection Test Device(Whole Blood)

Intended use:

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

Summary

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 migrate to the liver where they mature and release another form, the merozoites.

The One-Step Malaria pf(HRP II)/PANLDH Antigen Detection Test Device(Whole Blood) 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 specific to P.falcparum histidine rich protein-2(Pf HRP-2)and pan specific to the lactate dehydrogenase of Plasmodium species

Materials:

Materials Provided

Test Device

Assay Buffer

Micropipette

Instructions for Use

 Materials not Provided

Calibrated pipette

Lancet

Timer

Specimen Collection

Collect whole blood into a collection tube (containing EDTA,citrate or heparin) by venipuncture.

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 after long-term storage of more than three days can cause non-specific reaction.

When stored at 2~8°C,the whole blood sample should be used within three days.

1. Clean the fingertip with an alcohol swab.
2. Squeeze the end of the fingertip and pierce with a sterile needle provided.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Take a specimen micropipette provided, use the gracile side at the end of the micropipette to touch the finger prick site and take quantitative specimen. Reference as the below,

Directions for Use:

1. Use sample loop or pipette to add 5μl of whole blood into sample well（A）.
2. Add 2 drops(60μl) of assay buffer into well(B).
3. Read the test result within 20 minutes.

Interpretation of Results

Negative:

Only one pink/purple band appears on the control (C) region. No apparent band on the test region (Pan, Pf).

Positive:

P.f malaria

In addition to a pink / purple colored control (C) band, a    pink / purple colored band appear at the (P.f) region respectively. The result is P.f positive.

Pan malaria:

In additional to a pink / purple colored control(C) band, one pink / purple band appears at the (P.an) region.

Pan and P. f malaria:

In additional to a pink / purple colored control(C) band, one pink / purple band appears at the (Pan) region,the other pink / purple colored band appear at the (P.f) region respectively. The result is P.f positive and P.an positive.

Invalid:

The test is invalid if no bands appear or the control line(C) doesn’t appear. If this occurs, the test should be repeated using a new one.

Precautions:

1. For professional in vitro diagnostic use only, Do not use after expiration date.
2. Read the instructions carefully before performing the test.
3. The test device must remain in the sealed pouch until use. Do not use if the pouch or device are damaged or if any lines are visible on the device before contact with the specimen. Do not freeze.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Handle all specimens as potentially infectious.
6. Follow standard bio-safety guidelines for handling and disposal of potentially infective material.
7. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.
8. Humidity and temperature can adversely affect results.

Storage and Stability:

1. The device can be stored at room temperature (2-30°C)。
2. The test device is stable through the expiration date printed on the sealed pouch.
3. The test device must remain in the sealed pouch until use. Do not freeze. Do not uses beyond the expiration date.