Malaria P.f/Pan Rapid Diagnostic Test Kit with Whole blood Sample
【INTENDED USE】
The Malaria P.f/Pan Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
For professional use only.
【INTRODUCTION】
Malaria is caused by a protozoan which invades human red blood cells. World Health Organization estimates that 3.3 billion were at risks of acquiring malaria in 2006, with 247 million of these developing clinical malaria (86% in Africa), and nearly 1 million (mostly African children) dying from the disease. Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century. The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology.
【PRINCIPLE】
This reagent uses immunochromatography to detect the specific soluble protein PF lactate dehydrogenase and pan lactate dehydrogenase contained in erythrocytes or in plasmodium released outside erythrocytes.
During detection, add 5 μ l of whole blood sample to the reagent sampling hole, and then add 3-4 drops of lysate. The lysed sample is chromatographed upward under the capillary effect. If the sample contains PF/PAN lactate dehydrogenase, it will react with the pre-labeled lactate dehydrogenase antibody to form a complex. Under the action of chromatography, it will be captured by the PF/PAN lactate dehydrogenase antibody pre-fixed on the membrane, forming one or two red reaction lines in the detection area, which is the positive result at this time; If the sample does not contain PF/PAN lactate dehydrogenase and no red reaction line is formed in the detection area, it is negative at this time. No matter whether the substance to be tested is in the sample or not, a red reaction line will be formed in the quality control area, which is the standard to judge whether the sample quantity is sufficient and whether the chromatographic process is normal, and also the internal control standard for the reagent.
【WARNINGS AND PRECAUTIONS】
- Immunoassay for in vitro diagnostic use only.
- Do not use after expiration date.
- The test should remain in the sealed pouch until use.
- The used test should be discarded according to local regulations.
【CONTENTS】
- Rapid Test.
- Buffer
- Disposable pipettes
- Instruction for use.
【STORAGE AND STABILITY】
- The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
- The test must remain in the sealed pouch until use.
- Keep away from direct sunlight, moisture and heat.
- Do not freeze.
- Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【OPERATION】
- Test must be in room temperature (15ºC to 30ºC)
- Donor collects urine specimen in a urine cup.
- Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
- Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
- The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.
【INTERPRETATION OF RESULTS】
POSITIVE:* Two or Three distinct colored lines appear.
P. falciparum or mixed malaria infection:one line appears in the control region, one line appears in Pan line region and one line appears in P.f line region.
P. falciparum infection: one line appears in the control region, and one line appears in P.f line region.
Non-falciparum Plasmodium species infection : one line appears in the control region and one line appears in Pan line region.
*NOTE: The color intensity of P.f or Pan test lines may vary depending on the concentration of antigens, viz., HRP-II or Aldolase present in the specimen.
NEGATIVE: Only one colored line appears in the control region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
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