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.
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. The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P.falciparum-specific HRP-II antigens and/or Pan-malarial Aldolase antigens found in P.falciparum(P.f), P.vivax(P.v), P.ovale(P.o) and P.malariae(P.m). The test utilizes colloid gold conjugate to selectively detect P.f-specific and Pan-malarial antigens (P.f, P.v, P.o and P.m) in whole blood.
• Rapid Test.
• Buffer
• Disposable pipettes
• Instruction for use.
• 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.
Sample Collection&Storage
• The Malaria P.f/ Pan Rapid Test Device (Whole Blood) is intended for use with human whole blood specimens only.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days of collection.
• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a disposable specimen pipette:
• To use a Pipette: Transfer 5 μL of whole blood to Well-1 (W1) of the test device, then add 3~4 full drops of buffer to Well-2 (W2), and start the timer. (See illustration 1 below). Avoid trapping air bubbles in W1.
• To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration 1 below. Transfer the specimen to W1 of the test device, then add 3~4 full drops of buffer to W2 and start the timer. Avoid trapping air bubbles in W1.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
About Us
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
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