The Malaria plasmodium falciparum (P.f.) Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum in whole blood.
For professional use only.
For in vitro diagnostic use only.
Malaria is caused by a protozoan which invades human red blood cells.1 Malaria is one of the world's most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants, young children. Over half of the world's population lives in malarious areas. 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.2 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. Rapid Test is a rapid test to qualitatively detect the presence of the P.f. antigen.
• 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. Rapid Test can be performed using whole blood.
• Both Fingerstick Whole Blood and Venipuncture Whole Blood can be used.
• To collect Fingerstick Whole Blood specimens:
• Wash the patient's hand with soap and warm water or clean with an alcohol swab. Allow to dry.
• Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
• Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
• Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
• Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. For long term storage, specimens should be kept below -20°C. Whole blood collected by fingerstick should be tested immediately.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than three times.
• If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic 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 dropper:
• To use a Pipette: Transfer 5 μL of whole blood to the specimen well (S) of the test device, then add 3~4 full drops of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration 1below.
• To use a Disposable Specimen Dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration 2 below (approximately 5μL). Transfer the specimen to the specimen well (S) of the test device, then add 3~4 full drops of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S)
3. Wait for the red 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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