|Test Parameter:||Malaria P.f/Pan||Principle:||Immunochromatography|
|Storage:||Room Temperature 2-30℃||Main Component:||Rapid Test Cassette + Buffer + Dropper + IFU|
|Sample:||Blood||Reading Time:||In 15 Mins|
Plasmodium Falciparum Diagnostics Cassette Test,
Immunochromatography Diagnostics Cassette Test,
Plasmodium Vivax Rapid Test Kit
The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
Malaria is caused by a protozoan which invades human red blood cells.1 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. 2 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.3 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.
The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f, P.v, P.o and P.m antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-Aldolase antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test strip. The mixture then migrates upward on the membrane by capillary action, reacts with anti-Histidine-Rich Protein II (HRP-II) antibodies on the membrane on P.f Test Line region and with anti-Aldolase antibodies on the membrane on Pan Line region. If the specimen contains HRP-II or Plasmodium-specific Aldolase or both, a colored line will appear in P.f line region or Pan line region or two colored lines will appear in P.f line region and Pan line region. The absence of the colored lines in P.f line region or Pan line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific Aldolase. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Rapid Test Cassette in Pouch
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).
The test is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
1. The Malaria P.f/ Pan Rapid Test Device (Whole Blood) is intended for use with human whole blood specimens only.
2. 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.
3. Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
4. 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.
5. If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
6. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
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 pipette:
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.
For details, please contact Dewei staff for Instruction Manual!