Malaria (p.f/pan) Antibody Rapid Test

Malaria (Malaria) is an infectious disease caused by plasmodium parasites in the human body. Infected by malaria mosquito bites or transfusion of the blood of a person carrying malaria parasites. Different malaria parasites cause vivax, vivax, falciparum, and ovarian malaria respectively. Malaria is mainly manifested as periodic and regular attacks, with body chills, fever, and hyperhidrosis. After a long period of repeated attacks, it can cause pelvic blood and splenomegaly. Children have a high morbidity rate, mostly in summer and autumn. The mortality rate of falciparum malaria is extremely high. Therefore, it is very important to reduce the time to eliminate through detection.


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Intended Use of Malaria (p.f/pan) Antibody Rapid Test


The Malaria P.f./P.v. Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of two kinds of circulating Plasmodium falciparum (P.f.) and Plasmodium vivax(P.v.) in whole blood.

General Description of Malaria (p.f/pan) Antibody Rapid Test


Malaria is caused by a protozoan which invades human red blood cells.1Malaria 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 the 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.2The 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./P.v. Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P. falciparumspecific HRP-II antigens and/or Pan-malarial Lactate Dehydrogenase antigens found in P. falciparum (P.f), and P. vivax (P.v.).

The test utilizes colloid gold conjugate to selectively detect P.f-specific and P. vivax (P.v.)-specific antigensin whole blood.

The Test Principle of Malaria (p.f/pan) Antibody Rapid Test


The Malaria P.f./P.v. Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f and P.vantigens in whole blood. The membrane is precoated with anti-HRP-II antibodies and anti-pLDH 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-pLDH antibodies on the membrane on P.v. Line region. 


If the specimen contains HRP-II or Plasmodium-specific P.vivaLDH or both, a colored line will appear in P.f line region or P.v. line region or two colored lines will appear in P.f line region and P.v. line region. The absence of the colored lines in P.f line region or P.v. line region indicates that the specimen does not contain HRP II and/or Plasmodium-specific P.vivaLDH. 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. 

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