The LOMINA Malariae 5x Test is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax malariae in whole blood.
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/P.v Rapid Test Strips (Whole Blood) is a rapid test to qualitatively detect the presence of the P.falciparum-specific HRP-II antigens and/or P.vivax LDH antigens found in P.vivax(P.v), The test utilizes colloid gold conjugate to selectively detect P.f-specific and P.v-malarial antigens in whole blood.
The test is developed and tested for the use of whole blood samples.
Test duration: 10 min
IVD category: IVD other
Disease category: Infectious Disease
The LOMINA Malariae 5x Rapid Test Strips (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f, P.v antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti- P.vivax LDH 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- P.vivax LDH antibodies on the membrane on P.v Line region. If the specimen contains HRP-II or P.vivax LDH 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 P.vivax LDH. 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.