Lomina Malariae 5x antibody test

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.

Intended Use:

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.

The Malaria Pf/Pv Rapid Test:

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.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of  whole blood samples.

Whole blood

Major Parameters, Characteristics & Limits

Test duration: 10 min

IVD category: IVD other

Disease category: Infectious Disease

Sensitivity: 98.7% (95%CI: 93.1%-100%)
Specificity: 99.3% (95%CI*: 96.3%-100%)
Accuracy: 99.1% (95%CI*: 96.8%-99.9%)

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Instructions for use (IFU)

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

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