PLASMODIUM (MALARIA) - RT & POC

Primary DI

06936791020085

Basic UDI-DI Code

B-06936791020085

Reference

EX0401-25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This product is intended for use of qualitative test of plasmodium falciparum/ plasmodium vivax lactate dehydrogenase (LDH) in venous whole blood of human. As an insect-borne infectious disease that seriously destroys human health, malaria is not only a widespread disease in some developing countries in tropical and subtropical areas, but also one of the most dreadful infections that threaten people's health. The plasmodium lactate dehydrogenase (LDHp) is currently a major and commonly used target antigen in the Immunochromatography Diagnostic Technology for falciparum malaria/vivax malaria. LDHp is significantly different from LDH of the host animal in the aspects of physical and chemical properties, immunological traits and enzymology. In the reaction of catalyzing lactic acid to produce pyruvic acid, LDHp could quickly use the NAD analog of 3-Acetylpyridine NAD (APAD) as the coenzyme, while the LDH of red blood cell (LDHr) participates in the reaction quite slowly with the presence of APAD. Besides, the species- and genus-specificity of LDHp makes it an ideal target antigen for plasmodium test. As LDHp could only be produced in live plasmodium, the blood LDHp level is positively correlated with the hemoplasmodium. Therefore, LDHp could also be used to detect if the plasmodium is dead, and further monitor the efficacy of medicines and the relapse. The test results of this product are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).