PLASMODIUM (MALARIA) - RT & POC

Primary DI

06936791020078

Basic UDI-DI Code

B-06936791020078

Reference

EX0301-25

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 in vitro qualitative test of plasmodium falciparum/ plasmodium vivax lactate dehydrogenase (LDH) in human venous blood. 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. This product is used for clinicians' auxiliary diagnosis of plasmodium falciparum infection, plasmodium vivax infection or infection by both, and the test result is only used for clinical reference, instead of being used as a sole basis for confirming or excluding such diseases.

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