PCT Assay Kit CLIA

Primary DI

06974521001591

Basic UDI-DI Code

B-06974521001591

Reference

SUPM042036

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro quantitative detection of PCT in human serum, plasma or whole blood. Procalcitonin (PCT) consists of 116 amino acids and its molecular weight is about 12.8KDa. PCT is produced by procalcitonin precursor (pre-PCT) after N terminal signal is cut through enzymolysis. PCT will produce mature calcitonin (CT) after further enzymolysis. Under physiological conditions, PCT and CT are synthesized by thyroid C cells. Under healthy condition, the content of PCT in human serum is very low. In case of bacterial infection, the content of PCT decreases sharply. PCT is an important marker of specificity to distinguish from bacterial infection and inflammatory responses caused by other reasons. 2 Change in the PCT content reflects the severity of inflammatory response: A high PCT content means serious infection and a decrease in PCT content means that that infection is eased or eliminated. When the PCT content is greater than 0.5ng/mL, the patient has the risk of systematic inflammatory response; when the PCT content is greater than 10ng/mL, the patient is likely to have septicopyemia and infectious shock. Research shows that test of PCT content can be used for auxiliary diagnosis of bacterial infection and to guide the treatment of patients with partial bacterial infection or systematic infection using antibiotics.

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