Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

Primary DI

D-GECEA-402aPK

Basic UDI-DI Code

B-GECEA-402aPK

Reference

GECEA-402a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Carcinoembrvonic antigen (CEA) is a glvcoprotein involved in cell adhesion, with a molecular weight of 180 kDa. CEA is present in high concentrations during fetal development, but ceases after birth. Therefore, it is not usually present in the blood of healthy adults. The normal CEA range for a non-smoking adult is less than 2.5 ng/mL and less than 5.0 ng/mL in a smoker. CEA, a prime oncofetal antigen, was first described by Gold and Feldman as a specific marker for adenocarcimonas of the gastrointestinal tract in adults.' Additional studies have also shown that increased CEA levels are also found in patients with other types of carcinomas such as breast,lung, genitourinary tract and Iymphoid tissue.23 Benign conditions that can also cause significantly higher than normal CEAlevels include inflammation of lung and gastrointestinal (Gl) tract and benign liver cancer. In colorectal cancer, the clinicaluse of CEA testing is for monitoring response to therapy and for documenting the progression of the disease.The Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a combination of colloidal gold coniugate and monoclonal antibodies to selectivelv detect elevated levels of CEA in whole blood. serum or plasma. The test has a cut-off value of 5ng/ml.

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