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The CEA Test Device is a rapid visual immunoassay for the qualitative presumptive detection of human carcinoembryonic antigen (CEA). This test is intended for use as an aid in the diagnosis of various cancers.
The CEA Test Device is a rapid visual immunoassay for the qualitative presumptive detection of human carcinoembryonic antigen (CEA). This test is intended for use as an aid in the diagnosis of various cancers.
Carcinoembryonic antigen (CEA) is a tumor-associated antigen characterized as an oncofetal glycoprotein of approximately 200,000 molecular weight with Beta electrophoretic mobility, a single protein chain of about 800 amino acids, and 50-80% carbohydrate composition. CEA was first present as a specific antigen for adenocarcinoma of the colon. More recent studies have demonstrated CEA presence in a variety of malignancies, particularly those involving ectodermal tissues of gastrointestinal or pulmonary origin. Small amounts have also been demonstrated in secretions from the colonic mucosa. Additionally, CEA-like substances have been reported in normal bile from non-icteric patients. CEA testing can have significant value in the monitoring of patients. Persistent elevation in circulating CEA following treatment is strongly indicative of occult metastic and/or residual disease. A persistent rising CEA value may be associated with progressive malignant disease and poor therapeutic response. A declining CEA value is generally indicative of a favorable prognosis and good response to treatment. Measurement of CEA has been shown to be clinically relevant in the follow-up management of patients with colorectal, breast, lung, prostatic, pancreatic, ovarian, and other carcinomas. Follow-up studies of patients with colorectal, breast and lung carcinomas suggest that the preoperative CEA level has prognostic significance.
The test is developed and tested for the use of blood samples taken from a finger.
Whole blood
Test duration: 5 min
IVD category: IVD other
Disease category: Tumor markers
Sensitivity: 98.9% (95%CI: 96.2%-99.9%)
Specificity: 99.5% (95%CI*: 98.2%-99.9%)
Accuracy: 99.3% (95%CI*: 98.3%-99.8%)
The LOMINA CEA Antigen Rapid Test Device (Whole Blood/Serum/Plasma) detects human carcinoembryonic antigen (CEA) through visual interpretation of color development on the internal strip. CEA antibodies are immobilizedon the test region of the membrane. During testing, the specimen reacts with CEA antibodies conjugated to colored particles and precoated onto the sample pad of the test.The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane.If there are sufficient CEA antigens in the specimen,a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicatingthat the proper volume of specimen has been added and membrane wicking has occurred.
A single coloured line appears in the control area (C). No coloured line appears in the test area (T).
Two coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area (T). The intensity of the colour in the test area (T) will vary depending on the concentration of antibodies present in the sample. Therefore, any shade of colour in the test area (T) should be considered positive.
The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.
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