CEA Tumor Marker Test Strip Blood Specimen Two Site Sandwich Immunoassay

Good sensitivity Carcinoembryonic Antigen (CEA) rapid test strip Tumor Marker, professional package, blood test

CEA Rapid Diagnostic Test strip

Intended Use:

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid, qualitative, two site sandwich immunoassay for the detection of Carcino Embryonic Antigen (CEA) levels in human serum / plasma / whole blood.

SUMMARY:

CEA is a large family of related cell-surface glycoproteins. The CEA family consists of about 10 genes located on chromosome 19. Up to 36 different glycoproteins have been identified in the CEA family. CEA is a glycoprotein with a molecular mass of 150300 kDa and contains 45-55% carbohydrate. It is a single polypeptide chain consisting of 641 amino acids, with lysine in the Nterminal. CEA was first described in 1965, when its presence was demonstrated in foetal gut tissue and in tumours from the gastrointestinal tract. Subsequently, CEA was detected in the circulation of patients and recognized as a serum marker for colorectal cancer. In the early diagnosis of disease recurrence following surgical resection, a serial increase in CEA levels is the first evidence of tumour. In patients with disseminated tumours, serial determinations are useful for monitoring response to therapy. CEA values decrease with effective treatment, while they increase with disease refractory to therapy or progressive metastases.

Test Principle:

CEA rapid test utilizes the principle of immunochromatography, a unique two site immunoassay on a nitrocellulose membrane. The conjugate pad contains two components - monoclonal anti-CEA antibody conjugated to colloidal gold and rabbit IgG conjugated to colloidal gold. As the test specimen flows through the membrane test assembly of the device, the highly specific monoclonal anti-CEA antibody-colloidal gold conjugate complexes with the CEA in the specimen and travels on the membrane due to capillary action along with the rabbit IgG-colloidal gold conjugate. This complex moves further on the membrane to the test region (T) where it is immobilized by another specific monoclonal anti-CEA antibody coated on the membrane leading to formation of a coloured band, if CEA level is equal to or higher than 5 ng/ml . The absence of this coloured band in the test region indicates a negative test result. The rabbit IgG-colloidal gold conjugate and unbound complex, if any, move further on the membrane and are subsequently immobilized by the anti-rabbit antibodies coated on the membrane at the control region (C), forming a coloured band. The control band formation is based on the ‘Rabbit / anti-Rabbit globulin’ system. Since it is completely independent of the analyte detection system, it facilitates formation of consistent control band signal independent of the analyte concentration. This control band acts as a procedural control and serves to validate the test results

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) has correctly identified a panel of specimens and has been compared to a leading commercial CEA EIA test using clinical specimens. The results show that the relative sensitivity of the CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is 98.9%, and the relative specificity is 99.5%.

Relative Sensitivity: 98.9% (95%CI*: 96.2%-99.9%) * Confidence Interval

Relative Specificity: 99.5% (95%CI*: 98.2%-99.9%)

Accuracy: 99.3% (95%CI*: 98.3%-99.8%)