POCT Carcinoembryonic Antigen CEA Rapid Diagnostic Test Kit Blood Sample One Step Test Kit

POCT Carcinoembryonic Antigen CEA Rapid Diagnostic Test Kit One Step Blood Sample

INTENDED USE
The CEA Rapid Test Kit (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of human carcinoembryonic antigen (CEA) in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of various cancers.
 
INTRODUCTION

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.
 
TEST PRINCIPLE
The CEA Rapid Test Kit detects human carcinoembryonic antigen (CEA) through visual interpretation of color development on the internal strip. CEA antibodies are immobilized on 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, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
 
MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Buffer

• Pipette
• Instruction Manual
 
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
 
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.

SAMPLE COLLECTION

1) The CEA Rapid Test Kit (Whole Blood/Serum/Plasma) is intended for use with human whole blood, serum, or plasma specimens only.

2) Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

3) Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

4) Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

5) Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

6) If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

7) Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

OPERATION 

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.

2) Transfer 3 drops of whole blood/serum/plasma to the specimen well (S) of the device with the provided disposable pipette, and start the timer.

OR

Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

3) If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).

4) Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

For detailed information, please contact Dewei person for Manual Instruction.