Medical IVD Rapid Diagnostic Test Kits CEA Test Strip

【INTENDED USE】

The Carcinoembryonic antigen (CEA) Rapid Test (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.

【PRINCIPLE】

The CEA Rapid Test 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

• Package insert

【PRECAUTIONS】

• For professional in vitro diagnostic use only.

• Do not use after expiration date indicated on package. Do not use the test if the foil pouch is damaged. Do not reuse tests.

• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).

• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.

• Read the entire procedure carefully prior to testing.

• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

• Humidity and temperature can adversely affect results.

• Used testing materials should be discarded according to local regulations.

【STORAGE AND STABILITY】

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture and heat.

 • DO NOT FREEZE.

【SAMPLE COLLECTION】

 The CEA Rapid Test is intended for use with human whole blood, serum, or plasma specimens only.

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

 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.

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

 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.

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

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

【DIRECTION OF USE】

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. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the cassette, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.

2. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes. 【INTERPRETATION OF RESULTS】

POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

【QUALITY CONTROL】

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.

• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

【LIMITATIONS】

1. The CEA Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human CEA. No meaning should be inferred from the color intensity or width of any apparent bands.

2. The CEA Rapid Test will only indicate the presence of human CEA inthespecimen and should not be used as the sole criteria for the diagnosis of variouscancers. 3. If the test result is negative and clinical symptoms persist, additional testingusing other clinical methods is recommended. A negative result does not at anytimerule out the possibility of cancer, as CEA may be present belowtheminimumdetection level of the test. As with all diagnostic tests, a confirmed diagnosis should only bemadebyaphysician after all clinical and laboratory findings have been evaluated.

【PERFORMANCE CHARACTERISTIC】

Relative Sensitivity: 99.33%

Relative Specificity: 99.44%

Overall Agreement: 99.41%

For further operation or performance details, please refer to final instruction manual.