The CEA Test Cassette (Serum/Plasma) is based on Fluorescence immunoassay for the
quantitative detection of CEA in serum or plasma to aid in monitoring of cancer patients.
【SUMMARY】
Carcinoembryonic Antigen (CEA) is a tumor-associated antigen characterized as an
oncofetal glycoprotein.1 CEA is expressed in a variety of malignancies, particularly
pulmonary or gastrointestinal tumors (e.g. colon cancer, liver cancer and lung cancer).
CEA normally occurs in fetal gut tissue with detectable serum levels essentially
disappearing after birth.2,3 Therefore, elevated levels of CEA can be of significant value in
the diagnosis of primary carcinomas.
In addition to quantitative assessment, CEA testing plays an important role in the
monitoring of cancer patients. Clinical evidence indicates that CEA levels can serve as
predictive markers in both pre- and post-treatment of cancer. Progressive elevation of
CEA may signal tumor recurrence 3-36 months before clinical evidence of metastasis.
Persistent elevation of circulating CEA following treatment is strongly indicative of occult
metastatic and residual diseases and deficient therapeutic response.4
【PRINCIPLE】
The CEA Test Cassette (Serum/Plasma) detects CEA based on
Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad If the specimen contains CEA, it attaches to the fluorescent microspheres
conjugated anti-CEA antibodies. Then the complex will be captured by the capture
antibodies coated on the nitrocellulose membrane (Test line). The concentration of CEA
in the sample correlates with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and standard curve, the concentration
of CEA in the sample can be calculated by
Analyzer to show CEA
concentration in specimen.
【REAGENTS】
The test includes anti-CEA monoclonal antibody coated fluorphores and anti-CEA
antibody coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests 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 proper disposal of specimens. Wear protective clothing such as
laboratory coats, disposable gloves and eye protection when specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The CEA Test Cassette should only be used with the
Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The test should be stored at 4-30°C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the test from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Sample Taking
Collect the specimen according to standard procedures.
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.
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.
EDTA, Heparin sodium can be used as the anticoagulant tube for collecting the
specimen.
Sample Dilution / Sample Stability
Transfer 50 μl of serum or plasma to the buffer tube with the micro pipette.
Close the tube and shake the sample by hand vigorously for approximately 10
seconds to mix the sample and dilution buffer.
Let the diluted sample homogenize for approximately 1 minute. The sample can then
be used immediately or stored for up to 8 hours.
【MATERIALS】
Materials provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
Materials required but not provided
• Timer
• Centrifuge • Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-
30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or
“Quick test” mode.
2. Remove the ID card and insert it into the Analyzer ID Card Slot.
3. Pipette 50 μl of serum or plasma into the buffer tube, mix the specimen and the
buffer well.
4. Pipette 75 μl diluted sample into the sample well of the cassette. Start the timer at
the same time.
5. There are two test modes for Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample,Insert the test cassette into
the Analyzer click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time. The Analyzer will automatically countdown 15 minutes. After
the countdown, the Analyzer will give the result at once.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Analyzer.
The result of tests for CEA is calculated by Fluorescence Immunoassay
Analyzer and display the result on the screen. For additional information, please refer to
the user manual of Fluorescence Immunoassay Analyzer.
Linearity range of CEA is 1-500 ng/mL.
Reference range:<4ng/ml.