Carcinoembryonic Antigen (CEA) Rapid Test Cassette One Step
Disposable For Diagnosis
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 40 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 98.90% |
| Specificity | 99.50% |
| Accuracy | 99.30% |
| Cut-Off | 5 ng/mL |
Applications:
The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid
chromatographic immunoassay for the qualitative detection of CEA in
whole blood, serum or plasma to aid in monitoring of cancer
patients.
Description:
Carcinoembryonic Antigen (CEA) is a tumor-associated antigen
characterized as an oncofetal glycoprotein. 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 qualitative 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 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.
The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a
combination of anti-CEA antibody coated particles and anti-CEA
antibodies to detect elevated levels of CEA in whole blood, serum
or plasma. The minimum detection level is 5ng/ml.
How to use?
Allow the test, specimen, buffer and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it as soon as
possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 1 drop of serum or
plasma (approximately 25 ul) to the specimen well of test Cassette,
then add 1 drop of buffer (approximately 40 ul) and start the
timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 2 drops of whole blood
(approximately 50 ul) to the specimen area, then add 1 drop of
buffer (approximately 40 ul), and start the timer. See illustration
below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer
approximately 50 ul of fingerstick whole blood specimen to the
specimen area of test cassette, then add 1 drop of buffer
(approximately 40 ul) and start the timer. See illustration below.
· To use hanging drops: Allow 2 hanging drops of fingerstick whole
blood specimen (approximately 50 ul) to fall into the specimen area
of test cassette, then add 1 drop of buffer (approximately 40 ul)
and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 5
minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration)
POSITIVE:* Two distinct colored lines appear. One colored line
should be in the control region (C) and another colored line should
be in the test region (T).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of CEA present in the specimen.
Therefore, any shade of color in the test region (T) should be
considered positive.
NEGATIVE: One colored line appears in the control region (C). No
apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test cassette. If the problem persists, discontinue using the
test kit immediately and contact your local distributor.
Order Information
| Cat. No. | Product Description | Specimen | Format | Kit Size | Cut-Off | Status |
|
| TCE-402 | CEA Rapid Test Cassette | WB/S/P | Cassette | 40 T | 5ng/mL | CE |
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