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One Step Strip Style CEA Test
INTRODUCTION
One Step Strip Style CEA Test is a rapid direct binding
test for the detection of Carcinoma Embryonic Antigen (CEA)
in serum as an aid in the diagnosis of colorectal,
breast, lung and pancreas cancers. The test is based on
the principle of sandwich immunoassay for determination
of CEA in serum. Monoclonal and polyclonal antibodies
are employed to identify CEA specifically. This one
step test is very sensitive and only takes about 10-20
minutes. The sensitivity of the test can reach to 4
mg/L.
SPECIMEN COLLECTION
For serum, collect blood into a container without
anticoagulant. Allow the blood to clot and separate the
serum from the clot. Use the serum for testing.
If
the specimen cannot be tested on the day of collection,
store the serum specimen in a refrigerator or freezer.
Bring the specimens to room temperature before testing.
Do not freeze and thaw the specimen repeatedly.
TEST PROCEDURE
1.
Following the illustration, dip the strip with
arrow pointing down into the vessel of serum for about
10 seconds. Do not immerse past the MAX line (i.e.
Marker Line).
2.
Wait for 10 minutes and read results. Do not read
results after 30 minutes.
INTERPRETATION OF RESULTS
Ø
Negative:
Only one colored band appears on the control region.
No apparent band on the test region.
Ø
Positive:
Distinct color bands appear on the control and test
regions. Both test line and control line indicate a
positive CEA result. Color intensity of the test bands
may vary.
Ø
Invalid:
A total absence of color in both regions is an
indication of procedure error and/or that the test
reagent has deteriorated.
STORAGE AND STABILITY
The test kits can be stored at room temperature (18 to
30°C) in the
sealed pouch to the date of expiration. The test kits
should be kept away from direct sunlight, moisture and
heat.
