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One Step Cassette Style CEA Test
INTRODUCTION
One Step Cassette 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.
When you are ready to begin testing, open the
sealed pouch by tearing along the notch. Remove the
test from the pouch.
2.
Draw 0.2ml (about 4 drops) sample into the
pipette, and dispense it into the sample well on the
cassette.
3.
Wait 10-20 minutes and read results. Do not read
results after 30 minutes.
INTERPRETATION OF RESULTS
Ø
Negative:
Only one colored band appears on the control (C) region
. No apparent band on the test (T) region.
Ø
Positive:
In addition to a pink colored control (C) band, a
distinct pink colored band will also appear in the test
(T) region.
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.
PRECAUTION
1.
For in vitro diagnostic use only.
2.
Do not use test kit beyond the expiry date.
3.
The test device should not be reused.
