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OneStep CEA InstaTest, Catalog #13060, Page 1
Atlas Link
One Step CEA InstaTest
Serum Test
Cat. No. 13060-50
INTENDED USE
The Atlas Link OneStep CEA InstaTest is a colloidal-goldantibody complex based immunoassay designed for the
qualitative determination of human carcinoembryonic antigen
(CEA) in serum or plasma.
It is intended as an aid in
monitoring cancer patients for disease progression or
response to therapy or for the detection of recurrent or
residual disease.
This test provides only preliminary data. Positive results should be
confirmed by other methods such as radioimmunoassay (RIA) or enzyme
immunoassay (EIA).
SUMMARY AND EXPLANATION OF THE TEST
Carcinoembryonic antigen (CEA), first described in 1965 by
Gold and Freeman, 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.
The development of the radioimmunoassay (RIA) in 1969 by
Thompson et al made it possible to detect a very low
concentration of CEA in circulation blood, other body fluids,
and normal and diseased tissues. Two years later, Hansen et
al developed a modified RIA for CEA. The QuikPac II
OneStep CEA Test is a recently developed, sensitive and less
complicated immunoassay of CEA.
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.
CEA testing is not recommended as a screening procedure to
detect cancer in the general population; however, use of the
CEA test as an adjunctive test in the prognosis and
management of cancer patients is widely accepted.
PRINCIPLE OF THE TEST
The OneStep CEA InstaTest is an immunochromatographic
assay which utilizies a unique combination of monoclonal
and polyclonal antibodies to selectively identify CEA in
serum or plasma specimens with a high degree of sensitivity.
Elevated levels of CEA are detected in ten minutes or less.
Serum specimen migrates through the absorbent device and
mixes with labeled antibody-dye conjugate in the test
membrane. CEA antigen present in the specimen binds to the
labeled conjugate to form an antibody-antigen complex. In
the test zone, anti-CEA antibody binds to the antibodyantigen complex causing a pink-rose test band to appear in
the test zone "T." The test band indicates that the CEA level
in the sample specimen is at or above the detection sensitivity
of the test. In the control zone "C," unbound sample-dye
conjugate binds to immobilized reagents producing a rosepink color control band. The control band appears when the
test is conducted correctly and the reagents are functioning
properly.
REAGENTS AND MATERIALS PROVIDED
1.
Test Cassette.
2.
Sample Dropper.
An absorbent device with an
antibody coated membrane
and a pad treated with
polyclonal IgG-dye conjugate
in a protein matrix containing
sodium azide.
A transfer pipette is included
with each test device inside
the foil pouch.
3. Test Instructions.
Optional Components:
4. Negative Control, 1.0 ml One vial of zero concentration
of CEA supplied in liquid
form, ready to use.
5. Positive Control, 1.0 ml One vial contains CEA
supplied in liquid form, ready
to use.
MATERIAL REQUIRED, BUT NOT PROVIDED
1.
2.
3.
Specimen collection container.
Centrifuge capable of 1000 x g (for centrifuging whole
blood specimens).
Clock or timer.
STORAGE AND STABILITY
Do not freeze. The testing device may be stored at room
temperature (15º-28ºC), however the controls must be
refrigerated at 2º-8ºC.
WARNINGS AND PRECAUTIONS
This kit contains no infectious reagents, however proper
precautions should always be taken when handling patient
specimens.
1.
Preclude any pipetting by mouth.
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
OneStep CEA InstaTest, Catalog #13060, Page 2
2.
3.
4.
5.
6.
7.
8.
Do not allow smoking or eating where specimen and
reagents are being handled.
Wear disposable gloves while handling kit reagents or
specimens. Wash hands thoroughly afterwards.
Avoid splashing or aerosol formation.
Clean up spills thoroughly using an appropriate
intermediate-to-high level disinfectant.
Decontaminate and dispose of all specimens and
potentially contaminated materials as if they were
infectious.
Do not use reagents after the expiration date.
For in vitro diagnostic use only.
INTERPRETATION OF RESULTS
C
T
C
T
C
T
S
S
S
POSITIVE
NEGATIVE
INVALID
QUALITY CONTROL
An internal procedure control has been incorporated into the
test to ensure proper kit performance and reliability.
The use of a control is recommended to verify proper kit
performance. Quality control samples should be tested
according to quality control requirements established by the
testing laboratory.
Use the control in the same manner as a specimen by
following the test procedure. The expected results should be
obtained when using the control.
1.
2.
3.
Positive. Two rose-pink color bands appear in the result window, one
in the Control Zone "C" and one in Test Zone "T." A positive result
indicates CEA is present in the sample at or above the 5 ng/ml
detection cutoff.
Negative. One rose-pink color band appears in the Control Zone "C"
with no apparent color band in the Test Zone "T". The CEA level of
the specimen is below the 5 ng/ml detection cutoff of the test.
Invalid. If no rose-pink color band is visible in the control zone "C,"
the test result is invalid. Retest the specimen using a new test device.
Note: There is no meaning attributed to line color intensity or width.
SPECIMEN COLLECTION AND PREPARATION
Collect blood aseptically by venipuncture into a clean tube
without anticoagulants. Permit blood to clot for twenty to
thirty minutes at room temperature. Centrifuge to obtain
clear serum and transfer serum into a clean plastic or glass
tube. The test may be performed using human serum or
plasma.
LIMITATIONS OF THE TEST
If specimens are not immediately tested they should be
refrigerated at 2-8° C. For storage periods greater than three
days, freezing is recommended (-20ºC). If specimens are to
be shipped, they should be packed in compliance with federal
regulations covering the transportation of etiologic agents.
4.
1.
2.
3.
5.
Specimens containing precipitate may yield inconsistent test
results. Such specimens must be clarified prior to assaying.
The test is limited to the detection CEA in serum,
plasma, or recalcified plasma.
The test is for in vitro diagnostic use only.
Although the test is very accurate in detecting elevated
CEA levels, a low incidence of false results may occur.
The test is a qualitative screening assay and is not
suggested for quantitative CEA determination.
As with all diagnostic tests, a definitive clinical diagnosis
should not be based on the results of a single test, but
should only be made by the physician after all clinical
and laboratory findings have been evaluated.
PERFORMANCE CHARACTERISTICS
TEST PROCEDURE
Bring unopened test components and sample specimens to room temperature
prior to testing.
1.
Open a foil pouch by tearing along the splice and remove
the test cassette and
sample dropper.
2. Holding the dropper
vertically, add four
full drops of sample
specimen without air
bubbles to the sample
well "S" of the test
device.
3. Read the result at ten minutes.
IMPORTANT: Do not interpret the result after more than 10
minutes. Discard the test device after reading and recording the
result.
1.
Sensitivity
The analytical sensitivity of the OneStep CEA InstaTest
is 5 ng/ml.
2.
Accuracy
A study was performed using ninety-five positive and
negative serum specimens. Each specimen was assayed
with the OneStep CEA InstaTest and a commercially
available CEA test according to the respective package
insert instructions.
Correlation Study
OneStep
Commercial Test
+/+
+/-
40
0
-/+
-/-
1
54
Relative Sensitivity:
97.6%
Relative Specificity:
100%
The data demonstrates an excellent correlation between the two tests.
The clinical significance of the two tests is comparable.
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
OneStep CEA InstaTest, Catalog #13060, Page 3
3.
Cross-reactivity
The OneStep CEA InstaTest was conducted on patient
samples in the presence of excessive hemolysis, bilirubin
and lipemia. No interference was noted up to the
concentration indicated.
Bilirubin
Hemoglobin
Total Lipids
Triglycerides
30.0 mg/dl
2000 mg/dl
1700.0 mg/dl
700.0 mg/dl
BIBLIOGRAPHY
1.
Thompson, D.M.P., Krupey, J., Freedman, D.O., and Gold, P., The
Radioimmunoassay of Circulating Carcinoembryonic Antigen of the
Human Digestive System, Proc. Natl. Acad. Sci. USA, Vol. 64, p. 161,
1969.
2. Reynoso, G., Chu. T.M., Holyoke, D., et al: Carcinoembrryonic
Antigen in Patients with Different Cancers; JAMA, Vol. 220, p. 361,
1972.
3. Zamcheck, N., Carcinoembryonic Antigen; Quantitative Variations in
Circulating Levels in Benign and Malignant Digestive Tract Disease,
Adv. Itern. Med., Vol. 19, p.143, 1974.
4. Gold, P., and Freedman, S.O., Specific Carcinoembryonic Antigens of
the Human Digestive System, J. Exp. Med., Vol. 122, p. 467, 1965.
5. Gold, P., and Freedman, S.O., Demonstration of Tumor Specific
Antigens in Human Colonic Carcinoma by Immunologic Tolerance and
Absorption Techniques, J. Exp. Med., Vol. 121, p.439, 1965.
6. Lokich, J.J., Zamcheck, N., and Lowenstein, M., Sequential
Carcinoembryonic Antigen Levels in the therapy of Metastatic Breast
Cancer, Ann. Intern. Med., Vol. 89, p. 902, 1978.
7. Wanebo, H.J., Rao, B., Pinsky, C., et al Preoperative Carcinoembryonic
Antigen Level assa Prognosis Indicator in Colorectal Cancer, N. Engl.
J. Med., Vol. 299, p. 448, 1978.
8. Steward, A.M., Nixon, D., Zamcheck, N., and Aisenber, A.,
Carcinoembryonic Antigen in Breast Cancer Patients; Serum Levels
and Disease Progress. Cancer, Vol. 33, p. 1246, 1974.
9. Skarin, A.T., Nixon, D., Zamcheck, N., et al Carcinoembryonic
Antigen: Clinical Correlation and Chemotherapy for Metastatic
Gastrointestinal Cancer. Cancer, Vol. 33, p. 1239, 1974.
10. Khoo, S.K., Warner, N.L., Lie, J.T. and Mackay, I.R.,
Carcinoembryonic Antigenic Activity of Tissue Extracts; A
Quantitative Study of Malignant and Benign Neoplasms Cirrhotic
Liver, Normal Adult and Fetal Organs. Cancer, Vol. 11, p. 68, 1973.
11. Coligan, J.E., Lautenschieger, J.T., Egar, M.L. and Todd, C.W.,
Isolation and Characterization of Cacinoembryonic Antigen,
Immunochemistry Vol. 9, p. 377, 1972.
12. Schein, P.S., Tumor Markers in Cecil's Textbook of Medicine, Eds:
Wyngarden, J.B., and Smith, L.H., 17th
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]