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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]