Carbohydrate Antigen (CA) 19-9

CPT: 86301
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Test Details

Synonyms

  • CA 19-9

Use

Monitor gastrointestinal, pancreatic, liver, and colorectal malignancies

Limitations

The measured CA 19-9 value of a patient's sample can vary depending on the testing procedure used. CA 19-9 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.

The determination of CA 19-9 cannot be used for the early detection of pancreatic carcinoma.1

Three percent to 7% of the population have the Lewis a-negative/b-negative blood group configuration and are unable to express the mucin with the reactive determinant CA 19-9. Patients known to be genotypically negative for Lewis blood group antigens will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis blood group antigen may be insufficient to detect true Lewis antigen-negative individuals. Even patients who are genotype positive for the Lewis antigen may produce varying levels of CA 19-9 as the result of gene dosage effect. This must be taken into account when interpreting the findings.2

As the mucin is excreted exclusively via the liver, even slight cholestasis can lead to clearly elevated CA 19-9 serum levels in some cases.

As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or who have received them for diagnostic purposes.1 In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur.1 The test contains additives, which minimize these effects.

For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.

Methodology

Electrochemiluminescence immunoassay (ECLIA)

Reference Interval

0−35 units/mL

Additional Information

This assay intended for the in vitro quantitative determination of CA 19-9 tumor-associated antigen in human serum and plasma.1 The assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in the monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.

The CA 19-9 values measured are defined by the use of the monoclonal antibody 1116-NS-19-9. The 1116-NS-19-9-reactive determinants on a glycolipid having a molecular weight of approximately 10,000 daltons are measured. This mucin corresponds to a hapten of Lewis-a blood group determinants and is a component of a number of mucous membrane cells.3,4

Mucin occurs in fetal gastric, intestinal, and pancreatic epithelia. Low concentrations can also be found in adult tissue in the liver, lungs, and pancreas.2,5

CA 19-9 assay values can assist in the differential diagnosis and monitoring of patients with pancreatic carcinoma (sensitivity 70% to 87%).6-12 There is no correlation between tumor mass and the CA 19-9 assay values; however, patients with CA 19-9 serum levels >10,000 units/mL almost always have distal metastasis.2

Specimen Requirements

Specimen

Serum

Volume

0.8 mL

Minimum Volume

0.3 mL (Note: This volume does not allow for repeat testing.)

Container

Red-top tube or gel-barrier tube

Collection

If red-top tube is used, transfer separated serum to a plastic transport tube.

Storage Instructions

Refrigerate

Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Causes for Rejection

Citrate plasma specimen; improper labeling

Clinical Information

Special Instructions

Values obtained with different assay methodologies should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor a patient's course of therapy. This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring required, please use the serial monitoring number 480053 to order.

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.

Footnotes

1. AFP α1-Fetoprotein on Elecsys 1010/2010 and Modular Analytics E170 [Package insert]. 2005-07, V1, Indianapolis, Ind: Roche Diagnostics; 2005.
2. Stieber P, Fateh-Moghadam A. Sensible Use of Tumor Markers. (Tumormaker und ihr sinnvoller Einsatz). Marloffstein-Rathsberg: Juergen Hartmann Verlag; 1993. Boehringer Mannheim, Cat. N° 1536869 (Engl), 1320947 (Deutsch). ISBN 3-926725-07-9 dtsch/engl.
3. Koprowski H, Steplewski Z, Mitchell K, Herlyn M, Herlyn D, Fuhrer P. Colorectal carcinoma antigens detected by hybridoma antibodies. Somatic Cell Genet. 1979 Nov; 5(6):957-971. 94699
4. Hansson GC, Zopf D. Biosynthesis of the cancer-associated sialyl-Lea antigen. J Biol Chem. 1985 Aug 5; 260(16):9388-9392. 4019478
5. Herlyn M, Sears HF, Steplewski Z, Koprowski H. Monoclonal antibody detection of a circulating tumor-associated antigen. Presence of antigen in sera of patients with colorectal, gastric, and pancreatic carcinoma. J Clin Immunol. 1982 Apr; 2(2):135-140. 7068815
6. Ritts RE Jr, Del Villano BC, Go VL, Herberman RB, Klug TL, Zurawski VR Jr. Initial clinical evaluation of an immunoradiometric assay for CA 19-9 using the NCI serum bank. Int J Cancer. 1984 Mar 15; 33(3):339-345. 6199316
7. Farini R, Fabris C, Bonvicini P, et al. CA 19-9 in the differential diagnosis between pancreatic cancer and chronic pancreatitis. Eur J Cancer Clin Oncol. 1985 Apr; 21(4):429-432. 3859414
8. Safi F, Roscher R, Beger HG. The clinical relevance of the tumor marker CA 19-9 in the diagnosing and monitoring of pancreatic carcinoma. Bull Cancer. 1990; 77(1):83-91. 2180502
9. Steinberg WM, Gelfand R, Anderson KK, et al. Comparison of the sensitivity and specificity of the CA 19-9 and carcinoembryonic antigen assays in detecting cancer of the pancreas. Gastroenterology. 1986 Feb; 90(2):343-349. 2416628
10. Fritsche HA Jr, Gelder FB. Serum tumor markers for pancreatic carcinoma. Immunol Ser. 1990; 53:289-296. 2100561
11. Steinberg W. The clinical utility of the CA-19-9 tumor-associated antigen. Am J Gastroenterol. 1990 Apr; 85(4):350-355. 2183589
12. Diamandis EP, Fritsche HA, Lilja H, et al. Tumor Markers: Physiology, Pathobiology, Technology, and Clinical Applications. 1st ed. Washington, DC: AACC Press; 2002.

References

Beretta E, Malesci A, Zerbi A, et al. Serum CA 19-9 in the postsurgical follow-up of patients with pancreatic cancer. Cancer. 1987 Nov 15; 60(10):2428-2431. 3478117
Pleskow DK, Berger HJ, Gyves J, Allen E, McLean A, Podolsky DK. Evaluation of a serologic marker, CA 19-9, in the diagnosis of pancreatic cancer. Ann Intern Med. 1989 May 1; 110(9):704-709. 2930108
Satake K, Kanazawa G, Kho I, Chung Y, Umeyama K. Evaluation of serum pancreatic enzymes, carbohydrate antigen 19-9, and carcinoembryonic antigen in various pancreatic diseases. Am J Gastroenterol. 1985 Aug; 80(8):630-636. 2411125
Shimomura C, Eguchi K, Kawakami A, et al. Elevation of a tumor-associated antigen CA 19-9 levels in patients with rheumatic diseases. J Rheumatol. 1989 Nov; 16(11):1410-1415. 2600938
Torosian MH. The clinical usefulness and limitations of tumor markers. Surg Gynecol Obstet. 1988 Jun; 166(6):567-579 (review). 2453934

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
002261 CA 19-9 24108-3 002282 CA 19-9 U/mL 24108-3

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