Test Catalog

Test Id : 199PT

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Carbohydrate Antigen 19-9 (CA 19-9), Peritoneal Fluid

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

An adjunct to cytology to differentiate between malignancy-related ascites and benign causes of ascites formation

Method Name
A short description of the method used to perform the test

Immunoenzymatic Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

CA 19-9, Peritoneal Fluid

Aliases
Lists additional common names for a test, as an aid in searching

CA 19-9 (Carbohydrate Antigen 19-9)

Cancer Antigen 19-9 (CA 19-9)

CA19-9 Paracentesis Fluid

CA19-9 Ascites Fluid

CA19-9 Abdominal Fluid

Specimen Type
Describes the specimen type validated for testing

Peritoneal

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Container/Tube: Plain, plastic, screw-top tube

Specimen Volume: 2 mL

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Peritoneal Frozen (preferred) 90 days
Ambient 7 days
Refrigerated 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

An adjunct to cytology to differentiate between malignancy-related ascites and benign causes of ascites formation

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Malignancy accounts for approximately 7% of cases of ascites formation. Malignant disease can cause ascites by various mechanisms, including peritoneal carcinomatosis (53%), massive liver metastasis causing portal hypertension (13%), peritoneal carcinomatosis plus massive liver metastasis (13%), hepatocellular carcinoma plus cirrhosis (7%), and chylous ascites due to lymphoma (7%). The evaluation and diagnosis of malignancy-related ascites is based on the patient clinical history, ascites fluid analysis, and imaging tests.

 

The overall sensitivity of cytology for the detection of malignancy-related ascites ranges from 58% to 75%. Cytology examination is most successful in patients with ascites related to peritoneal carcinomatosis, as viable malignant cells are exfoliated into the ascitic fluid. However, only approximately 53% of patients with malignancy-related ascites have peritoneal carcinomatosis. Patients with other causes of malignancy-related ascites almost always have a negative cytology.

 

Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen. CA 19-9 may be elevated in the serum patients with gastrointestinal malignancies, such as cholangiocarcinoma, pancreatic cancer, or colon cancer. Measurement of CA 19-9 in ascitic fluid is sometimes used in combination with cytology for detecting malignancy-related ascites.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

A peritoneal fluid carbohydrate antigen 19-9 (CA 19-9) concentration greater than 32 U/mL is suspicious, but not diagnostic, of a malignancy-related ascites. This clinical decision limit cutoff yielded 44% sensitivity and 93% specificity in a study of 137 patients presenting with ascites. However, ascites caused by malignancies not associated with increase serum CA 19-9 concentrations, including lymphoma, mesothelioma, leukemia, and melanoma, routinely had CA 19-9 concentrations less than 32 U/mL. Therefore, negative results should be interpreted with caution, especially in patients who have or are suspected of having a malignancy not associated with elevated CA 19-9 levels in serum.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Do not use peritoneal fluid carbohydrate antigen 19-9 (CA 19-9) concentrations as absolute evidence of the presence or the absence of malignant disease. The CA 19-9 result should be interpreted in conjunction with information from the clinical evaluation of the patient and other diagnostic procedures.

 

Approximately 10% of the White population does not express CA 19-9 due to the deficiency of a fucosyltransferase enzyme. Consequently, low values in these individuals are not informative regarding malignancy-related ascites.

 

In some immunoassays, the presence of unusually high concentrations of analyte may result in a high-dose "hook" effect. This may result in a lower or even normal measured analyte concentration. If the reported result is inconsistent with the clinical presentation, the laboratory should be alerted for troubleshooting.

 

In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

 

CA 19-9 values are method-dependent; therefore, the same method should be used to serially monitor patients.

Supportive Data

An in-house study was performed to select a clinical decision limit to differentiate between malignancy-related benign causes of ascites with high specificity. The study included 83 cases of benign ascites and 54 cases of malignancy-related ascites. Within the malignancy-related ascites, there were 9 specimens with malignancies known not to secrete carbohydrate antigen 19-9 (CA 19-9) in serum (lymphoma, leukemia, melanoma, sarcoma, and neuroendocrine tumors). Amongst the group that are known to secrete CA 19-9 in serum (n=45), there were the following malignancies: pancreatic, breast, gastric, colon, bladder, cholangiocarcinoma, gynecological cancers, peritoneal carcinomatosis, and hepatocellular carcinoma. Using a clinical decision limit cutoff of greater than 32 U/mL, the specificity was 93% for the benign ascites group. The sensitivity was 49% for those malignancies associated with elevated CA 19-9 in serum.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Trape J, Molina R, Sant F: Clinical evaluation of the simultaneous determination of tumor markers in fluid and serum and their ratio in the differential diagnosis of serous effusions. Tumour Biol. 2004 Sep-Dec;25(5-6):276-281

2. Sari R, Yildirim B, Sevinc A, Bahceci F, Hilmioglu F: The importance of serum and ascites fluid alpha-fetoprotein, carcinoembryonic antigen, CA 19-9, and CA 15-3 levels in differential diagnosis of ascites etiology. Hepatogastroenterology. 2001 Nov-Dec;48(42):1616-1621

3. Block DR, Algeciras-Schimnich A: Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids. Crit Rev Clin Lab Sci. 2013 Jul-Oct;50(4-5):107-124. doi: 10.3109/10408363.2013.844679

4. Jain T, Ram S, Kumar H, Saroch A, Sharma V, Singh H: Ascitic and serum levels of tumor biomarkers (CA 72-4, CA 19-9, CEA AND CA 125) in discrimination of cause of ascites: A prospective study. Arq Gastroenterol. 2022 Apr-Jun;59(2):198-203. doi: 10.1590/S0004-2803.202202000-37

Method Description
Describes how the test is performed and provides a method-specific reference

The instrument used is a Beckman Coulter DXI 800. The Access GI Monitor assay is a 2-site immunoenzymatic sandwich assay. A sample is added to a reaction vessel along with paramagnetic particles coated with polyclonal goat antibiotin antibody, mouse monoclonal biotin conjugate, and buffered protein solution. After incubation in a reaction vessel, separation in a magnetic field, and washing to remove materials not bound to the solid phase, a monoclonal-alkaline phosphatase conjugate is added. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field, while unbound materials are washed away. The chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of carbohydrate antigen 19-9 (CA 19-9) in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve.(Package insert: Access GI Monitor Assay, Beckman Coulter, Inc; 2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86301

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
199PT CA 19-9, Peritoneal Fluid 50781-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
199PN CA 19-9, Peritoneal Fluid 50781-4
SITEE Site 39111-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports