Test ID: 199PT
Carbohydrate Antigen 19-9 (CA 19-9), Peritoneal Fluid
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
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 needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Body fluid container
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Peritoneal | Frozen (preferred) | 90 days |
| Ambient | 7 days | |
| Refrigerated | 7 days |
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 >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 <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) levels concentration 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 Caucasian 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.
Immunometric assays can, in rare occasions, be subject to interferences such as "hooking" at very high analyte concentrations (false-low results) and heterophilic antibody interference (false-high results). If the clinical picture does not fit the laboratory result, these possibilities should be considered.
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 >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 Provides recommendations for further 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, et al: 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
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: Beckman Coulter, Inc., Fullerton, CA, 2010)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86301
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 199PN | CA 19-9, Peritoneal Fluid | 50781-4 |
| SITEE | Site | 31208-2 |
External
link
PDF
document
Excel
document
Word
document