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Test Code MISC2MAYOPF199 Carbohydrate Antigen 19-9 (CA 19-9), Pleural Fluid

Reporting Name

CA 19-9, Pleural Fluid

Useful For

An adjuvant to cytology and imaging studies to differentiate between nonmalignant and malignant causes of pleural effusions

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Pleural Fluid


Specimen Required


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


Specimen Minimum Volume

0.5 mL (Samples <0.5 mL may be rejected)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Pleural Fluid Frozen (preferred) 90 days
  Refrigerated  14 days
  Ambient  7 days

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Saturday

Test Classification

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

86301

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PF199 CA 19-9, Pleural Fluid 19163-5

 

Result ID Test Result Name Result LOINC Value
P199 CA 19-9, Pleural Fluid 19163-5
SITE8 Site 39111-0

Clinical Information

Pleural effusions occur as a consequence of either nonmalignant conditions (including congestive heart failure, pneumonia, pulmonary embolism, and liver cirrhosis) or malignant conditions (including lung, breast, and lymphoma cancers). Diagnosing the cause of an effusion can be difficult, requiring cytological examination of the fluid. Analysis of various tumor markers in pleural fluid has shown that these markers can differentiate between effusions caused by nonmalignant and malignant conditions and can enhance cytology findings.

 

Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen. Healthy adults typically produce low to undetectable levels of CA 19-9. Serum concentrations of CA 19-9 may be elevated in patients with certain malignancies that secrete CA 19-9 into circulation, including cholangiocarcinoma, colorectal, stomach, bile duct, lung, ovarian, and pancreatic cancers.

 

Pleural fluid concentrations of CA 19-9 have been reported to be elevated in patients with certain malignancies. Malignancies that can secrete CA 19-9 and elevate serum CA 19-9 concentrations, including cholangiocarcinoma, colorectal, stomach, bile duct, lung, ovarian, and pancreatic cancers, typically also elevate CA 19-9 in pleural fluid. In contrast, malignancies that do not secrete CA 19-9, including mesothelioma, lymphoma, leukemia, and melanoma, have low concentrations of CA 19-9 in pleural fluid comparable to concentrations observed in nonmalignant effusions.

CA 19-9 results should be used in conjunction with cytological analysis of pleural fluid, imaging studies, and other clinical findings.

Interpretation

A pleural fluid carbohydrate antigen 19-9 (CA 19-9) concentration of 20.0 U/mL or higher is suspicious, but not diagnostic, of a malignant source of the effusion. This cutoff yielded a sensitivity of 35%, specificity of 95%, and positive predictive value of 88% in a study of 200 patients presenting with effusion. CA 19-9 concentrations were significantly higher in effusions caused by CA 19-9-secreting malignancies, including cholangiocarcinoma, colorectal, stomach, bile duct, lung, ovarian, and pancreatic cancers. However, effusions caused by non-CA 19-9-secreting malignancies, including lymphoma, mesothelioma, leukemia, and melanoma, routinely had CA 19-9 concentrations below 20.0 U/mL. Therefore, negative results should be interpreted with caution, especially in patients who have or are suspected of having a non-CA 19-9-secreting malignancy.

 

Correlation of all tumor marker results with cytology and imaging is highly recommended.

Method Description

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 antigen 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)

Report Available

1 to 3 days

Reject Due To

Gross hemolysis Reject
Gross icterus OK

Method Name

Immunoenzymatic Assay

Forms

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

Secondary ID

60230