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Test Code CA 19'-9 Carbohydrate Antigen 19-9 (CA 19-9), Serum

Reporting Name

Carbohydrate Ag 19-9, S

Useful For

As a potential adjunct for diagnosis and monitoring of pancreatic cancer

 

Potentially differentiating patients with cholangiocarcinoma and primary sclerosing cholangitis (PSC) from those with PSC alone


Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions:

1. Within 2 hours of collection, serum gel tubes should be centrifuged.

2. Within 2 hours of collection, red-top tubes should be centrifuged, and the serum aliquoted into a plastic vial.


Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 7 days
  Frozen  90 days
  Ambient  8 hours

Day(s) Performed

Monday through Saturday

Seattle Children's Hospital Note:

TAT: 3 - 5 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Method Name

Immunoenzymatic Assay

Method Description

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 a buffered protein solution. After incubation in a reaction vessel, separation in a magnetic field and washing remove materials not bound to the solid phase. A monoclonal-alkaline phosphatase conjugate is then 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 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 in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve.(Package insert: Access GI Monitor. Beckman Coulter; 04/2020)

Reference Values

<35 U/mL

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86301

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CA19 Carbohydrate Ag 19-9, S 83084-4

 

Result ID Test Result Name Result LOINC Value
CA19 Carbohydrate Ag 19-9, S 83084-4

Report Available

1 to 3 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross Icterus OK

Forms

If not ordering electronically, complete, print, and send Oncology Test Request (T729)