Test Catalog

Test Id : DCP

Des-Gamma-Carboxy Prothrombin, Serum

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

Risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC)

 

Aiding in the monitoring of HCC patients post therapy if des-gamma-carboxy prothrombin (DCP) level was elevated prior to therapy

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

Isotachophoresis with Laser-Induced Fluorescence

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

Des-Gamma-Carboxy Prothrombin, S

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

For diagnostic use, this test is most cost-effective for at-risk patients with normal levels of total and L3 alpha fetoprotein in serum. For more information see L3AFP / Alpha-Fetoprotein (AFP) L3% and Total, Hepatocellular Carcinoma Tumor Marker, Serum.

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

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.2 mL

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

Gross hemolysis Reject
Gross lipemia 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
Serum Frozen (preferred) 90 days
Refrigerated 7 days

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

Risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC)

 

Aiding in the monitoring of HCC patients post therapy if des-gamma-carboxy prothrombin (DCP) level was elevated prior to therapy

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

Des-gamma-carboxy prothrombin (DCP), also known as the protein induced by vitamin K absence or antagonist II (PIVKA-II), is an abnormal form of the coagulation protein, prothrombin. DCP is a nonfunctional prothrombin resulting from a lack of carboxylation of 10 glutamic acid residues in the N-terminal portion of the molecule. In normal liver, prothrombin undergoes post-translational carboxylation before release into the peripheral blood. The carboxylation converts specific amino-terminal glutamic acid residues to gamma-carboxyglutamic acid. The vitamin K dependent carboxylase responsible for the carboxylation is absent in many hepatocellular carcinoma (HCC) cells, and an abnormal prothrombin with all or some of unconverted glutamic acid is secreted. Therefore, this noncarboxylated form (DCP) has been used as an HCC biomarker.

 

DCP is considered a complementary biomarker to alpha fetoprotein (AFP) and third electrophoretic form of lentil lectin-reactive AFP% (AFP-L3%) for assessing the risk of developing HCC. The elevation of both AFP-L3 and DCP indicate progression of HCC, albeit they reflect different features of the progression. In a prospective study of patients in the United States with an established diagnosis of HCC, the sensitivities for AFP, AFP-L3%, and DCP were 68%, 62%, and 73%, respectively. When the 3 markers were combined, the sensitivity was 86%. In another study, DCP levels were shown to correlate with tumor size and metastatic HCC. In this study, compared to AFP and AFP-L3%, DCP had the highest sensitivity (87%) and the highest positive predictive value (87%) in patients with HCC due to chronic hepatitis B and C infections. A number of studies have shown that elevated serum DCP is significantly related to portal vein invasion and/or intrahepatic metastasis, which significantly affect prognosis for patients with HCC.

 

DCP can be elevated in other conditions besides HCC. Conditions such as obstructive jaundice, intrahepatic cholestasis causing chronic decrease in vitamin K, and ingestion of drugs such as warfarin or wide-spectrum antibiotics can result in high concentrations of DCP. In addition, 25% to 50% of patients with HCC will have a DCP value within the reference range. Because of this, a normal DCP value does not rule out HCC.

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.

<7.5 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

In patients with an elevated des-gamma-carboxy prothrombin (DCP) result (> or =7.5 ng/mL), the risk of developing hepatocellular carcinoma (HCC) is 36.5% (95% CI 23.5%-49.6%). The risk of developing HCC with a negative DCP result (<7.5 ng/mL) is 7.6% (95% CI 4.4%-10.8%).

 

For patients with HCC and an elevated DCP level prior to therapy, an elevated DCP level posttherapy is associated with an increased risk of HCC recurring.

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

Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedures, may have circulating anti-animal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.

 

Serum markers are not specific for malignancy, and values may vary by method. Do not interpret des-gamma-carboxy prothrombin (DCP) levels as absolute evidence of the presence or absence of malignant disease. Results should be used in conjunction with information from the clinical evaluation of the patient, cytology, and imaging procedures.

 

DCP producing tumors other than hepatocellular carcinoma can show elevated DCP values.

 

Liver disease caused by other etiologies such as alcohol liver disease, hematochromatosis, Wilson disease, autoimmune hepatitis, and steatohepatitis have not been studied with this assay.

 

Medication containing vitamin K preparations may cause a negative bias with DCP values.

 

Medication containing vitamin K antagonist or antibiotic may cause a positive bias with DCP values.

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

1. Lai Q, Iesari S, Levi Sandri GB, Lerut J: Des-gamma-carboxy prothrombin in hepatocellular cancer patients waiting for liver transplant: a systematic review and meta-analysis. Int J Biol Markers. 2017 Oct 31;32(4):e370-e374. doi: 10.5301/ijbm.5000276

2. Zhu R, Yang J, Xu L, et al: Diagnostic Performance of Des-gamma-carboxy Prothrombin for Hepatocellular Carcinoma: A Meta-Analysis. Gastroenterol Res Pract. 2014;2014:529314. doi: 10.1155/2014/529314

3. De J, Shen Y, Qin J, et al: A Systematic Review of Des-gamma-Carboxy Prothrombin for the Diagnosis of Primary Hepatocellular Carcinoma. Medicine (Baltimore). 2016 Apr;95(17):e3448. doi: 10.1097/MD.0000000000003448

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

Testing is performed using the uTASWako i30 instrument and the uTASWako DCP Immunological Test System and reagents. Sample is added to the reagent well with the fluorescent dye labeled anti-human prothrombin antibody (mouse monoclonal) to form the primary immunocomplex. The second labeled antibody solution, anion-conjugated anti-human des-gamma-carboxy prothrombin (DCP) antibody (mouse monoclonal), is concentrated by isotachophoresis when voltage is applied. The concentrated anion-conjugated antibody then reacts with the primary immunocomplex to form the secondary immunocomplex. This secondary complex is further concentrated during isotachophoresis and is separated from unbound fluorescent dye-labeled antibody by capillary gel electrophoresis. The remaining dye labeled DCP is measured by laser-induced fluorescence. The concentration of DCP in the specimen is directly proportional to the amount of fluorescence.(Package insert: uTASWako i30 DCP, version 18.07.18K11. Wako Diagnostics 07/2018)

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, Wednesday, Friday

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.

Same day/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

12 months

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.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 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
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.

83951

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