Des-Gamma-Carboxy Prothrombin (DCP), Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC)
An aid in the monitoring of HCC patients post therapy if des-gamma-carboxy prothrombin (DCP) level was elevated prior to therapy. An elevated DCP level is associated with increased risk of recurring HCC.
Isotachophoresis with Laser-Induced Fluorescence
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Des-Gamma-Carboxy Prothrombin, S
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.
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 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.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Frozen (preferred)||90 days|
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.
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%).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
For diagnostic use, this test is most cost-effective in at-risk patients with normal levels of total and L3 alpha fetoprotein in serum.
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 Provides recommendations for further in-depth reading of a clinical nature
1. Carr B, Kanke F, Wise M, Satomura S: Clinical evaluation of Lens culinaris agglutinin-reactive alpha-fetoprotein and des-gamma-carboxy prothrombin in histologically proven hepatocellular carcinoma in the United States. Dig Dis Sci 2007;52:776-782
2. Durazo FA, Blatt LM, Corey WG, et al: Des-gamma-carboxyprothrombin, alpha-fetoprotein and AFP-L3 in patients with chronic hepatitis, cirrhosis and hepatocellular carcinoma. J Gastroenterol Hepatol 2008;23:1541-1548
3. Marrero JA, Feng Z, Wang Y, et al: Alpha-fetoprotein, des-gamma carboxyprothrombin, and lectin-bound alpha-fetoprotein in early hepatocellular carcinoma. Gastroenterology 2009;137:110-118
4. Bertino G, Ardiri AM, Calvagno GS, et al: Prognostic and diagnostic value of des-gamma-carboxy prothrombin in liver cancer. Drug News Perspect 2010 Oct;23(8):498-508
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 11.03.08K02. Wako Diagnostics, Richmond, VA)
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, Wednesday, Friday; 10 a.m.
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.
Same day/1 day
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.
This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
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|
|DCP||Des-Gamma-Carboxy Prothrombin, S||34444-0|