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Protocol - Liver Function - Assay

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Description:

A standard liver panel is comprised of the following bioassays that are performed on refrigerated serum or plasma: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, albumin, total protein, and gamma-glutamyl transferase (GGT).

Protocol:

Exclusion Criteria

Persons will be excluded from this component if they:

  • Report that they have hemophilia; or
  • Report that they have received cancer chemotherapy in the last 4 weeks.

SP = Sample Person

1. Do you have hemophilia?

[ ] 1 Yes

[ ] 2 No

[ ] 7 Refused

[ ] 9 Don't Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If the SP answers "No" or "Don't Know," blood is drawn from the SP.

2. Have you received cancer chemotherapy in the past 4 weeks or do you anticipate such therapy in the next 4 weeks?

[ ] 1 Yes

[ ] 2 No

[ ] 7 Refused

[ ] 9 Don't Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If the SP answers "No" or "Don't Know," blood is drawn from the SP.

Note from the Gastrointestinal Working Group: The investigator should record the reason a person is excluded from the blood draw.

Venipuncture Procedures

Please review chapter 4 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2007–2008 for a full description of phlebotomy procedures: 2007-2008 NHANES laboratory procedures manual .

Venipuncture should generally be performed using the median cubital, cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then the right arm/hand.

Note from the Gastrointestinal Working Group: Blood should be collected in an appropriate 5- or 10-mL red-top tube.

Recording the Results of the Venipuncture Procedure

Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture.

Please review chapter 4 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2007–2008 for a full description of phlebotomy procedures: 2007-2008 NHANES Lab Manual.

Please see the 2007-2008 NHANES Lab Procedures Manual for methods for each of the bioassays.

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required
A laboratory technician or phlebotomist who is trained and found to be competent (i.e., tested by an expert) in the conduct of bioassays.
Equipment Needs
Phlebotomy supplies, laboratory to perform assays
Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Bioassay

Life Stage:

Adolescent, Adult

Participants:

Adolescents and adults aged 12 years and older

Specific Instructions:
There are many different methods used to obtain the liver function values. The 2007-2008 National Health and Nutrition Examination Survey (NHANES) used both the Beckman Synchron LX20 and Beckman UniCel® DxC800 Synchron, which yielded comparable results. Regardless of the method used, it is critical to know the reference ranges for that method so that the user can correctly interpret the results of the bioassay. Etiology can be determined using abdominal computed tomography (CT).
Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) 2007-2008 protocol was selected as the best practice methodology and one of the most widely used protocols to measure liver function.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Person Liver Function Test Laboratory Finding Result 3163061 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Liver func assay proto 62967-5 LOINC
Derived Variables

None

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2007). National Health and Nutrition Examination Survey Questionnaire. Laboratory procedures manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

General References

Pendino, G. M., Mariano, A., Surace, P., Caserta, C. A., Fiorillo, M. T., Amante, A., Bruno, S., Mangano, C., Polito, I., Amato, F., Cotichini, R., Stroffolini, T., Mele, A., & the ACE Collaborating Group. (2005). Prevalence and etiology of altered liver tests: A population-based survey in a Mediterranean town. Hepatology, 41(5), 1151-1159. doi: 10.1002/hep.20689

Protocol ID:

190801

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX190801_Alanine_Aminotransferase_Assay_Type PX190801060000 Record the type of assay used to perform the determination of alanine aminotransferase: 4 N/A
PX190801_Albumin_Assay_Type PX190801260000 Record the type of assay used to perform the determination of albumin: 4 N/A
PX190801_Alkaline_Phosphatase_Assay_Type PX190801160000 Record the type of assay used to perform the determination of alkaline phosphatase: 4 N/A
PX190801_Aspartate_Aminotransferase_Assay_Type PX190801110000 Record the type of assay used to perform the determination of aspartate aminotransferase: 4 N/A
PX190801_Bilirubin_Assay_Type PX190801210000 Record the type of assay used to perform the determination of bilirubin: 4 N/A
PX190801_Blood_Draw_Comments PX190801040200 Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol. 4 Variable Mapping
PX190801_Blood_Draw_Done PX190801040000 Was blood drawn? 4 Variable Mapping
PX190801_Blood_Draw_Sample PX190801040100 Was full amount obtained? 4 Variable Mapping
PX190801_Chemotherapy PX190801020000 Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? 4 N/A
PX190801_Coefficient_Of_Variation_Alanine_Aminotransferase PX190801090000 Coefficient of variation for the assay for tissue transglutaminase antibody 4 N/A
PX190801_Coefficient_Of_Variation_Bilirubin_Assay PX190801240000 Coefficient of variation for the bilirubin assay: 4 N/A
PX190801_Coefficient_Variation_Albumin_Assay PX190801290000 Coefficient of variation for the albumin assay: 4 N/A
PX190801_Coefficient_Variation_Alkaline_Phosphatase_Assay PX190801190000 Coefficient of variation for the alkaline phosphatase assay: 4 N/A
PX190801_Coefficient_Variation_Aspartate_Aminotransferase_Assay PX190801140000 Coefficient of variation for the aspartate aminotransferase assay: 4 N/A
PX190801_Coefficient_Variation_Gammaglutamyl_Transferase_Assay PX190801390000 Coefficient of variation for the gamma-glutamyl transferase assay: 4 N/A
PX190801_Coefficient_Variation_Total_Protein_Assay PX190801340000 Coefficient of variation for the total protein assay: 4 N/A
PX190801_Equipment_Aspartate_Aminotransferase_Assay PX190801120100 Make of the equipment used to perform the determination of aspartate aminotransferase: 4 N/A
PX190801_Equipment_Make_Alanine_Aminotransferase_Assay PX190801070100 Make of the equipment used to perform the determination of alanine aminotransferase. 4 N/A
PX190801_Equipment_Make_Albumin_Assay PX190801270100 Make of the equipment used to perform the determination of albumin: 4 N/A
PX190801_Equipment_Make_Alkaline_Phosphatase_Assay PX190801170100 Make of the equipment used to perform the determination of alkaline phosphatase: 4 N/A
PX190801_Equipment_Make_Bilirubin_Assay PX190801220100 Make of the equipment used to perform the determination of bilirubin: 4 N/A
PX190801_Equipment_Make_Gammaglutamyl_Transferase_Assay PX190801370000 Make of the equipment used to perform the determination of gamma-glutamyl transferase: 4 N/A
PX190801_Equipment_Make_Total_Protein_Assay PX190801320100 Make of the equipment used to perform the determination of total protein: 4 N/A
PX190801_Equipment_Manufacturer_Alanine_Aminotransferase_Assay PX190801070200 Manufacturer of the equipment used to perform the determination of alanine aminotransferase. 4 N/A
PX190801_Equipment_Manufacturer_Albumin_Assay PX190801270200 Manufacturer of the equipment used to perform the determination of albumin: 4 N/A
PX190801_Equipment_Manufacturer_Alkaline_Phosphatase_Assay PX190801170200 Manufacturer of the equipment used to perform the determination of alkaline phosphatase: 4 N/A
PX190801_Equipment_Manufacturer_Aspartate_Aminotransferase_Assay PX190801120200 Manufacturer of the equipment used to perform the determination of aspartate aminotransferase: 4 N/A
PX190801_Equipment_Manufacturer_Bilirubin_Assay PX190801220000 Manufacturer of the equipment used to perform the determination of bilirubin: 4 N/A
PX190801_Equipment_Manufacturer_Gammaglutamyl_Transferase_Assay PX190801370100 Manufacturer of the equipment used to perform the determination of gamma-glutamyl transferase: 4 N/A
PX190801_Equipment_Manufacturer_Total_Protein_Assay PX190801320200 Manufacturer of the equipment used to perform the determination of total protein: 4 N/A
PX190801_Exclusion_Criteria PX190801030000 Please mark reason for exclusion 4 N/A
PX190801_Gammaglutamyl_Transferase_Assay_Type PX190801360000 Record the type of assay used to perform the determination of gamma-glutamyl transferase: 4 N/A
PX190801_Hemophilia PX190801010000 Do you have hemophilia? 4 Variable Mapping
PX190801_Repeatability_Alanine_Aminotransferase_Assay PX190801080000 Repeatability of the assay for tissue alanine aminotransferase 4 N/A
PX190801_Repeatability_Of_Alkaline_Phosphatase_Assay PX190801180000 Repeatability of the alkaline phosphatase assay: 4 N/A
PX190801_Repeatability_Of_Aspartate_Aminotransferase_Assay PX190801130000 Repeatability of the aspartate aminotransferase assay: 4 N/A
PX190801_Repeatability_Of_Gammaglutamyl_Transferase_Assay PX190801380000 Repeatability of the gamma-glutamyl transferase assay: 4 N/A
PX190801_Repeatability_Of_The_Albumin_Assay PX190801280000 Repeatability of the albumin assay: 4 N/A
PX190801_Repeatability_Of_The_Bilirubin_Assay PX190801230000 Repeatability of the bilirubin assay: 4 N/A
PX190801_Repeatability_Of_Total_Protein_Assay PX190801330000 Repeatability of the total protein assay: 4 N/A
PX190801_Results_Gammaglutamyl_Transferase_Assay PX190801400000 Results of gamma-glutamyl transferase assay 4 N/A
PX190801_Results_Of_Alanine_Aminotransferase_Assay PX190801100000 Results of alanine aminotransferase assay: 4 N/A
PX190801_Results_Of_Albumin_Assay PX190801300000 Results of albumin assay: 4 N/A
PX190801_Results_Of_Alkaline_Phosphatase_Assay PX190801200000 Results of alkaline phosphatase assay: 4 N/A
PX190801_Results_Of_Aspartate_Aminotransferase_Assay PX190801150000 Results of aspartate aminotransferase assay: 4 N/A
PX190801_Results_Of_Bilirubin_Assay PX190801250000 Results of bilirubin assay: 4 N/A
PX190801_Results_Of_Total_Protein_Assay PX190801350000 Results of total protein assay 4 N/A
PX190801_Sample_Comments PX190801050000 Record comments to describe the sample during processing: 4 Variable Mapping
PX190801_Total_Protein_Assay_Type PX190801310000 Record the type of assay used to perform the determination of total protein: 4 N/A
Research Domain Information
Measure Name:

Liver Function - Assay

Release Date:

December 13, 2010

Definition

This is a measure to assess liver functionality and cellular integrity.

Purpose

This is a screener to detect the presence and type of liver disease and determine the extent of damage to the liver.

Keywords

Liver, liver function, alanine aminotransferase, ALT, aspartate aminotransferase, AST, alkaline phosphatase, ALP, National Health and Nutrition Examination Survey, NHANES, bilirubin, albumin, protein, total protein, gamma-glutamyl transferase GGT, assay, bioassay, liver panel, liver disease, Gastrointestinal