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Protocol - Liver Function - Assay

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Protocol Name from Source:

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

Availability:

Publicly available

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: [alink[NHANES_Lab_Manual.pdf|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: [alink[NHANES_Lab_Manual.pdf|2007-2008 NHANES Lab Manual]].

Please see the [alink[NHANES_Lab_Manual.pdf|2007-2008 NHANES Lab Procedures Manual]] for methods for each of the bioassays.

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
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adolescent, Adult

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).
Research Domain Information

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.

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 Result3163061CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Liver func assay proto62967-5LOINC

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_HemophiliaPX190801010000Do you have hemophilia?4Variable Mapping
PX190801_ChemotherapyPX190801020000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks?4N/A
PX190801_Exclusion_CriteriaPX190801030000Please mark reason for exclusion4N/A
PX190801_Blood_Draw_DonePX190801040000Was blood drawn?4Variable Mapping
PX190801_Blood_Draw_SamplePX190801040100Was full amount obtained?4Variable Mapping
PX190801_Blood_Draw_CommentsPX190801040200Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol.4Variable Mapping
PX190801_Sample_CommentsPX190801050000Record comments to describe the sample during processing:4Variable Mapping
PX190801_Alanine_Aminotransferase_Assay_TypePX190801060000Record the type of assay used to perform the determination of alanine aminotransferase:4N/A
PX190801_Equipment_Make_Alanine_Aminotransferase_AssayPX190801070100Make of the equipment used to perform the determination of alanine aminotransferase.4N/A
PX190801_Equipment_Manufacturer_Alanine_Aminotransferase_AssayPX190801070200Manufacturer of the equipment used to perform the determination of alanine aminotransferase.4N/A
PX190801_Repeatability_Alanine_Aminotransferase_AssayPX190801080000Repeatability of the assay for tissue alanine aminotransferase4N/A
PX190801_Coefficient_Of_Variation_Alanine_AminotransferasePX190801090000Coefficient of variation for the assay for tissue transglutaminase antibody4N/A
PX190801_Results_Of_Alanine_Aminotransferase_AssayPX190801100000Results of alanine aminotransferase assay:4N/A
PX190801_Aspartate_Aminotransferase_Assay_TypePX190801110000Record the type of assay used to perform the determination of aspartate aminotransferase:4N/A
PX190801_Equipment_Aspartate_Aminotransferase_AssayPX190801120100Make of the equipment used to perform the determination of aspartate aminotransferase:4N/A
PX190801_Equipment_Manufacturer_Aspartate_Aminotransferase_AssayPX190801120200Manufacturer of the equipment used to perform the determination of aspartate aminotransferase:4N/A
PX190801_Repeatability_Of_Aspartate_Aminotransferase_AssayPX190801130000Repeatability of the aspartate aminotransferase assay:4N/A
PX190801_Coefficient_Variation_Aspartate_Aminotransferase_AssayPX190801140000Coefficient of variation for the aspartate aminotransferase assay:4N/A
PX190801_Results_Of_Aspartate_Aminotransferase_AssayPX190801150000Results of aspartate aminotransferase assay:4N/A
PX190801_Alkaline_Phosphatase_Assay_TypePX190801160000Record the type of assay used to perform the determination of alkaline phosphatase:4N/A
PX190801_Equipment_Make_Alkaline_Phosphatase_AssayPX190801170100Make of the equipment used to perform the determination of alkaline phosphatase:4N/A
PX190801_Equipment_Manufacturer_Alkaline_Phosphatase_AssayPX190801170200Manufacturer of the equipment used to perform the determination of alkaline phosphatase:4N/A
PX190801_Repeatability_Of_Alkaline_Phosphatase_AssayPX190801180000Repeatability of the alkaline phosphatase assay:4N/A
PX190801_Coefficient_Variation_Alkaline_Phosphatase_AssayPX190801190000Coefficient of variation for the alkaline phosphatase assay:4N/A
PX190801_Results_Of_Alkaline_Phosphatase_AssayPX190801200000Results of alkaline phosphatase assay:4N/A
PX190801_Bilirubin_Assay_TypePX190801210000Record the type of assay used to perform the determination of bilirubin:4N/A
PX190801_Equipment_Manufacturer_Bilirubin_AssayPX190801220000Manufacturer of the equipment used to perform the determination of bilirubin:4N/A
PX190801_Equipment_Make_Bilirubin_AssayPX190801220100Make of the equipment used to perform the determination of bilirubin:4N/A
PX190801_Repeatability_Of_The_Bilirubin_AssayPX190801230000Repeatability of the bilirubin assay:4N/A
PX190801_Coefficient_Of_Variation_Bilirubin_AssayPX190801240000Coefficient of variation for the bilirubin assay:4N/A
PX190801_Results_Of_Bilirubin_AssayPX190801250000Results of bilirubin assay:4N/A
PX190801_Albumin_Assay_TypePX190801260000Record the type of assay used to perform the determination of albumin:4N/A
PX190801_Equipment_Make_Albumin_AssayPX190801270100Make of the equipment used to perform the determination of albumin:4N/A
PX190801_Equipment_Manufacturer_Albumin_AssayPX190801270200Manufacturer of the equipment used to perform the determination of albumin:4N/A
PX190801_Repeatability_Of_The_Albumin_AssayPX190801280000Repeatability of the albumin assay:4N/A
PX190801_Coefficient_Variation_Albumin_AssayPX190801290000Coefficient of variation for the albumin assay:4N/A
PX190801_Results_Of_Albumin_AssayPX190801300000Results of albumin assay:4N/A
PX190801_Total_Protein_Assay_TypePX190801310000Record the type of assay used to perform the determination of total protein:4N/A
PX190801_Equipment_Make_Total_Protein_AssayPX190801320100Make of the equipment used to perform the determination of total protein:4N/A
PX190801_Equipment_Manufacturer_Total_Protein_AssayPX190801320200Manufacturer of the equipment used to perform the determination of total protein:4N/A
PX190801_Repeatability_Of_Total_Protein_AssayPX190801330000Repeatability of the total protein assay:4N/A
PX190801_Coefficient_Variation_Total_Protein_AssayPX190801340000Coefficient of variation for the total protein assay:4N/A
PX190801_Results_Of_Total_Protein_AssayPX190801350000Results of total protein assay4N/A
PX190801_Gammaglutamyl_Transferase_Assay_TypePX190801360000Record the type of assay used to perform the determination of gamma-glutamyl transferase:4N/A
PX190801_Equipment_Make_Gammaglutamyl_Transferase_AssayPX190801370000Make of the equipment used to perform the determination of gamma-glutamyl transferase:4N/A
PX190801_Equipment_Manufacturer_Gammaglutamyl_Transferase_AssayPX190801370100Manufacturer of the equipment used to perform the determination of gamma-glutamyl transferase:4N/A
PX190801_Repeatability_Of_Gammaglutamyl_Transferase_AssayPX190801380000Repeatability of the gamma-glutamyl transferase assay:4N/A
PX190801_Coefficient_Variation_Gammaglutamyl_Transferase_AssayPX190801390000Coefficient of variation for the gamma-glutamyl transferase assay:4N/A
PX190801_Results_Gammaglutamyl_Transferase_AssayPX190801400000Results of gamma-glutamyl transferase assay4N/A