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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).

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).
Availability

Available

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[ ]Dont Know

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

If the SP answers "No" or "Dont 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[ ]Dont Know

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

If the SP answers "No" or "Dont 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.

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

Lifestage

Adolescent, Adult

Participants

Adolescents and adults aged 12 years and older

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

Chinese, English

Standards
StandardNameIDSource
Logical Observation Identifiers Names and Codes (LOINC) Liver func assay proto 62967-5 LOINC
Human Phenotype Ontology Decreased liver function HP:0001410 HPO
caDSR Form PhenX PX190801 - Liver Function Assay 6885737 caDSR Form
Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

National Health and Nutrition Examination Survey Questionnaire (NHANES), Laboratory procedures manual, 2007

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

Measure Protocols
Protocol ID Protocol Name
190801 Liver Function - Assay
Publications

There are no publications listed for this protocol.