Protocol - Liver Function - Assay
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
Availability
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 assaysRequirements
| Requirement Category | Required |
|---|---|
| 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
| Standard | Name | ID | Source |
|---|---|---|---|
| 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 ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX190801_Alanine_Aminotransferase_Assay_Type | ||||
| PX190801060000 | Record the type of assay used to perform the more | N/A | ||
| PX190801_Albumin_Assay_Type | ||||
| PX190801260000 | Record the type of assay used to perform the more | N/A | ||
| PX190801_Alkaline_Phosphatase_Assay_Type | ||||
| PX190801160000 | Record the type of assay used to perform the more | N/A | ||
| PX190801_Aspartate_Aminotransferase_Assay_Type | ||||
| PX190801110000 | Record the type of assay used to perform the more | N/A | ||
| PX190801_Bilirubin_Assay_Type | ||||
| PX190801210000 | Record the type of assay used to perform the more | N/A | ||
| PX190801_Blood_Draw_Comments | ||||
| PX190801040200 | Record any comments about the blood draw, more | 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 | Variable Mapping | ||
| PX190801_Coefficient_Of_Variation_Alanine_Aminotransferase | ||||
| PX190801090000 | Coefficient of variation for the assay for more | 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 | N/A | ||
| PX190801_Coefficient_Variation_Aspartate_Aminotransferase_Assay | ||||
| PX190801140000 | Coefficient of variation for the aspartate more | N/A | ||
| PX190801_Coefficient_Variation_Gammaglutamyl_Transferase_Assay | ||||
| PX190801390000 | Coefficient of variation for the more | N/A | ||
| PX190801_Coefficient_Variation_Total_Protein_Assay | ||||
| PX190801340000 | Coefficient of variation for the total more | N/A | ||
| PX190801_Equipment_Aspartate_Aminotransferase_Assay | ||||
| PX190801120100 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Make_Alanine_Aminotransferase_Assay | ||||
| PX190801070100 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Make_Albumin_Assay | ||||
| PX190801270100 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Make_Alkaline_Phosphatase_Assay | ||||
| PX190801170100 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Make_Bilirubin_Assay | ||||
| PX190801220100 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Make_Gammaglutamyl_Transferase_Assay | ||||
| PX190801370000 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Make_Total_Protein_Assay | ||||
| PX190801320100 | Make of the equipment used to perform the more | N/A | ||
| PX190801_Equipment_Manufacturer_Alanine_Aminotransferase_Assay | ||||
| PX190801070200 | Manufacturer of the equipment used to more | N/A | ||
| PX190801_Equipment_Manufacturer_Albumin_Assay | ||||
| PX190801270200 | Manufacturer of the equipment used to more | N/A | ||
| PX190801_Equipment_Manufacturer_Alkaline_Phosphatase_Assay | ||||
| PX190801170200 | Manufacturer of the equipment used to more | N/A | ||
| PX190801_Equipment_Manufacturer_Aspartate_Aminotransferase_Assay | ||||
| PX190801120200 | Manufacturer of the equipment used to more | N/A | ||
| PX190801_Equipment_Manufacturer_Bilirubin_Assay | ||||
| PX190801220000 | Manufacturer of the equipment used to more | N/A | ||
| PX190801_Equipment_Manufacturer_Gammaglutamyl_Transferase_Assay | ||||
| PX190801370100 | Manufacturer of the equipment used to more | N/A | ||
| PX190801_Equipment_Manufacturer_Total_Protein_Assay | ||||
| PX190801320200 | Manufacturer of the equipment used to more | 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 | N/A | ||
| PX190801_Hemophilia | ||||
| PX190801010000 | Do you have hemophilia? | Variable Mapping | ||
| PX190801_Repeatability_Alanine_Aminotransferase_Assay | ||||
| PX190801080000 | Repeatability of the assay for tissue more | 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 | N/A | ||
| PX190801_Repeatability_Of_Gammaglutamyl_Transferase_Assay | ||||
| PX190801380000 | Repeatability of the gamma-glutamyl more | 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 | Variable Mapping | ||
| PX190801_Total_Protein_Assay_Type | ||||
| PX190801310000 | Record the type of assay used to perform the more | N/A | ||
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.