Protocol - Aspartate Aminotransferase Level
- Bilirubin Level
- Complete Blood Count (CBC)
- Lactate Dehydrogenase Level
- Liver Function - Assay
- Myocardial Infarction
- Reticulocyte Count
- Serum or Plasma Ferritin
Description
This protocol provides instructions for drawing, processing and storing blood according to the National Health and Nutrition Examination Survey (NHANES) methods. Because there are many comparable assays for measuring aspartate aminotransferase (AST), the protocol also provides basic guidelines to aid comparability among different studies.
Specific Instructions
The National Health and Nutrition Examination Survey (NHANES) instructions for drawing, processing and storing blood provide a standard methodology used successfully for many years to ensure comparable results across study sites. However, the Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that certain aspects (e.g., exclusion criteria) of the NHANES protocol are study specific and might not be applicable to all types of studies (e.g., sickle cell disease). Investigators who want to include participants that have hemophilia or have received cancer chemotherapy in the last 4 weeks will need to implement special venipuncture procedures.
Aspartate aminotransferase (AST) levels can be combined with other indirect markers of hemolysis (Bilirubin Levels, Reticulocyte Count, Lactate Dehydrogenase Level, and Haptoglobin Level) to derive a hemolytic component for sickle cell disease patients. AST is widely distributed in tissues (such as liver, heart, muscle, red cells, pancreas, etc.) and therefore is non-specific. The aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio may provide a more accurate index of hemolysis. AST is widely distributed in tissues (such as liver, heart, muscle, red cells, pancreas, etc.) and therefore is non-specific and not very sensitive to hepatocellular damage. The aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio may provide a more accurate index of hemolysis.
AST analysis is typically preformed on serum samples. However, the Working Group acknowledges that collection of blood samples for the measurement of analytes requires a general determination of whether to use serum or plasma for the assay and also a determination of the type of collection tube to be obtained. For example, if serum is to be used, a determination needs to be made as to whether red top or serum gel separator collection tubes are used. While comparable values are obtained for many analytes from either serum or plasma, there may be situations where differences are more pronounced and serum- or plasma-specific norms will be needed for references. The NHANES protocol presented here uses red top/serum separator tubes. At times it may be possible to collect both, but other considerations such as participant burden may be the deciding factor. It is important to match assay type with sample type. Some automated devices may preclude the use of serum, for example, while others may be optimized for it. Investigators should choose methods of collection that match the methods of analysis. This will best be done by communicating with the laboratory where the proposed assays will be performed. They will become an important partner with you in ensuring that there is compatibility from collection to assays to interpretation and reporting of levels and results.
The Sickle Cell Disease Curative Therapy Working Group recommends that aspartate aminotransferase (AST) levels be determined in sickle cell patients undergoing hematopoietic cell transplant at one time point pre-transplant (baseline) and 100 days, six months, and annually post-transplant.
Availability
Protocol
The following is a summary version of the full National Health and Nutrition Examination Survey 2011-2012 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 SP answers "No" or "Don’t Know," blood is drawn from the SP.
2. Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four 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 SP answers "No" or "Don’t Know," blood is drawn from the SP.
Venipuncture Procedures
Editor’s Note: Please review chapter 4 of the Laboratory Procedures Manual from the 2011-2012 National Health and Nutrition Examination Survey (NHANES) for a full description of phlebotomy procedures. This manual is posted here, and is also available at the NHANES website: 2011-2012 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.
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.
Blood Processing
Please review chapter 8 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2011-2012 for a full description of blood processing procedures: 2011-2012 NHANES Laboratory Procedures Manual.
- Allow the blood to clot by setting aside for 30 to 45 minutes at room temperature. Do not clot for more than an hour.
- Centrifuge the tube at room temperature to separate the serum and aliquot into an appropriate storage tube.
- Determine if the serum is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the serum.
Laboratory Assay for Aspartate Aminotransferase (AST)
The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that there are a number of different assays and instruments that are appropriate to measure the concentration of aspartate aminotransferase (AST). Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid comparability, the Working Group recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.
Reference Ranges for Aspartate Aminotransferase (AST):
| Age (years) | IU/L |
| 0-6 | 18-63 |
| 6-10 | 21-44 |
| 10-20 | 13-38 |
| >20 | 13-33 |
Personnel and Training Required
Phlebotomist
Equipment Needs
Laboratory with the ability to perform the aspartate aminotransferase (AST) assay.
Requirements
| 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
Toddler, Child, Adolescent, Adult, Senior, Pregnancy
Participants
Individuals age 1 year and older.
Selection Rationale
The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group selected the National Health and Nutrition Examination Survey 2011-2012 protocol as the best standardized methodology for blood collection, processing and storage.
Language
English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Human Phenotype Ontology | Elevated serum aspartate aminotransferase | HP:0031956 | HPO |
| caDSR Form | PhenX PX811201 - Aspartate Aminotransferase Level | 6252783 | caDSR Form |
Derived Variables
Hemolytic Component:
Aspartate aminotransferase levels can be combined with other indirect markers of hemolysis (Bilirubin Level, Reticulocyte Count, Lactate Dehydrogenase Level, and Haptoglobin Level) by principle component analysis (PCA) to derive a hemolytic component for sickle cell disease patients.
Nouraie, M., Lee, J. S., Zhang, Y., Kanias, T., Zhao, X., Xiong, Z., Oriss, T. B., Zeng, Q., Kato, G. J., Gibbs, J. S., Hildesheim, M. E., Sachdev, V., Barst, R. J., Machado, R. F., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E., Girgis, R. E., Morris, C.R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Goldsmith, J. C., Gordeuk, V. R., Galdwin, M. T., & Walk-PHASST Investigators and Patients. (2013). The relationship between the severity of hemolysis, clinical manifestations and risk of death in 415 patients with sickle cell anemia in the US and Europe. Haematologica, 98(3), 464-472.
Process and Review
Not applicable.
Protocol Name from Source
National Health and Nutrition Examination Survey Questionnaire (NHANES), Laboratory Procedures Manual, 2011
Source
Centers for Disease Control and Prevention (CDC). (2011). 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.
Robinson, Y., Cristancho, E., & Böning, D. (2004). An optimized method for the assay of the red blood cell--age-related enzyme aspartate aminotransferase. Laboratory Hematology, 10(3), 144-146.
General References
Nouraie, M., Lee, J. S., Zhang, Y., Kanias, T., Zhao, X., Xiong, Z., Oriss, T. B., Zeng, Q., Kato, G. J., Gibbs, J. S., Hildesheim, M. E., Sachdev, V., Barst, R. J., Machado, R. F., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E., Girgis, R. E., Morris, C.R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Goldsmith, J. C., Gordeuk, V. R., Galdwin, M. T., & Walk-PHASST Investigators and Patients. (2013). The relationship between the severity of hemolysis, clinical manifestations and risk of death in 415 patients with sickle cell anemia in the US and Europe. Haematologica, 98(3), 464-72. doi: 10.3324/haematol.2012.068965
Nsiah, K., Dzogbefia, V.P., Ansong, D., Osei Akoto, A., Boateng H. & Ocloo, D. (2011). Pattern of AST and ALT Changes in Relation to Hemolysis in Sickle Cell Disease. Clinical Medicine Insights: Blood Disorders, 4, 1-9
Potoka, K. P., & Gladwin, M. T. (2015).Vasculopathy and pulmonary hypertension in sickle cell disease. American Journal of Physiology - Lung Cellular and Molecular Physiology, 308, L314-L324.
Sachdev, V., Kato, G. J., Gibbs, J. S., Barst, R. J., Machado, R. F., Nouraie, M., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E. M., Girgis, R. E., Morris, C. R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Taylor, J. G. 6th, Hannoush, H., Goldsmith, J. C., Gladwin, M. T., Gordeuk, V. R., & Walk-PHASST Investigators. (2011). Echocardiographic markers of elevated pulmonary pressure and left ventricular diastolic dysfunction are associated with exercise intolerance in adults and adolescents with homozygous sickle cell anemia in the United States and United Kingdom. Circulation, 124(13), 1452-1460.
Protocol ID
811201
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX811201_Aspartate_Aminotransferase_Age | ||||
| PX811201030000 | Age | Variable Mapping | ||
| PX811201_Aspartate_Aminotransferase_Amount | ||||
| PX811201080000 | Red blood cell aspartate aminotransferase level | N/A | ||
| PX811201_Aspartate_Aminotransferase_Assay_Repeatability | ||||
| PX811201110000 | Repeatability of the red blood cell more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Blood_Draw_Results | ||||
| PX811201040000 | Record the results of the blood draw. | N/A | ||
| PX811201_Aspartate_Aminotransferase_Blood_Draw_Tube_Deviation | ||||
| PX811201050000 | Record reasons for a tube not being drawn more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Chemotheraphy_4weeks | ||||
| PX811201020000 | Have you received cancer chemotherapy in the more | Variable Mapping | ||
| PX811201_Aspartate_Aminotransferase_Coefficients_Variation_Assay | ||||
| PX811201120000 | Coefficients of variation of the red blood more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Equipment_Make | ||||
| PX811201090000 | Make of the equipment used to perform the more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Equipment_Manufacturer | ||||
| PX811201100000 | Manufacturer of the equipment used to more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Have_Hemophilia | ||||
| PX811201010000 | Do you have hemophilia? | Variable Mapping | ||
| PX811201_Aspartate_Aminotransferase_Serum_Description | ||||
| PX811201070200 | If serum is hemolyzed, turbid, lipemic, or more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Serum_Determination | ||||
| PX811201070100 | Determine if the serum is hemolyzed, turbid, more | N/A | ||
| PX811201_Aspartate_Aminotransferase_Venipuncture_Comments | ||||
| PX811201060000 | Record any comments about the venipuncture. | N/A | ||
Measure Name
Aspartate Aminotransferase
Release Date
July 30, 2015
Definition
A bioassay to measure levels of aspartate aminotransferase (AST), which is released into the blood following tissue damage.
Purpose
Elevated levels of aspartate aminotransferase (AST) are reflective of hemolysis associated with sickle cell disease. Additionally, elevated levels of AST are associated with myocardial infarction, liver disease, hemolysis and anemia, pancreatitis, muscle damage or inflammation, trauma and mononucleosis.
Keywords
Red blood cell aspartate aminotransferase, AST, hemolysis, hemoglobin, sickle cell disease, SCD, hypoxemia, hemolytic anemia, Liver, pancreas, Heart attack, muscle disease, mononucleosis, pulmonary hypertension, pH, cutaneous leg ulceration, hypoxemia, hemolytic anemia, chronic kidney disease, CKD, vasculopathy, stroke, hemolytic component, "Cardiovascular, Pulmonary, and Renal"
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 811201 | Aspartate Aminotransferase Level |
Publications
There are no publications listed for this protocol.