Protocol - Urinary Creatinine - Assay
- Blood Pressure (Adult/Primary)
- Personal History of Kidney Failure
- Serum Creatinine - Assay
- Urinary Microalbumin - Assay
Description
This protocol provides basic instructions for collecting and processing urine according to National Health and Nutrition Examination Survey (NHANES) methods. Creatinine concentration in a participant’s morning urine sample is measured according to the Jaffe rate method. The protocol also lists reference ranges for healthy adults.
Specific Instructions
The Diabetes Working Group (WG) recommends that the urine creatinine assay be performed on urine collected during a participant’s morning void but notes that a random sample is also acceptable.
Note from the Diabetes WG: Urine should be stored at -80°C until testing and shipped on dry ice to prevent thawing.
The Sickle Cell Disease Research and Scientific Panel notes that urine creatinine is used to standardize the excretion of certain solutes in urine (urine concentration of solute "x" divided by the urine concentration of creatinine), and avoids a 24-hour urine collections. In a steady state, the urine excretion rate of creatinine is constant for a particular individual, thus providing a method to detect changes in their excretion rates in a longitudinal fashion. However, the urinary excretion of creatinine reflects the level of muscle mass, which is affected by nutrition, gender and age characteristics. Since muscle mass may be decreased in some individuals with sickle cell disease, caution should be used when comparing values in adults vs children or vs non-sickle cell disease populations.
Availability
Protocol
The following is a summary version of the full National Health and Nutrition Examination Survey 2007-2008 protocol.
Urine Collection
Editor’s Note: Please review chapter 5 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2007-2008 for a full description of urine collection and processing procedures: 2007-2008 NHANES Lab Manual.
The coordinator explains the following instructions to the subject before urine collection:
• Wash hands with soap and water;
• It is important that the cup and cap not touch or come into contact with any parts of the body, clothing, or external surfaces; and
• Close container to minimize exposure to air.
Refrigerate all insufficient urine samples. When additional urine is obtained, pool the urine, mix, and process.
Record the Results of Urine Specimen Collection
Note whether or not urine was collected, and note whether the volume of urine was sufficient or required a second specimen.
Note whether blood is present/visible in the specimen.
Process the Urine for the Urinary Creatinine Assay
Pour 3 mL of the specimen for urine creatinine into a 5 mL vessel.
Laboratory Procedure for Urinary Creatinine
The Diabetes Working Group (WG) recommends that urine creatinine concentration be determined according to the Jaffe rate method developed by the University of Minnesota for use in the National Health and Nutrition Examination Survey: Urine Creatinine Laboratory Assay.
To aid comparability, the Diabetes WG recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.
REFERENCE RANGES
| Age, years | Range per day |
| 2-3 | 6-22 mg/kg/d |
| 4-16 | 12-30 mg/kg/d |
| > 16, male | 1.0-2.0 g/d |
| > 16, female | 0.8-1.8 g/d |
Personnel and Training Required
Personnel to collect the urine Laboratory to perform the Jaffe rate assay
Equipment Needs
Supplies to collect and process urine
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
Child, Adolescent, Adult, Senior
Participants
Participants 6 years of age and older
Selection Rationale
The National Health and Nutrition Examination Survey 2007-2008 protocol was selected as the best practice methodology and one of the most widely used protocols to measure urine creatinine. Additionally, the Jaffe protocol used by the National Health and Nutrition Examination Survey and developed by the University of Minnesota has been used in other studies, including Atherosclerosis Risk in Communities (ARIC) and Family Investigation of Nephropathy and Diabetes (FIND).
Language
Chinese, English, Other languages available at source
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Logical Observation Identifiers Names and Codes (LOINC) | Urinary creatinine assay proto | 62811-5 | LOINC |
| Human Phenotype Ontology | Abnormal circulating creatinine levels | HP:0012100 | HPO |
| caDSR Form | PhenX PX141601 - Urinary Creatinine Assay For Kidney Function | 6170170 | caDSR Form |
Derived Variables
Microalbuminuria Ratio of urine microalbumin to urine creatinine
| Ratio of albumin/creatinine (ug/mg) | |
| Normal | < 30 |
| Microalbuminuria | 30-299 |
| Macroalbuminuria | > 299 |
American Diabetes Association (ADA). (2014a). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(Suppl. 1), S81-S90.
American Diabetes Association (ADA). (2014b). standards of medical care in diabetes-2014. Diabetes Care, 37(Suppl. 1), S14-S80.
Process and Review
The Expert Review Panel #1 reviewed the measures in the Anthropometrics, Diabetes, Physical Activity and Physical Fitness, and Nutrition and Dietary Supplements domains.
Guidance from the ERP includes:
• Changed the name of measure
• Revised descriptions of measure
Back-compatible: no changes to Data Dictionary
Previous version in Toolkit archive (link)
Protocol Name from Source
National Health and Nutrition Examination Survey (NHANES), Laboratory Procedures Manual, 2007
Source
Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2007a). 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.
Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2007b). National Health and Nutrition Examination Survey Questionnaire. University of Minnesota Laboratory Procedures Manual for Urinary Creatinine by Beckman Synchron CX3 Clinical Analyzer. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
General References
Allon, M., Lawson, L., Eckman, J.R., Delaney, V., & Bourke, E. (1988). Effects of nonsteroidal antiinflammatory drugs on renal function in sickle cell anemia. Kidney International, 34, 500-506.
de Jong, P.E., de Jong-Van Den Berg, T.W., Sewrajsingh, G.S., Schouten, H., Donker, A.J.M., & Statius van Eps, L.W. (1980). The influence of indomethacin on renal hemodynamics in sickle cell anemia. Clinical Science, 59, 245-250.
Guasch, A., Cua, M., & Mitch, W.E. (1996). Early detection and the course of glomerular injury in patients with sickle cell anemia. Kidney International, 49, 786-791.
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. (2013). KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney International Supplement, 3, 1-150.
Protocol ID
141601
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX141601_Assay_Repeatability | ||||
| PX141601040000 | Repeatability of the assay | N/A | ||
| PX141601_Coefficient_Of_Variation | ||||
| PX141601050000 | Coefficient of variation for the assay | N/A | ||
| PX141601_Equipment_Make | ||||
| PX141601030100 | Make of the equipment used to determine the more | N/A | ||
| PX141601_Equipment_Manufacturer | ||||
| PX141601030200 | Manufacturer of the equipment used to more | N/A | ||
| PX141601_Sample_Comments | ||||
| PX141601020000 | Record any comments about the urine during more | Variable Mapping | ||
| PX141601_Urinary_Creatinine_Concentration | ||||
| PX141601060000 | Concentration of urinary creatinine | N/A | ||
| PX141601_Urine_Collection_Comments | ||||
| PX141601010000 | Record any comments about the urine more | N/A | ||
Measure Name
Urinary Creatinine Assay
Release Date
May 10, 2010
Definition
A bioassay to measure urine concentration of creatinine, a muscle metabolite that is filtered out of blood by the kidneys.
Purpose
The urinary creatinine measure should be done in conjunction with urinary microalbumin to determine the ratio of urine albumin to urine creatinine, which can predict the risk of nephropathy (National Health and Nutrition Examination Survey and University of Minnesota Laboratory Procedure Manual for Urinary Creatinine, 2008).
Keywords
diabetes, nephropathy, kidney, kidney disease, kidney failure, microalbuminuria, macroalbuminuria, NHANES, sickle cell disease, SCD
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 141601 | Urinary Creatinine - Assay |
Publications
Bartholomew, T. S., et al. (2024) Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services Addiction Science & Clinical Practice. 2024 March; 19(1). doi: 10.1186/s13722-024-00447-9