Microalbuminuria, 24 Hour, Urine
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluating diabetic patients to assess the potential for early onset of nephropathy
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Microalbuminuria, 24 Hr, U
Microalbuminuria, 24 Hr Col, Urine test performed at Mayo New England
Microalbuminuria, 24 Hr Col, Urine test performed at Mayo New England
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Plastic, 10-mL urine tube (Supply T068)
Specimen Volume: 5 mL
1. Collect urine for 24 hours.
2. No preservative.
3. Mix well before taking 5-mL aliquot.
1. 24-Hour volume is required.
2. See Urine Preservatives in Special Instructions for multiple collections.
Urine Preservative Collection Options
50% Acetic Acid
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Urine||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Albumin excretion increases in patients with diabetes who are destined to develop diabetic nephropathy. More importantly, at this phase of increased albumin excretion before overt proteinuria develops, therapeutic maneuvers can be expected to significantly delay, or possibly prevent, development of nephropathy. These maneuvers include aggressive blood pressure maintenance (particularly with angiotensin-converting enzyme inhibitors), aggressive blood sugar control, and possibly decreased protein intake. Thus, there is a need for addressing small amounts of urinary albumin excretion (in the range of 30-300 mg/day, ie, microalbuminuria).
The National Kidney Foundation convened an expert panel to recommend guidelines for the management of patients with diabetes and microalbuminuria. These guidelines recommend that all type 1 diabetic patients older than 12 years and all type 2 diabetic patients younger than 70 years should have their urine tested for microalbuminuria yearly when they are under stable glucose control.(1)
The preferred specimen is a 24-hour collection, but a 10-hour overnight collection (9 p.m. to 7 a.m.) or a random collection are acceptable. Recent studies have shown that correcting albumin for creatinine excretion rates has similar discriminatory value with respect to diabetic renal involvement, and it is now suggested that an albumin/creatinine ratio from a random urine specimen is a valid screening tool.(2) Several studies have addressed the question of whether this needs to be a fasting urine, an exercised urine, or an overnight urine specimen. From these studies, it is clear that the first-morning urine specimen is less sensitive, but more specific. A positive result should be confirmed by a first-morning random or 24-hour timed urine specimen.
Studies have also shown that microalbuminuria is a marker of generalized vascular disease and is associated with stroke and heart disease.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
24-Hour excretion: <30 mg/24 hours
Excretion rate: <20 mcg/min
An albumin excretion rate >30 mg/24 hours is considered to be microalbuminuric. By definition, the upper end of microalbuminuria is thought to be 300 mg/24 hours. Although this level has not been rigorously defined, it is felt that at this level it is more difficult to change the course of diabetic nephropathy. We have established normal values in our laboratory and agree with the 30 mg/24 hour level. A normal excretion rate of 20 mcg/min has also been established in the literature and is consistent with our data. Thus, microalbuminuria has been defined at 30 to 300 mg/24 hours.
The literature has defined the albumin/creatinine ratio (mg/g) <17 as normal for males and <25 for females(2) and is consistent with our normal data. A ratio of albumin to creatinine of > or =300 indicates overt albuminuria. Thus, microalbuminuria has been defined as an albumin/creatinine ratio of 17 to 299 for males and 25 to 299 for females.
Due to biologic variability, any patient who has an albumin/creatinine ratio or urinary albumin excretion rate in the positive microalbuminuria range should have this confirmed with a second specimen. If there is discrepancy, a third specimen is recommended. If 2 of 3 results are in the positive microalbuminuria range, this is evidence for incipient nephropathy and warrants increased efforts at glucose control, aggressive blood pressure control, and institution of therapy with an angiotensin-converting enzyme inhibitor (if the patient can tolerate it).
On 02/10/2009, the reagent system used for the immunoturbidimetric albumin assay was changed. This resulted in a small but statistically significant change in albumin measurements. To directly compare results after the date of this method change to previous values the old urinary albumin concentration should be multiplied by 1.11. Given the normal physiologic variability of albumin excretion in individuals and the small magnitude of this correction factor, in most instances this calculation will not be necessary for clinical management of patients.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Urine may be collected and transported ambient, refrigerated, frozen, or preserved in toluene, thymol, or boric acid. Specimens in which nitric acid, hydrochloric acid, sodium carbonate or acetic acid has been added are unacceptable because of precipitation of albumin by these acids.
Urine collected during menses may contain excess albumin and collection during this time should be avoided.
Heavy exercise may increase albumin excretion and should be avoided during collection. Normal values apply to a nonexercised state.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Bennett PH, Haffner S, Kasiske BL, et al: Diabetic Renal Disease Recommendations--Screening and management of microalbuminuria in patients with diabetes mellitus: Recommendations to the Scientific Advisory Board of the National Kidney Foundation from an ad hoc committee of the Council on Diabetes Mellitus of the National Kidney Foundation. Am J Kid Dis 1995;25:107-112
2. Zelmanovitz T, Gross JL, Oliveira JR, et al: The receiver operating characteristics curve in the evaluation of a random urine specimen as a screening test for diabetic nephropathy. Diabetes Care 20:1997;516-519
3. Krolewski AS, Laffel LM, Krolewski M,et al: Glycosylated hemoglobin and the risk of microalbuminuria in patients with insulin-dependent diabetes mellitus. New Engl J Med 1995;332:1251-1255
4. Package insert for Tina-Quant Albumin reagents kit for urinary albumin, Roche Diagnostics, Indianapolis, IN
Method Description Describes how the test is performed and provides a method-specific reference
Albumin is measured by immunoturbidimetry utilizing antibody to human albumin in an automated immunoprecipitin analysis system. (Package insert: Tina-Quant Albumin Reagents Kit for urinary albumin, Roche Diagnostics, Indianapolis, IN, March 2007)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Continuously
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Same day/1 day
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|MI24H||Microalbuminuria, 24 Hr, U||14956-7|
|24HEX||24 Hour Excretion||14956-7|