NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Assessing intermediate-term glycemic control
Colorimetric Rate Reaction
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Protein Bound Glucose
Protein Bound Glucose
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.
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 0.5 mL
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 reject; 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.
|Serum||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Fructosamine is a general term, which applies to any glycated protein. It is formed by the nonenzymatic reaction of glucose with the a- and e-amino groups of proteins to form intermediate compounds called aldimines. These aldimines may dissociate or undergo an Amadori rearrangement to form stable ketoamines called fructosamines. This nonenzymatic glycation of specific proteins in vivo is proportional to the prevailing glucose concentration during the lifetime of the protein. Therefore, glycated protein measurements in the diabetic patient is felt to be a better monitor of long-term glycemic control than individual or sporadic glucose determinations. The best known of these proteins is glycated hemoglobin which is often measured as hemoglobin A1C, and reflects glycemic control over the past 6 to 8 weeks. In recognition of the need for a measurement which reflects intermediate-term glycemic control and was easily automated, a nonspecific test, termed fructosamine, was developed. Since albumin is the most abundant serum protein, it accounts for 80% of the gylcated serum proteins, and thus, a high proportion of the fructosamine. Although a large portion of the color generated in the reaction is contributed by glycated albumin, the method will measure all proteins, each with a different half-life and different levels of glycation.
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.
In general, fructosamine reflect glycemic control in diabetic patients over the previous 2 to 3 weeks. High values indicate poor control.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Since the assay is nonspecific, color may be generated by compounds other than glycated proteins. Interferences are seen from ascorbic acid (vitamin C) and elevated bilirubin values.
However, the second-generation assays have been shown to be highly specific for glycated proteins.
Fasting blood glucose and hemoglobin A1c are the usual and preferred means of monitoring glycemic control.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Tietz Textbook of Clinical Chemistry, Edited by Burtis and Ashwood. Philadelphia, WB Saunders Company, 1999
2. Austin GE, Mullins RH, Morin LG: Non-enzymatic glycation of individual plasma proteins in normoglycemic and hyperglycemic patients. Clin Chem 1987;33:2220-2224
3. Schleicher ED, Mayer R, Wagner EM, Gerbitz KD: Is serum fructosamine assay specific for determination of glycated serum protein? Clin Chem 1988;34:320-323
Method Description Describes how the test is performed and provides a method-specific reference
The fructosamine assay is a colorimetric test based on the ability of ketoamines to reduce nitroblue tetrazolium to formazan in an alkaline medium. The rate of formation of formazan is directly proportional to the concentration of fructosamine, and is measured photometrically at 546 nm.(Package insert: Roche Fructosamine reagent, Roche Diagnostics Corp., Indianapolis, IN 1999)
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.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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|