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Test ID: HYPOG
Hypoglycemic Agent Screen, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

82439

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Evaluation of suspected insulinoma characterized by hypoglycemia and increased plasma insulin concentration.

 

Detecting drugs that stimulate insulin secretion

 

If hypoglycemia is the result of 1 of these drugs, the test will detect the drug at physiologically significant concentrations in serum during an episode of hypoglycemia.

 

Drugs detected by this procedure are:

-The first-generation sulfonylureas-acetohexamide, chlorpropamide, tolazamide, and tolbutamide

-The second-generation sulfonylureas--glimepiride, glipizide, and glyburide

-The meglitinide-repaglinide

 

Drugs designed to make tissues more sensitive to insulin that do not induce hypoglycemia, such as pioglitazone, rosiglitazone, and troglitazone (recently withdrawn from the United States market) are not included in this screen test.

 

Drugs that lower blood glucose through mechanisms not related to stimulation of insulin secretion, such as acarbose, metformin, and miglitol are not included in this screen test.

Method Name A short description of the method used to perform the test

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Hypoglycemic Agent Scrn, S

Aliases Lists additional common names for a test, as an aid in searching

Amaryl
Chlorpropamide
Dymelor
Glimepiride
Glipizide
Glucotrol
Glyburide
Meglitinides
Micronase
Prandin
Repaglinide
Sulfonylurea Hypoglycemic Serum
Sulfonylureas
Tolazamide (Tolinase)
Acetohexamide (Dymelor)
Orinase (Tolbutamide)
Diabinese (Chlorpropamide)

Specimen Type Describes the specimen type needed for testing

Serum Red

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.

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.

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.

1.1 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

Serum gel tube

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Serum RedFrozen (preferred)14 days
 Ambient 14 days
 Refrigerated 14 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The metabolic and hormonal profiles of insulinoma and sulfonylurea-induced hypoglycemia are identical. Therefore, in the evaluation of the hypoglycemic patient, the possible use of oral hypoglycemic agents as the cause for low blood glucose and elevated plasma insulin must be considered. Absence of hypoglycemic drugs in blood serum during an episode of low blood glucose should be demonstrated before considering pancreatic exploration for suspected insulinoma.

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.

ACETOHEXAMIDE

Negative: <1,000 ng/mL

 

CHLORPROPAMIDE

Negative: <1,000 ng/mL

 

TOLAZAMIDE

Negative: <20 ng/mL

 

TOLBUTAMIDE

Negative: <50 ng/mL

 

GLIMEPIRIDE

Negative: <20 ng/mL

 

GLIPIZIDE

Negative: <3 ng/mL

 

GLYBURIDE

Negative: <3 ng/mL

 

REPAGLINIDE

Negative: <3 ng/mL

Note: The report indicates a specific drug is positive if that drug is detected at a concentration greater than the sensitivity limit. The test sensitivity limit listed for each drug is lower than the concentration that will cause increased insulin and decreased glucose.

Interpretation Provides information to assist in interpretation of the test results

Use of hypoglycemic agents outside of the context of treatment of type 2 diabetes is likely to cause hypoglycemia associated with elevated plasma insulin. Patients presenting with hypoglycemia due to ingestion of a first-, second-, or third-generation hypoglycemic agent will have drug present in serum greater than the minimum effective concentration (see Reference Values). Presence of drug indicates that the patient has recently ingested a hypoglycemic agent.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Proper interpretation requires that the blood specimen be drawn during or close to the time of a hypoglycemic episode. Drugs will not be detected (and are not likely to be present) if blood is drawn when blood glucose is normal in nondiabetic patients.

 

All drugs that stimulate insulin secretion undergo extensive metabolism before excretion. The parent drug is therefore not present in urine. Blood serum is the specimen of choice for detecting use of the hypoglycemic drugs: urine or plasma is not an acceptable specimen.

 

This test is not intended for therapeutic drug monitoring.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

Ben-Ami H, Nagachandran P, Mendelson A, Edoute Y: Drug-induced hypoglycemic coma in 102 diabetic patients. Arch Int Med 1999;159:281-284

Method Description Describes how the test is performed and provides a method-specific reference

Serum specimens are subjected to organic extraction. The extract is analyzed by liquid chromatography-tandem mass spectrometry.(Unpublished Mayo information)

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, Wednesday, Friday (9 a.m. cutoff)

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.

2 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

8 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

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.

80100

G0431-government payers (if appropriate)

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 IDReporting NameLOINC Code
21294Acetohexamide27007-4
21295Chlorpropamide3474-4
21296Tolazamide9629-7
21297Tolbutamide4061-8
21298Glimepiride40465-7
21299Glipizide10539-5
21300Glyburide10540-3
21301Repaglinide38542-7
21308Comment48767-8