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Test ID: INS
Insulin, Serum

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

8664

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

Diagnosing insulinoma, when used in conjunction with proinsulin and C-peptide measurements

 

Management of diabetes mellitus

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

Electrochemiluminescence Immunoassay

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

Insulin, S

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

Fasting Insulin
Immunoreactive Insulin
Insulin Assay
Insulin Level, Serum
Native Insulin

Specimen Type Describes the specimen type needed for testing

Serum

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:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: 

1. Fasting.

2. Avoid hemolysis.

3. Label specimens with corresponding draw times.

Additional Information: If multiple specimens are drawn, send separate order for each 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.

0.5 mL

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

Hemolysis

Mild reject; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

Autopsy specimen

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
SerumFrozen (preferred)180 days
 Refrigerated 7 days

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

Insulin is a hormone produced by the beta cells of the pancreas. It regulates the uptake and utilization of glucose and is also involved in protein synthesis and triglyceride storage.

 

Type 1 diabetes (insulin-dependent diabetes) is caused by insulin deficiency due to destruction of insulin-producing pancreatic islet (beta) cells. Type 2 diabetes (noninsulin dependent diabetes) is characterized by resistance to the action of insulin (insulin resistance).

 

Insulin levels may be increased in patients with pancreatic beta cell tumors (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.

2.6-24.9 mcIU/mL

Interpretation Provides information to assist in interpretation of the test results

During prolonged fasting, when the patient's glucose level is reduced to <40 mg/dL, elevated insulin level plus elevated levels of proinsulin and C-peptide suggest insulinoma.

 

Insulin levels generally decline in patients with type 1 diabetes mellitus.

 

In the early stage of type 2 diabetes, insulin levels are either normal or elevated. In the late stage of type 2 diabetes, insulin levels decline.

 

In normal individuals, insulin levels parallel blood glucose levels.

 

To compare insulin and C-peptide concentrations (ie, insulin to C-peptide ratio):

-Convert insulin to pmol/L: insulin concentration in mcIU/mL x 6.945 = insulin concentration in pmol/L.

-Convert C-peptide to pmol/L: C-peptide concentration in ng/mL x 331 = C-peptide concentration in pmol/L.

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

Human anti-mouse antibodies (HAMA) may interfere with the assay.

 

Patients on insulin therapy may develop anti-insulin antibodies. These antibodies may interfere in the assay system, causing inaccurate results. In such individuals, measurement of free insulin (FINS/81728 Insulin, Free, Serum) should be performed.

 

This assay has 100% cross-reactivity with recombinant human insulin (Novolin R and Novolin N). It does not recognize other commonly used analogues of injectable insulin (ie, insulin lispro, insulin aspart, and insulin glargine).

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

Threatte GA, Henry JB: Carbohydrates. In Clinical Diagnosis and Management by Laboratory Methods. 19th edition. Edited by JB Henry. Philadelphia, WB Saunders Company, 1996, pp 194-207

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

The Roche Cobas insulin method is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal insulin-specific antibody and a monoclonal insulin-specific antibody. Insulin in the specimen reacts with both the biotinylated monoclonal insulin-specific antibody (mouse) and the monoclonal insulin-specific antibody (mouse) labeled with a ruthenium complex, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured. (Package insert: Roche Insulin reagent, Roche Diagnostic Corp., Indianapolis, IN 2010-10, V1)

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 Friday 5 a.m. – 12 a.m., Saturday 6 a.m. – 6 p.m.

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

3 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 months

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 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.

83525-Each

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
INSInsulin, S20448-7