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Test ID: GDT
Gadolinium, Dermal, Tissue

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

89302

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

This test is useful for evaluation of dermal tissue. No other tissue types have been validated. The reference range applies only to dermal tissue.

 

Diagnosis of nephrogenic systemic fibrosis by documenting gadolinium deposition in affected dermal tissue.

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

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

Inducively Coupled Plasma-Mass Spectrometry (ICP-MS)

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

Gadolinium, T

Specimen Type Describes the specimen type needed for testing

Dermal Tissue

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:

Preferred: Mayo metal-free specimen vial (blue label) (Supply T173)

Acceptable: Paraffin block is also acceptable if not more than 1 or 2 cuts have been made to it for slides.

Specimen Volume: 2 mg

Collection Instructions:

1. 2 mg of tissue from a skin-punch biopsy is required, at least 2 mm in diameter and 2 mm in depth.

2. Any specimen vial other than a Mayo metal-free vial used should be plastic, leached with 10% nitric acid for 2 days, rinsed with redistilled water, and dried in clean air.

Additional Information:

1. This test is useful for evaluation of dermal tissue. No other tissue types have been validated. The reference range applies only to dermal tissue. Fresh, refrigerated, or frozen tissue is preferred.

2. If tissue is other than dermal tissue, see MSCM/20522 Miscellaneous Metals Testing.

3. See Cautions for paraffin block information.

4. Paraffin blocks will be returned 3 days after analysis.

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 cm (14-gauge needle), 1 cm (18-gauge needle), or 2 mm x 2 mm (punch)
0.3 mg by dry weight

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

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

 

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
Dermal TissueRefrigerated (preferred)14 days
 Ambient 14 days
 Frozen 14 days

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

Gadolinium is a member of the lanthanide series of the periodic table of elements and is considered a nonessential element. Due to its paramagnetic properties, chelated gadolinium is commonly employed as contrast media for magnetic resonance imaging (MRI) and computer tomography (CT) scanning.

 

Gadolinium is eliminated primarily by the renal filtration. In healthy subjects with normal renal function, the plasma half-life of gadolinium is approximately 90 minutes. Patients with reduced renal function exhibit increased gadolinium excretion half-life.

 

Patient with reduced renal function exposed to gadolinium chelates used as MRI or CT contrast media may be affected by nephrogenic systemic fibrosis. In this syndrome, prolonged retention of gadolinium is thought to allow the gadolinium cation to dissociate from its synthetic organic chelator and deposit predominantly in the skin, although other organs may be affected as well. These patients are often severely debilitated by progressive skin thickening and tightening. Fibrosis of skeletal muscle, lungs, liver, testes, and myocardium have also been observed, often with fatal results.

 

Three hemodialysis treatments are required to substantially remove gadolinium from patients with impaired renal function; peritoneal dialysis is not effective.

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.

<0.5 mcg/g

Interpretation Provides information to assist in interpretation of the test results

Elevated gadolinium (>0.5 mcg/g) observed in dermal tissue specimens collected more than 48 hours after administration of gadolinium-containing contrast media indicates gadolinium deposition. These patients have increased risk of nephrogenic systemic fibrosis (NSF).

 

In individuals with NSF, affected tissues are likely to contain gadolinium at concentrations in the range of 4 to 186 mcg/g. Unaffected tissues from gadolinium-exposed subjects exhibit gadolinium concentration of 0.6 mcg/g to 28 mcg/g.              

 

A reportable gadolinium concentration in tissue suggests recent administration of gadolinium-containing contrast media. In association with reduced renal function, these findings indicate a risk of NSF.

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

This test is useful for evaluation of dermal tissue. No other tissue types have been validated. The reference range applies only to dermal tissue.

 

Tissue gadolinium concentration will be elevated if the specimen is collected <48 hours of administration of gadolinium-containing contrast media. This elevation is due to residual gadolinium present from contrast media infusion. Elevated gadolinium in a specimen collected <48 hours after contrast media infusion does not indicate risk of nephrogenic systemic fibrosis.

Supportive Data

Dermal tissue gadolinium concentrations observed in Mayo Clinic patients with nephrogenic systemic fibrosis (NSF) were in the range of 6 to 186 mcg/g. Non-Mayo Clinic studies observed gadolinium concentrations in

NSF patient biopsies from involved sites ranging from 4.8 mcg/g to 106.2 mcg/g.(6,7)

 

Gadolinium (Gd[3+]) has an atomic mass of 157.25 g/mole

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

1. Otherson JB, Maize JC, Woolson RF, Budisavljevic MN: Nephrogenic systemic fibrosis after exposure to gadolinium in patients with renal failure. Nephrol Dial Transplant 2007;10:1093-1100

2. Perazella MA: Nephrogenic systemic fibrosis, kidney disease, and gadolinium: is there a link? Clin J AM Soc Nephrol 2007;2:200-202

3. Saitoh T, Hayasaka K, Tanaka Y, et al: Dialyzability of gadodiamide in hemodialysis patients. Radiat Med 2006;24:445-451

4. High WA, Ayers RA, Cowper SE: Gadolinium is quantifiable within the tissue of patients with nephrogenic systemic fibrosis. J Am Acad Dermatol 2007;56:710-712

5. High WA, Ayers RA, Chandler J, et al: Gadolinium is detectable within the tissue of patients with nephrogenic systemic fibrosis. J Am Acad Dermatol 2007;56:21-26

6. Christensen KN, Lee CU, Hanley MM, et al: Quantification of gadolinium in fresh skin and serum samples from patients with nephrogenic systemic fibrosis. J Am Acad Dermat 2011;64(1):91-96

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

Gadolinium in tissue is analyzed by inductively coupled plasma-mass spectrometry. Aqueous acidic calibrating standards, reagent blanks, quality control specimens, and patient sample digests are diluted with aqueous acidic diluent containing internal standards. These diluted samples are aspirated by a pneumatic high-pressure nebulizer driven by argon gas and directed into a high temperature (6800 K) argon gas discharge (plasma). This discharge decomposes, atomizes, and ionizes the nebulized particles. All atoms, molecules, and ions formed in the discharge are extracted into a mass spectrometer through a platinum orifice. Gadolinium ions are separated from the concomitants by the quadrupole-mass spectrometer. Instrument detector signals from the gadolinium ions are directly proportional to the concentration in the digested sample. (Christensen KN, Lee CU, Hanley MM, et al: Quantification of gadolinium in fresh skin and serum samples from patients with nephrogenic systemic fibrosis. J Am Acad Dermat 2011;64[1]:91-96)

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.

Thursday; 11 a.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.

2 days

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

7 days

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

Fresh tissue: 1 month Block: returned to client after 3 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.

83018

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
29249Gadolinium, TIn Process