NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis of nephrogenic systemic fibrosis by documenting gadolinium retention in the body
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
Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
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.
Collection Container/Tube: Plain, royal-blue top Monoject trace element blood collection tube-product #8881-307006 (Supply T184)
Submission Container/Tube: 7-mL Mayo metal-free, screw-capped, polypropylene vial (Supply T173)
Specimen Volume: 1.6 mL
1. Allow the specimen to clot for 30 minutes; then centrifuge the specimen to separate serum from the cellular fraction.
2. Remove the stopper. Carefully pour specimen into a 7-mL Mayo metal-free, screw-capped, polypropylene vial (Supply T173), avoiding transfer of the cellular components of blood. Do not insert a pipette into the serum to accomplish transfer, and do not ream the specimen with a wooden stick to assist with serum transfer.
3. See Metals Analysis-Collection and Transport in Special Instructions for complete instructions.
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 OK
Mild OK; Gross OK
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.
|Serum||Refrigerated (preferred)||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 and computer tomography 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 an increased gadolinium excretion half-life.
Gadolinium has been associated with the nephrogenic systemic fibrosis in patients with impaired renal function. 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. Because the ionic radius of gadolinium (3+) is similar to that of calcium (2+), it may also deposit in bone.
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.
Elevated gadolinium (>0.5 ng/mL) observed in a serum specimen draw >48 hours after administration of gadolinium-containing contrast media indicates impaired ability to eliminate gadolinium. These patients have an increased risk of developing nephrogenic systemic fibrosis.
A normal value is <0.5 ng/mL; the lower limit of the assay's reportable range is 0.1 ng/mL.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Serum gadolinium concentration will be elevated if the specimen is drawn <96 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 drawn <96 hours after contrast media infusion does not indicate risk of nephrogenic systemic fibrosis.
An evaluation of serum gadolinium concentration in 100 unexposed, healthy human subjects generated a reference range of greater than 0.1 ng/mL to 0.5 ng/mL (median value 0.2 ng/mL) with no evidence or age or gender trend. Serum gadolinium concentrations observed in Mayo Clinic patients with nephrogenic systemic fibrosis (NSF) were in the range of 2 ng/mL to 5 ng/mL. No peer reviewed reports of serum gadolinium concentrations in NSF were found on literature search.
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. Othersen JB, Maize JC, Woolson RF, Budisavljevic MN: Nephrogenic systemic fibrosis after exposure to gadolinium in patients with renal failure. Nephrol Dial Transplant 2007;22:3179-3185
2. Perazella MA: Nephrogenic systemic fibrosis, kidney disease, and gadolinium: is there a link? Clin J Am Soc Nephrol 2007;2:200-202
3. Leung N, Pittelkow M, Lee CU, et al: Chelation of gadolinium with deferoxamine in a patient with nephrogenic systemic fibrosis. NDT Plus 2009;2:309-311
4. 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
This assay is performed on an inductively coupled plasma-mass spectrometer. Calibrating standards and blanks are diluted with an aqueous acidic diluent containing internal standard(s). Quality control specimens and patient samples are diluted in an identical manner. In turn, all diluted blanks, calibrating standards, quality control specimens and patient specimens are aspirated into a pneumatic nebulizer and the resulting aerosol directed to the hot plasma discharge by a flow of argon. In the annular plasma the aerosol is vaporized, atomized, then ionized. The ionized gases plus neutral species formed in the annular plasma space are aspirated from the plasma through an orifice into a quadrupole mass spectrometer. The mass range from 1 amu to 263 amu is rapidly scanned multiple times and ion counts tabulated for each mass of interest. Instrument response is defined by the linear relationship of analyte concentration vs. ion count ratio (analyte ion count/internal standard ion count). Analyte concentrations are derived by reading the ion count ratio for each mass of interest and determining the concentration from the response line. (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.
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 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.
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|
|29251||Gadolinium, S||In Process|