Cobalt/Creatinine Ratio, Random, Urine
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Detecting cobalt exposure
Monitoring metallic prosthetic implant wear
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
|Test ID||Reporting Name||Available Separately||Always Performed|
|COBC||Cobalt/Creat Ratio, U||No||Yes|
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
COBC: Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
CDCR: Enzymatic Colorimetric Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Cobalt/Creat Ratio, Random, U
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: Clean, plastic urine collection container
Submission Container/Tube: Plastic, 10-mL urine tube (Supply T068) or clean, plastic aliquot container with no metal cap or glued insert
Specimen Volume: 3 mL
1. Collect a random urine specimen.
2. See Metals Analysis-Collection and Transport in Special Instructions for complete instructions.
Additional Information: High concentrations of gadolinium and iodine are known to interfere with most metals tests. If either gadolinium- or iodine-containing contrast media has been administered, a specimen should not be collected for 96 hours.
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.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Urine||Refrigerated (preferred)||28 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Cobalt is rare but widely distributed in the environment. It is an essential cofactor in vitamin B12. While cobalt is an essential element, cobalt deficiency has not been reported in humans.
Cobalt is used in the manufacture of hard alloys with high melting points and resistance to oxidation. Cobalt salts are also used in the glass and pigment industry. Previously, cobalt salts were sometimes used as foam stabilizers in the brewing industry; this practice was banned due to the cardiovascular diseases it induced. The radioactive isotope of cobalt, (60)Co, is used as a gamma emitter in experimental biology, cancer therapy, and industrial radiography.
Cobalt is not highly toxic, but large doses will produce adverse clinical manifestations. Acute symptoms are pulmonary edema, allergy, nausea, vomiting, hemorrhage, and renal failure. Chronic symptoms include pulmonary syndrome, skin disorders, and thyroid abnormalities. The inhalation of dust during machining of cobalt alloyed metals can lead to interstitial lung disease. Improperly handled (60)Co can cause radiation poisoning from exposure to gamma radiation.
Urine cobalt concentrations are likely to be increased above the reference value in patients with metallic joint prosthesis. Prosthetic devices produced by Zimmer Company and Johnson & Johnson typically are made of aluminum, vanadium, and titanium. Prosthetic devices produced by Depuy Company, Dow Corning, Howmedica, LCS, PCA, Osteonics, Richards Company, Tricon, and Whiteside typically are made of chromium, cobalt, and molybdenum. This list of products is incomplete, and these products change occasionally; see prosthesis product information for each device for composition details.
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.
0.0-1.9 mcg/g Creatinine
Reference values apply to all ages.
Concentrations > or =2.0 mcg/g creatinine indicate excess exposure. There are no Occupational Safety and Health Administration (OSHA) blood or urine criteria for occupational exposure to cobalt.
Prosthesis wear is known to result in increased circulating concentration of metal ions. In a patient with a cobalt-based implant, modest increase (2-4 mcg/g creatinine) in urine cobalt concentration is likely to be associated with a prosthetic device in good condition. Excessive exposure is indicated when urine cobalt concentration is >5 mcg/g creatinine, consistent with prosthesis wear. Urine concentrations >20 mcg/g creatinine in a patient with a cobalt-based implant suggest significant prosthesis wear. Increased urine trace element concentrations in the absence of corroborating clinical information do not independently predict prosthesis wear or failure.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not useful to assess vitamin B12 activity.
High concentrations of gadolinium and iodine are known to interfere with most metals tests. If either gadolinium- or iodine-containing contrast media has been administered, a specimen should not be collected for 96 hours.
Specimen collection procedures for cobalt require special specimen collection tubes, rigorous attention to ultraclean specimen collection and handling procedures, and analysis in an ultraclean facility. Unless all of these precautions are taken, elevated urine cobalt results may be an incidental and misleading finding.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Keegan GM, Learmonth ID, Case CP: A systematic comparison of the actual, potential, and theoretical health effects of cobalt and chromium from industry and surgical implants. Crit Rev Toxicol 2008;38:645-674
2. Lhotka C, Szekes T, Stefan I, et al: Four-year study of cobalt and chromium blood levels in patients managed with two different metal-on-metal total hip replacements. J Orthop Res 2003;21:189-195
3. Lison D, De Boeck M, Verougstraete V, Kirsch-Volders M: Update on the genotoxicity and carcinogenicity of cobalt compounds. Occup Environ Med 2001;58(10):619-625
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 standards. 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, and 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 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 versus 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.(Unpublished Mayo method)
Creatinine is measured using an enzymatic method based on the determination of sarcosine from creatinine with the aid of creatininase, creatinase, and sarcosine oxidase. The liberated hydrogen peroxide is measured via a modified Trinder reaction using a colorimetric indicator.(Package Insert: Roche Diagnostics, Indianapolis IN, 2004)
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|
|32871||Cobalt/Creat Ratio, U||In Process|
|32886||Co Concentration||In Process|