NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Monitoring metallic prosthetic implant wear
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-Optical Emission Spectrometry (ICP-OES)
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: 1.2 mL
1. Allow 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, avoiding transfer of the cellular components of blood. Do not insert a pipet 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.
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.
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)||10 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Titanium is the ninth most abundant element in the earth’s crust. Multiple oxidation states between 2+ and 4+ allow formation of a variety of compounds. There is no evidence that titanium is an essential element. Due in part to titanium’s oxide formation propensity, the element is considered to be nontoxic. Soils, drinking water, and air all contain trace amounts of titanium. The food processing industry uses large quantities of titanium as a food additive; processed foods contain higher levels than are found in most produce and organic food-stuffs. The average daily oral intake through food consumption is 0.1 to 1 mg/day, which accounts for more than 99% of exposure. Gastrointestinal absorption of titanium is low (approximately 3%) and the majority of ingested titanium is rapidly excreted in the urine and stool. The total body burden of titanium is usually in the range of 9 to 15 mg, a significant portion of which is contained in the lung. Titanium dust entering the respiratory tract is nonirritating and is almost completely nonfibrogenic in humans.
Titanium-containing alloys are used in some artificial joints, prosthetic devices, and implants. Titanium dioxide allows osseointegration between an artificial medical implant and bone. Despite their wide use, exposure to these materials has not been linked to toxicity. In one study patients monitored up to 36 months following joint replacement with titanium-containing joints showed a statistically significant increase in detectable serum titanium within the study group. While titanium concentrations are not a measure of toxicity, they are useful in determining whether implant breakdown is occurring. Serum titanium concentrations are likely to be increased above the reference range in patients with metallic joint prosthesis. Prosthetic devices produced by Zimmer Company and Johnson and Johnson typically are made of aluminum, vanadium, and titanium. 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.
Prosthesis wear is known to result in increased circulating concentration of metal ions. In the absence of an implant, circulating titanium is <1 ng/mL. Modest increase (1.0-3.0 ng/mL) in serum titanium concentration is evident with a prosthetic device in good condition. Serum concentrations >10 ng/mL in a patient with titanium-based implant suggest prosthesis wear. Increased serum titanium concentration in the absence of corroborating clinical information does 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
Titanium is a trace metal commonly used in alloys and readily present in the environment. Thus, contamination of the collection site and of the specimen must be avoided. Failure to use metal-free collection procedures and devices may cause falsely increased results. See Specimen Required for collection and processing information.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Chao EY, Frassica F, Prichard DJ, Moyer TP. Metal ion release in patients with porous coated megaprostheses. 41st Annual Meeting of the Orthopaedic Research Society, Orlando, Florida, 1995 Feb 13-16
2. Jacobs JJ, Skipor AK, Patterson LM, et al: Metal release in patients who have had a primary total hip arthroplasty. A prospective, controlled, longitudinal study. J Bone Joint Surg Am 1998 Oct;80(10):1447-1458
3. Liu T-K, Liu S-H, Chang C-H, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med1998;185:253-262
4. Krachler M, Domj W, Irgolic KJ. Concentrations of trace elements in osteoarthritic knee-joint effusions. Biol Trace Elem Res 2000;75:253-263
Method Description Describes how the test is performed and provides a method-specific reference
Titanium concentrations in serum can be determined by inductively coupled plasma optical emission spectrometry. Aqueous acidic calibrating standards, quality control samples, patient specimens, and blanks are diluted with diluent containing an internal standard. In turn, all diluted blanks, calibrating standards, quality control samples, 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. Emission signals from titanium and the internal standard are observed axially by the emission spectrometer. Instrumentation response is defined by the linear relationship of analyte concentrations versus the ratio of the titanium emission signals to the internal standard. After reagent blank subtraction, unknown sample titanium concentrations are calculated by entering the net unknown intensity ratios into the linear calibration equation. (Unpublished Mayo Method)
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; 5 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
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|
|89367||Titanium, S||In Process|