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Test Code COSY Cobalt, Synovial Fluid


Ordering Guidance


This test should only be used in individuals with metallic prosthetic implants. The significance of cobalt concentrations in synovial fluid in patients without implants is unknown.



Specimen Required


Patient Preparation:  High concentrations of gadolinium and iodine are known to interfere with most inductively coupled plasma mass spectrometry-based metal tests. If either gadolinium- or iodine-containing contrast media has been administered, a specimen should not be collected for at least 96 hours.

Supplies: Metal Free B-D Tube (EDTA), 6 mL (T183)

Container/Tube: Royal blue top (metal-free EDTA)

Specimen Volume: 1 mL

Collection Instructions: See Metals Analysis Specimen Collection and Transport for complete instructions.

Additional Information: Cobalt is present in the black rubber plunger seals found in most disposable syringes. As a result, synovial fluid should not be collected in these devices as contamination may occur.


Useful For

Monitoring metallic prosthetic implant wear and local tissue destruction in failed hip arthroplasty constructs

 

This test is not useful for assessment of nutritional status or potential cobalt toxicity.

Method Name

Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)

Reporting Name

Cobalt, Synovial Fl

Specimen Type

Synovial Fluid

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Synovial Fluid Refrigerated (preferred) 90 days
  Ambient  90 days
  Frozen  90 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Per US Food and Drug Administration recommendations, orthopedic surgeons should consider measuring and following serial cobalt concentrations in EDTA anticoagulated whole blood in symptomatic patients with metal-on-metal hip implants as part of their overall clinical evaluation. However, a recent publication(1) has shown synovial fluid measurements were superior to whole blood and serum Cobalt concentrations in predicting local tissue destruction in failed hip arthroplasty constructs.

 

Prosthetic devices produced by Depuy Company, Dow Corning, Howmedica, LCS, PCA, Osteonics, Richards Company, Tricon, and Whiteside are typically made of chromium, cobalt, and molybdenum. This list of products is incomplete, and these products' compositions change occasionally; see each prostheses' product information for composition details.

 

Cobalt is a naturally occurring, hard, gray element widely distributed in the environment. It is used to produce alloys in the manufacturing of aircraft engines, cutting tools, and some artificial hip and knee joint prosthesis devices.

 

Cobalt is an essential cofactor for vitamin B12, which is necessary for neurological function, brain function, and the formation of blood. For most people, food is the largest source of cobalt intake. The greatest environmental exposure occurs in mining processes, cemented tungsten-carbide industry, cobalt powder industry, and alloy production industry.

 

Cobalt is not highly toxic; however large doses may produce adverse clinical manifestations. Acute symptoms include pulmonary edema, allergy, nausea, vomiting, hemorrhage, and kidney failure. Chronic exposure to cobalt-containing hard metal (dust or fume) can result in a serious lung disease called hard metal lung disease, which is a type of pneumoconiosis (lung fibrosis). Furthermore, inhalation of cobalt particles can cause respiratory sensitization, asthma, shortness of breath, and decreased pulmonary function. Even though the primary route of occupational exposure to cobalt is the respiratory tract, skin contact is also important because dermal exposures to hard metal and cobalt salts can result in significant systemic uptake. Sustained exposures can cause skin sensitization, which may result in eruptions of contact dermatitis. In cases of suspected toxicity, blood, serum, or urine concentrations of cobalt can be checked. Vitamin B12 should be used to assess nutritional status.

Reference Values

0-17 years: Not established

≥18 years: <19.8 ng/mL

Interpretation

Based on an internal study, synovial fluid cobalt concentrations of 19.8 ng/mL or above were more likely due to a metal reaction (eg, adverse local tissue reaction [ALTR]/adverse reaction to metal debris [ARMD]) versus a nonmetal reaction in patients undergoing metal-on-metal revision (sensitivity of 92.3% and specificity of 96.3%).

Cautions

This test is intended for monitoring of implant wear and should not be ordered to assess nutritional status or potential cobalt toxicity.

 

Because this test uses mass spectrometry detection, the radioactive form of cobalt, (60)Co, is not quantified.

 

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. Elevated trace element concentrations in the absence of corroborating clinical information do not independently predict prosthesis wear or failure.

Method Description

The metal of interest is analyzed by inductively coupled plasma mass spectrometry.(Unpublished Mayo method)

Day(s) Performed

Friday

Report Available

2 to 8 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

83018

LOINC Code Information

Test ID Test Order Name Order LOINC Value
COSY Cobalt, Synovial Fl 23842-8

 

Result ID Test Result Name Result LOINC Value
606352 Cobalt, Synovial Fl 23842-8