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3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase (HMGCR) Antibody, IgG
2013101
Ordering Recommendation

Differential diagnosis of myositis in patients with or without statin exposure.

Mnemonic
HMGCR
Methodology
Semi-Quantitative Enzyme-Linked Immunosorbent Assay
Performed
Fri
Reported
1-15 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
 
Collect
Serum Separator Tube (SST). 
Specimen Preparation
Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.15 mL) 
Storage/Transport Temperature
Refrigerated. Also acceptable: Frozen. 
Unacceptable Conditions
Other body fluids. Contaminated, hemolyzed, grossly icteric, or severely lipemic specimens. 
Remarks
 
Stability
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) 
Reference Interval
0-19 Units: Negative
Interpretive Data
IgG antibodies to 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) are mainly associated with necrotizing autoimmune myopathy (NAM) in a subset of statin-treated patients. Although infrequent, these antibodies may also be observed in statin-naive patients with NAM. Strong clinical correlation is recommended in the absence of muscle fiber necrosis, elevated serum creatine kinase, perimysial pathology, and/or statin exposure.

Compliance Statement A: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.

Note
CPT Code(s)
83516
Components
Component Test Code*Component Chart NameLOINC
2013102HMGCR Antibody, IgG
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases