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3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase (HMGCR) Antibody, IgG
Ordering Recommendation
Differential diagnosis of myositis in patients with or without statin exposure.
Methodology
Semi-Quantitative Enzyme-Linked Immunosorbent Assay
Performed
Fri
Reported
1-15 days
New York DOH Approval Status
Specimen Required
Serum Separator Tube (SST).
Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.15 mL)
Refrigerated. Also acceptable: Frozen.
Other body fluids. Contaminated, hemolyzed, grossly icteric, or severely lipemic specimens.
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.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Analyte Specific Reagent (ASR)
Note
Hotline History
CPT Codes
83516
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2013102 | HMGCR Antibody, IgG | 93493-5 |
Aliases
- HMG
- HMG antibody
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