Ordering Recommendation

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

New York DOH Approval Status

This test is New York state approved.

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)

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Fri

Reported

1-15 days

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.

Compliance Category

Analyte Specific Reagent (ASR)

Note

Hotline History

N/A

CPT Codes

83516

Components

Component Test Code* Component Chart Name LOINC
2013102 HMGCR Antibody, IgG 93493-5
* 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

  • HMG
  • HMG antibody
3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase (HMGCR) Antibody, IgG