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

Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum (Min: 0.3 mL) to an ARUP standard transport tube.

Storage/Transport Temperature

Refrigerated. Also acceptable: Frozen.

Unacceptable Conditions

Contaminated, heat-inactivated, clots, fibrin, gross red blood cells, severely lipemic, severely hemolyzed, or severely icteric 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 (ELISA)

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.

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
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Aliases

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