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.
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: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay. Analyte Specific Reagent. 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, the FDA has determined that such clearance or approval is not necessary.

Note
Hotline History
N/A
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
3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase (HMGCR) Antibody, IgG