Differential diagnosis of myositis in patients with or without statin exposure.
Semi-Quantitative Enzyme-Linked Immunosorbent Assay
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)
0-19 Units: Negative
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.
|Component Test Code*||Component Chart Name||LOINC|
|2013102||HMGCR Antibody, IgG||93493-5|