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Expected turnaround time for a result, beginning when ARUP has received the specimen.
1-15 days
New York DOH Approval Status
Indicates test has been approved by the New York State Department of Health.
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
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.
0-19 Units: Negative
Interpretive Data
Background information for test. May include disease information, patient result explanation, recommendations, details of testing, associated diseases, explanation of possible patient results.
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
Additional information related to the test.
Hotline History
N/A
CPT Codes
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* 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
Other names that describe the test. Synonyms.
HMG
HMG antibody
3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase (HMGCR) Antibody, IgG