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Statin Sensitivity SLCO1B1, 1 Variant
2008426
Ordering Recommendation

Identify individuals at increased risk for statin-related muscle toxicity.

Mnemonic
SLCO1B1
Methodology
Polymerase Chain Reaction/Fluorescence Monitoring
Performed
Mon, Thu
Reported
5-10 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
 
Collect
Lavender (EDTA) or pink (K2EDTA), or yellow (ACD Solution A or B). 
Specimen Preparation
Transport 3 mL whole blood. (Min: 1 mL) 
Storage/Transport Temperature
Refrigerated. 
Unacceptable Conditions
Plasma or serum. Heparinized specimens. 
Remarks
 
Stability
Ambient: 72 hours; Refrigerated: 2 weeks; Frozen: 1 month 
Reference Interval
By report
Interpretive Data
Background Information for Statin Sensitivity SLCO1B1, 1 Variant:
Characteristics:
Simvastatin is a commonly prescribed hypolipidemic drug used for cholesterol reduction and control. Approximately 1-5 percent of exposed individuals may experience a dose-dependent myopathy (skeletal muscle toxicity). Symptoms may include pain, muscle weakness, and cramps. The organic anion transporter polypeptide 1B1, encoded by SLCO1B1, transports active simvastatin acid from the blood stream into the liver. This test detects a common variant that reduces the function of the transporter, resulting in an increased plasma concentration of the drug.
Inheritance:
Autosomal co-dominant.
Cause:
Simvastatin hypersensitivity reaction is strongly associated with the SLCO1B1*5 allele. The mechanism is related to changes in the activity of organic anion-transporter polypeptide 1B1 (OATP1B1).
Allele Tested:
SLCO1B1*5 (rs4149056, c.521T>C).
Allele Frequency:
Middle Eastern 5 percent, Caucasian 1-3 percent, African 0-2 percent,Asian 0-2 percent, Less than 1 percent in other populations.
Clinical Sensitivity:
Drug-dependent.
Methodology:
Polymerase Chain Reaction (PCR) and Fluorescence Monitoring.
Analytical Sensitivity and Specificity:
Greater than 99 percent.
Limitations:
Only the targeted SLCO1B1 variant will be detected. Diagnostic errors can occur due to rare sequence variations. Risk of therapeutic failure or adverse reactions with statins may be affected by genetic and non-genetic factors that are not detected by this test. This result does not replace the need for therapeutic or clinical monitoring.

Compliance Statement C: The performance characteristics of this test were validated by ARUP Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. ARUP is authorized under Clinical Laboratory Improvement Amendments (CLIA) and by all states to perform high-complexity testing. Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

Components
Component Test Code*Component Chart NameLOINC
2008427Statin Sensitivity SLCO1B1, Specimen
2008428Statin Sensitivity SLCO1B1,*5 Genotype
* 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
  • Simvastatin myotoxicity assay
  • Statin-induced myopathy assay