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Pharmacogenetics · Assays
Viennalab Distributed by Goffin Diagnostics

SLCO1B1 PCR Assay

The Viennalab SLCO1B1 c.521T>C RealFast Assay determines the SLCO1B1 c.521T>C genotype in a human genomic DNA extract by real-time PCR. The variant reduces hepatic uptake of statins, and carriers of the c.521C allele have an increased risk of simvastatin-induced myopathy. Simvastatin is widely prescribed to lower LDL cholesterol. Its dose-dependent adverse events include myopathy and rhabdomyolysis. The genotype supports dose adjustment according to the CPIC guideline for simvastatin.

Real-Time PCR CE-IVD Viennalab 1 Unit (100 Reactions), 1 Unit (32 Reactions)
Technique
Real-Time PCR
Brand
Viennalab
Packaging
1 Unit (100 Reactions), 1 Unit (32 Reactions)
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Product details

This kit in detail

  • Detects the SLCO1B1 c.521T>C variant
  • Identifies carriers at increased risk of statin myopathy
  • Supports simvastatin dosing per the CPIC guideline
  • Real-time PCR with variant-specific probes
  • Whole peripheral blood, dried blood spots, buccal swabs or saliva
  • 32 or 100 reactions per kit, REF 7-213 and REF 7-210

The Viennalab SLCO1B1 c.521T>C RealFast Assay determines the SLCO1B1 c.521T>C genotype in a human genomic DNA extract, so that the simvastatin dose can be adjusted to the transport capacity of the liver.

Clinical background

SLCO1B1 encodes the transporter OATP1B1, which takes statins up into the hepatocyte. The c.521T>C variant lowers that uptake, so the plasma concentration of the drug rises. Carriers of the c.521C allele have an increased risk of simvastatin-induced myopathy and of rhabdomyolysis, the adverse events that limit the dose of this widely prescribed lipid-lowering drug.

Application

The genotype supports dose adjustment or the choice of another statin, in line with the CPIC guideline for simvastatin. Dosing guided by the genotype reduces the risk that follows from an empirical starting dose.

Method

The assay uses real-time PCR with the RealFast 2x Genotyping Mix and the SLCO1B1 c.521T>C Assay Mix. A TT-control and a CC-control are supplied. DNA isolated from whole peripheral blood, dried blood spots, buccal swabs or saliva can be used, and DNA extraction reagents are not supplied with the kit; ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), ordered separately.

  • RealFast 2x Genotyping Mix (white cap, 1000 / 320 µl)
  • SLCO1B1 c.521T>C Assay Mix (purple cap, 550 µl)
  • SLCO1B1 c.521T>C TT-Control (green cap, 75 µl)
  • SLCO1B1 c.521T>C CC-Control (red cap, 75 µl)

REF 7-210 (100 reactions) and REF 7-213 (32 reactions). DNA extraction reagents are not supplied with the kit. ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), which is ordered separately.

Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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