title: A novel approach for quantitation of glucosylceramide in human dried blood spot using LC-MS/MS.
abstract: BACKGROUND
  Glucosylceramide, an efficacy biomarker for Gaucher Type 1 disease, exhibits poor solubility in polar solvents and whole blood which makes it difficult to prepare a homogenous blood standard.
  
  
  RESULTS
  We developed a novel method using standard addition approach by spiking a small volume of analyte solution on the surface of prespotted dried blood spot. The whole spots were punched out for subsequent extraction and LC-MS/MS analysis. The assay performance met all validation acceptance criteria. Glucosylceramide concentrations in 50 paired plasma and dry blood spot samples obtained from Gaucher Type 1 patients were tested and the results demonstrated the feasibility of using the DBS method for clinical biomarker monitoring.
  
  
  CONCLUSIONS
  The new approach greatly improves assay precision and accuracy.
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Allena Ji
authors.initials: AJ
authors.lastname: Ji
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Haixing
authors.initials: H
authors.lastname: Wang
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Enida
authors.initials: E
authors.lastname: Ziso-Qejvanaj
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Kefei
authors.initials: K
authors.lastname: Zheng
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Lee Lee
authors.initials: LL
authors.lastname: Chung
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Foley
authors.affiliation: Biological Mass Spectrometry & Biomarker Research, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Wei-Lien
authors.initials: WL
authors.lastname: Chuang
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Richards
authors.affiliation: Clinical Specialty Laboratory, DSAR, Sanofi, 1 The Mountain Road, Framingham, MA 01701, USA.
authors.forename: Crystal
authors.initials: C
authors.lastname: Sung
mesh_terms: D015415:Biomarkers / Q000097:blood; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D059788:Dried Blood Spot Testing / Q000379:methods* / Q000592:standards; D005776:Gaucher Disease / Q000175:diagnosis; D005963:Glucosylceramides / Q000097:blood* / Q000592:standards; D006801:Humans; D011786:Quality Control; D053719:Tandem Mass Spectrometry / Q000592:standards
chemical_list: D015415:Biomarkers; D005963:Glucosylceramides