title: Development of an ultra-sensitive Simoa assay to enable GDF11 detection: a comparison across bioanalytical platforms.
abstract: BACKGROUND
  Four bioanalytical platforms were evaluated to optimize sensitivity and enable detection of recombinant human GDF11 in biological matrices; ELISA, Meso Scale Discovery, Gyrolab xP Workstation and Simoa HD-1. Results & methodology: After completion of custom assay development, the single-molecule ELISA (Simoa) achieved the greatest sensitivity with a lower limit of quantitation of 0.1 ng/ml, an improvement of 100-fold over the next sensitive platform (MSD).
  
  
  CONCLUSIONS
  This improvement was essential to enable detection of GDF11 in biological samples, and without the technology the sensitivity achieved on the other platforms would not have been sufficient. Other factors such as ease of use, cost, assay time and automation capability can also be considered when developing custom immunoassays, based on the requirements of the bioanalyst.
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Myzithras
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Hua
authors.initials: H
authors.lastname: Li
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Tammy
authors.initials: T
authors.lastname: Bigwarfe
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Erica
authors.initials: E
authors.lastname: Waltz
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Priyanka
authors.initials: P
authors.lastname: Gupta
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Low
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Hayes
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: MacDonnell
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ahlberg
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Franti
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors.forename: Simon
authors.initials: S
authors.lastname: Roberts
mesh_terms: D000818:Animals; D000906:Antibodies / Q000276:immunology; D019921:Biotinylation; D019485:Bone Morphogenetic Proteins / Q000032:analysis* / Q000235:genetics / Q000378:metabolism; D004797:Enzyme-Linked Immunosorbent Assay / Q000191:economics / Q000379:methods*; D055412:Growth Differentiation Factors / Q000032:analysis* / Q000235:genetics / Q000378:metabolism; D006801:Humans; D057230:Limit of Detection; D051379:Mice; D051381:Rats; D011994:Recombinant Proteins / Q000032:analysis / Q000096:biosynthesis / Q000276:immunology
chemical_list: D000906:Antibodies; D019485:Bone Morphogenetic Proteins; C492266:GDF11 protein, human; D055412:Growth Differentiation Factors; D011994:Recombinant Proteins
keywords: ELISA; GDF11; Gyrolab; MSD; Simoa; immunoassay; ligand-binding assay (LBA)