title: A highly sensitive polyclonal antibody-based ELISA for therapeutic monitoring and pharmacokinetic studies of lenalidomide.
abstract: This article describes, for the first time, a highly sensitive and specific enzyme-linked immunosorbent assay (ELISA) for therapeutic monitoring and pharmacokinetic studies of lenalidomide (LND), the potent drug for treatment of multiple myeloma (MM). The assay employed a polyclonal antibody that specifically recognizes LND with high affinity, and LND conjugate of bovine serum albumin (LND-BSA) immobilized onto microplate wells as a solid phase. The assay involved a competitive binding reaction between LND, in plasma sample, and the immobilized LND-BSA for the binding sites on a limited amount of the anti-LND antibody. The assay limit of detection was 0.05 ng/mL and the effective working range at relative standard deviations (RSD) of ≤5% was 0.1-20 ng/mL. Analytical recovery of LND from spiked plasma was 100.98 ± 3.05. The precisions of the assay were satisfactory; RSD was 2.96-6.67% and 4.46-7.14%, for the intra- and inter-assay precision, respectively. The procedure is convenient, and one can analyze ∼200 samples per working day, facilitating the processing of large-number batch of samples in clinical laboratories. The proposed ELISA has a great value in routine analysis of LND for its therapeutic monitoring and pharmacokinetic studies.
authors.affiliation: a Department of Pharmaceutical Chemistry, College of Pharmacy , King Saud University , Riyadh , Saudi Arabia.
authors.forename: Nourah Z
authors.initials: NZ
authors.lastname: Alzoman
authors.forename: Ibrahim A
authors.initials: IA
authors.lastname: Darwish
authors.forename: Reem M
authors.initials: RM
authors.lastname: Abuhejail
mesh_terms: D000818:Animals; D002417:Cattle; D003001:Cloning, Molecular; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007106:Immune Sera / Q000276:immunology*; D000077269:Lenalidomide; D009101:Multiple Myeloma / Q000188:drug therapy*; D011817:Rabbits; D012680:Sensitivity and Specificity; D012710:Serum Albumin, Bovine / Q000737:chemistry; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use
chemical_list: D007106:Immune Sera; D012710:Serum Albumin, Bovine; D013792:Thalidomide; D000077269:Lenalidomide