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.

Keywords:

• ELISA
• lenalidomide
• multiple myeloma
• pharmacokinetic studies
• polyclonal antibody
• therapeutic monitoring

ACKNOWLEDGMENT

The authors would like to extend their appreciation to the Deanship of Scientific Research at King Saud University for its funding of this research through the research group project no. RGP-VPP-225.

Notes

^a Values are mean of three determinations ± RSD (%).

^a Values are mean of eight determinations ± SD.

^b RSD is the relative standard deviation.

^a Values are mean of three determinations ± SD.