Development of a highly sensitive ELISA for determination of darunavir in plasma samples using a polyclonal antibody with high affinity and specificity.

Abdulrahman A Almehizia, Rashed N Herqash, Ibrahim A Darwish

Bioanalysis 2020 Mar

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Aim: To support pharmacokinetic studies and therapeutic monitoring of darunavir (DRV), a highly sensitive ELISA was developed for the determination of DRV in plasma samples at picogram levels. Results: The assay LOD and LOQ were 15 and 30 pg ml-1, respectively. The working range of the assay was 20-2000 pg ml-1. Analytical recoveries of DRV from spiked plasma were in the ranges of 98.4-113.0 and 86.0-99.1% for intra-assay and inter-assay runs, respectively. The precision of the assay was satisfactory. Conclusion: The ELISA is characterized by high throughput and it is expected to significantly contribute to routine analysis of DRV in its pharmacokinetic studies and therapeutic monitoring.

Citation

Abdulrahman A Almehizia, Rashed N Herqash, Ibrahim A Darwish. Development of a highly sensitive ELISA for determination of darunavir in plasma samples using a polyclonal antibody with high affinity and specificity. Bioanalysis. 2020 Mar;12(6):355-366