Process for detection and optional quantification of an analyte

摘要

The present disclosure relates to a process for detecting and optionally quantifying an analyte in a sample in the presence of a soluble target of the analyte. The soluble target forms a complex with the analyte and thus may interfere in determining the total analyte concentration. The process of the present invention utilizes a unique modified citrate buffer for diluting the sample containing the analyte and the soluble target which in turn helps in dissociating the analyte-soluble target complex, thereby enabling the process of the disclosure to detect and optionally quantify measure the analyte accurately.

主权项

1. A process for detection and quantification of trastuzumab in a biological sample, said process comprising:
(a) diluting the biological sample with a modified citrate buffer comprising citrate-HCl at a concentration of about 125 mM and polysorbate-20 at a concentration of about 0.1% w/v, the modified citrate buffer having a pH of 3.5, and (b) performing an assay to detect and quantify trastuzumab in the biological sample, wherein the biological sample comprises at least one interfering substance that binds trastuzumab, wherein the at least one interfering substance is an extracellular domain of HER-2 (HER-2-ECD) and wherein said interfering substance and trastuzumab combine to form a complex in the biological sample.