Methods, devices, and reagents for monitoring paclitaxel concentration in plasma for pharmacokinetic-guided dosing of paclitaxel

A method for assaying paclitaxel in a liquid sample, comprising:

• (a) applying the liquid sample comprising paclitaxel to a lateral flow assay device, the device comprising
• (i) a sample receiving zone for receiving the liquid sample;
• (ii) a detection reagent zone in liquid communication with the sample receiving zone and downstream in flow direction from the sample receiving zone,
• wherein the detection reagent zone comprises a detection reagent deposited thereon,
• wherein the detection reagent is a paclitaxel antibody, functional fragment, or functional derivative thereof that binds paclitaxel, wherein the paclitaxel antibody, functional fragment, or functional derivative thereof is labeled with a detectable reporting group,
• wherein the paclitaxel antibody, functional fragment, or functional derivative thereof is selected from
• a first antibody, functional fragment, or functional derivative thereof having a variable light chain amino acid sequence comprising complementarity-determining sequences SEQ ID NO:
• 9, SEQ ID NO:
• 10, and SEQ ID NO:
• 11, and a variable heavy chain amino acid sequence comprising complementarity-determining sequences SEQ ID NO:
• 12, SEQ ID NO:
• 13, and GV, or
• a second antibody, functional fragment, or functional derivative thereof having a variable light chain amino acid sequence comprising complementarity-determining sequences SEQ ID NO:
• 14, SEQ ID NO:
• 15, and SEQ ID NO:
• 16, and a variable heavy chain amino acid sequence comprising complementarity-determining sequences SEQ ID NO:
• 17, SEQ ID NO:
• 18, and SEQ ID NO:
• 19;
• and
• (iii) a capture zone in liquid communication with the detection reagent zone and downstream in flow direction from the detection reagent zone,
• wherein the capture zone comprises first, second, and third capture reagents immobilized thereon,
• wherein the first capture reagent is a paclitaxel material capable of binding the detection reagent,
• wherein the second capture reagent is a paclitaxel material capable of binding the detection reagent,
• wherein the third capture reagent is an antibody capable of binding the detection reagent,
• wherein the first capture reagent is positioned at a first distance downstream in flow direction from the upstream end of the capture zone,
• wherein the second capture reagent is positioned at a second distance downstream in flow direction from the upstream end of the capture zone,
• wherein the third capture reagent is positioned at a third distance downstream in flow direction from the upstream end of the capture zone,
• wherein the second distance is greater than the first distance,
• wherein the third distance is greater than the first and second distances, and
• wherein the ratio of the first distance to the second distance is from greater than about 0.0 to about 0.4, when the paclitaxel antibody, functional fragment, or functional derivative thereof is the first antibody, functional fragment, or functional derivative thereof or
• wherein the ratio of the first distance to the second distance is from about 0.2 to about 1.0, when the paclitaxel antibody, functional fragment, or functional derivative thereof is the second antibody, functional fragment, or functional derivative thereof;
• and
• (b) allowing the sample to flow from the sample receiving zone through the detection reagent zone to provide detection reagent with paclitaxel;
• (c) allowing the detection reagent with paclitaxel to flow through the capture zone,
• whereby the first and second capture reagents compete with paclitaxel for binding with the detection reagent, and
• whereby the third capture reagent binds excess detection reagent;
• and
• (d) observing the amount of detection reagent bound to the first and second capture reagents relative to the third capture reagent.