{"id":5193,"date":"2022-10-06T17:32:00","date_gmt":"2022-10-06T17:32:00","guid":{"rendered":"https:\/\/medicalaffairs.travere.com\/?post_type=publication&#038;p=5193"},"modified":"2025-09-30T23:59:15","modified_gmt":"2025-09-30T23:59:15","slug":"urine-cystine-quantification-binding-thiol-drugs","status":"publish","type":"publication","link":"https:\/\/clleancode.top\/travere-redesign\/publications\/urine-cystine-quantification-binding-thiol-drugs\/","title":{"rendered":"Accurate 24\u2010h Urine Cystine Quantification for Patients on Cystine\u2010Binding Thiol Drugs"},"content":{"rendered":"\n\n\n\n<section class=\"o-hero-section o-hero--banner o-hero--blue o-hero--cropped\">\n    <img decoding=\"async\" width=\"1921\" height=\"1081\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header.png\" class=\"a-img a-img--right h-full\" alt=\"Hero Section Background Image\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header.png 1921w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header-300x169.webp 300w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header-1024x576.webp 1024w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header-768x432.webp 768w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header-1536x864.webp 1536w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/11\/kidney-stones_header-290x163.webp 290w\" sizes=\"auto, (max-width: 1921px) 100vw, 1921px\" \/>    <div class=\"container\">\n        <div class=\"m-hero-inner m-hero-inner--post\">\n            <div class=\"m-breadcrumb\">\n                <nav class=\"breadcrumbs\" aria-label=\"breadcrumb\"><span><span><a href=\"https:\/\/clleancode.top\/travere-redesign\/\">Home<\/a><\/span><\/span><\/nav>            <\/div>\n            <h1 class=\"a-heading a-heading--h1 h-white\">Accurate 24\u2010h Urine Cystine Quantification for Patients on Cystine\u2010Binding Thiol Drugs<\/h1>                    <\/div>\n    <\/div>\n<\/section>\n\n\r\n\t<section style=\"margin-top:calc(-150px * var(--scale));\" class=\"section-container wp-block-grizzly-section-container\">\r\n\t\t\t\t<div class=\"container\">\r\n\t\t\t\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<div class=\"info-block info-block-publication search__container-publication search__container\">\n\t<div class=\"info-block-top\">\n\t\t<div>\n\t\t\t\t\t\t\t<div class=\"info-block-type\"><i class=\"icon2-journal\"><\/i> Journal article<\/div>\n\t\t\t\n\t\t\t\t\t\t\t<div class=\"info-block-type\">\n\t\t\t\t\t<i class=\"icon2-calendar\"><\/i> Published on October 6, 2022\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t<p>Topics: <\/p>\n\t\t\t\t\t\t\t\t\t<span class=\"a-tag\">Nephrology<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"a-tag\">Cystinuria<\/span>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\n\t<div class=\"info-block-bottom\">\n\t\t\t\t\t<div class=\"info-block-box\">\n\t\t\t\tContributors:<br \/><span>Mikel CC, Goldfarb DS, Ponte A et\u00a0al.<\/span>\n\t\t\t<\/div>\n\t\t\n\t\t<div class=\"info-block-box\">\n\t\t\t\t\t\t\tName of Journal:<br \/><span>Urolithiasis<\/span><br \/><br \/><br \/>\n\t\t\t\n\t\t\t\t\t\t\t<a href=\"#\" data-url=\"https:\/\/link.springer.com\/article\/10.1007\/s00240-022-01364-9\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"btn btn-outline leaving-modal-toggle btn-leaving\" aria-label=\"View Publication\">View Publication<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div class=\"info-block-box info-block-doi\">\n\t\t\t\tDOI:<br 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For more information, review the <a href=\"https:\/\/travere.com\/privacy\/\" target=\"_blank\">Travere privacy policies<\/a>.<\/span><\/label><\/span><\/span><\/span>\n  <\/div>\n  <div class=\"form-group text-right\">\n    <input class=\"wpcf7-form-control wpcf7-submit has-spinner btn\" id=\"request-submit\" type=\"submit\" value=\"Yes, continue\" \/>\n  <\/div>\n<\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div> <\/div>\n\n\t\t<\/div>\r\n\t<\/section>\r\n\t\n\n\r\n\t<section class=\"section-container wp-block-grizzly-section-container\">\r\n\t\t\t\t<div class=\"container\">\r\n\t\t\t\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-center has-heading-4-font-size\" id=\"h-summary\" style=\"margin-top:calc(60px * var(--scale));margin-bottom:calc(30px * var(--scale))\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-teal-color\"><span class=\"fw-600\">Summary<\/span><\/mark><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-heading-5-font-size\" id=\"h-a-method-for-urine-cystine-quantification-was-validated-for-patients-with-cystinuria-receiving-a-cystine-binding-thiol-drug-cbtd-1\"><span class=\"fw-600\">A method for urine cystine quantification was validated for patients with cystinuria receiving a cystine-binding thiol drug (CBTD)<sup>1<\/sup><\/span><\/h3>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-heading-5-font-size\" id=\"h-background\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Background<\/mark><\/span><\/h4>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Cystinuria is a genetic disorder that leads to recurrent kidney and bladder stones, which affect quality of life and kidney function.<sup>2-4<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Cystinuria treatment aims to reduce stone formation by increasing the solubility of cystine in urine.<sup>5<\/sup> For large stones, or when conservative management is not effective, a cystine-binding thiol drug (CBTD) may be required.<sup>6<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The level of urinary cysteine should be monitored to adjust the dose of CBTD appropriately.<sup>5<\/sup> However, distinguishing free cystine from cysteine-thiol drug complexes is challenging.<sup>7<\/sup> A valid, reliable, and practical method for quantifying urinary cystine is needed.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-aim\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Aim<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>This study aimed to validate a high-performance liquid chromatography\u2013tandem mass spectrometry (HPLC\u2013MS\/MS) method for quantifying urinary cystine for patients with cystinuria receiving a CBTD.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-approach\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Approach<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Calibration, linearity, and range of detection in urine samples<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The HPLC\u2013MS\/MS method had been previously used for determining cystine levels in whole kidney cells.<sup>1,8<\/sup> For this study, the method was applied to urine samples and a calibration curve was plotted for the range 0.03-1.00 mg\/mL.<sup>1<\/sup> The limit of detection (LOD) and limit of quantification (LOQ) were calculated from this curve.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Accuracy and precision<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Six replicates of target concentrations were used as calibrators.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Accuracy was determined by mean accuracy percentage.<sup>1<\/sup> Repeatability was assessed with the calculated standard deviation (SD) and coefficient of variation (CV).<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Intermediate precision was defined by the relative percent difference (RPD) of three sets of calibrators.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Potential interferences and matrix effects<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>To assess the potential of the HPLC\u2013MS\/MS method for interference from exogenous compounds, nine mixtures were prepared containing common over-the-counter (OTC), prescription, and illicit drugs.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>To assess the potential for interference from endogenous compounds, urine samples from patients without cystinuria were assessed to determine a false positive rate.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Matrix effects were assessed by adding cystine solutions (2 mg\/mL) in equal volume to blank urine or each of the nine interference mixtures.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Quantification of cystine level in patient urine samples<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Twenty-four hour urine samples were gathered from 24 patients with cystinuria who were receiving CBTD.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-findings\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Findings<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">The HPLC\u2013MS\/MS method was validated for its accuracy, repeatability, precision, linearity, LOD, and LOQ<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Cystine was separated from cysteine-tiopronin drug complexes in under three minutes by HPLC.<sup>1<\/sup> The calibration curve showed a linear response (<em>R<\/em><sup>2<\/sup>=0.998). LOD was 0.002 mg\/mL and LOQ was 0.005 mg\/mL.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Accuracy, repeatability, and precision were determined with six replicates of calibrators, giving the following results<sup>1<\/sup>:<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li><span class=\"fw-600\">Accuracy (mean accuracy percentage):<\/span> 97.7-102.3%<\/li>\n\n\n\n<li><span class=\"fw-600\">Repeatability (coefficient of variation):<\/span> 1.2-3.3%<\/li>\n\n\n\n<li><span class=\"fw-600\">Precision (RPD)<\/span>: 1.2-9.3%<\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">No cystine false positives were seen for exogenous compounds, such as other drugs, or endogenous compounds<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>For one interference mixture, a significant matrix effect was seen.<sup>1<\/sup> This mixture contained acetaminophen, caffeine, cotinine, ibuprofen, naproxen, nicotine, phentermine, and pseudoephedrine.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">The HPLC\u2013MS\/MS method quantified cystine levels from patient urine samples<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Mean cystine concentrations were<sup>1<\/sup>:<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li><span class=\"fw-600\">Aliquot A:<\/span> 111.10 g\/L (Range: 51.31-179.46 g\/L)<\/li>\n\n\n\n<li><span class=\"fw-600\">Aliquot B (cystine solubilized with sodium carbonate):<\/span> 242.21 g\/L (Range: 61.14-741.80 g\/L)<\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-key-takeaway\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Key takeaway<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Using a HPLC\u2013MS\/MS method, urinary cysteine can be quantified reliably for patients with cystinuria receiving a CBTD.<sup>1<\/sup><br><br><br><br><br><\/p>\n\n\n\n<div class=\"newsletter\">\n\t<div class=\"newsletter-icon\">\n\t\t<span class=\"icon2-newsletter\"><\/span>\n\t<\/div>\n\t<div class=\"newsletter-text\">\n\t\t<p><strong>Sign up<\/strong> to receive scientific updates<br \/>\nfor healthcare 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For more information, review the <a href=\"https:\/\/travere.com\/privacy\/\" target=\"_blank\" rel=\"noopener\">Travere  privacy policies<\/a>.<\/p>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div id=\"invalid-newsletter\" class=\"invalid\">\n\t\t\t<div id=\"invalid-box-newsletter\">\n\t\t\t\t<span class=\"icon2-info-fill\"><\/span>\n\t\t\t<\/div>\n\t\t\t<div>\n\t\t\t\t<p><strong>Invalid email address.<\/strong><br \/>\n\t\t\t\tMake sure email is in correct format: <a href=\"\">name@example.com<\/a><\/p>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-footnotes\" style=\"margin-bottom:calc(30px * var(--scale))\"><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Footnotes<\/mark><\/span><\/h5>\n\n\n\n<p class=\"has-small-font-size\" style=\"margin-bottom:calc(30px * var(--scale))\">CBTD, cystine-binding thiol drug; CV, coefficient of variation: HPLC, high-performance liquid chromatography; LOD, limit of detection; LOQ, limit of quantification; OTC, over-the-counter; MS\/MS, tandem\u2013mass spectrometry; RPD, relative percent difference; SD, standard deviation.<\/p>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ol class=\"wp-block-list\">\n<li class=\"has-small-font-size\">Mikel CC et al. <em>Urolithiasis<\/em>. 2022;50(6):721-727.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Prot-Bertoye C et al. <em>Clin J Am Soc Nephrol<\/em>. 2015;10:842-851.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Woodard LE et al. <em>BMC Nephrol<\/em>. 2019;20:227.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Parr JM et al. <em>BJU Int<\/em>. 2015;116(suppl 3):31-35.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Eisner BH et al. <em>J Endourol<\/em>. 2020;34:1103-1110.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Pearle MS. <em>J Urol<\/em>. 2014;192:316-324.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Goldfarb DS et al. <em>Kidney Int<\/em>. 2006;69:1041-1047.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Jamalpoor A et al. <em>Biomed Chromatogr<\/em>. 2018;32:e4238.<\/li>\n<\/ol>\n<\/div>\n\n\n<p class=\"has-text-align-right\" style=\"margin-top:calc(30px * var(--scale));margin-bottom:calc(300px * var(--scale))\">MA-DS-24-0043 | November 2024<\/p>\n<\/div>\n\n\t\t<\/div>\r\n\t<\/section>\r\n\t","protected":false},"featured_media":5194,"template":"","meta":{"inline_featured_image":false,"header_bg_color":"transparent","header_fixed":true,"post_description":"","post_download_link":"","journal_link":"","pdf_file_link":""},"product":[],"therapeutic_area":[97],"disease_area":[194],"study_registry":[],"study_type":[],"resource_type":[177,180],"class_list":["post-5193","publication","type-publication","status-publish","has-post-thumbnail","hentry","therapeutic_area-neph","disease_area-cystinuria","resource_type-publication","resource_type-summary"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.9 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Measuring Urinary Cystine in Patients with Cystinuria on a CBTD | Travere Medical Affairs<\/title>\n<meta name=\"description\" content=\"Learn more about quantifying urinary cystine in patients with cystinuria receiving a cystine-binding thiol drug. 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