Lateral Flow Immunoassay

Lateral Flow Immunoassay

l Raphael C. Wong Editors Harley Y. Tse Lateral Flow Immunoassay 13

Editors Raphael C. Wong Branan Medical Corporation 10015 Muirlands Road Irvine, CA 92618 USA raphael@brananmedical.com Harley Y. Tse Wayne State University School of Medicine Department of Immunology and Microbiology 540 E. Canfield Avenue Detroit, MI 48201 USA htse@wayne.edu ISBN: 978-1-58829-908-6 e-isbn: 978-1-59745-240-3 DOI 10.1007/978-1-59745-240-3 Library of Congress Control Number: 2008939893 # Humana Press, a part of Springer ScienceþBusiness Media, LLC 2009 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Humana Press, c/o Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper springer.com

To our families for their patience and support during the preparation of this book. This book epitomizes the friendship and collaboration of the co-editors for over forty years.

Preface Since its initial development in the 1980s, the technology of Lateral Flow Immunoassay has gained wide acceptance. The main reason for its popularity is the simplicity of the test design. The lateral flow immunoassay devices are compact and easily portable. Most of them do not require external reagent for results. Addition of a liquid sample would initiate and complete the test. Results are quick and easy to interpret, usually without the help of an instrument. The technology is also powerful. Multiple analytes can be tested simultaneously with a single device. It can also be easily combined with other technology to provide a comprehensive analysis like simultaneous drug and alcohol determinations by the police force in a roadside testing situation. Manufacturing of the test is relatively easy and inexpensive. Advancement in the detection moieties, improvement in material components, availability of better processing equipment, and increased attention to quality manufacturing all contribute to increase in the reliability, accuracy, and applications of the technology. However, the continuing demand for quantitative result and sensitivity has presented great challenge for assay developer. In this book, we have compiled the essence of the current state of the art of this technology and addressed what can be expected in the future. After an introduction on the evolution of the technology, some market information is provided. They are followed by discussions on the various materials, biological and chemical components involved in making the test. A chapter on manufacturing equipment and process completes the production section. Later chapters concentrate on the common issues encountered by the users or developers of the technology. Discussions are made on the design of handheld readers, the causes of false results and some way to reduce them, and the regulatory aspects in the development and marketing of lateral flow immunoassay devices. We hope this book will enhance the understanding on the lateral flow immunoassay technology, enable better products to be made, and provide impetus for further technology advancement. Irvine, California, USA Detroit, Michigan, USA Raphael C. Wong Harley Y.Tse vii

Contents 1 Evolution in Lateral Flow Based Immunoassay Systems... 1 Brendan O Farrell 2 Market Trends in Lateral Flow Immunoassays... 35 Shara Rosen 3 Material Platform for the Assembly of Lateral Flow Immunoassay Test Strips... 51 Jennifer S. Ponti 4 Antibodies: Key to a Robust Lateral Flow Immunoassay... 59 Michael C. Brown 5 Colloidal Gold and Other Labels for Lateral Flow Immunoassays... 75 Peter Chun 6 Nitrocellulose Membranes for Lateral Flow Immunoassays: A Technical Treatise... 95 Michael A. Mansfield 7 FUSION 5: A New Platform For Lateral Flow Immunoassay Tests.... 115 Kevin Jones 8 Manufacturing the Next Generation of Highly Sensitive and Reproducible Lateral Flow Immunoassay... 131 Thomas C. Tisone and Brendan O Farrell 9 Handheld and Portable Reader Devices for Lateral Flow Immunoassays... 157 Konrad Faulstich, Roman Gruler, Michael Eberhard, Dirk Lentzsch, and Klaus Haberstroh ix

x Contents 10 Quantitative, False Positive, and False Negative Issues for Lateral Flow Immunoassays as Exemplified by Onsite Drug Screens... 185 Raphael C. Wong and Harley Y. Tse 11 Regulatory Issues in the Development and Marketing of Lateral Flow Immunoassays... 205 Raphael C. Wong Index... 219

Contributors Michael C. Brown Strategic Diagnostics, 128 Sandy Drive, Newark, DE 19713, USA, mbrown@sdix.com Peter Chun, Ph.D., President EASE Laboratories Inc., 338 North Canal Street, Unit 9, South San Francisco, CA 94080, USA, pechun2@yahoo.com Michael Eberhard ESE GnbH, Ludwigshafenerstr, 29, D-78333, Stockach, Germany, Michael.Eberhard@ese-gmbh.de Konrad Faulstich, Dr. ESE GmbH, Ludwigshafenerstr, 29, D-78333, Stockach, Germany, Konrad.Faulstich@ese-gmbh.de Roman Gruler ESE GnbH, Ludwigshafenerstr, 29, D-78333, Stockach, Germany, Roman.Gruler@ese-gmbh.de Klaus Haberstroh ESE GnbH, Ludwigshafenerstr, 29, D-78333, Stockach, Germany, Klaus.Haberstroh@ese-gmbh.de Kevin Jones Technical Marketing Manager, Diagnostics, Whatman Inc., 13 Lake Drive, Boonton, NJ 07005, USA, Kevin.jones@whatman.com Dirk Lentzsch, ESE GnbH Ludwigshafenerstr, 29, D-78333, Stockach, Germany, Dirk.Lentzsch@ese-gmbh.de Michael A. Mansfield, Ph.D. Diagnostic Business Unit, Millipore Corporation, 80 Ashby Road, MS 75C, Bedford, MA 01730, USA, Michael_mansfield@millipore.com Brendan O Farrell, Ph.D. Principal, Diagnostic Consulting Network, 6084 Corte del Cedro, Carlsbad, CA 92011, USA, bofarrell@dcndx.com Jennifer S. Ponti Director of Sales & Marketing, G&L Precision Die Cutting, Inc., 1766 Junction Avenue, San Jose, CA 95112, USA, jponti@glprecision.com Shara Rosen, Senior Consultant, StratCom, 1743 Sunnybrooke, Montreal, QC H9B 1R5, Canada, stratcom@total.net Thomas C. Tisone, Ph.D., President BioDot, Inc., 17781 Sky Park Circle, Irvine, CA 92614, USA, tom.tisone@biodot.com xi

xii Contributors Harley Y. Tse, Ph.D. Department of Immunology and Microbiology, Wayne State University School of Medicine, 540 E. Canfield Ave., Detroit MI 48201, USA, htse@wayne.edu Raphael C. Wong, President Branan Medical Corporation, 140, Technology Drive, Suite 400, Irvine, CA 92618, USA, raphael@brananmedical.com