IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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PROCESSING TECHNOLOGIES Manufacturing ELISAs That Are Easy on the Environment Five steps to sustainability, from replacing toxic compounds in bufer solutions to wasting less water. by massimO albeRTi, Henny nielsen, and Julie Zink 16 IVD TEC HNOL O G Y | SP RIN G 2013 magenta cyan yellow black antibody can vary, but the most common is horseradish peroxidase (HRP) or alkaline phosphatase enzyme (AP). Detection and quantitation of the bound, labeled secondary antibody is accomplished by assessing its enzymatic activity in the presence of a substrate. 1. Replace Toxic Preservatives From initial plate coating to terminal detection, nearly every step of an ELISA involves the use of a buffer solution. For a standard 96-well plate, approximately 20 to 30 mL of bufer is required for each step, and a typical assay requires anywhere from seven to nine total steps. Many buffers use toxic preservatives that enable long-term storage from six months to several years. Some preservatives used in bufers contain azide, mercury, or other toxic compounds. While these are efective at preventing bacterial or fungal growth, they can be hazardous to humans and the environment. One alternative to using toxic preservatives is to flter out potential biological contaminants by means of 0.1- to 0.2-um flters. For added protection, several nontoxic preservatives FREETRANSFORM/ISTOCkPHOTO.COM O ver the past decade, IVD manufacturers have been working toward more environmentally conscious and sustainable manufacturing. Much of this efort has been focused on reducing facility water and energy use, cutting waste, increasing recycling, and sourcing recycled and recyclable product packaging. Eco-sensible options are now available to IVD manufacturers for the development and production of the components in diagnostic assays. Many common components in diagnostic immunoassays contain biological and chemical hazards, which are traditionally used to increase assay quality and prolong shelf life. Considering that the average automated immunoassay analyzer in a clinical lab can run 200 tests per hour while processing samples 24/7, these components can generate a considerable amount of hazardous waste. Wellestablished eco-sensible options now are available that do not compromise assay quality, stability or cost. In this article, we will specifcally focus on the eco-sensible options available to ELISA IVD manufacturers. Te most common type of diagnostic ELISA is the sandwich assay. It is a powerful detection tool for specifc markers. In a sandwich ELISA, the analyte is immobilized by a capture antibody adsorbed to a microwell plate. A labeled secondary antibody is then used to sandwich the analyte. Washing occurs between each step of the process, allowing for only analytespecifc complexes to remain bound to the plate. Te label on the secondary i v d t e c hnol ogy. com ES236986_IV1305_016.pgs 04.24.2013 23:43 UBM

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