{"id":511029,"date":"2024-11-05T14:12:34","date_gmt":"2024-11-05T14:12:34","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/clsi-i-la21-a2-2008\/"},"modified":"2024-11-05T14:12:34","modified_gmt":"2024-11-05T14:12:34","slug":"clsi-i-la21-a2-2008","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/clsi\/clsi-i-la21-a2-2008\/","title":{"rendered":"CLSI I\/LA21-A2-2008"},"content":{"rendered":"<p>Clinical and Laboratory Standards Institute document I\/LA21-A2&#8211;Clinical Evaluation of Immunoassays; Approved Guideline&#8211;Second Edition addresses all aspects of the clinical evaluation of immunoassays developed for commercial or in-house use.<\/p>\n<p> Existing CLSI documents provide guidance for assessing analytical performance, methods comparison, and clinical accuracy of laboratory tests. This document focuses on unique characteristics of immunoassays, and provides a guide to designing, executing, and analyzing a clinical evaluation. In addition, this document will aid developers of &#034;in-house&#034; assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.<\/p>\n<p> The elements of this guideline include: 1) a development plan for an effective analysis and evaluation; 2) a discussion of the planning and design considerations that are necessary for a successful evaluation; 3) a description of requirements for conducting the evaluation through monitoring and database management; and 4) a brief review of the analytical performance measures that must be in place before testing clinical specimens.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Clinical Evaluation of Immunoassays<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/clsi\/\"><b>CLSI<\/b><\/a><\/td>\n<td>2008-01-01<\/td>\n<td>72<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":511036,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2671],"product_tag":[],"class_list":{"0":"post-511029","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-clsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/511029","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/511036"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=511029"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=511029"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=511029"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}