{"id":1376,"date":"2022-06-29T02:33:14","date_gmt":"2022-06-29T02:33:14","guid":{"rendered":"https:\/\/r2diagnostics.in\/?page_id=1376"},"modified":"2022-06-29T02:33:14","modified_gmt":"2022-06-29T02:33:14","slug":"emicizumab-controls","status":"publish","type":"page","link":"https:\/\/r2diagnostics.in\/?page_id=1376","title":{"rendered":"Emicizumab Controls"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-right:10px;--awb-padding-left:10px;--awb-margin-top:50px;--awb-margin-bottom:22px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:50%;--awb-order-small:0;--awb-spacing-right-small:3.84%;--awb-spacing-left-small:3.84%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><div class=\"et_pb_row et_pb_row_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h2 style=\"text-align: center;\">Emicizumab Controls<\/h2>\n<div class=\"et_pb_row et_pb_row_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<div class=\"et_pb_row et_pb_row_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<div class=\"et_pb_row et_pb_row_4\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_5 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<div class=\"et_pb_row et_pb_row_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<div class=\"et_pb_row et_pb_row_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h5><strong>Assay Type<\/strong><\/h5>\n<\/div>\n<\/div>\n<div class=\"et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">Control Plasmas and Calibrators<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"et_pb_row et_pb_row_2\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_3 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h5><strong>Description<\/strong><\/h5>\n<\/div>\n<\/div>\n<div class=\"et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">Plasma Controls, Level 1 (25ug\/mL) Level 2 (75ug\/mL)<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"et_pb_row et_pb_row_3\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h5><strong>Intended Use<\/strong><\/h5>\n<\/div>\n<\/div>\n<div class=\"et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">Emicizumab Controls Level 1 and Level 2 are assayed controls intended for quality control of a modified one-stage FVIII activity assay for determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyze<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"et_pb_row et_pb_row_4\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_5 et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<h5><strong>Uses<\/strong><\/h5>\n<\/div>\n<\/div>\n<div class=\"et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">Emicizumab Controls may be used together with the Emicizumab Calibrator and a modified one-stage FVIII assay as QC material for use in a laboratory\u2019s quality control program.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><div class=\"fusion-layout-column 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It has been sent.<\/span><\/div><button type=\"button\" class=\"close toggle-alert\" data-dismiss=\"alert\" aria-label=\"Close\">&times;<\/button><\/div><div class=\"fusion-alert alert error alert-danger fusion-alert-center fusion-form-response fusion-form-response-error fusion-alert-capitalize awb-alert-native-link-color alert-dismissable awb-alert-close-boxed\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"alert-icon\"><i class=\"awb-icon-exclamation-triangle\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-alert-content\">There was an error trying to send your message. Please try again later.<\/span><\/div><button type=\"button\" class=\"close toggle-alert\" data-dismiss=\"alert\" aria-label=\"Close\">&times;<\/button><\/div><\/div><div class=\"fusion-form-field fusion-form-submit-field fusion-form-label-above\" style=\"\" data-form-id=\"1082\"><div ><button type=\"submit\" class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span  button-default form-form-submit\" data-form-number=\"1082\" tabindex=\"\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">LET'S TALK<\/span><\/button><\/div><\/div><\/div><\/div><\/div><\/div><\/form><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-flex-grow:0;--awb-flex-shrink:0;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-flex-grow-medium:0;--awb-flex-shrink-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-flex-grow-small:0;--awb-flex-shrink-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<h5><b>Ordering Information<\/b><\/h5>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">\n<table>\n<thead>\n<tr>\n<th class=\"views-field-field-catalog-number\">Catalog #<\/th>\n<th class=\"views-field-field-catalog-product\">Product<\/th>\n<th class=\"views-field-field-catalog-kit-config\">Kit Configuration<\/th>\n<th class=\"views-field-field-catalog-regulatory-classification\">Regulatory Classification<\/th>\n<th class=\"views-field-field-catalog-product-insert-pdf\">Product Insert (PDF)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>152-401-CE<\/td>\n<td>Emicizumab Controls<\/td>\n<td>5 x 1 mL each<\/td>\n<td>CE*<\/td>\n<td class=\"views-field views-field-field-catalog-insert\"><a href=\"https:\/\/r2diagnostics.com\/wp-content\/uploads\/2021\/03\/LL-4533_CE_E-Emi-Controls-Level-1-and-Level-2.pdf\" target=\"_blank\" rel=\"attachment wp-att-1117 noopener noreferrer\">CE Emi Controls Level 1 and Level 2<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>*Not available in the United States<\/p>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">\n<table>\n<thead>\n<tr>\n<th class=\"views-field-field-catalog-number\">Catalog #<\/th>\n<th class=\"views-field-field-catalog-product\">Product<\/th>\n<th class=\"views-field-field-catalog-kit-config\">Kit Configuration<\/th>\n<th class=\"views-field-field-catalog-regulatory-classification\">Regulatory Classification<\/th>\n<th class=\"views-field-field-catalog-product-insert-pdf\">Product Insert (PDF)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>152-401-RUO<\/td>\n<td>Emicizumab Controls<\/td>\n<td>5 x 1 mL each<\/td>\n<td>RUO<\/td>\n<td class=\"views-field views-field-field-catalog-insert\"><a href=\"https:\/\/r2diagnostics.com\/wp-content\/uploads\/2018\/09\/RUO-Emi-Controls.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">RUO Emi Controls<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<h5><b>Principle of the Test<\/b><\/h5>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">The principle of the modified one-stage FVIII assay for emicizumab measurement relies upon measuring the degree of correction of the APTT when patient plasma is added to FVIII deficient plasma. The degree of correction is related to the amount of emicizumab in the patient\u2019s sample. Control of the accuracy of the emicizumab result is enabled by using Emicizumab Controls with assayed emicizumab values.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<h5><b>Reporting Units<\/b><\/h5>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">25 ug\/mL and 75 ug\/mL<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<div class=\"table-1\">\n<h5><b>Handbooks and Guidelines<\/b><\/h5>\n<\/div>\n<\/div>\n<div class=\"table-1\">\n<div class=\"table-1\">\n<ul>\n<li>Westgard J,\u00a0<u>Basic QC Practices: Third Edition<\/u>, Westgard QC Inc., 2010.<\/li>\n<li>Kitchen S, Olson J, and Preston F, Chapter 5 \u201cInternal Quality Control\u201d, in\u00a0<u>Quality in Laboratory Hemostasis and Thrombosis<\/u>, Kitchen, Olson, and Preston ed., Wiley-Blackwell, 2009.<\/li>\n<li>CLIA 88 current regulations:\u00a0<a href=\"https:\/\/wwwn.cdc.gov\/clia\/regs\/toc.aspx\">http:\/\/wwwn.cdc.gov\/clia\/regs\/toc.aspx<\/a>.<\/li>\n<li>Westgard J., et. al.,\u00a0<u>CLIA Final Rules for Quality Systems<\/u>, Westgard QC Inc., 2004.<\/li>\n<li>ISO 15189 \u201cMedical laboratories \u2014 Particular requirements for quality and competence\u201d, International Organization for Standardization,\u00a0<a href=\"http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_ics\/catalogue_detail_ics.htm?csnumber=42641\">http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_ics\/catalogue_detail_ics\u2026.<\/a><\/li>\n<li>Clinical Laboratory Standards Institute, \u201cQuality Management System: A Model for Laboratory Services; Approved Guideline\u2014Fourth Edition\u201d, CLSI document GP26-A4, 2011.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons\" 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