{"id":787,"date":"2022-06-05T11:58:14","date_gmt":"2022-06-05T11:58:14","guid":{"rendered":"https:\/\/mgpindia.com\/fend\/?page_id=787"},"modified":"2022-08-26T20:43:43","modified_gmt":"2022-08-26T20:43:43","slug":"analytic-core-lab-rutgers","status":"publish","type":"page","link":"https:\/\/www.fend-tb.org\/staging\/9960\/sites\/analytic-core-lab-rutgers\/","title":{"rendered":"Analytic Core Lab Rutgers"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Header&#8221; _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#2E548A&#8221; custom_padding=&#8221;0px|0px|||false|false&#8221; border_color_top=&#8221;#41BBCF&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; 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_builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; background_enable_color=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/fend-tb.org\/wp-content\/uploads\/2022\/07\/lab-test-14a.jpg&#8221; _builder_version=&#8221;4.17.6&#8243; _module_preset=&#8221;default&#8221; box_shadow_style=&#8221;preset2&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_button button_url=&#8221;https:\/\/academichealth.rutgers.edu\/&#8221; url_new_window=&#8221;on&#8221; button_text=&#8221;Visit&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;14px&#8221; button_text_color=&#8221;#FFFFFF&#8221; button_bg_color=&#8221;#3663af&#8221; button_border_width=&#8221;1px&#8221; button_border_color=&#8221;#3663af&#8221; button_border_radius=&#8221;1px&#8221; button_letter_spacing=&#8221;4px&#8221; button_font=&#8221;Montserrat|||on|||||&#8221; button_use_icon=&#8221;off&#8221; custom_padding=&#8221;10px|20px|10px|20px|true|true&#8221; button_border_color_last_edited=&#8221;off|desktop&#8221; button_border_radius_tablet=&#8221;&#8221; button_border_radius_phone=&#8221;&#8221; button_border_radius_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221; button_bg_color__hover_enabled=&#8221;on|desktop&#8221; button_bg_color__hover=&#8221;RGBA(255,255,255,0)&#8221; button_bg_enable_color__hover=&#8221;on&#8221; button_border_width__hover_enabled=&#8221;off|hover&#8221; button_border_width__hover=&#8221;1px&#8221; button_border_radius__hover_enabled=&#8221;on|desktop&#8221; button_border_radius__hover=&#8221;1px&#8221; button_border_color__hover_enabled=&#8221;off|hover&#8221; button_border_color__hover=&#8221;#FFFFFF&#8221;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;About&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#FFFFFF&#8221; background_image=&#8221;https:\/\/fend-tb.org\/wp-content\/uploads\/2022\/02\/high-school_34.png&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat-x&#8221; z_index=&#8221;500&#8243; custom_margin=&#8221;||||false|false&#8221; custom_margin_tablet=&#8221;0px||||false|false&#8221; custom_margin_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;80px|80px|80px|80px|true|true&#8221; custom_padding_tablet=&#8221;50px|50px|50px|50px|true|true&#8221; custom_padding_phone=&#8221;50px|20px|50px|20px|true|true&#8221; box_shadow_style=&#8221;preset3&#8243; box_shadow_vertical=&#8221;60px&#8221; box_shadow_blur=&#8221;60px&#8221; box_shadow_spread=&#8221;0px&#8221; box_shadow_color=&#8221;rgba(14,15,43,0.1)&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Montserrat||||||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>The Analytic Core Laboratory Rutgers provides a means for FEND-TB to independently test key assay parameters to ensure that assays are ready for evaluation at FEND-TB Clinical Study Sites. The Analytic Core Lab performs several types of assessments, as described below.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||true|false&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.17.6&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;100px||||false|false&#8221; custom_padding_tablet=&#8221;60px||||false|false&#8221; custom_padding_phone=&#8221;30px||30px||true|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.17.6&#8243; _module_preset=&#8221;003e9429-8e11-4d9e-968b-8881092bbf81&#8243; header_2_font=&#8221;Roboto|500|||||||&#8221; header_2_text_color=&#8221;#000000&#8243; header_2_font_size=&#8221;20px&#8221; custom_padding=&#8221;||||false|false&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;20px&#8221; header_2_font_size_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Performance<\/h2>\n<p>The Analytic Core Lab confirms key performance specifications of prototype tests as described by the manufacturer. As needed, performance testing includes tests of sensitivity, the limit of detection (LOD), specificity, and ubiquity using the FEND-TB sample collection.<\/p>\n<h2>Defects, Design Errors &amp; Procedure Testing<\/h2>\n<p>The Analytic Core Lab tests assay procedures and determines whether the workflow is suitable for testing at Clinical Study Site laboratories.<\/p>\n<h2>Safety<\/h2>\n<p>As needed, the Analytic Core Lab assesses and tests the biosafety of the assay procedures.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/fend-tb.org\/wp-content\/uploads\/2022\/07\/lab-test-7.jpg&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;|-10vw|||false|false&#8221; custom_margin_tablet=&#8221;|0%|||false|false&#8221; custom_margin_phone=&#8221;&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; border_radii=&#8221;on|50px|50px|50px|50px&#8221; box_shadow_style=&#8221;preset3&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.17.6&#8243; _module_preset=&#8221;003e9429-8e11-4d9e-968b-8881092bbf81&#8243; header_2_font=&#8221;Roboto|500|||||||&#8221; header_2_text_color=&#8221;#000000&#8243; header_2_font_size=&#8221;20px&#8221; custom_padding=&#8221;||||false|false&#8221; hover_enabled=&#8221;0&#8243; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;20px&#8221; header_2_font_size_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>&nbsp;<\/p>\n<h2>Post-Clinical Study Discordant Analysis<\/h2>\n<p>The Analytic Core Lab can perform specific testing to help developers find the cause of unexpected discordances or errors identified during the FEND-TB clinical investigation.<\/p>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||true|false&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||||false|false&#8221; custom_padding_tablet=&#8221;||||false|false&#8221; custom_padding_phone=&#8221;||||true|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][et_pb_image src=&#8221;http:\/\/www.fend-tb.org\/wp-content\/uploads\/2022\/08\/Analytical-Core-Lab-3.jpg&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;|||-10vw|false|false&#8221; custom_margin_tablet=&#8221;|||0%|false|false&#8221; custom_margin_phone=&#8221;&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; border_radii=&#8221;on|50px|50px|50px|50px&#8221; box_shadow_style=&#8221;preset3&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; title_text=&#8221;Analytical Core Lab 3&#8243;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; custom_padding_last_edited=&#8221;on|tablet&#8221; custom_padding=&#8221;100px||||false|false&#8221; sticky_enabled=&#8221;0&#8243; custom_padding_tablet=&#8221;60px||||false|false&#8221; custom_padding_phone=&#8221;30px||30px||true|false&#8221;][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; header_2_font=&#8221;Roboto|500|||||||&#8221; header_2_text_color=&#8221;#000000&#8243; header_2_font_size=&#8221;20px&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;20px&#8221; header_2_font_size_last_edited=&#8221;on|desktop&#8221; custom_padding=&#8221;||40px||false|false&#8221; hover_enabled=&#8221;0&#8243;]<\/p>\n<h2>Leadership Committee<\/h2>\n<p>The FEND-TB Leadership Committee may also choose to use the Analytic Core Laboratory results to determine whether an assay meets minimal requirements and a \u201cgo\u201d decision can be made to progress that assay to evaluation under the appropriate FEND-TB study protocol at the appropriate FEND-TB Clinical Study Sites. If a \u201cno-go\u201d decision is made, the Analytic Core Laboratory will provide feedback to the developer to help it resolve outstanding performance issues, after which the revised assay could be resubmitted via the FEND-TB website for consideration for re-assessment.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;off|off|off&#8221; _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#f5f0eb&#8221; custom_padding=&#8221;120px||120px||true|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row make_equal=&#8221;on&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#FFFFFF&#8221; background_image=&#8221;https:\/\/fend-tb.org\/wp-content\/uploads\/2022\/02\/high-school_34.png&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;bottom_left&#8221; background_repeat=&#8221;repeat-x&#8221; z_index=&#8221;500&#8243; custom_margin=&#8221;||||false|false&#8221; custom_margin_tablet=&#8221;0px||||false|false&#8221; custom_margin_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;80px|80px|80px|80px|true|true&#8221; custom_padding_tablet=&#8221;30px|30px|30px|30px|true|true&#8221; custom_padding_phone=&#8221;30px|30px|30px|30px|true|true&#8221; box_shadow_style=&#8221;preset3&#8243; box_shadow_vertical=&#8221;60px&#8221; box_shadow_blur=&#8221;60px&#8221; box_shadow_spread=&#8221;0px&#8221; box_shadow_color=&#8221;rgba(14,15,43,0.1)&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blog fullwidth=&#8221;off&#8221; posts_number=&#8221;15&#8243; include_categories=&#8221;50&#8243; excerpt_length=&#8221;130&#8243; show_more=&#8221;on&#8221; show_author=&#8221;off&#8221; show_date=&#8221;off&#8221; show_pagination=&#8221;off&#8221; use_overlay=&#8221;on&#8221; overlay_icon_color=&#8221;#FFFFFF&#8221; hover_overlay_color=&#8221;rgba(0,0,0,0.5)&#8221; hover_icon=&#8221;&#x4c;||divi||400&#8243; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; header_font=&#8221;Roboto||||||||&#8221; header_font_size=&#8221;16px&#8221; header_line_height=&#8221;1.5em&#8221; body_font=&#8221;Montserrat||||||||&#8221; body_font_size=&#8221;14px&#8221; meta_font=&#8221;Montserrat|||on|||||&#8221; meta_font_size=&#8221;12px&#8221; meta_letter_spacing=&#8221;2px&#8221; read_more_font=&#8221;|||on|||||&#8221; read_more_text_color=&#8221;#BE7B61&#8243; read_more_font_size=&#8221;12px&#8221; read_more_letter_spacing=&#8221;2px&#8221; read_more_line_height=&#8221;2em&#8221; border_width_all=&#8221;0px&#8221; box_shadow_style_image=&#8221;preset2&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_blog][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Analytic Core Lab RutgersThe Analytic Core Laboratory Rutgers provides a means for FEND-TB to independently test key assay parameters to ensure that assays are ready for evaluation at FEND-TB Clinical Study Sites. The Analytic Core Lab performs several types of assessments, as described below.Performance The Analytic Core Lab confirms key performance specifications of prototype tests [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":751,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"nf_dc_page":"","_et_pb_use_builder":"on","_et_pb_old_content":"<!-- wp:paragraph -->\n<p>this is where the text will come<\/p>\n<!-- \/wp:paragraph -->","_et_gb_content_width":"1080","footnotes":""},"folder":[],"class_list":["post-787","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Analytic Core Lab Rutgers - FEND-TB<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.fend-tb.org\/sites\/analytic-core-lab-rutgers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Analytic Core Lab Rutgers - FEND-TB\" \/>\n<meta property=\"og:description\" content=\"Analytic Core Lab RutgersThe Analytic Core Laboratory Rutgers provides a means for FEND-TB to independently test key assay parameters to ensure that assays are ready for evaluation at FEND-TB Clinical Study Sites. 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