[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-168753-105":53,"doc-detail-168753-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","nordval-study-plan-template-quant-2026","NordVal Study Plan Template - Quant - 2026","","Study plan template for NordVal quantitative microbiological alternative method validation. Provides sections to define versioning, alternative and reference methods, and the validation standard aligned with NordVal Protocol No. 1 and EN ISO 16140-2:2016/Amd 1:2024, including guidance for estimating the Limit of Detection (LOD). Includes fields for participating companies and expert laboratories, abbreviation lists, and structured outlines for MCS and ILS, covering scope, food categories, products, and key performance characteristics such as trueness, accuracy profile, LOQ, and selectivity.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":46,"@type":70,"position":76},"https://docshare.wps.com/template/paper-templates/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/nordval-study-plan-template-quant-2026/168753/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/nordval-study-plan-template-quant-2026/168753.png","ImageObject",442,249,{"name":88,"@type":89},"Clementine","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-27","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What validation standard does the template follow?","Question",{"text":108,"@type":109},"It aligns with NordVal Protocol No. 1 for validating microbiological alternative methods against a reference method, following EN ISO 16140-2:2016/Amd 1:2024 and the NordVal added requirement and guidance for estimating the Limit of Detection (LOD).","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What information must be provided for the methods being compared?",{"text":113,"@type":109},"The template includes fields for the alternative method/kit name and the reference method, with placeholders to briefly describe each and link comparison flow information to the referenced appendix where applicable.",{"name":115,"@type":106,"acceptedAnswer":116},"Which performance characteristics are covered in the quantitative MCS section?",{"text":117,"@type":109},"The outline specifies relative trueness, accuracy profile, limit of quantification (LOQ), selectivity including inclusivity and exclusivity, plus guidance for expression and interpretation of results in the MCS report.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},168753,1790292555,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":45,"category_name":46,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":73},1374391974564,"https://ap-avatar.wpscdn.com/avatar/14000253aa45c000a9e?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779874745381141002","[This informative text should be deleted from the study plan. General recommendations are: 1) Write the study plan in the chronological order as presented in the NordVal protocol 1; 2) Use the same document for the study plan and the MCS and ILS reports that follow; 3) NordVal International should recommend the study plan before the MCS is initiated, and the MCS before the ILS is initiated.]\nVersion Aug 2026: the chapters \"Validation Standard\" and \"References\" were updated to reflect the new NordVal Protocol 1 version June 2026 and \u0013HYPERLINK \"https://www.iso.org/standard/83200.html\"\u0014ISO 16140-2:2016/Amd 1:2024\u0015.\n[Title of the validation study including method name, validation protocol and food categories]\nVersion\n[Study Plan Version X, date / MCS Report Version X, date / ILS Report Version X, date]\nAlternative method/Kit name\n[Name of alternative method]\nReference method\n[Name of reference method]\nValidation standard\u0005\n[NordVal International Protocol No. 1. Validation of microbiological alternative (proprietary) methods against a reference method. This Protocol follows the EN ISO 16140-2:2016: Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method and its amendment \u0013HYPERLINK \"https://www.iso.org/standard/83200.html\"\u0014ISO 16140-2:2016/Amd 1:2024\u0015. Additional to the EN ISO 16140-2, the NordVal Protocol includes the requirement of and guide to estimate the Limit of Detection (LOD) (4.1.2).]\nCompany\n[Contact person, laboratory name, address, phone, email, webpage]\nExpert Laboratory\n[Contact person, laboratory name, address, phone, email, webpage]\nAbbreviations\n[List all abbreviations used in this document that are not listed in the Definitions in NordVal Protocol 1]\n\u000f\n\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc236661430\" \u0014[Title of the validation study including method name, validation protocol and food categories]\t\u0013 PAGEREF _Toc236661430 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661431\" \u0014Version\t\u0013 PAGEREF _Toc236661431 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661432\" \u0014Alternative method/Kit name\t\u0013 PAGEREF _Toc236661432 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661433\" \u0014Reference method\t\u0013 PAGEREF _Toc236661433 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661434\" \u0014Validation standard\t\u0013 PAGEREF _Toc236661434 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661435\" \u0014Company\t\u0013 PAGEREF _Toc236661435 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661436\" \u0014Expert Laboratory\t\u0013 PAGEREF _Toc236661436 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661437\" \u0014Abbreviations\t\u0013 PAGEREF _Toc236661437 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661438\" \u00141.\tIntroduction\t\u0013 PAGEREF _Toc236661438 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661439\" \u0014Aim of the study\t\u0013 PAGEREF _Toc236661439 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661440\" \u0014Alternative method\t\u0013 PAGEREF _Toc236661440 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661441\" \u0014Reference method\t\u0013 PAGEREF _Toc236661441 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661442\" \u00142.\tScope\t\u0013 PAGEREF _Toc236661442 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661443\" \u0014Categories\t\u0013 PAGEREF _Toc236661443 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661444\" \u0014Products\t\u0013 PAGEREF _Toc236661444 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661445\" \u0014Method Performance Characteristics\t\u0013 PAGEREF _Toc236661445 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661446\" \u00143.\tMethod Comparison Study (Quantitative methods)\t\u0013 PAGEREF _Toc236661446 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661447\" \u0014Sample preparation\t\u0013 PAGEREF _Toc236661447 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661448\" \u0014Relative trueness study\t\u0013 PAGEREF _Toc236661448 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661449\" \u0014Accuracy profile study\t\u0013 PAGEREF _Toc236661449 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661450\" \u0014Limit of quantification study\t\u0013 PAGEREF _Toc236661450 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661451\" \u0014Selectivity (inclusivity and exclusivity) study\t\u0013 PAGEREF _Toc236661451 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661452\" \u0014Inclusivity\t\u0013 PAGEREF _Toc236661452 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661453\" \u0014Exclusivity\t\u0013 PAGEREF _Toc236661453 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc236661454\" \u0014Expression and interpretation of results in the","cbCaiuwvVmczTQRF","https://ap.wps.com/l/cbCaiuwvVmczTQRF","docx",156541,6,"English","# Introduction\n## Aim of the study\n## Alternative method\n## Reference method\n# Scope\n## Categories\n## Products\n## Method Performance Characteristics\n# Method Comparison Study (Quantitative methods)\n## Sample preparation\n## Relative trueness study\n## Accuracy profile study\n## Limit of quantification study\n## Selectivity (inclusivity and exclusivity) study\n## Inclusivity\n## Exclusivity\n## Expression and interpretation of results in the MCS report\n# Interlaboratory study, ILS\n## Number of laboratories and samples\n## Expression and interpretation of results in the ILS report\n# References\n# Appendix","[{\"question\":\"What validation standard does the template follow?\",\"answer\":\"It aligns with NordVal Protocol No. 1 for validating microbiological alternative methods against a reference method, following EN ISO 16140-2:2016/Amd 1:2024 and the NordVal added requirement and guidance for estimating the Limit of Detection (LOD).\"},{\"question\":\"What information must be provided for the methods being compared?\",\"answer\":\"The template includes fields for the alternative method/kit name and the reference method, with placeholders to briefly describe each and link comparison flow information to the referenced appendix where applicable.\"},{\"question\":\"Which performance characteristics are covered in the quantitative MCS section?\",\"answer\":\"The outline specifies relative trueness, accuracy profile, limit of quantification (LOQ), selectivity including inclusivity and exclusivity, plus guidance for expression and interpretation of results in the MCS report.\"}]","NordVal Study Plan Template - Quant - 2026 | DOCX",1788236540]