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While NAAT services are often unavailable or delayed in low- and middle-income settings, lateral flow antigen rapid diagnostic tests (Ag-RDTs) can deliver results in 15–30 minutes and help close testing gaps when minimum performance requirements are met. This monitored implementation protocol enables rapid, systematic data collection, aggregation, and analysis to evaluate impact across diverse health system settings.",{"@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":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/antigen-detection-rapid-diagnostic-tests-for-coronavirus-disease-2019-covid-19-master-protocol-for-monitored-implementation-version-10-date-25-november2020/168666/",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/antigen-detection-rapid-diagnostic-tests-for-coronavirus-disease-2019-covid-19-master-protocol-for-monitored-implementation-version-10-date-25-november2020/168666.png","ImageObject",442,249,{"name":88,"@type":89},"Seraphina","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":9},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"Why are SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) emphasized in this protocol?","Question",{"text":108,"@type":109},"Ag-RDTs are easy to perform and provide results within 15–30 minutes, helping address limited or delayed NAAT testing services and supporting rapid case detection when minimum performance requirements are met.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What is the purpose of the “monitored implementation” master protocol?",{"text":113,"@type":109},"It enables rapid and systematic collection and sharing of data in a standardized format to support aggregation, tabulation, and analysis across different settings and levels of the health system.",{"name":115,"@type":106,"acceptedAnswer":116},"How does the protocol align Ag-RDT use with existing guidance?",{"text":117,"@type":109},"The proposed conditions and settings for Ag-RDT use are aligned with WHO interim guidance on antigen detection for COVID-19 using rapid immunoassays.","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},168666,1788235590,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":9,"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":125,"read_time":140},962075114101,"https://ap-avatar.wpscdn.com/avatar/e000253a75eb197efd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1780044092746381165","Antigen detection rapid diagnostic tests for coronavirus disease 2019 (COVID-19): master protocol for monitored implementation\nVersion: 1.0\nDate: 25 November2020\n\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc56002440\" \u00141\tSummary\t\u0013 PAGEREF _Toc56002440 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002441\" \u00142\tBackground\t\u0013 PAGEREF _Toc56002441 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002442\" \u00142.1\tIntroduction\t\u0013 PAGEREF _Toc56002442 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002443\" \u00142.2\tObjectives\t\u0013 PAGEREF _Toc56002443 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002444\" \u00143\tMethods\t\u0013 PAGEREF _Toc56002444 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002445\" \u00143.1\tDesign and duration\t\u0013 PAGEREF _Toc56002445 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002446\" \u00143.1.1\tSites\t\u0013 PAGEREF _Toc56002446 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002447\" \u00143.1.2\tScenarios\t\u0013 PAGEREF _Toc56002447 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002448\" \u00143.1.3\tEligibility criteria for participation\t\u0013 PAGEREF _Toc56002448 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002449\" \u00143.1.4\tEndpoints\t\u0013 PAGEREF _Toc56002449 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002450\" \u00143.2\tCase definition\t\u0013 PAGEREF _Toc56002450 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002451\" \u00143.3\tSafety\t\u0013 PAGEREF _Toc56002451 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002452\" \u00143.4\tStorage of assays\t\u0013 PAGEREF _Toc56002452 \\h \u001419\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002453\" \u00143.5\tRecruitment of participants\t\u0013 PAGEREF _Toc56002453 \\h \u001419\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002454\" \u00143.6\tData collection\t\u0013 PAGEREF _Toc56002454 \\h \u001420\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002455\" \u00143.7\tTesting procedures\t\u0013 PAGEREF _Toc56002455 \\h \u001422\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002456\" \u00143.7.1\tUse of Ag-RDTs\t\u0013 PAGEREF _Toc56002456 \\h \u001422\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002457\" \u00143.7.2\tSpecimen collection\t\u0013 PAGEREF _Toc56002457 \\h \u001422\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002458\" \u00143.7.3\tSpecimen transport and storage\t\u0013 PAGEREF _Toc56002458 \\h \u001422\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002459\" \u00143.7.4\tConfirmatory NAAT\t\u0013 PAGEREF _Toc56002459 \\h \u001422\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002460\" \u00143.8\tEthical considerations\t\u0013 PAGEREF _Toc56002460 \\h \u001423\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002461\" \u00143.8.1\tInformed consent\t\u0013 PAGEREF _Toc56002461 \\h \u001423\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002462\" \u00143.8.2\tTreatment of subjects\t\u0013 PAGEREF _Toc56002462 \\h \u001423\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002463\" \u00143.8.3\tData handling and record keeping\t\u0013 PAGEREF _Toc56002463 \\h \u001423\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002464\" \u00143.8.4\tPublication policy\t\u0013 PAGEREF _Toc56002464 \\h \u001424\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002465\" \u00144\tStatistical analysis\t\u0013 PAGEREF _Toc56002465 \\h \u001424\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002466\" \u00144.1\tSample size\t\u0013 PAGEREF _Toc56002466 \\h \u001424\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002467\" \u00144.1.1\tEndpoints related to Ag-RDT performance\t\u0013 PAGEREF _Toc56002467 \\h \u001425\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002468\" \u00144.1.2\tEndpoints related to health worker competency and compliance\t\u0013 PAGEREF _Toc56002468 \\h \u001425\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002469\" \u00144.1.3\tEndpoints related to impact\t\u0013 PAGEREF _Toc56002469 \\h \u001425\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002470\" \u00144.1.4\tCost effectiveness\t\u0013 PAGEREF _Toc56002470 \\h \u001426\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002471\" \u00144.2\tStatistical considerations\t\u0013 PAGEREF _Toc56002471 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002472\" \u00145\tFinancing\t\u0013 PAGEREF _Toc56002472 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002473\" \u00146\tReferences\t\u0013 PAGEREF _Toc56002473 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002474\" \u00147\tAcknowledgments\t\u0013 PAGEREF _Toc56002474 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc56002475\" \u00148\tReferences\t\u0013 PAGEREF _Toc56002475 \\h \u001428\u0015\u0015\n\u0015\u0004\nSummary\nBackground\nIntroduction\nThe COVID-19 pandemic has created a need to rapidly scale-up testing services and provide diagnoses to implement test-trace-isolate strategies which are essential to effectively treat andcare for patients and to control the spread of the virus. Hundreds of diagnostic products are now available on the market, targeting detection of viral RNA, viral antigens and host antibodies against SARS-CoV-2.\nServices for SARS-CoV-2 NAAT assays have often been unavailable, especially outside of metropolitan areas in low- and middle- income countries (LMICs), or backlogged for several days to weeks, precluding the clinical utility of the results. Lateral flow a","cbCaiu4nAiNMA9vr","https://ap.wps.com/l/cbCaiu4nAiNMA9vr","docx",645486,97,"English","# Summary\n# Background\n## Introduction\n# Objectives\n# Methods\n## Design and duration\n## Case definition\n## Safety\n## Storage of assays\n## Recruitment of participants\n## Data collection\n## Testing procedures\n## Statistical analysis\n## Financing\n# References\n# Acknowledgments","[{\"question\":\"Why are SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) emphasized in this protocol?\",\"answer\":\"Ag-RDTs are easy to perform and provide results within 15–30 minutes, helping address limited or delayed NAAT testing services and supporting rapid case detection when minimum performance requirements are met.\"},{\"question\":\"What is the purpose of the “monitored implementation” master protocol?\",\"answer\":\"It enables rapid and systematic collection and sharing of data in a standardized format to support aggregation, tabulation, and analysis across different settings and levels of the health system.\"},{\"question\":\"How does the protocol align Ag-RDT use with existing guidance?\",\"answer\":\"The proposed conditions and settings for Ag-RDT use are aligned with WHO interim guidance on antigen detection for COVID-19 using rapid immunoassays.\"}]","Antigen detection rapid diagnostic tests for coronavirus disease 2019 (COVID-19): master protocol for monitored implementation - Version 1.0 - Date 25 November2020 | DOCX",34]