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It documents dossier assessment and quality system site inspection outcomes, followed by subsequent report amendments up to version 4.0, including software updates, labeling changes for notified body and IVDR requirements, and updates related to authorized representative and manufacturing commitments. The report also states intended use and assay principle, plus kit contents and required-not-provided materials for use with specified instruments and reagents.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/abbott-realtime-hiv-1-qualitative-manual-who-prequalification-public-report-version-40/646472/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/abbott-realtime-hiv-1-qualitative-manual-who-prequalification-public-report-version-40/646472.png","ImageObject",300,407,{"name":92,"@type":93},"\tCallum ","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-10","2026-10-23",true,{"@type":102,"interactionType":103,"userInteractionCount":14},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"When was Abbott RealTime HIV-1 Qualitative (Manual) accepted and listed on the WHO prequalified diagnostics list?","Question",{"text":112,"@type":113},"The product was accepted for the WHO list of prequalified diagnostics and was listed on 30 May 2013.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What do MR and FT mean in the prequalification status table?",{"text":117,"@type":113},"MR means Meets Requirements, and FT means Fast-Tracked.",{"name":119,"@type":110,"acceptedAnswer":120},"What is the assay principle of the Abbott RealTime HIV-1 Qualitative?",{"text":121,"@type":113},"It uses PCR to generate amplified product from HIV-1 nucleic acids. HIV-1 target presence is detected by fluorescent signals from labeled probes on the Abbott m2000rt instrument, and an unrelated RNA sequence is co-amplified as an internal control to verify correct process performance.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},646472,1792762188,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":129,"read_time":144,"preview_page_count":4},137451211410,"https://ap-avatar.wpscdn.com/avatar/2000bb0a9246f588df?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786362646172706240","WHO Prequalification of Diagnostics Programme  \nPUBLIC REPORT  \nProduct: Abbott RealTime HIV-1 Qualitative (Manual)  \nNumber: PQDx 0151-027-00  \nThe Abbott RealTime HIV-1 Qualitative (Manual) with product code 4N66-90, manufactured by Abbott Molecular Inc., 1300 East Touhy Avenue, Des Plaines, IL 60018, United States of America, CE-marked regulatory version, was accepted for the WHO list of prequalified diagnostics and was listed on 30 May 2013. This version of the product is intended to be used in conjunction with the following instruments/reagents: 9K15-01, 4N66-80, 4N66-03 or higher, 6K12-24 and 4N66-66 (optional) .  \nSummary of prequalification status for Abbott RealTime HIV-1 Qualitative  \n(Manual)  \n\n|  | Date | Outcome |\n| --- | --- | --- |\n| Status on PQ list | 30-May-2013 | listed |\n| Dossier assessment | 20-May-2013 | MR |\n| Site inspection(s) of quality management system | FT | MR |\n| Product performance evaluation | FT | MR |\n\nMR: Meets Requirements  \nFT: Fast-Tracked  \nReport amendments and/or product changes  \nThis public report has since been amended. Amendments may have arisen because of changes to the prequalified product for which WHO has been notified and has undertaken a review. Amendments to the report are summarized in the following table, and details of each amendment are provided below.  \n\n| Version | Summary of amendment | Date of report amendment |\n| --- | --- | --- |\n| 2.0 | Implemented software change | 1-Jun-2018 |\n| 3.0 | 1. The Notified Body number on the Abbott RealTime HIV-1 Quantitative and Qualitative kit labels and package inserts has | 24-Jul-2019 |\n\n\n|  | been updated to reflect the new notified body Polskie Centrum Badan I Certyfikacji S.A. (PCBC) Notified Body number of 1434.\u003Cbr>2. The word \"abbott\" has been aligned to the center of the Abbott logo (where applicable) . Labelling (labels and IFU) have been revised and version numbers updated.\u003Cbr>3. Update on manufacturing site inspection commitments. |  |\n| --- | --- | --- |\n| 4.0 | Updated Abbott’s European Authorized Representative (EC Rep) legal entity name from Abbott GmbH & Co. KG to Abbott GmbH. Labeling changes to comply with the labeling requirements for product registered under IVDR. | 1-Nov-2021 |\n\nIntended use:  \nAccording to the claim of Abbott Molecular Inc,“Abbott RealTime HIV-1 Qualitative is an in vitro amplification assay for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acids from human plasma and dried blood spots (DBS). The Abbott RealTime HIV-1 Qualitative is intended to be used as an aid in the diagnosis of HIV-1 infection in pediatric and adult subjects. The Abbott RealTime HIV-1 Qualitative is not intended to be used as a donor screening test for HIV-1.  \nThe intended users for the Abbott RealTime HIV-1 Qualitative are laboratory and healthcare professionals”.  \nAssay principle:  \nAccording to the claim of Abbott Molecular Inc, “Abbott RealTime HIV-1 Qualitative assay uses PCR to generate amplified product from the HIV-1 nucleic acids in clinical specimens. The presence of HIV‑1 target sequence is indicated by the fluorescent signal generated through the use of fluorescent-labeled oligonucleotide probes on the Abbott m2000rt instrument. The probes do not generate a signal unless they are specifically bound to the amplified product. An RNA sequence that is unrelated to the HIV-1 target sequence is introduced into each specimen at the beginning of sample preparation. This unrelated RNA sequence is simultaneously amplified, and serves as an internal control (IC) to demonstrate that the process has proceeded correctly for each sample”.  \nTest kit contents:  \n\n| Item | Product code(s) |\n| --- | --- |\n| Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit (to reference the new assay CD-ROM version 3) | 4N66-90 (4 packs x 24 tests/pack) |\n\nMaterials required but not provided:  \n\n| Item | Product code(s) |\n| --- | --- |\n| Instrumentation: |  |\n| Abbott m2000rt Instrument with softw","cbCaievDWkDd758F","https://ap.wps.com/l/cbCaievDWkDd758F","pdf",2562273,36,"English","# WHO Prequalification of Diagnostics Programme\n## Public Report Overview\n## Prequalification Status Summary\n## Report Amendments and Versions\n## Intended Use\n## Assay Principle\n## Test Kit Contents\n## Materials Required but Not Provided","[{\"question\":\"When was Abbott RealTime HIV-1 Qualitative (Manual) accepted and listed on the WHO prequalified diagnostics list?\",\"answer\":\"The product was accepted for the WHO list of prequalified diagnostics and was listed on 30 May 2013.\"},{\"question\":\"What do MR and FT mean in the prequalification status table?\",\"answer\":\"MR means Meets Requirements, and FT means Fast-Tracked.\"},{\"question\":\"What is the assay principle of the Abbott RealTime HIV-1 Qualitative?\",\"answer\":\"It uses PCR to generate amplified product from HIV-1 nucleic acids. HIV-1 target presence is detected by fluorescent signals from labeled probes on the Abbott m2000rt instrument, and an unrelated RNA sequence is co-amplified as an internal control to verify correct process performance.\"}]","Abbott RealTime HIV-1 Qualitative (Manual) - WHO Prequalification Public Report - Version 4.0 | PDF",91]