{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T18:11:43Z","timestamp":1793124703604,"version":"4.5.0"},"reference-count":33,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"5","license":[{"start":{"date-parts":[[2024,11,6]],"date-time":"2024-11-06T00:00:00Z","timestamp":1730851200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,11,6]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>Laboratory benchmarking allows objective analysis of the analytical performance of malaria rapid diagnostic tests (RDTs). We present the analytical detection limits of the Rapigen BIOCREDIT Malaria Ag Pf\/Pv (pLDH\/pLDH), the Rapigen BIOCREDIT Malaria Ag Pf (pLDH\/HRPII), and two best-in-class WHO-prequalified comparator RDTs, generated using standardized panels containing recombinant antigen, in\u00a0vitro cultured parasites, international standards, and clinical samples. Detection limit antigen concentrations of HRP2, PfLDH, and PvLDH were determined for the Rapigen and comparator RDTs. Detection of antigens in international units (IU)\/mL was also evaluated. The Rapigen Ag Pf (pLDH\/HRPII) detected 3.9 and 3.9\u2009IU\/mL for PfLDH and HRP2, respectively, and the Ag Pf\/Pv (pLDH\/pLDH) detected 3.9 and 5.0\u2009IU\/mL for PfLDH and PvLDH, respectively. The comparator HRP2\/PfLDH and HRP2\/PvLDH detected 15.6 and 31.3\u2009IU\/mL for HRP2 and PfLDH and 15.6 and 50.0\u2009IU\/mL for HRP2 and PvLDH, respectively. The RDT clinical sensitivity was predicted through application of analytical detection limits to antigen concentration distributions from clinical symptomatic and asymptomatic cases. Febrile cases would be detected in a majority by both standard and Rapigen RDTs, but incremental increases in sensitivity in the Rapigen RDTs may be important for clinical cases currently missed by microscopy. Rapigen RDTs were predicted to have improved detection of asymptomatic cases and infections with parasites carrying hrp2 deletions through more sensitive PfLDH detection. Through the benchmarking and simulation of clinical sensitivity, a method for rapidly assessing the ability of new RDTs to meet clinical needs using high-sensitivity antigen distribution data is presented.<\/jats:p>","DOI":"10.4269\/ajtmh.24-0003","type":"journal-article","created":{"date-parts":[[2024,9,3]],"date-time":"2024-09-03T13:20:22Z","timestamp":1725369622000},"page":"956-966","source":"Crossref","is-referenced-by-count":13,"title":["Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria"],"prefix":"10.4269","volume":"111","author":[{"given":"Allison","family":"Golden","sequence":"first","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah C.","family":"Slater","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ihn Kyung","family":"Jang","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sayali","family":"Walke","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thanh T.","family":"Phan","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greg T.","family":"Bizilj","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Rashid","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Barney","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Smita","family":"Das","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa J.","family":"Rist","sequence":"additional","affiliation":[{"name":"Queensland Institute of Medical Research, Berghofer Medical Research Institute, Brisbane, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James S.","family":"McCarthy","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, The Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Melbourne, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois","family":"Nosten","sequence":"additional","affiliation":[{"name":"Shoklo Malaria Research Unit, Mahidol\u2013Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand;"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordi","family":"Landier","sequence":"additional","affiliation":[{"name":"Shoklo Malaria Research Unit, Mahidol\u2013Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand;"},{"name":"Aix Marseille University, l\u2019Institut de recherche pour le d\u00e9veloppement (IRD), L\u2019Institut national de la sant\u00e9 et de la recherche m\u00e9dicale (INSERM), Sciences \u00e9conomiques et sociales de la sant\u00e9 & traitement de l\u2019information m\u00e9dicale (SESSTIM), Institut des sciences de la sant\u00e9 publique (ISSPAM), Aix Marseille Institute of Public Health, Marseille, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mallika","family":"Imwong","sequence":"additional","affiliation":[{"name":"Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer C. C.","family":"Hume","sequence":"additional","affiliation":[{"name":"Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Issaka","family":"Sagara","sequence":"additional","affiliation":[{"name":"Malaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara A.","family":"Healy","sequence":"additional","affiliation":[{"name":"Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick E.","family":"Duffy","sequence":"additional","affiliation":[{"name":"Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Ntuku","sequence":"additional","affiliation":[{"name":"Malaria Elimination Initiative, Institute for Global Health Sciences, University of California, San Francisco, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davis","family":"Mumbengegwi","sequence":"additional","affiliation":[{"name":"Malaria Operational Research Program, Centre for Research Services at the University of Namibia, Windhoek, Namibia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle S.","family":"Hsiang","sequence":"additional","affiliation":[{"name":"Malaria Elimination Initiative, Institute for Global Health Sciences, University of California, San Francisco, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean C.","family":"Murphy","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Rek","sequence":"additional","affiliation":[{"name":"Infectious Diseases Research Collaboration, Kampala, Uganda;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Torres","sequence":"additional","affiliation":[{"name":"Departamento de Ciencias Celulares y Moleculares, Facultad de Ciencias e Ingenier\u00eda, Universidad Peruana Cayetano Heredia, Lima, Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dionicia","family":"Gamboa","sequence":"additional","affiliation":[{"name":"Departamento de Ciencias Celulares y Moleculares, Facultad de Ciencias e Ingenier\u00eda, Universidad Peruana Cayetano Heredia, Lima, Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gonzalo 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