{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:18:46Z","timestamp":1790806726429,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Transfusion\u2010transmitted malaria can occur when donors have unrecognized asymptomatic infection with submicroscopic parasitemia, highlighting the need to detect low\u2010level parasitemia in blood donor screening. However, these highly sensitive blood donor testing algorithms may refer donors to clinicians who use diagnostic algorithms with less analytical sensitivity. Here we describe the analytical sensitivity of a Health Canada (HC)\/FDA approved blood donor screening test compared to commonly used diagnostic test algorithms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design and Methods<\/jats:title>\n                    <jats:p>\n                      The Roche cobas\u00ae Malaria NAT performance was assessed. A dilution series of known malaria\u2010positive clinical specimens was prepared (\n                      <jats:italic>Plasmodium falciparum<\/jats:italic>\n                      ,\n                      <jats:italic>P. vivax<\/jats:italic>\n                      , and\n                      <jats:italic>P. ovale<\/jats:italic>\n                      ) (1:10\n                      <jats:sup>4<\/jats:sup>\n                      \u201310\n                      <jats:sup>7<\/jats:sup>\n                      ). Percent parasitemia (%parasitemia) via microscopy of clinical samples was used to estimate the infected red blood cells (iRBCs\/mL) assuming 5\u2009\u00d7\u200910\n                      <jats:sup>9<\/jats:sup>\n                      RBC\/mL. Limit of detection (LoD) at 50% and 95% was calculated. LoDs were compared to currently used Canadian diagnostic methods.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Comparison of whole blood and base matrix LoD\n                      <jats:sub>95<\/jats:sub>\n                      and LoD\n                      <jats:sub>50<\/jats:sub>\n                      were within 1 log for detection of\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      spp. Overall,\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      spp. LoD\n                      <jats:sub>50<\/jats:sub>\n                      was 13.3 iRBC\/mL and 2.4\u2009\u00d7 10\n                      <jats:sup>\u22127<\/jats:sup>\n                      % parasitemia while LoD\n                      <jats:sub>95<\/jats:sub>\n                      was 167.1 iRBC\/mL and 2.8\u2009\u00d7 10\n                      <jats:sup>\u22126<\/jats:sup>\n                      % parasitemia. LoDs were on average &gt;2 logs lower than other diagnostic tests employed in Canada.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Blood operators using highly sensitive donor testing\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      NATs should develop approaches to educate clinicians on characteristics of these tests, as analytical sensitivities may be more sensitive than current diagnostic testing algorithms. Key groups to engage for management of\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      NAT\u2010positive donors include primary care practitioners, infectious diseases physicians, tropical\/travel medicine experts, clinical microbiologists, and public health.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/trf.70295","type":"journal-article","created":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T05:58:02Z","timestamp":1782194282000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Donor management implications for high\u2010sensitivity detection of low\u2010level malaria parasitemia in blood donor screening"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9129-5136","authenticated-orcid":false,"given":"Carmen L.","family":"Charlton","sequence":"first","affiliation":[{"name":"Medical Microbiology Canadian Blood Services  Edmonton Alberta Canada"},{"name":"Dept of Laboratory Medicine and Pathology University of Alberta  Edmonton Alberta Canada"},{"name":"Surveillance and Discovery Laboratory  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Conrod","sequence":"additional","affiliation":[{"name":"Surveillance and Discovery Laboratory  Ottawa Ontario Canada"},{"name":"Canadian Blood Services  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dilini","family":"Kumaran","sequence":"additional","affiliation":[{"name":"Surveillance and Discovery Laboratory  Ottawa Ontario Canada"},{"name":"Canadian Blood Services  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig","family":"Jenkins","sequence":"additional","affiliation":[{"name":"Surveillance and Discovery Laboratory  Ottawa Ontario Canada"},{"name":"Canadian Blood Services  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandy","family":"Shokoples","sequence":"additional","affiliation":[{"name":"Provincial Public Health Laboratory Alberta (ProvLab)  Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"LeeAnn","family":"Turnbull","sequence":"additional","affiliation":[{"name":"Provincial Public Health Laboratory Alberta (ProvLab)  Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruwandi","family":"Kariyawasam","sequence":"additional","affiliation":[{"name":"Dept of Laboratory Medicine and Pathology University of Alberta  Edmonton Alberta Canada"},{"name":"Provincial Public Health Laboratory Alberta (ProvLab)  Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantale","family":"Pambrun","sequence":"additional","affiliation":[{"name":"Canadian Blood Services  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2519-1109","authenticated-orcid":false,"given":"Steven J.","family":"Drews","sequence":"additional","affiliation":[{"name":"Medical Microbiology Canadian Blood Services  Edmonton Alberta Canada"},{"name":"Dept of Laboratory Medicine and Pathology University of Alberta  Edmonton Alberta Canada"},{"name":"Surveillance and Discovery Laboratory  Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00104-19"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2450\/2019.0222-18"},{"key":"e_1_2_10_4_1","unstructured":"Roche cobas\u00ae Malaria NAT Test Instructions for Use (IFU).https:\/\/www.fda.gov\/media\/177146\/download?attachmentAccessed July 24 2025"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.17549"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00195-13"},{"key":"e_1_2_10_7_1","unstructured":"Seracare.Certificate of analysis Basematrix 53 Defibrinated human plasma. 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