{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T06:04:23Z","timestamp":1781071463278,"version":"3.54.1"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T00:00:00Z","timestamp":1775174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T00:00:00Z","timestamp":1775174400000},"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"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Transfusion\u2010transmitted malaria remains a concern in non\u2010endemic regions due to asymptomatic parasitemia in donors with prior residence in or travel to malaria\u2010endemic areas. Nucleic acid testing (NAT)\u2010based screening has been proposed to mitigate this risk, and supplemental assays are needed to confirm reactive donations. We developed a pan\u2010\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      reverse transcription quantitative PCR (RT\u2010qPCR) assay with species identification capability as a supplemental tool for malaria donor screening.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design and Methods<\/jats:title>\n                    <jats:p>\n                      The assay targets a conserved region of the 18S rRNA shared by all five human\u2010infecting\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      species and is compatible with whole blood lysed using Grifols' parasite transport medium (PTM). Analytical performance was evaluated using in vitro transcripts and infected red blood cells (iRBCs), with the limit of detection (LoD) determined by probit analysis. Specificity was assessed against\n                      <jats:italic>Babesia microti<\/jats:italic>\n                      and 300 non\u2010exposed US donor samples. Clinical sensitivity was evaluated using infected specimens; species identification was performed by sequencing of RT\u2010qPCR amplicons.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The assay demonstrated high amplification efficiency (97.2%) and linearity (\n                      <jats:italic>R<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      \u2009=\u20090.99). The 95% LoD was 5.3 iRBCs\/mL (95% CI: 3.2\u20138.6), comparable to the Procleix Plasmodium Assay. Clinical sensitivity was 100% across all five\n                      <jats:italic>Plasmodium<\/jats:italic>\n                      species, and clinical specificity was 100% (95% CI: 99\u2013100%), with no cross\u2010reactivity with\n                      <jats:italic>Babesia<\/jats:italic>\n                      . Amplicon sequencing enabled accurate species\u2010level identification of all sequenced specimens.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This assay provides a sensitive confirmatory tool for malaria NAT\u2010based donor screening. Its compatibility with PTM lysates and species identification capabilities supports regulatory applications and research into asymptomatic parasitemia in semi\u2010immune donors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/trf.70207","type":"journal-article","created":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T04:48:58Z","timestamp":1775278138000},"page":"1130-1140","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and validation of a pan\u2010\n                    <i>Plasmodium<\/i>\n                    molecular assay as a confirmatory method for blood donor screening"],"prefix":"10.1111","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0250-0474","authenticated-orcid":false,"given":"Pamela","family":"Milani","sequence":"first","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"University of California San Francisco Department of Laboratory Medicine  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Wen","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leilani","family":"Montalvo","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia Bakkour","family":"Coco","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clara","family":"Di Germanio","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"University of California San Francisco Department of Laboratory Medicine  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Bres","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manisha","family":"Yadav","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Livezey","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Eduardo","family":"Levi","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2580-4289","authenticated-orcid":false,"given":"Jeffrey","family":"Linnen","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1446-125X","authenticated-orcid":false,"given":"Michael P.","family":"Busch","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"University of California San Francisco Department of Laboratory Medicine  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,3]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/piab083"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30299-9"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2006.00733.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1159\/000525414"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-018-2181-0"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.18061"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12004"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02290.x"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.17612"},{"key":"e_1_2_10_11_1","unstructured":"Research C for BE and. Recommendations to Reduce the Risk of Transfusion\u2010Transmitted Malaria [Internet]. FDA.2025[cited 2025 Aug 22]. Available from:https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/recommendations\u2010reduce\u2010risk\u2010transfusion\u2010transmitted\u2010malaria\u20100"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.43.1.402-405.2005"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2012.10-0658"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.19-0094"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.21-1226"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-015-1038-z"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofad202"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-015-0541-6"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12098"},{"key":"e_1_2_10_20_1","unstructured":"EP17 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures [Internet]. [cited 2025 Aug 22]. Available from:https:\/\/clsi.org\/shop\/standards\/ep17\/"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-021-03870-4"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pt.2022.11.008"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.omtm.2022.07.016"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra2405313"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.17726"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.70207","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/trf.70207","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.70207","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T05:30:31Z","timestamp":1781069431000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.70207"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,3]]},"references-count":24,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1111\/trf.70207"],"URL":"https:\/\/doi.org\/10.1111\/trf.70207","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,3]]},"assertion":[{"value":"2025-12-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}