{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T18:08:54Z","timestamp":1790878134409,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,11,29]],"date-time":"2023-11-29T00:00:00Z","timestamp":1701216000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Malaria is caused by protozoa of the genus <jats:italic>Plasmodium<\/jats:italic> and transmitted by <jats:italic>Anopheles<\/jats:italic> mosquitos. In the US, blood donors are assessed for malaria risk, including donor travel or previous residence in endemic areas and history of malaria by questionnaire and deferred for three months or three years, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The Procleix Plasmodium Assay is a qualitative nucleic acid test based on transcription\u2010mediated amplification (TMA) for the detection of 18S ribosomal RNA of <jats:italic>P. falciparum, P. ovale, P. vivax, P. malariae,<\/jats:italic> and <jats:italic>P. knowlesi<\/jats:italic> for use on the Procleix Panther system. Analytical sensitivity was evaluated with in vitro transcripts and infected red blood cells. For clinical specificity, 12,800 individual donations and 283 pools of 16 samples from routine US donors were screened. Malaria risk was evaluated by testing 862 donors deferred for 3\u2009years. Reactive results were confirmed with in\u2010house real\u2010time TMA assay and serology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Assay sensitivity was 8.47\u201311.89 RNA copies\/mL and 2.10\u20136.82 infected red cells\/mL. Specificity was 99.99% in 12,800 individual donations and 100% in 283 pools of 16. Of 862 tested deferred donor samples, one donor (0.12%) confirmed positive individually and in pools; he remained confirmed positive for 13\u2009months. The infected donor was a prior resident of a malaria\u2010endemic area in West Africa.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Procleix Plasmodium Assay showed high sensitivity and specificity and detected <jats:italic>Plasmodium<\/jats:italic> RNA in an asymptomatic presenting donor. This assay may prove helpful as a screening test versus the use of risk questions to reduce the number of donors deferred for malaria risk.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.17612","type":"journal-article","created":{"date-parts":[[2023,11,29]],"date-time":"2023-11-29T10:04:15Z","timestamp":1701252255000},"page":"94-103","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["A novel mitigation strategy for the prevention of <scp>transfusion\u2010transmitted<\/scp> malaria"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7735-8420","authenticated-orcid":false,"given":"Laura","family":"Tonnetti","sequence":"first","affiliation":[{"name":"Scientific Affairs American Red Cross  Rockville and Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9334-3158","authenticated-orcid":false,"given":"Jamel A.","family":"Groves","sequence":"additional","affiliation":[{"name":"Scientific Affairs American Red Cross  Rockville and Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deanna","family":"Self","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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9008-9154","authenticated-orcid":false,"given":"Bryan R.","family":"Spencer","sequence":"additional","affiliation":[{"name":"Scientific Affairs American Red Cross  Dedham Massachusetts 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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2580-4289","authenticated-orcid":false,"given":"Jeffrey M.","family":"Linnen","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5865-6366","authenticated-orcid":false,"given":"Susan L.","family":"Stramer","sequence":"additional","affiliation":[{"name":"Scientific Affairs American Red Cross  Rockville and Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,11,29]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"5","article-title":"Evaluation of malaria diagnostic methods as a key for successful control and elimination programs","volume":"5","author":"Mbanefo A","year":"2020","journal-title":"Trop Med Infect Dis"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.ss7002a1"},{"key":"e_1_2_8_4_1","unstructured":"Centers for Disease Control and Prevention. Locally Acquired Malaria Cases Identified in the United States. Available from:https:\/\/emergency.cdc.gov\/han\/2023\/han00496.asp#:~:text=On%20August%2018%2C%202023%2C%20a transmission%20of%20Plasmodium%20vivax%20(P.2023)"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.15630"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2012.10-0658"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200106283442603"},{"key":"e_1_2_8_8_1","volume-title":"Travel and related health history: malaria, prions, and other transfusion\u2010transmissible diseases","author":"Katz LM","year":"2019"},{"key":"e_1_2_8_9_1","article-title":"Revised recommendations to reduce the risk of transfusion\u2010transmitted malaria","author":"U.S. Department of Health and Human Services Food and drug Administration Center for Biologics Evaluation and Research","year":"2022","journal-title":"Guidance Ind"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781119719809.ch45"},{"key":"e_1_2_8_11_1","unstructured":"The Color of Blood: Red Cross Reflects on its Blood Collection History. Available from:https:\/\/www.redcross.org\/about-us\/news-and-events\/press-release\/2021\/the-color-of-blood--red-cross-reflects-on-its-blood-collection-hiistory.html"},{"key":"e_1_2_8_12_1","unstructured":"Grifols Procleix Plasmodium Assay\u2010product specifications. Available from:https:\/\/www.diagnostic.grifols.com\/en\/procleix-assays\/product-specifications"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tmrv.2015.03.004"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mib.2022.102231"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02290.x"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16718"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciad536"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.17612","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T09:03:30Z","timestamp":1705914210000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.17612"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11,29]]},"references-count":16,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1111\/trf.17612"],"URL":"https:\/\/doi.org\/10.1111\/trf.17612","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11,29]]},"assertion":[{"value":"2023-10-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}