{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T01:26:30Z","timestamp":1778808390471,"version":"3.51.4"},"reference-count":20,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T00:00:00Z","timestamp":1691020800000},"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":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The 2022 multi\u2010country outbreak of monkeypox (mpox) resulted in blood collection and public health agencies closely monitoring for changes in transmission dynamics that could pose a threat to the blood supply. While mpox virus (MPXV) is not known to be transfusion transmissible, there have been several studies demonstrating the detection of MPXV in blood. We evaluated the performance characteristics of a research use only (RUO) nucleic acid amplification test for MPXV. The assay was developed to detect MPXV DNA in plasma and serum specimens from human blood donors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Materials<\/jats:title><jats:p>The sensitivity of the RUO MPXV Assay was determined using a synthetic DNA sequence, purified full\u2010length genomic DNA, and a chemically inactivated virus. Specificity was determined using fresh plasma samples collected from blood donors during the outbreak. Plasma samples collected from donors considered at increased risk for exposure to mpox were also tested.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For sensitivity, the 95% limit of detection (LOD) ranged from 0.26 copies\/mL (inactivated virus) to 31.65 copies\/mL (synthetic DNA) to 166.61 copies\/mL (for full\u2010length DNA). All donor samples tested with the RUO MPXV Assay were nonreactive, resulting in a specificity of 100% (95% CI, 99.93%\u2013100.00%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The RUO MPXV Assay was developed as a potential blood donation screening assay in response to the outbreak. While not directly comparable, the 95% LOD fiducial limits obtained from partial\u2010 and full\u2010length DNA analysis were similar to other manufacturers' MPXV assays. Additionally, this assay demonstrated high specificity for screening blood donors.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.17500","type":"journal-article","created":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T07:05:45Z","timestamp":1691046345000},"page":"1797-1802","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Nucleic acid testing for monkeypox in United States blood donor specimens"],"prefix":"10.1111","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-9334-3158","authenticated-orcid":false,"given":"Jamel A.","family":"Groves","sequence":"first","affiliation":[{"name":"Scientific Affairs, American Red Cross  Rockville Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7735-8420","authenticated-orcid":false,"given":"Laura","family":"Tonnetti","sequence":"additional","affiliation":[{"name":"Scientific Affairs, American Red Cross  Rockville Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deanna","family":"Self","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manisha C.","family":"Yadav","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristin","family":"Livezey","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2580-4289","authenticated-orcid":false,"given":"Jeffery M.","family":"Linnen","sequence":"additional","affiliation":[{"name":"Grifols Diagnostic Solutions Inc.  San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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 Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,3]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jiph.2022.07.014"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7123e1"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.12513"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7145a4"},{"key":"e_1_2_9_6_1","unstructured":"U.S. Food and Drug Administration.Information for blood establishments regarding the monkeypox virus and blood donation.2022Published 2022. Accessed: 18 April 2023. Available at:https:\/\/www.fda.gov\/vaccines\u2010blood\u2010biologics\/safety\u2010availability\u2010biologics\/information\u2010blood\u2010establishments\u2010regarding\u2010monkeypox\u2010virus\u2010and\u2010blood\u2010donation"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11357-022-00611-6"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.17100"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tmrv.2022.09.004"},{"key":"e_1_2_9_10_1","unstructured":"Centers for Disease Control and Prevention.Science Brief: Detection and Transmission of Mpox Virus During the 2022 Clade IIb Outbreak.2023Accessed: 18 April 2023. Available at:https:\/\/www.cdc.gov\/poxvirus\/monkeypox\/about\/science\u2010behind\u2010transmission.html#asymptomatic"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2022.27.28.2200503"},{"key":"e_1_2_9_12_1","unstructured":"Grifols Diagnostic Solutions Inc. Procleix Ultrio Elite Assay product insert: GDSS\u2010IFU\u2010000006 v. 7.0.2022Emeryville CA 94608 USA."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.2307\/2981407"},{"key":"e_1_2_9_14_1","unstructured":"American Red Cross.Eligibility criteria: alphabetical. Accessed 18 April 2023. Available at:https:\/\/www.redcrossblood.org\/donate\u2010blood\/how\u2010to\u2010donate\/eligibility\u2010requirements\/eligibility\u2010criteria\u2010alphabetical.html"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid0707.017731"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12281-022-00448-8"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/bioengineering9100571"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2023.105424"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.17266"},{"key":"e_1_2_9_20_1","unstructured":"Centers for Disease Control and Prevention.U.S. mpox case trends reported to CDC. Accessed:18 April 2023. Available at:https:\/\/www.cdc.gov\/poxvirus\/mpox\/response\/2022\/mpx-trends.html"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(22)00586-2"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.17500","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,4]],"date-time":"2023-10-04T09:08:52Z","timestamp":1696410532000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.17500"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,3]]},"references-count":20,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["10.1111\/trf.17500"],"URL":"https:\/\/doi.org\/10.1111\/trf.17500","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,3]]},"assertion":[{"value":"2023-06-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-07-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-03","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}