{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T00:19:14Z","timestamp":1792196354659,"version":"4.4.0"},"reference-count":23,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2020,10,16]],"date-time":"2020-10-16T00:00:00Z","timestamp":1602806400000},"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":[[2020,12]]},"abstract":"<jats:title>Background<\/jats:title><jats:sec><jats:label\/><jats:p>Human immunodeficiency virus (HIV) and hepatitis B virus (HBV) are endemic in South Africa while hepatitis C virus (HCV) infection is rare. Two nucleic acid amplification technology platforms, the Procleix Ultrio Elite assay on the Panther instrument (Elite) and the cobas MPX assay on the cobas 6800 or 8800 system (MPX), are used worldwide. In 2015 these were evaluated in South African context.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>The sensitivity of HIV, HBV, and HCV was evaluated using reference panels and 2\u2010fold dilutions of 51 positive plasma samples tested in 12 to 24 replicates. The 95% and 50% lower limits of detection (LOD) were estimated by probit analysis and window period (WP) risk days by the Weusten model. Specificity was established by testing 3646 blood donations individually and instrument performance by evaluating all runs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Specificity was 99.94% for MPX and 99.97% for Elite. The following 95% LODs (95% confidence intervals [CIs]) were estimated for MPX and Elite, respectively: HBV, 17.8 (10.9\u201033.9) and 47.9 (29.1\u201092.4) cp\/mL; HCV, 21.9 (15.3\u201034.6) and 13.8 (8.9\u201024.0) cp\/mL; and HIV, 8.3 (5.5\u201014.7) and 10.4 (6.9\u201018.2) cp\/mL. On SA HBV and HIV dilution panels, relative sensitivity (range) of MPX was 3.20 (1.26\u20106.50) and 1.42 (0.26\u20102.72) fold higher than Elite. Downtime on cobas 6800 was 26 hours vs 6.6\u2009hours on Panther (<jats:italic>P<\/jats:italic> &lt;\u2009.001). We estimated infectious WPs for HBV, HCV, and HIV\u20101 at 13.8, 1.8, and 2.6\u2009days for Elite and 10.3, 2.1, and 2.4\u2009days for MPX.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Although MPX was significantly more sensitive for HBV, Elite was implemented due to instrument reliability during evaluation.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16137","type":"journal-article","created":{"date-parts":[[2020,10,16]],"date-time":"2020-10-16T17:31:50Z","timestamp":1602869510000},"page":"2929-2937","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Comparison of two nucleic acid amplification technology systems for detection of human immunodeficiency virus, <scp>hepatitis B virus, and hepatitis C virus<\/scp>"],"prefix":"10.1111","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3272-927X","authenticated-orcid":false,"given":"Charl","family":"Coleman","sequence":"first","affiliation":[{"name":"South African National Blood Service  Roodepoort South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1043-661X","authenticated-orcid":false,"given":"Nico","family":"Lelie","sequence":"additional","affiliation":[{"name":"Lelie Research  Alkmaar the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronel","family":"Rademeyer","sequence":"additional","affiliation":[{"name":"South African National Blood Service  Roodepoort South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry","family":"van Drimmelen","sequence":"additional","affiliation":[{"name":"Biologicals Quality Control B.V.  Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"van den Berg","sequence":"additional","affiliation":[{"name":"South African National Blood Service  Roodepoort South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4383-4526","authenticated-orcid":false,"given":"Marion","family":"Vermeulen","sequence":"additional","affiliation":[{"name":"South African National Blood Service  Roodepoort South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,10,16]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2005.00649.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02110.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2012.01640.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1159\/000496749"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12299"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13024"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13819"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13193"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14457"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14959"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.15420"},{"key":"e_1_2_8_13_1","unstructured":"Cobas MPX Multiplex HIV HCV & HBV nucleic acis test for use on the cobas 6800\/8800 Systems. Mannheim: Roche Diagnostics GmbH;2014."},{"key":"e_1_2_8_14_1","unstructured":"Procleix Ultrio Elite Assay.Rev.001. San Diego CA: Gen\u2010Probe;2014."},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12117"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12657"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02804.x"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2005.00602.x"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200309050-00005"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2005.04390.x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02322.x"},{"issue":"1","key":"e_1_2_8_22_1","first-page":"146","article-title":"Transmission of occult HBV infection by ID\u2010NAT screened blood (Abstract P273)","volume":"107","author":"Vermeulen M","year":"2014","journal-title":"Vox Sang"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2018-316490"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13061"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.16137","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/trf.16137","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.16137","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T01:22:59Z","timestamp":1693876979000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.16137"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,16]]},"references-count":23,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["10.1111\/trf.16137"],"URL":"https:\/\/doi.org\/10.1111\/trf.16137","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,16]]},"assertion":[{"value":"2020-06-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-21","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-10-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}