{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T02:10:23Z","timestamp":1788487823879,"version":"build-2803163510"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T00:00:00Z","timestamp":1769644800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"publisher","award":["RIA2018D-2498"],"award-info":[{"award-number":["RIA2018D-2498"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"publisher","award":["TB TRIAGE+"],"award-info":[{"award-number":["TB TRIAGE+"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>CD4 testing is the first step of the advanced human immunodeficiency virus (HIV) disease (AHD) care package. The semiquantitative VISITECT CD4 Advanced Disease test (VISITECT; AccuBio) is increasingly used but has variable reported performance. We compared its diagnostic accuracy and acceptability with that of the PIMA CD4 test (PIMA; Abbott) at the point of care within the AHD care package.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A mixed-methods study was embedded in a community-based tuberculosis case-finding trial in South Africa. Following a VISITECT batch recall (April 2023), a sample of trial participants with HIV underwent VISITECT and PIMA testing in parallel on a single venous blood sample. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. We conducted in-depth-interviews with people with HIV (PWH), focus group discussions with nurses, and participant observations with nurse-PWH pairs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 609 included PWH, 76 (12.5%) were found to have CD4 cell counts \u2264200\/\u00b5L with VISITECT versus 28 (4.8%) with PIMA. The sensitivity, specificity, PPV, and NPV for VISITECT, compared with PIMA, were 89.3% (95% confidence interval, 71.8%\u201397.7%), 91.2% (95% CI, 88.6%\u201393.4%), 32.9% (95% CI, 22.5%\u201344.6%) and 99.4% (95% CI, 98.4%\u201399.9%), respectively. Three VISITECT results (0.05%) were false-negative (CD4 cell counts, 16\/\u00b5L, 82\/\u00b5L, 175\/\u00b5L) and 51 (8.4%) were false-positive (median CD4 cell count, 563\/\u00b5L [interquartile range, 382\u2013739\/\u00b5L]). PWH and public sector nurses believed that point-of-care CD4 tests improve access to CD4 cell counts. Study nurses preferred PIMA to VISITECT in terms of accuracy, duration, user-friendliness, and yielding of a numeric CD4 result.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Compared with PIMA, VISITECT had good diagnostic accuracy but low PPV and was less acceptable to study nurses. The role of VISITECT should be further evaluated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofag043","type":"journal-article","created":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T12:31:31Z","timestamp":1769430691000},"source":"Crossref","is-referenced-by-count":2,"title":["Accuracy and Acceptability of the VISITECT CD4 Advanced Disease Test Compared With the PIMA CD4 Test at the Point of Care as Part of the Advanced HIV Disease Care Package: A Mixed-Methods Study"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5518-9600","authenticated-orcid":false,"given":"T","family":"Gils","sequence":"first","affiliation":[{"name":"Clinical Sciences, Institute of Tropical Medicine Department of , Antwerp ,","place":["Belgium"]},{"name":"University of Antwerp, Global Health Institute , Wilrijk ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Misra","sequence":"additional","affiliation":[{"name":"Human Science Research Council Centre for Community Based Research, , Pietermaritzburg ,","place":["South Africa"]},{"name":"University of the Witwatersrand Wits Health Consortium, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T","family":"Madonsela","sequence":"additional","affiliation":[{"name":"Human Science Research Council Centre for Community Based Research, , Pietermaritzburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T P","family":"Pita","sequence":"additional","affiliation":[{"name":"Human Science Research Council Centre for Community Based Research, , Pietermaritzburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Bosman","sequence":"additional","affiliation":[{"name":"Human Science Research Council Centre for Community Based Research, , Pietermaritzburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1051-5684","authenticated-orcid":false,"given":"I","family":"Ayakaka","sequence":"additional","affiliation":[{"name":"SolidarMed , Partnerships for Health, Maseru ,","place":["Lesotho"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Vlieghe","sequence":"additional","affiliation":[{"name":"University of Antwerp, Global Health Institute , Wilrijk ,","place":["Belgium"]},{"name":"Department of General Internal Medicine, Infectious Diseases and Tropical Medicine, University Hospital Antwerp , Edegem ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"van Heerden","sequence":"additional","affiliation":[{"name":"Human Science Research Council Centre for Community Based Research, , Pietermaritzburg ,","place":["South Africa"]},{"name":"University of the Witwatersrand Wits Health Consortium, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L","family":"Lynen","sequence":"additional","affiliation":[{"name":"Clinical Sciences, Institute of Tropical Medicine Department of , Antwerp ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1205-1484","authenticated-orcid":false,"given":"T","family":"Decroo","sequence":"additional","affiliation":[{"name":"Clinical Sciences, Institute of Tropical Medicine Department of , Antwerp ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6195-8237","authenticated-orcid":false,"given":"K","family":"Reither","sequence":"additional","affiliation":[{"name":"Swiss Tropical and Public Health Institute Department of Medicine, , Allschwil ,","place":["Switzerland"]},{"name":"University of Basel , Basel ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,1,29]]},"reference":[{"key":"2026022022450831900_ofag043-B1","author":"Joint United Nations Programme on HIV\/AIDS (UNAIDS)"},{"key":"2026022022450831900_ofag043-B2","doi-asserted-by":"crossref","first-page":"e26415","DOI":"10.1002\/jia2.26415","article-title":"Global prevalence of advanced HIV disease in healthcare settings: a rapid review","volume":"28","author":"Ford","year":"2025","journal-title":"J Int AIDS 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