{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T05:00:05Z","timestamp":1788670805020,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T00:00:00Z","timestamp":1747612800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Tropical Med Int Health"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>We assessed the diagnostic accuracy and usability of the rapid semiquantitative point of care VISITECT\u00ae CD4 Advanced Disease Assay, compared to routinely obtained CD4 counts among people living with HIV in Ethiopia and Indonesia. We consecutively enrolled people living with HIV aged \u226510\u2009years who were newly diagnosed, had interrupted antiretroviral treatment for \u22653\u2009months, or were feeling unwell. Venous blood was drawn to obtain CD4 counts on routinely available test instruments and a VISITECT\u00ae CD4 Advanced Disease Assay result. The sensitivity of VISITECT\u00ae CD4 Advanced Disease Assay was high (97.8%, 95% confidence interval [CI], 94.4\u201399.4%), but the specificity was low (32.7%, 95%CI, 27.9\u201337.8%). It significantly increased to 42.5% (95%CI, 33.2\u201352.1%) after retraining of laboratory staff, but remained low. The low specificity of VISITECT\u00ae CD4 Advanced Disease Assay was due to poor capacity in test reading by routine staff. Reading the test strip is error\u2010prone and requires intensive and regular training. Reading aids may improve the usability of this essential point of care test.<\/jats:p>","DOI":"10.1111\/tmi.14124","type":"journal-article","created":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T09:11:07Z","timestamp":1747645867000},"page":"685-693","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["<scp>VISITECT<\/scp>\n                    \u00ae\n                    <scp>CD4<\/scp>\n                    advanced disease assay in routine use: Diagnostic accuracy and usability, Ethiopia and Indonesia"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3024-0198","authenticated-orcid":false,"given":"Petra","family":"de Haas","sequence":"first","affiliation":[{"name":"KNCV Tuberculosis Foundation  The Hague The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Hepple","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation  The Hague The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yohannes","family":"Babo","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation Ethiopia Office  Addis Ababa Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisca","family":"Srioetami","sequence":"additional","affiliation":[{"name":"Yayasan KNCV Indonesia  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Misikir","family":"Amare","sequence":"additional","affiliation":[{"name":"Ethiopian Public Health Institute  Addis Ababa Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bihil","family":"Sherefdin","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation Ethiopia Office  Addis Ababa Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrii","family":"Slyzkyi","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation  The Hague The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denisa","family":"Widyaputri","sequence":"additional","affiliation":[{"name":"Yayasan KNCV Indonesia  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4064-5412","authenticated-orcid":false,"given":"Erni Juwita","family":"Nelwan","sequence":"additional","affiliation":[{"name":"Division of Tropical Medicine and Infectious Diseases, Department of Internal Medicine Cipto Mangunkusumo Hospital  Jakarta Indonesia"},{"name":"Faculty of Medicine Universitas Indonesia  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jhon","family":"Sugiharto","sequence":"additional","affiliation":[{"name":"Yayasan KNCV Indonesia  Jakarta Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Bedru","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation Ethiopia Office  Addis Ababa Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2071-3038","authenticated-orcid":false,"given":"Edine","family":"Tiemersma","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation  The Hague The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,19]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"WHO case definitions of HIV for surveillance and revised clinical staging and immunological classification of HIV\u2010related disease in adults and children","author":"WHO","year":"2007"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00042-10"},{"key":"e_1_2_7_4_1","volume-title":"Lateral flow urine lipoarabinomannan assay (LF\u2010LAM) for the diagnosis of active tuberculosis in people living with HIV","author":"WHO","year":"2019"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(11)70251-1"},{"key":"e_1_2_7_6_1","article-title":"Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV","volume":"10","author":"Bjerrum S","year":"2019","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.7189\/jogh.12.04004"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.09.068981"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1089\/AID.2018.0223"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000214"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-016-1931-2"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0157546"},{"key":"e_1_2_7_13_1","volume-title":"Supply chain implications of the latest CD4 market changes. Navigating the changing CD4 landscape to ensure HIV diagnostic service continuity","author":"Hurpy MXH","year":"2023"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-019-3948-x"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0230453"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003092"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-012799"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01277-18"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003505"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cegh.2024.101616"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiae374"},{"key":"e_1_2_7_22_1","unstructured":"WHO.WHO prequalification of in vitro diagnostics. Public Report. Product: VISITECT CD4_Advanced Disease. WHO reference number: PQDx 0384\u2013077\u201000. WHO Geneva: July 2023 version 5.2023.https:\/\/extranet.who.int\/prequal\/sites\/default\/files\/whopr_files\/PQDx_0384-077-00_VISTECT-CD4_AdvancedDisease_v5.0.pdf"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph20021435"},{"key":"e_1_2_7_24_1","volume-title":"Improving health system efficiency. 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