{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T14:50:35Z","timestamp":1791989435693,"version":"4.4.0"},"reference-count":18,"publisher":"Wiley","issue":"19","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the performance and reader\u2010dependent variability of the VISITECT CD4 lateral flow assay (LFA) as a screening tool for identifying advanced HIV disease (AHD; CD4\u2009\u2264\u2009200 cells\/\u03bcL) during routine programmatic implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a two\u2010phase diagnostic evaluation in Argentina, including a training phase (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009100) and a validation phase (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009249), for a total of 349 participants, comparing VISITECT CD4\u2010LFA with flow cytometry. Diagnostic performance was assessed using the manufacturer\u2010recommended cut\u2010off. Sensitivity, specificity, and accuracy were calculated with 95% confidence intervals (CI). Receiver operating characteristic (ROC) analysis was used to estimate the implicit CD4 thresholds applied by readers.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The VISITECT CD4\u2010LFA showed 100% sensitivity (95% CI 94\u2013100) in both phases. Specificity improved from 19% (95% CI 8\u201335) to 40% (95% CI 31\u201349) after training, with accuracy increasing from 42% (95% CI 33\u201353) to 57% (95% CI 51\u201363). ROC analysis demonstrated a shift in the implicit reader threshold from 363 to 270 cells\/\u03bcL, indicating improved interpretation with experience.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The VISITECT CD4\u2010LFA is a highly sensitive point\u2010of\u2010care (POC) tool for AHD screening, though its visual design limits specificity, highlighting the need for reader\u2010independent technologies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcla.70340","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T05:35:56Z","timestamp":1787204156000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Performance Evaluation of the\n                    <scp>VISITECT CD4<\/scp>\n                    Lateral Flow Point\u2010Of\u2010Care Assay for Identifying Advanced\n                    <scp>HIV<\/scp>\n                    Disease"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8706-1054","authenticated-orcid":false,"given":"Mariana","family":"Andreani","sequence":"first","affiliation":[{"name":"Divisi\u00f3n Laboratorio de An\u00e1lisis Cl\u00ednicos, Secci\u00f3n Microbiolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia E.","family":"Frola","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Infectolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliana","family":"Guelfand","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Laboratorio de An\u00e1lisis Cl\u00ednicos, Secci\u00f3n Microbiolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabiana C.","family":"Chaile","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Laboratorio de An\u00e1lisis Cl\u00ednicos, Secci\u00f3n Microbiolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Barletta","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Infectolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda J.","family":"Rol\u00f3n","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Infectolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariana","family":"Erbin","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Laboratorio de An\u00e1lisis Cl\u00ednicos, Secci\u00f3n Microbiolog\u00eda Hospital General de Agudos \u201cDr. Juan A. Fern\u00e1ndez\u201d  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan L.","family":"Rodriguez\u2010Tudela","sequence":"additional","affiliation":[{"name":"Global Action for Fungal Infections (GAFFI)  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.13487"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25546"},{"key":"e_1_2_10_4_1","volume-title":"Guidelines for Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy","author":"World Health Organization","year":"2017"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix1139"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e31826f9e3b"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916\u2010014\u20100173\u20107"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000341"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiae374"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijregi.2024.100403"},{"key":"e_1_2_10_11_1","volume-title":"Bolet\u00edn N\u00b0 40: Respuesta al VIH y las ITS en la Argentina","author":"Direcci\u00f3n de Respuesta al VIH, ITS, Hepatitis Virales y Tuberculosis","year":"2023"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0230453"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003072"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003505"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/tmi.14124"},{"key":"e_1_2_10_16_1","volume-title":"Guidelines for Diagnosing, Preventing and Managing Cryptococcal Disease Among Adults, Adolescents and Children Living With HIV","author":"World Health Organization","year":"2022"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/jof7040268"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879\u2010024\u201009257\u20105"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s43008\u2010024\u201000158\u20105"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.70340","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.70340","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.70340","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T14:29:34Z","timestamp":1791988174000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.70340"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,19]]},"references-count":18,"journal-issue":{"issue":"19","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/jcla.70340"],"URL":"https:\/\/doi.org\/10.1002\/jcla.70340","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,19]]},"assertion":[{"value":"2026-03-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70340"}}