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VISITECT CD4 Advanced Disease (VISITECT; AccuBio, Ltd) is an instrument-free, point-of-care, semiquantitative test allowing visual identification of CD4 \u2264 200 cells\/\u00b5L or &amp;gt;200 cells\/ \u00b5L from finger-prick or venous blood.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM, people with HIV \u226518 years old were prospectively recruited in 7 countries from outpatient departments if a tuberculosis symptom was present, and from inpatient departments. Participants provided venous blood for CD4 measurement using flow cytometry (reference standard) and finger-prick blood for VISITECT (index text), performed at point-of-care. Sensitivity, specificity, and positive and negative predictive values of VISITECT to determine CD4 \u2264 200 cells\/ \u00b5L were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 1604 participants, the median flow cytometry CD4 was 367 cells\/\u00b5L (interquartile range, 128\u2013626 cells\/\u00b5L) and 521 (32.5%) had CD4 \u2264 200 cells\/\u00b5L. VISITECT sensitivity was 92.7% (483\/521; 95% confidence interval [CI], 90.1%\u201394.7%) and specificity was 61.4% (665\/1083; 95% CI, 58.4%\u201364.3%). For participants with CD4 0\u2013100, 101\u2013200, 201\u2013300, 301\u2013500, and &amp;gt;500 cells\/\u00b5L, VISITECT misclassified 4.5% (95% CI, 2.5%\u20137.2%), 12.5 (95% CI, 8.0%\u201318.2%), 74.1% (95% CI, 67.0%\u201380.5%), 48.0% (95% CI, 42.5%\u201353.6%), and 22.6% (95% CI, 19.3%\u201326.3%), respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>VISITECT's sensitivity, but not specificity, met the World Health Organization's minimal sensitivity and specificity threshold of 80% for point-of-care CD4 tests. VISITECT's quality needs to be assessed and its accuracy optimized. VISITECT\u2019s utility as CD4 triage test should be investigated.<\/jats:p>\n                    <jats:p>Clinical Trials Registration.\u2003NCT04089423.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiae374","type":"journal-article","created":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T18:25:39Z","timestamp":1721672739000},"page":"e82-e90","source":"Crossref","is-referenced-by-count":15,"title":["A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries"],"prefix":"10.1093","volume":"231","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5518-9600","authenticated-orcid":false,"given":"Tinne","family":"Gils","sequence":"first","affiliation":[{"name":"Department of Clinical Sciences, Institute of Tropical Medicine , Antwerp ,","place":["Belgium"]},{"name":"Global Health Institute, University of Antwerp , Wilrijk 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