A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seven countries

A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seven countries. Gils, T., Hella, J., Jacobs, B. K M, Sossen, B., Mukoka, M., Muyoyeta, M., Nakabugo, E., Van Nguyen, H., Ubolyam, S., Macé, A., Vermeulen, M., Nyangu, S., Sanjase, N., Sasamalo, M., Dinh, H. T., Ngo, T. A., Manosuthi, W., Jirajariyavej, S., Denkinger, C. M, Nguyen, N. V., Avihingsanon, A., Nakiyingi, L., Székely, R., Kerkhoff, A. D, MacPherson, P., Meintjes, G., Reither, K., & Ruhwald, M. The Journal of Infectious Diseases, jul, 2024.

Paper doi abstract bibtex

Background CD4 measurement is pivotal in the management of advanced HIV disease. VISITECT® CD4 Advanced Disease (AccuBio Limited, Alva, UK; VISITECT) is an instrument-free, point-of-care, semi-quantitative test allowing visual identification of a CD4 ≤200 cells/µl, or \textgreater200 cells/µl from finger-prick or venous blood. Methods As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM (clinicaltrials.gov: NCT04089423), people living with HIV of ≥18 years old were prospectively recruited in seven 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 a CD4 ≤200 cells/µl were evaluated. Results Among 1604 participants, the median flow cytometry CD4 was 367 (IQR 128−626) cells/µl and 521 (32.5%) had a CD4 ≤200 cells/µl. VISITECT sensitivity was 92.7% (483/521, 95% CI 90.1−94.7%) and specificity was 61.4% (665/1083, 95% CI 58.4−64.3%). For participants with a CD4 between 0−100, 101−200, 201−300, 301−500, and \textgreater500 cells/µl, VISITECT misclassified 4.5% (95% CI 2.5-7.2%), 12.5 (95% CI 8.0-18.2%), 74.1% (95% CI 67.0-80.5%), 48.0% (95% CI 42.5-53.6%), and 22.6% (95% CI 19.3-26.3%), respectively. Conclusions 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´s utility as CD4 triage test should be investigated.

@article{Gils2024,
abstract = {Background CD4 measurement is pivotal in the management of advanced HIV disease. VISITECT{\textregistered} CD4 Advanced Disease (AccuBio Limited, Alva, UK; VISITECT) is an instrument-free, point-of-care, semi-quantitative test allowing visual identification of a CD4 ≤200 cells/µl, or {\textgreater}200 cells/µl from finger-prick or venous blood. Methods As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM (clinicaltrials.gov: NCT04089423), people living with HIV of ≥18 years old were prospectively recruited in seven 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 a CD4 ≤200 cells/µl were evaluated. Results Among 1604 participants, the median flow cytometry CD4 was 367 (IQR 128−626) cells/µl and 521 (32.5{\%}) had a CD4 ≤200 cells/µl. VISITECT sensitivity was 92.7{\%} (483/521, 95{\%} CI 90.1−94.7{\%}) and specificity was 61.4{\%} (665/1083, 95{\%} CI 58.4−64.3{\%}). For participants with a CD4 between 0−100, 101−200, 201−300, 301−500, and {\textgreater}500 cells/µl, VISITECT misclassified 4.5{\%} (95{\%} CI 2.5-7.2{\%}), 12.5 (95{\%} CI 8.0-18.2{\%}), 74.1{\%} (95{\%} CI 67.0-80.5{\%}), 48.0{\%} (95{\%} CI 42.5-53.6{\%}), and 22.6{\%} (95{\%} CI 19.3-26.3{\%}), respectively. Conclusions 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´s utility as CD4 triage test should be investigated.},
author = {Gils, Tinne and Hella, Jerry and Jacobs, Bart K M and Sossen, Bianca and Mukoka, Madalo and Muyoyeta, Monde and Nakabugo, Elizabeth and {Van Nguyen}, Hung and Ubolyam, Sasiwimol and Mac{\'{e}}, Aur{\'{e}}lien and Vermeulen, Marcia and Nyangu, Sarah and Sanjase, Nsala and Sasamalo, Mohamed and Dinh, Huong Thi and Ngo, The Anh and Manosuthi, Weerawat and Jirajariyavej, Supunnee and Denkinger, Claudia M and Nguyen, Nhung Viet and Avihingsanon, Anchalee and Nakiyingi, Lydia and Sz{\'{e}}kely, Rita and Kerkhoff, Andrew D and MacPherson, Peter and Meintjes, Graeme and Reither, Klaus and Ruhwald, Morten},
doi = {10.1093/INFDIS/JIAE374},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Gils et al. - 2024 - A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seve.pdf:pdf},
issn = {0022-1899},
journal = {The Journal of Infectious Diseases},
keywords = {12 FIND,13 Viet Tiep ⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯,2000 Antwerpen,Belgium,Geneva,Nationalestraat 155,OA,Switzerland,cell: 0032/49033378,email: tgils@itgbe,fund{\_}ack,original,the global alliance for diagnostics},
mendeley-tags = {OA,fund{\_}ack,original},
month = {jul},
title = {{A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seven countries}},
url = {https://dx.doi.org/10.1093/infdis/jiae374},
year = {2024}
}

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VISITECT® CD4 Advanced Disease (AccuBio Limited, Alva, UK; VISITECT) is an instrument-free, point-of-care, semi-quantitative test allowing visual identification of a CD4 ≤200 cells/µl, or \\textgreater200 cells/µl from finger-prick or venous blood. Methods As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM (clinicaltrials.gov: NCT04089423), people living with HIV of ≥18 years old were prospectively recruited in seven 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 a CD4 ≤200 cells/µl were evaluated. Results Among 1604 participants, the median flow cytometry CD4 was 367 (IQR 128−626) cells/µl and 521 (32.5%) had a CD4 ≤200 cells/µl. VISITECT sensitivity was 92.7% (483/521, 95% CI 90.1−94.7%) and specificity was 61.4% (665/1083, 95% CI 58.4−64.3%). For participants with a CD4 between 0−100, 101−200, 201−300, 301−500, and \\textgreater500 cells/µl, VISITECT misclassified 4.5% (95% CI 2.5-7.2%), 12.5 (95% CI 8.0-18.2%), 74.1% (95% CI 67.0-80.5%), 48.0% (95% CI 42.5-53.6%), and 22.6% (95% CI 19.3-26.3%), respectively. Conclusions 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´s utility as CD4 triage test should be investigated.","author":[{"propositions":[],"lastnames":["Gils"],"firstnames":["Tinne"],"suffixes":[]},{"propositions":[],"lastnames":["Hella"],"firstnames":["Jerry"],"suffixes":[]},{"propositions":[],"lastnames":["Jacobs"],"firstnames":["Bart","K","M"],"suffixes":[]},{"propositions":[],"lastnames":["Sossen"],"firstnames":["Bianca"],"suffixes":[]},{"propositions":[],"lastnames":["Mukoka"],"firstnames":["Madalo"],"suffixes":[]},{"propositions":[],"lastnames":["Muyoyeta"],"firstnames":["Monde"],"suffixes":[]},{"propositions":[],"lastnames":["Nakabugo"],"firstnames":["Elizabeth"],"suffixes":[]},{"propositions":[],"lastnames":["Van Nguyen"],"firstnames":["Hung"],"suffixes":[]},{"propositions":[],"lastnames":["Ubolyam"],"firstnames":["Sasiwimol"],"suffixes":[]},{"propositions":[],"lastnames":["Macé"],"firstnames":["Aurélien"],"suffixes":[]},{"propositions":[],"lastnames":["Vermeulen"],"firstnames":["Marcia"],"suffixes":[]},{"propositions":[],"lastnames":["Nyangu"],"firstnames":["Sarah"],"suffixes":[]},{"propositions":[],"lastnames":["Sanjase"],"firstnames":["Nsala"],"suffixes":[]},{"propositions":[],"lastnames":["Sasamalo"],"firstnames":["Mohamed"],"suffixes":[]},{"propositions":[],"lastnames":["Dinh"],"firstnames":["Huong","Thi"],"suffixes":[]},{"propositions":[],"lastnames":["Ngo"],"firstnames":["The","Anh"],"suffixes":[]},{"propositions":[],"lastnames":["Manosuthi"],"firstnames":["Weerawat"],"suffixes":[]},{"propositions":[],"lastnames":["Jirajariyavej"],"firstnames":["Supunnee"],"suffixes":[]},{"propositions":[],"lastnames":["Denkinger"],"firstnames":["Claudia","M"],"suffixes":[]},{"propositions":[],"lastnames":["Nguyen"],"firstnames":["Nhung","Viet"],"suffixes":[]},{"propositions":[],"lastnames":["Avihingsanon"],"firstnames":["Anchalee"],"suffixes":[]},{"propositions":[],"lastnames":["Nakiyingi"],"firstnames":["Lydia"],"suffixes":[]},{"propositions":[],"lastnames":["Székely"],"firstnames":["Rita"],"suffixes":[]},{"propositions":[],"lastnames":["Kerkhoff"],"firstnames":["Andrew","D"],"suffixes":[]},{"propositions":[],"lastnames":["MacPherson"],"firstnames":["Peter"],"suffixes":[]},{"propositions":[],"lastnames":["Meintjes"],"firstnames":["Graeme"],"suffixes":[]},{"propositions":[],"lastnames":["Reither"],"firstnames":["Klaus"],"suffixes":[]},{"propositions":[],"lastnames":["Ruhwald"],"firstnames":["Morten"],"suffixes":[]}],"doi":"10.1093/INFDIS/JIAE374","file":":C$\\$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Gils et al. - 2024 - A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seve.pdf:pdf","issn":"0022-1899","journal":"The Journal of Infectious Diseases","keywords":"12 FIND,13 Viet Tiep ⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯,2000 Antwerpen,Belgium,Geneva,Nationalestraat 155,OA,Switzerland,cell: 0032/49033378,email: tgils@itgbe,fund_ack,original,the global alliance for diagnostics","mendeley-tags":"OA,fund_ack,original","month":"jul","title":"A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seven countries","url":"https://dx.doi.org/10.1093/infdis/jiae374","year":"2024","bibtex":"@article{Gils2024,\r\nabstract = {Background CD4 measurement is pivotal in the management of advanced HIV disease. VISITECT{\\textregistered} CD4 Advanced Disease (AccuBio Limited, Alva, UK; VISITECT) is an instrument-free, point-of-care, semi-quantitative test allowing visual identification of a CD4 ≤200 cells/µl, or {\\textgreater}200 cells/µl from finger-prick or venous blood. Methods As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM (clinicaltrials.gov: NCT04089423), people living with HIV of ≥18 years old were prospectively recruited in seven 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 a CD4 ≤200 cells/µl were evaluated. Results Among 1604 participants, the median flow cytometry CD4 was 367 (IQR 128−626) cells/µl and 521 (32.5{\\%}) had a CD4 ≤200 cells/µl. VISITECT sensitivity was 92.7{\\%} (483/521, 95{\\%} CI 90.1−94.7{\\%}) and specificity was 61.4{\\%} (665/1083, 95{\\%} CI 58.4−64.3{\\%}). For participants with a CD4 between 0−100, 101−200, 201−300, 301−500, and {\\textgreater}500 cells/µl, VISITECT misclassified 4.5{\\%} (95{\\%} CI 2.5-7.2{\\%}), 12.5 (95{\\%} CI 8.0-18.2{\\%}), 74.1{\\%} (95{\\%} CI 67.0-80.5{\\%}), 48.0{\\%} (95{\\%} CI 42.5-53.6{\\%}), and 22.6{\\%} (95{\\%} CI 19.3-26.3{\\%}), respectively. Conclusions 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´s utility as CD4 triage test should be investigated.},\r\nauthor = {Gils, Tinne and Hella, Jerry and Jacobs, Bart K M and Sossen, Bianca and Mukoka, Madalo and Muyoyeta, Monde and Nakabugo, Elizabeth and {Van Nguyen}, Hung and Ubolyam, Sasiwimol and Mac{\\'{e}}, Aur{\\'{e}}lien and Vermeulen, Marcia and Nyangu, Sarah and Sanjase, Nsala and Sasamalo, Mohamed and Dinh, Huong Thi and Ngo, The Anh and Manosuthi, Weerawat and Jirajariyavej, Supunnee and Denkinger, Claudia M and Nguyen, Nhung Viet and Avihingsanon, Anchalee and Nakiyingi, Lydia and Sz{\\'{e}}kely, Rita and Kerkhoff, Andrew D and MacPherson, Peter and Meintjes, Graeme and Reither, Klaus and Ruhwald, Morten},\r\ndoi = {10.1093/INFDIS/JIAE374},\r\nfile = {:C$\\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Gils et al. - 2024 - A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seve.pdf:pdf},\r\nissn = {0022-1899},\r\njournal = {The Journal of Infectious Diseases},\r\nkeywords = {12 FIND,13 Viet Tiep ⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯⎯,2000 Antwerpen,Belgium,Geneva,Nationalestraat 155,OA,Switzerland,cell: 0032/49033378,email: tgils@itgbe,fund{\\_}ack,original,the global alliance for diagnostics},\r\nmendeley-tags = {OA,fund{\\_}ack,original},\r\nmonth = {jul},\r\ntitle = {{A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seven countries}},\r\nurl = {https://dx.doi.org/10.1093/infdis/jiae374},\r\nyear = {2024}\r\n}\r\n","author_short":["Gils, T.","Hella, J.","Jacobs, B. 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