Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Zibusiso Ndlovu; Lamin Massaquoi; Ndim Eugene Bangwen; John N. Batumba; Rachelle U. Bora; Joelle Mbuaya; Roger Nzadi; Nadine Ntabugi; Patrick Kisaka; Gisele Manciya; Ramzia Moudashirou; Harry Pangani; Patrick Mangochi; Roberta Makoko; David Van Laeken; Claude Kwitonda; Yuster Ronoh; Kuziwa Kuwenyi; Reinaldo Ortuno; Douglas Mangwanya; Edmore Zvidzai; Tapiwa Mupepe; Sekesai Zinyowera; Emmanuel Fajarde; Tom Ellman

doi:10.1371/journal.pone.0230453

Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Zibusiso Ndlovu, Lamin Massaquoi, Ndim Eugene Bangwen, John N. Batumba, Rachelle U. Bora, Joelle Mbuaya, Roger Nzadi, Nadine Ntabugi, Patrick Kisaka, Gisele Manciya, Ramzia Moudashirou, Harry Pangani, Patrick Mangochi, Roberta Makoko, David Van Laeken, Claude Kwitonda, Yuster Ronoh, Kuziwa Kuwenyi, Reinaldo Ortuno, Douglas MangwanyaEdmore Zvidzai, Tapiwa Mupepe, Sekesai Zinyowera, Emmanuel Fajarde, Tom Ellman

Clinical Reference Laboratory

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Abstract

Background

In sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm(3). This study evaluated the diagnostic performance of this index test.

Methods

Consenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test.

Results

Among 708 patients, 67.2% were female and median CD4 was 297cells/mm(3). The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.0% [95% CI: 91.3-97.5] and specificity was 81.9% [95% CI: 78.2-85.2%]. Using FP samples, the sensitivity of the Visitect CD4 LFA was 98.3% [95% CI: 95.0-99.6] and specificity was 77.2% [95% CI: 71.6-82.2%]. Usability of the Visitect CD4 LFA was high across the study sites with 97% successfully completed tests. Due to the required specific multiple incubation and procedural steps during the Visitect CD4 LFA testing, few health workers (7/26) were not confident to manage testing whilst multi-tasking in their clinical work.

Conclusions

Visitect CD4 LFA is a promising test for decentralized CD4 screening in resource-limited settings, without access to CD4 testing and and it can trigger prompt management of patients with AHD. Lay health cadres should be considered to conduct Visitect CD4 LFA testing in PHCs as well as coordinating all other POC quality assurance.

Original language	English
Article number	e0230453
Journal	PLoS ONE
Volume	15
Issue number	4
Number of pages	11
ISSN	1932-6203
DOIs	https://doi.org/10.1371/journal.pone.0230453
Publication status	Published - 2020

Keywords

ANTIRETROVIRAL THERAPY
COUNTS

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10.1371/journal.pone.0230453Licence: CC BY

2020ponee0230453Final published version, 796 KBLicence: CC BY

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Ndlovu, Z., Massaquoi, L., Bangwen, N. E., Batumba, J. N., Bora, R. U., Mbuaya, J., Nzadi, R., Ntabugi, N., Kisaka, P., Manciya, G., Moudashirou, R., Pangani, H., Mangochi, P., Makoko, R., Van Laeken, D., Kwitonda, C., Ronoh, Y., Kuwenyi, K., Ortuno, R., ... Ellman, T. (2020). Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening. PLoS ONE, 15(4), Article e0230453. https://doi.org/10.1371/journal.pone.0230453

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title = "Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening",

abstract = "BackgroundIn sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm(3). This study evaluated the diagnostic performance of this index test.MethodsConsenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test.ResultsAmong 708 patients, 67.2% were female and median CD4 was 297cells/mm(3). The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.0% [95% CI: 91.3-97.5] and specificity was 81.9% [95% CI: 78.2-85.2%]. Using FP samples, the sensitivity of the Visitect CD4 LFA was 98.3% [95% CI: 95.0-99.6] and specificity was 77.2% [95% CI: 71.6-82.2%]. Usability of the Visitect CD4 LFA was high across the study sites with 97% successfully completed tests. Due to the required specific multiple incubation and procedural steps during the Visitect CD4 LFA testing, few health workers (7/26) were not confident to manage testing whilst multi-tasking in their clinical work.ConclusionsVisitect CD4 LFA is a promising test for decentralized CD4 screening in resource-limited settings, without access to CD4 testing and and it can trigger prompt management of patients with AHD. Lay health cadres should be considered to conduct Visitect CD4 LFA testing in PHCs as well as coordinating all other POC quality assurance.",

keywords = "ANTIRETROVIRAL THERAPY, COUNTS",

author = "Zibusiso Ndlovu and Lamin Massaquoi and Bangwen, {Ndim Eugene} and Batumba, {John N.} and Bora, {Rachelle U.} and Joelle Mbuaya and Roger Nzadi and Nadine Ntabugi and Patrick Kisaka and Gisele Manciya and Ramzia Moudashirou and Harry Pangani and Patrick Mangochi and Roberta Makoko and {Van Laeken}, David and Claude Kwitonda and Yuster Ronoh and Kuziwa Kuwenyi and Reinaldo Ortuno and Douglas Mangwanya and Edmore Zvidzai and Tapiwa Mupepe and Sekesai Zinyowera and Emmanuel Fajarde and Tom Ellman",

note = "FTX; DOAJ; (CC BY 4.0)",

year = "2020",

doi = "10.1371/journal.pone.0230453",

language = "English",

volume = "15",

journal = "PLoS ONE",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "4",

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Ndlovu, Z, Massaquoi, L, Bangwen, NE, Batumba, JN, Bora, RU, Mbuaya, J, Nzadi, R, Ntabugi, N, Kisaka, P, Manciya, G, Moudashirou, R, Pangani, H, Mangochi, P, Makoko, R, Van Laeken, D, Kwitonda, C, Ronoh, Y, Kuwenyi, K, Ortuno, R, Mangwanya, D, Zvidzai, E, Mupepe, T, Zinyowera, S, Fajarde, E & Ellman, T 2020, 'Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening', PLoS ONE, vol. 15, no. 4, e0230453. https://doi.org/10.1371/journal.pone.0230453

TY - JOUR

T1 - Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

AU - Ndlovu, Zibusiso

AU - Massaquoi, Lamin

AU - Bangwen, Ndim Eugene

AU - Batumba, John N.

AU - Bora, Rachelle U.

AU - Mbuaya, Joelle

AU - Nzadi, Roger

AU - Ntabugi, Nadine

AU - Kisaka, Patrick

AU - Manciya, Gisele

AU - Moudashirou, Ramzia

AU - Pangani, Harry

AU - Mangochi, Patrick

AU - Makoko, Roberta

AU - Van Laeken, David

AU - Kwitonda, Claude

AU - Ronoh, Yuster

AU - Kuwenyi, Kuziwa

AU - Ortuno, Reinaldo

AU - Mangwanya, Douglas

AU - Zvidzai, Edmore

AU - Mupepe, Tapiwa

AU - Zinyowera, Sekesai

AU - Fajarde, Emmanuel

AU - Ellman, Tom

N1 - FTX; DOAJ; (CC BY 4.0)

PY - 2020

Y1 - 2020

N2 - BackgroundIn sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm(3). This study evaluated the diagnostic performance of this index test.MethodsConsenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test.ResultsAmong 708 patients, 67.2% were female and median CD4 was 297cells/mm(3). The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.0% [95% CI: 91.3-97.5] and specificity was 81.9% [95% CI: 78.2-85.2%]. Using FP samples, the sensitivity of the Visitect CD4 LFA was 98.3% [95% CI: 95.0-99.6] and specificity was 77.2% [95% CI: 71.6-82.2%]. Usability of the Visitect CD4 LFA was high across the study sites with 97% successfully completed tests. Due to the required specific multiple incubation and procedural steps during the Visitect CD4 LFA testing, few health workers (7/26) were not confident to manage testing whilst multi-tasking in their clinical work.ConclusionsVisitect CD4 LFA is a promising test for decentralized CD4 screening in resource-limited settings, without access to CD4 testing and and it can trigger prompt management of patients with AHD. Lay health cadres should be considered to conduct Visitect CD4 LFA testing in PHCs as well as coordinating all other POC quality assurance.

AB - BackgroundIn sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm(3). This study evaluated the diagnostic performance of this index test.MethodsConsenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test.ResultsAmong 708 patients, 67.2% were female and median CD4 was 297cells/mm(3). The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.0% [95% CI: 91.3-97.5] and specificity was 81.9% [95% CI: 78.2-85.2%]. Using FP samples, the sensitivity of the Visitect CD4 LFA was 98.3% [95% CI: 95.0-99.6] and specificity was 77.2% [95% CI: 71.6-82.2%]. Usability of the Visitect CD4 LFA was high across the study sites with 97% successfully completed tests. Due to the required specific multiple incubation and procedural steps during the Visitect CD4 LFA testing, few health workers (7/26) were not confident to manage testing whilst multi-tasking in their clinical work.ConclusionsVisitect CD4 LFA is a promising test for decentralized CD4 screening in resource-limited settings, without access to CD4 testing and and it can trigger prompt management of patients with AHD. Lay health cadres should be considered to conduct Visitect CD4 LFA testing in PHCs as well as coordinating all other POC quality assurance.

KW - ANTIRETROVIRAL THERAPY

KW - COUNTS

U2 - 10.1371/journal.pone.0230453

DO - 10.1371/journal.pone.0230453

M3 - A1: Web of Science-article

SN - 1932-6203

VL - 15

JO - PLoS ONE

JF - PLoS ONE

IS - 4

M1 - e0230453

ER -

Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Abstract

Keywords

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