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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Performance of the pointcare NOW system for CD4 counting in HIV patients based on five independent evaluations
PLoS ONE, Volume 7, No. 8, Article e41166, Year 2012
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Description
Introduction: Point-of-care (POC) CD4 testing can improve access to treatment by enabling decentralization and reducing patient loss-to-follow-up. As new POC CD4 technologies become available, their performance should be assessed before widespread deployment. This study reports the findings of five independent evaluations of the PointCare NOW CD4 system. Materials/Methods: Evaluations were conducted in Southern Africa (Mozambique, South Africa) and North America (Canada, USA). 492 blood samples (55 from HIV-negative blood donors and 437 from HIV-infected patients, including 20 children aged between 12 and 59 months) were tested with both the PointCare NOW and reference flow cytometry instruments. Assessment of bias, precision and levels of clinical misclassification for absolute and percent CD4 count was conducted. Results: PointCare NOW significantly overestimated CD4 absolute counts with a mean relative bias of +35.0%. Bias was greater in samples with CD4 counts below ≤350cells/μl (+51.3%) than in the CD4 >350cells/μl stratum (15.1%). Bias in CD4% had a similar trend with an overall relative mean bias of +25.6% and a larger bias for low CD4 stratum (+40.2%) than the higher CD4 stratum (+5.8%). Relative bias for CD4% in children was -6.8%. In terms of repeatability, PointCare NOW had a coefficient of variation of 11%. Using a threshold of 350cells/μl, only 47% of patients who qualified for antiretroviral therapy with reference CD4 testing, would have been eligible for treatment with PointCare NOW test results. This was 39% using a 200cells/μl threshold. Agreement with infant samples was higher, with 90% qualifying at a 25% eligibility threshold. Conclusion: The performance of the PointCare NOW instrument for absolute and percent CD4 enumeration was inadequate for HIV clinical management in adults. In children, the small sample size was not large enough to draw a conclusion. This study also highlights the importance of independent evaluation of new diagnostic technology platforms before deployment. © 2012 Passmore et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3415398/bin/pone.0041166.s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3415398/bin/pone.0041166.s002.xls
https://efashare.b-cdn.net/share/pmc/articles/PMC3415398/bin/pone.0041166.s003.xls
Authors & Co-Authors
Bergeron, Michèle
Canada, Ottawa
Public Health Agency of Canada
Daneau, Géraldine
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Ding, Tao
Canada, Ottawa
Public Health Agency of Canada
Sitoe, Nádia E.
Mozambique, Maputo
Instituto Nacional da Saúde
Westerman, Larry E.
United States, Atlanta
National Center for Hiv, Viral Hepatitis, Std, and tb Prevention
Stokx, Jocelijn
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Jani, Ilesh Vinodrai
Mozambique, Maputo
Instituto Nacional da Saúde
Coetzee, Lindi Marie
South Africa, Johannesburg
School of Pathology
Scott, Lesley Erica
South Africa, Johannesburg
School of Pathology
De Weggheleire, Anja
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Boel, Luc
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Stevens, Wendy Susan
South Africa, Johannesburg
School of Pathology
Glencross, Deborah Kim
South Africa, Johannesburg
School of Pathology
Peter, Trevor F.
United States, Boston
Clinton Health Access Initiative, Inc.
Statistics
Citations: 25
Authors: 14
Affiliations: 6
Identifiers
Doi:
10.1371/journal.pone.0041166
e-ISSN:
19326203
Research Areas
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study
Study Locations
Mozambique
South Africa