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Performance of the PointCare NOW system for CD4 counting in HIV patients based on five independent evaluations

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Show simple item record Bergeron, M. Daneau, G. Ding, T. Sitoe, N. E. Westerman, L. E. Stokx, J. Jani, I. V. Coetzee, L. M. Scott, L. De Weggheleire, A. Boel, L. Stevens, W. S. Glencross, D. K. Peter, T. F. 2012-12-14T14:59:40Z 2012-12-14T14:59:40Z 2012
dc.identifier.issn 1932-6203
dc.identifier.other ITG-B2B
dc.identifier.other ITG-C6B
dc.identifier.other ITG-C10B
dc.identifier.other ITG-B11B
dc.identifier.other MULTI
dc.identifier.other DBM
dc.identifier.other U-IMMUN
dc.identifier.other DCS
dc.identifier.other U-TLM
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other FTA
dc.identifier.other E-only
dc.identifier.other Abstract
dc.identifier.other UPD53
dc.description.abstract 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 </= 350 cells/microl (+51.3%) than in the CD4 >350 cells/microl 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 350 cells/microl, 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 200 cells/microl 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. en
dc.language English en
dc.subject Viral diseases en
dc.subject HIV en
dc.subject AIDS en
dc.subject Eligibility en
dc.subject Assessment en
dc.subject Performance en
dc.subject Evaluation en
dc.subject Test kits en
dc.subject CD4 lymphocyte count en
dc.subject Flow cytometry en
dc.subject Bias en
dc.subject Classification en
dc.subject Repeatability en
dc.subject Adults en
dc.subject Children en
dc.subject Laboratory techniques and procedures en
dc.title Performance of the PointCare NOW system for CD4 counting in HIV patients based on five independent evaluations en
dc.type Article-E en
dc.citation.issue 8 en
dc.citation.jtitle PLoS ONE en
dc.citation.volume 7 en
dc.citation.pages e41166 en
dc.citation.jabbreviation PLoS ONE en

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