ArticlePloS one2012
Performance of the PointCare NOW system for CD4 counting in HIV patients based on five independent evaluations.
Article in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Performance of point-of-care CD4 testing technologies in resource-constrained settings: a systematic review and meta-analysis.BMC infectious diseases · 2016Pooled it
- CD4 enumeration technologies: a systematic review of test performance for determining eligibility for antiretroviral therapy.PloS one · 2015Pooled it
- Electrochemical microfluidic biosensor for the detection of CD4Microsystems & nanoengineering · 2025Article
- Microfluidic Assays for CD4 T Lymphocyte Counting: A Review.Biosensors · 2025Review
- Assessment of two POC technologies for CD4 count in Morocco.AIDS research and therapy · 2020Article
- Diagnosis of Human Immunodeficiency Virus Infection.Clinical microbiology reviews · 2019Review
- Point of Care Diagnostics for HIV in Resource Limited Settings: An Overview.Medicina (Kaunas, Lithuania) · 2018Review
- Evaluation of the FACSPresto, a New Point of Care Device for the Enumeration of CD4% and Absolute CD4+ T Cell Counts in HIV Infection.PloS one · 2016Article
- Article
- South Africa's experience with provision of quality HIV diagnostic services.African journal of laboratory medicine · 2016Article
- Laboratory and field evaluation of the Partec CyFlow miniPOC for absolute and relative CD4 T-cell enumeration.PloS one · 2015Article
- Developments in CD4 and viral load monitoring in resource-limited settings.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014Review
- Development, validation and clinical evaluation of a low cost in-house HIV-1 drug resistance genotyping assay for Indian patients.PloS one · 2014Article
- Compatibility of stabilized whole blood products with CD4 technologies and their suitability for quality assessment programs.PloS one · 2014Article
- Field evaluation of a broadly sensitive HIV-1 in-house genotyping assay for use with both plasma and dried blood spot specimens in a resource-limited country.Journal of clinical microbiology · 2013Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPoint-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/
methodsEvaluations 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.
resultsPointCare 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/µl (+51.3%) than in the CD4 >350 cells/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 350 cells/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 200 cells/µl threshold. Agreement with infant samples was higher, with 90% qualifying at a 25% eligibility threshold.
conclusionThe 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.