Observational studyBulletin of the World Health Organization2015
Errors generated by a point-of-care CD4+ T-lymphocyte analyser: a retrospective observational study in nine countries.
Observational study in Bulletin of the World Health Organization, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 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
16 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pooled it
- Impact of SMS/GPRS Printers in Reducing Time to Early Infant Diagnosis Compared With Routine Result Reporting: A Systematic Review and Meta-Analysis.Journal of acquired immune deficiency syndromes (1999) · 2017Pooled it
- Performance of point-of-care CD4 testing technologies in resource-constrained settings: a systematic review and meta-analysis.BMC infectious diseases · 2016Pooled it
- Acceptability and feasibility of point-of-care CD4 testing on HIV continuum of care in low and middle income countries: a systematic review.BMC health services research · 2016Pooled it
- Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT®CD4) for use in resource-limited settings.The Journal of international medical research · 2020Article
- Assessment of two POC technologies for CD4 count in Morocco.AIDS research and therapy · 2020Article
- Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening.PloS one · 2020Article
- A flow-through cell counting assay for point-of-care enumeration of CD4 T-cells.Journal of virological methods · 2019Article
- Toward Improving Accessibility of Point-of-Care Diagnostic Services for Maternal and Child Health in Low- and Middle-Income Countries.Point of care · 2019Article
- Qualitative assessment of South African healthcare worker perspectives on an instrument-free rapid CD4 test.BMC health services research · 2019Article
- Point-of-care CD4 technology invalid result rates in public health care settings across five countries.PloS one · 2019Observational
- CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPrestoThe open AIDS journal · 2017Article
- 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
- Experience from a pilot point-of-care CD4 enumeration programme in Kenya.African journal of laboratory medicine · 2016Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo estimate the proportion of invalid results generated by a CD4+ T-lymphocyte analyser used by Médecins Sans Frontières (MSF) in field projects and identify factors associated with invalid results.
methodsWe collated 25,616 CD4+ T-lymphocyte test results from 39 sites in nine countries for the years 2011 to 2013. Information about the setting, user, training, sampling technique and device repair history were obtained by questionnaire. The analyser performs a series of checks to ensure that all steps of the analysis are completed successfully; if not, an invalid result is reported. We calculated the proportion of invalid results by device and by operator. Regression analyses were used to investigate factors associated with invalid results.
findingsThere were 3354 invalid test results (13.1%) across 39 sites, for 58 Alere PimaTM devices and 180 operators. The median proportion of errors per device and operator was 12.7% (interquartile range, IQR: 10.3-19.9) and 12.1% (IQR: 7.1-19.2), respectively. The proportion of invalid results varied widely by country, setting, user and device. Errors were not associated with settings, user experience or the number of users per device. Tests performed on capillary blood samples were significantly less likely to generate errors compared to venous whole blood.
conclusionThe Alere Pima CD4+ analyser generated a high proportion of invalid test results, across different countries, settings and users. Most error codes could be attributed to the operator, but the exact causes proved difficult to identify. Invalid results need to be factored into the implementation and operational costs of routine CD4+ T-lymphocyte testing.
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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.