SynthesisBMC medicine2015
A meta-analysis of the performance of the Pima™ CD4 for point of care testing.
Synthesis in BMC medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
28 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pooled it
- Feasibility of antiretroviral treatment monitoring in the era of decentralized HIV care: a systematic review.AIDS research and therapy · 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
- Point-of-care CD4 testing: Differentiated care for the most vulnerable.Journal of global health · 2022Trial
- Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.PLoS medicine · 2016Trial
- Task shifting of point-of-care testing to lay health workers in rural primary health facilities in Nsanje, Malawi.Global health action · 2026Article
- Evaluation of point-of-care Alere Pima CD4 test for low CD4 cell counts test in Uganda.Scientific reports · 2025Article
- Impact of Hepatitis B Virus Point-of-care DNA Viral Load Testing Compared With Laboratory-based Standard-of-care Approaches on Uptake of HBV Viral Load Testing, Treatment, and Turnaround Times: A Systematic Review and Meta-analysis.Open forum infectious diseases · 2024Article
- Point of Care CD4 Testing in National Household Surveys - Results and Quality Indicators from Eleven Population-Based HIV Impact Assessment (PHIA) Surveys.Microbiology spectrum · 2023Article
- Scaling up delivery of HIV services in Africa through harnessing trends across global emerging innovations.Frontiers in health services · 2023Review
- Performance Evaluation of BD FACSPrestoDiagnostics (Basel, Switzerland) · 2022Article
- Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.Clinical microbiology reviews · 2019Review
- Field Performance of PIMA Point-of-Care Machine for CD4 Enumeration Under a Mobile HIV Counseling and Testing Program in Remote Fishing Communities of Lake Victoria, Uganda.AIDS research and human retroviruses · 2019Article
- Field Performance and Diagnostic Accuracy of a Low-Cost Instrument-Free Point-of-Care CD4 Test (Visitect CD4) Performed by Different Health Worker Cadres among Pregnant Women.Journal of clinical microbiology · 2019Article
- Onsite healthcare worker acceptability and performance of the point-of-care Pima CD4 assay in Dar es Salaam, Tanzania.African journal of laboratory medicine · 2019Article
- Rapid antiretroviral therapy initiation in low- and middle-income countries: A resource-based approach.PLoS medicine · 2019Article
- How to implement new diagnostic products in low-resource settings: an end-to-end framework.BMJ global health · 2018Article
- The value of point-of-care CD4+ and laboratory viral load in tailoring antiretroviral therapy monitoring strategies to resource limitations.AIDS (London, England) · 2017Article
- Laboratory-based performance evaluation of PIMA CD4+ T-lymphocyte count point-of-care by lay-counselors in Kenya.Journal of immunological methods · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundThe Alere point-of-care (POC) Pima™ CD4 analyzer allows for decentralized testing and expansion to testing antiretroviral therapy (ART) eligibility. A consortium conducted a pooled multi-data technical performance analysis of the Pima CD4.
methodsPrimary data (11,803 paired observations) comprised 22 independent studies between 2009-2012 from the Caribbean, Asia, Sub-Saharan Africa, USA and Europe, using 6 laboratory-based reference technologies. Data were analyzed as categorical (including binary) and numerical (absolute) observations using a bivariate and/or univariate random effects model when appropriate.
resultsAt a median reference CD4 of 383 cells/μl the mean Pima CD4 bias is -23 cells/μl (average bias across all CD4 ranges is 10 % for venous and 15% for capillary testing). Sensitivity of the Pima CD4 is 93% (95% confidence interval [CI] 91.4% - 94.9%) at 350 cells/μl and 96% (CI 95.2% - 96.9%) at 500 cells/μl, with no significant difference between venous and capillary testing. Sensitivity reduced to 86% (CI 82% - 89%) at 100 cells/μl (for Cryptococcal antigen (CrAg) screening), with a significant difference between venous (88%, CI: 85% - 91%) and capillary (79%, CI: 73% - 84%) testing. Total CD4 misclassification is 2.3% cases at 100 cells/μl, 11.0% at 350 cells/μl and 9.5 % at 500 cells/μl, due to higher false positive rates which resulted in more patients identified for treatment. This increased by 1.2%, 2.8% and 1.8%, respectively, for capillary testing. There was no difference in Pima CD4 misclassification between the meta-analysis data and a population subset of HIV+ ART naïve individuals, nor in misclassification among operator cadres. The Pima CD4 was most similar to Beckman Coulter PanLeucogated CD4, Becton Dickinson FACSCalibur and FACSCount, and less similar to Partec CyFlow reference technologies.
conclusionsThe Pima CD4 may be recommended using venous-derived specimens for screening (100 cells/μl) for reflex CrAg screening and for HIV ART eligibility at 350 cells/μl and 500 cells/μl thresholds using both capillary and venous derived specimens. These meta-analysis findings add to the knowledge of acceptance criteria of the Pima CD4 and future POC tests, but implementation and impact will require full costing analysis.
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Registered trials
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.