ArticlePloS one2015
Field Evaluation of a Point-of-Care CD4 Analyzer for Monitoring HIV Patients in the Interior of the Amazon Region, Brazil.
Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis 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
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.
- Pooled it
- Qualitative assessment of South African healthcare worker perspectives on an instrument-free rapid CD4 test.BMC health services research · 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
- The feasibility of fingerstick blood collection for point-of-care HIV-1 viral load monitoring in rural Zambia.Global health innovation · 2018Article
- Advances in addressing technical challenges of point-of-care diagnostics in resource-limited settings.Expert review of molecular diagnostics · 2016Review
- Errors generated by a point-of-care CD4+ T-lymphocyte analyser: a retrospective observational study in nine countries.Bulletin of the World Health Organization · 2015Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
objectiveTo evaluate the accuracy of the PIMA point-of-care CD4 analyzer (PIMA) under field conditions in comparison to the current CD4 count system (FACSCalibur), and to evaluate the operational suitability and acceptability of health professionals (HP) and HIV-patients in using the PIMA in health clinics in the Amazon Region.
methodsCD4 counts were measured onsite by the PIMA using fingerprick blood and in the reference laboratory by both the PIMA and FACSCalibur using venous blood. We used the Bland-Altman method to estimate the mean bias, and calculated the sensitivity and specificity at <200 and <500 cell/μL thresholds. Patients (n = 404) and HP (n = 7) were interviewed on the acceptability and operational suitability of the PIMA.
resultsUsing fingerprick blood (n = 337), the PIMA showed a concordance correlation coefficient (Rc) of 0.81, mean difference of -111.9 cell/μL, 93.1%/98.5% sensitivity, and 89.2%/56.7% specificity at <200 and <500 cell/μL thresholds, respectively. Venous blood (n = 340) showed an Rc of 0.89, mean difference of -83.4 cell/μL, 98.3%/97.5% sensitivity, and 93.9%/66.0% specificity at <200 and <500 cell/μL thresholds, respectively. The capillary PIMA was well accepted and found operationally appropriate by patients and HP.
conclusionsThe agreement between both instruments was poor and the PIMA underestimated CD4 cell counts, which was more pronounced at CD4 counts ≥500 cell/μl. The PIMA's performance with fingerprick blood was less reliable than its performance with venous blood. In Brazil, where antiretroviral treatment is initiated regardless of CD4 counts, the PIMA's systematic bias towards CD4 underestimation may limit its role for monitoring HIV-patients.
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Registered trials
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