Evidence map›Paper›PMID 27388763›Full record

ArticlePloS one2016

Evaluation of the FACSPresto, a New Point of Care Device for the Enumeration of CD4% and Absolute CD4+ T Cell Counts in HIV Infection.

Azure Tariro Makadzange, Carola Bogezi, Kathryn Boyd, Anesu Gumbo, Dorinda Mukura, Allen Matubu, Chiratidzo Ellen Ndhlovu

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
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  5. Performance Evaluation of BD FACSPrestoDiagnostics (Basel, Switzerland) · 2022
    Article
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  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Azure Tariro MakadzangeRagon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, United States of America.
Carola BogeziDepartment of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Kathryn BoydDepartment of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Anesu GumboDepartment of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Dorinda MukuraDepartment of Obstetrics and Gynecology, UZ-UCSF Collaborative Project, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Allen MatubuDepartment of Obstetrics and Gynecology, UZ-UCSF Collaborative Project, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Chiratidzo Ellen NdhlovuDepartment of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
University of Zimbabwe · ZWUniversity of Zimbabwe-University of California San Francisco · ZW

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Determinants of Immune Control in HIV perinatally infected children in sub-SaharaK08AI104348 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MAKADZANGE, AZURE TARIRO · 2013 to 2016
$745k
NCATS NIH HHS UL1 TR001102NIAID NIH HHS K08 AI104348
6 · The paper itself

Abstract

introductionEnumeration of CD4+ T lymphocytes is important for pre-ART disease staging and screening for opportunistic infections, however access to CD4 testing in resource limited settings is poor. Point of care (POC) technologies can facilitate improved access to CD4 testing. We evaluated the analytical performance of a novel POC device the FACSPresto compared to the FACSCalibur as a reference standard and to the PIMA, a POC device in widespread use in sub-Saharan Africa.

methodSpecimens were obtained from 253 HIV infected adults. Venous blood samples were analyzed on the FACSPresto and the FACSCalibur, in a subset of 41 samples additional analysis was done on the PIMA.

resultsThe absolute CD4 count results obtained on the FACSPresto were comparable to those on the FACSCalibur with low absolute (9.5cells/μl) and relative bias (3.2%). Bias in CD4% values was also low (1.06%) with a relative bias of 4.9%. The sensitivity was lower at a CD4 count threshold of ≤350cells/μl compared with ≤500cells/μl (84.9% vs. 92.8%) resulting in a high upward misclassification rate at low CD4 counts. Specificity at thresholds of ≤350cells/μl and ≤500cells/μl were 96.6% and 96.8% respectively. The PIMA had a high absolute (-68.6cells/μl) and relative bias (-10.5%) when compared with the FACSCalibur. At thresholds of ≤350cells/μl and ≤500cells/μl the sensitivity was 100% and 95.5% respectively; specificity was 85.7% and 84.2% respectively. The coefficients of repeatability were 4.13%, 5.29% and 9.8% respectively. DISCUSSION: The analytic performance of the FACSPresto against the reference standard was very good with better agreement and precision than the PIMA. The FACSPresto had comparable sensitivity at a threshold of 500 cells/μl and better specificity than the PIMA. However the FACSPresto showed reduced sensitivity at low CD4 count thresholds.

conclusionThe FACSPresto can be reliably used as a POC device for enumerating absolute CD4 count and CD4% values.

Indexed as

Cell SeparationFlow CytometryPoint-of-Care SystemsCD4 Lymphocyte CountCD4-Positive T-LymphocytesHIV InfectionsHumansReproducibility of ResultsSensitivity and Specificity

Identifiers

PMID27388763
PMCPMC4936750
OpenAlexW2460768747

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.