Evidence map›Paper›PMID 33076996›Full record

ArticleAIDS research and therapy2020

Accuracy of the tuberculosis point-of-care Alere determine lipoarabinomannan antigen diagnostic test using α-mannosidase treated and untreated urine in a cohort of people living with HIV in Guatemala.

Juan Ignacio García, Johanna Meléndez, Rosa Álvarez, Carlos Mejía-Chew, Holden V Kelley, Sabeen Sidiki, Alejandra Castillo, Claudia Mazariegos, Cesar López-Téllez, Diana Forno and 6 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in AIDS research and therapy, 2020. 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 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 44% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 4 countries.

Juan Ignacio García *Fundació Sida i Societat, Technical Advisor Unit (UAT), Escuintla National Hospital, Escuintla, 5001, Guatemala. juangarcia@txbiomed.org.ORCID http://orcid.org/0000-0001-8263-3140
Johanna Meléndez *Unidad de Atención Integral del VIH e Infecciones Crónicas del Hospital Roosevelt "Dr. Carlos Rodolfo Mejía Villatoro", Guatemala City, Guatemala.
Rosa Álvarez *Sección de Microbiología, Departamento de Laboratorios Clínicos, Hospital Roosevelt, Guatemala City, Guatemala.
Carlos Mejía-ChewDivision of Infectious Diseases, Department of Medicine, Washington University School of Medicine, St. Louis, MO, 63110, USA.
Holden V KelleyPopulation Health Program, Tuberculosis Group, Texas Biomedical Research Institute, San Antonio, TX, 78227, USA.
Sabeen SidikiPopulation Health Program, Tuberculosis Group, Texas Biomedical Research Institute, San Antonio, TX, 78227, USA.
Alejandra CastilloClinica de Atención Integral Dr. Isaac Cohen Alcahé, Hospital de Especialidad Dr. Robles, Quetzaltenango, Guatemala.
Claudia MazariegosClinica de Atención Integral Dr. Isaac Cohen Alcahé, Hospital de Especialidad Dr. Robles, Quetzaltenango, Guatemala.
Cesar López-TéllezClinica de Atención Integral Dr. Isaac Cohen Alcahé, Hospital de Especialidad Dr. Robles, Quetzaltenango, Guatemala.
Diana FornoDivision of Global HIV/AIDS, Centers for Disease Control and Prevention, Central America Regional Office, Guatemala City, Guatemala.
Nancy AyalaNational Reference Laboratory, Amatitlan, Guatemala.
Joan-Miquel Balada-LlasatDepartment of Pathology, The Ohio State University, Wexner Medical Center, Columbus, OH, USA.
Carlos Rodolfo Mejía-VillatoroUnidad de Atención Integral del VIH e Infecciones Crónicas del Hospital Roosevelt "Dr. Carlos Rodolfo Mejía Villatoro", Guatemala City, Guatemala.
Shu-Hua WangInternal Medicine Department, Infectious Disease Division College of Medicine (COM), The Ohio State University (OSU), Columbus, OH, 43210, USA.
Jordi B TorrellesPopulation Health Program, Tuberculosis Group, Texas Biomedical Research Institute, San Antonio, TX, 78227, USA. JTorrelles@txbiomed.org.
Janet IkedaClinica de Atención Integral Dr. Isaac Cohen Alcahé, Hospital de Especialidad Dr. Robles, Quetzaltenango, Guatemala. janet.m.ikeda@gmail.com.
Texas Biomedical Research Institute · USRoosevelt Hospital · GTCentro Universitario de Occidente · GTNational Institute for Seismology, Vulcanology, Meteorology and Hydrology · GTThe Ohio State University · USThe Ohio State University Wexner Medical Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImproved point-of-care diagnostic tests for tuberculosis (TB) in severe immune suppressed people living with HIV (PLWH) are needed to decrease morbidity and mortality outcomes. The aim of the study is to evaluate the performance of the lipoarabinomannan antigen test (LAM-test) with and without α-mannosidase pre-treated urine in a cohort of PLWH in primary care clinics in Guatemala. We further determined TB incidence, and mortality rates and its risk factors in PLWH with TB symptoms.

methodsProspective longitudinal study of PLWH with TB symptoms. Urine samples were collected at 2 HIV sites to test the sensitivity of the LAM-test in urine with and without α-mannosidase pre-treatment. A composite reference standard of either a positive Mycobacterium tuberculosis complex culture and/or GeneXpert

resultsThe overall sensitivity of the LAM-test was of 56.1% with 95% CI of (43.3-68.3). There were no differences in the LAM-test sensitivity neither by hospital nor by CD4 T cell values. LAM-test sensitivity in PLWH with < 200 CD4 T cells/µl was of 62.2% (95% CI 46.5-76.2). There were no significant differences in sensitivity when comparing LAM-test results obtained from untreated vs. α-mannosidase treated urine [55.2% (95% CI 42.6-67.4) vs. 56.9% (95% CI 44-69.2), respectively]. TB incidence in our cohort was of 21.4/100 person years (PYs) (95% CI 16.6-27.6), and mortality rate was of 11.1/100 PYs (95% CI 8.2-15.0). Importantly, PLWH with a positive LAM-test result had an adjusted hazard ratio (aHR) of death of 1.98 (1.0-3.8) with a significant p value of 0.044 when compared to PLWH with a negative LAM-test result.

conclusionsIn this study, α-mannosidase treatment of urine did not significantly increase the LAM-test performance, however; this needs to be further evaluated in a large-scale study due to our study limitations. Importantly, high rates of TB incidence and mortality were found, and a positive LAM-test result predicted mortality in PLWH with TB clinical symptoms.

Indexed as

HIV InfectionsTuberculosisDiagnostic Tests, RoutineGuatemalaHumansLipopolysaccharidesLongitudinal StudiesPoint-of-Care SystemsProspective StudiesSensitivity and SpecificitylipoarabinomannanLipopolysaccharidesHIVLipoarabinomannan antigenMycobacterium tuberculosisPoint-of-care diagnosisTuberculosisUrine

Identifiers

PMID33076996
PMCPMC7570414
OpenAlexW3093032080

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.