Evidence map›Paper›PMID 32173144›Full record

ArticleDiagnostic microbiology and infectious disease2020

First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis.

Pamela Nabeta, Pratibha Seshadri, Joshua Havumaki, Silindile Mbhele, Layla Hendricks, Mark D Perkins, Mark P Nicol, Claudia M Denkinger

Open access · hybridAbstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Diagnostic microbiology and infectious disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 99% 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

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

8 authors at 3 institutions in 5 countries.

Pamela NabetaFIND, Chemin des Mines 9, 1202, Geneva, Switzerland. Electronic address: Pamela.Nabeta@finddx.org.
Pratibha SeshadriDivision of Infectious Diseases, Beth Israel Deaconess Medical Center, 330 Brookline Ave, 02215, Boston, USA. Electronic address: pratibha.seshadri@gmail.com.
Joshua HavumakiFIND, Chemin des Mines 9, 1202, Geneva, Switzerland. Electronic address: joshsh@umich.edu.
Silindile MbheleDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Anzio Rd, Observatory, Cape Town, 7925, South Africa and National Health Laboratory Service, South Africa. Electronic address: slee.mbhele@gmail.com.
Layla HendricksDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Anzio Rd, Observatory, Cape Town, 7925, South Africa and National Health Laboratory Service, South Africa. Electronic address: layla.sinoda@gmail.com.
Mark D PerkinsFIND, Chemin des Mines 9, 1202, Geneva, Switzerland. Electronic address: markdanielperkins@gmail.com.
Mark P NicolDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Anzio Rd, Observatory, Cape Town, 7925, South Africa and National Health Laboratory Service, South Africa; School of Biomedical Sciences, University of Western Australia, Hackett Drive, Crawley, Perth, Australia 6009. Electronic address: Mark.Nicol@uct.ac.za.
Claudia M DenkingerFIND, Chemin des Mines 9, 1202, Geneva, Switzerland; Division of Tropical Medicine, Center of Infectious Diseases, University Hospital of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. Electronic address: Claudia.Denkinger@uni-heidelberg.de.
FIND · CHNational Health Laboratory Service · ZABeth Israel Deaconess Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective was to evaluate the sensitivity and specificity of a novel prototype test, TB REaD™, a reporter enzyme fluorescence-based assay, for pulmonary tuberculosis and to determine the optimal threshold for test positivity. This blinded, prospective study enrolled 250 patients, of which 23.2% were Mycobacterium tuberculosis complex (MTB) culture-positive. At the manufacturer-set threshold, sensitivity of the assay was 93.1% (95% confidence interval [CI] 83.3-98.1) and specificity was 8.9% (95% CI 5.2-13.8). The highest accuracy was seen at a higher threshold: sensitivity 58.6% (95% CI 44.9-71.4), specificity 59.4% (95% CI 52.1%-66.4%), with sensitivity by smear status being 40.0% (95% CI 21.1-61.3) for smear-negative and 72.7% (95% CI 54.5-86.7) for smear-positive. This study demonstrated limited accuracy of the TB REaD™ prototype for detection of pulmonary TB. Further improvements are necessary, potentially exploring probes that are more specific to MTB.

Indexed as

Adultbeta-LactamasesBiomarkersClinical Enzyme TestsFemaleFluorescenceHumansMaleMiddle AgedMycobacterium tuberculosisPoint-of-Care SystemsProspective StudiesReagent Kits, DiagnosticSensitivity and SpecificitySputumTuberculosis, Pulmonarybeta-LactamasesBiomarkersReagent Kits, DiagnosticDiagnosisTB REaD™Tuberculosisβ-Lactamase

Identifiers

PMID32173144
PMCPMC7262578
OpenAlexW3008221405

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.