Evidence map›Paper›PMID 31714934›Full record

ArticlePloS one2019

Monitoring quality indicators for the Xpert MTB/RIF molecular assay in Ethiopia.

Abebaw Kebede, Dereje Beyene, Bazezew Yenew, Getu Diriba, Zemedu Mehamd, Ayinalem Alemu, Misikr Amare, Gobena Ameni

Abstract read
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Rifampicin-resistantJournal of clinical tuberculosis and other mycobacterial diseases · 2025
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  7. Review
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  14. Effect of sputum quality and role of XpertAfrican journal of laboratory medicine · 2022
    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

8 authors.

Abebaw KebedeEthiopian Public Health Institute, Addis Ababa, Ethiopia.ORCID 0000-0002-6154-7275
Dereje BeyeneDepartment of Microbial, Cellular and Molecular Biology, College of Natural and Computational Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Bazezew YenewEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Getu DiribaEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Zemedu MehamdEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Ayinalem AlemuEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Misikr AmareEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Gobena AmeniAklilu Lemma Institute of Pathology, Addis Ababa University, Addis Ababa, Ethiopia.

Funding

Ethiopia-Emory TB Research Training ProgramD43TW009127 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Kidist Bobosha · 2013 to 2026
$3.4M
FIC NIH HHS D43 TW009127
6 · The paper itself

Abstract

introductionIn Ethiopia, >300 GeneXpert instruments have been deployed for tuberculosis (TB) testing using the Xpert MTB/RIF cartridge. Implementing quality indicators is necessary for monitoring and evaluating the quality of Xpert MTB/RIF diagnostic services.

objectiveTo assess the use of quality indicators for the Xpert MTB/RIF molecular assay in Ethiopia and to compare the findings with the predefined targets described in the literature.

methodsClinical specimens collected from patients with suspected TB were subjected to Xpert MTB/RIF testing at the National TB Reference Laboratory (NTRL) between January and December 2018. Data were collected from GeneXpert software and Laboratory Information System (LIS) databases. Quality indicators were calculated and analyzed. Bivariate and multivariate analyses were performed using SPSS software version 20 (SPSS Inc., Chicago, Illinois, USA).

resultsOf the 2515 specimens tested, 2274 (90.4%) had successful test results; 18.2% were positive for Mycobacterium tuberculosis (MTB). Among MTB positives (n = 413), 4.8% and 1.0% were rifampicin (RIF)-resistant and RIF-indeterminate cases, respectively. Unsuccessful results were 241 (9.6%); 8.9% of the total number of tests were errors, 0.04% had invalid results and 0.6% 'no result'. The most frequent error was probe check failure (error 5007). Instrument module A4, B2, B3, C3, and D3 (p<0.05) and tester experience (p<0.05) had a statistically significant association with errors in multivariate analysis. Additional 42 MTB cases (9.2% of the total cases) were detected among unsuccessful results by follow-up tests. Sixty-four percent of the initial test results were released within the turnaround time (TAT) ≤24 hours.

conclusionMost of the quality indicators for the Xpert MTB/RIF molecular assay were maintained within the targets. However, the error rate and TAT were out of the targets. Defective modules and lacking experience were the factors affecting successful test outcomes.

Indexed as

Molecular Diagnostic TechniquesAdolescentAdultDiagnostic Tests, RoutineEthiopiaFemaleHumansMaleMiddle AgedMycobacterium tuberculosisTuberculosisYoung Adult

Identifiers

PMID31714934
PMCPMC6850546

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Registered trials

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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.