Evidence map›Paper›PMID 27654338›Full record

ArticleJournal of clinical microbiology2016

A Multilaboratory, Multicountry Study To Determine MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing of Selected First-Line Antituberculosis Drugs, Second-Line Injectables, Fluoroquinolones, Clofazimine, and Linezolid.

Koné Kaniga, Daniela M Cirillo, Sven Hoffner, Nazir A Ismail, Devinder Kaur, Nacer Lounis, Beverly Metchock, Gaby E Pfyffer, Amour Venter

Open access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical microbiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 4% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Non-commercial phenotypic assays for the detection of Mycobacterium tuberculosis drug resistance: a systematic review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Pooled it
  3. Article
  4. Article
  5. Rifampicin has no role in treatment ofThe European respiratory journal · 2024
    Article
  6. Article
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  12. Activity of Pyrazinamide againstAntibiotics (Basel, Switzerland) · 2021
    Article
  13. Article
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  16. Article
  17. Article
  18. 1,4-Benzoquinone antimicrobial agents againstProceedings of the National Academy of Sciences of the United States of America · 2019
    Article
  19. Standards for MIC testing that apply to the majority of bacterial pathogens should also be enforced for Mycobacterium tuberculosis complex.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2019
    Article
  20. Article
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

9 authors at 9 institutions in 6 countries.

Koné KanigaJanssen Research & Development, LLC, Titusville, New Jersey, USA kkaniga@its.jnj.com.
Daniela M CirilloIRCCS, San Raffaele Scientific Institute, Milan, Italy.
Sven HoffnerTB Supranational Reference Laboratory, The Public Health Agency of Sweden, Solna, Sweden.
Nazir A IsmailNational TB Reference Laboratory, Center for Tuberculosis, National Institute of Communicable Diseases, Johannesburg, South Africa.
Devinder KaurUniversity of Massachusetts Medical School, Massachusetts Supranational TB Reference Laboratory, Boston, Massachusetts, USA.
Nacer LounisJanssen Pharmaceutica NV, Beerse, Belgium.
Beverly MetchockReference Laboratory, Division of TB Elimination, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Gaby E PfyfferDepartment of Medical Microbiology, Center of Laboratory Medicine, Luzerner Kantonsspital LUKS, Luzern, Switzerland.
Amour VenterTASK Applied Science, SA MRC Centre for TB Research, DST/NRF Center of Excellence for Biomedical TB Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
Centers for Disease Control and Prevention · USJanssen (Belgium) · BEJanssen (United States) · USLuzerner Kantonsspital · CHNational Health Laboratory Service · ZAPublic Health Agency of Sweden · SETask Applied Science · ZAUniversity of Massachusetts Chan Medical School · USVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our objective was to establish reference MIC quality control (QC) ranges for drug susceptibility testing of antimycobacterials, including first-line agents, second-line injectables, fluoroquinolones, and World Health Organization category 5 drugs for multidrug-resistant tuberculosis using a 7H9 broth microdilution MIC method. A tier-2 reproducibility study was conducted in eight participating laboratories using Clinical Laboratory and Standards Institute (CLSI) guidelines. Three lots of custom-made frozen 96-well polystyrene microtiter plates were used and prepared with 2× prediluted drugs in 7H9 broth-oleic acid albumin dextrose catalase. The QC reference strain was Mycobacterium tuberculosis H37Rv. MIC frequency, mode, and geometric mean were calculated for each drug. QC ranges were derived based on predefined, strict CLSI criteria. Any data lying outside CLSI criteria resulted in exclusion of the entire laboratory data set. Data from one laboratory were excluded due to higher MIC values than other laboratories. QC ranges were established for 11 drugs: isoniazid (0.03 to 0.12 μg/ml), rifampin (0.03 to 0.25 μg/ml), ethambutol (0.25 to 2 μg/ml), levofloxacin (0.12 to 1 μg/ml), moxifloxacin (0.06 to 0.5 μg/ml), ofloxacin (0.25 to 2 μg/ml), amikacin (0.25 to 2 μg/ml), kanamycin (0.25 to 2 μg/ml), capreomycin (0.5 to 4 μg/ml), linezolid (0.25 to 2 μg/ml), and clofazimine (0.03 to 0.25 μg/ml). QC ranges could not be established for nicotinamide (pyrazinamide surrogate), prothionamide, or ethionamide, which were assay nonperformers. Using strict CLSI criteria, QC ranges against the M. tuberculosis H37Rv reference strain were established for the majority of commonly used antituberculosis drugs, with a convenient 7H9 broth microdilution MIC method suitable for use in resource-limited settings.

Indexed as

Antitubercular AgentsClofazimineFluoroquinolonesHumansLinezolidMicrobial Sensitivity TestsMycobacterium tuberculosisQuality ControlTuberculosis, Multidrug-ResistantAntitubercular AgentsClofazimineFluoroquinolonesLinezolid

Identifiers

PMID27654338
PMCPMC5121386
OpenAlexW2556390964

What OpenQuestion holds

Textmetadata
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.