Evidence map›Paper›PMID 24586360›Full record

ArticlePloS one2014

A multi-site validation in India of the line probe assay for the rapid diagnosis of multi-drug resistant tuberculosis directly from sputum specimens.

Neeraj Raizada, K S Sachdeva, D S Chauhan, Bharti Malhotra, Kishore Reddy, P V Dave, Yamuna Mundade, Pranav Patel, Ranjani Ramachandran, Ram Das and 6 more

Open access · goldAbstract readValidation Study
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
4.7field-weighted citation impact, top 5% 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

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Time to treatment for rifampicin-resistant tuberculosis: systematic review and meta-analysis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2017
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Molecular Diagnosis of Tuberculosis.Chonnam medical journal · 2018
    Review
  12. Article
  13. Article
  14. Phenotypic and Genotypic Analysis of Multidrug-ResistantTuberculosis research and treatment · 2017
    Article
  15. Line probe assay for detection ofThe Indian journal of medical research · 2017
    Article
  16. Article
  17. Redefining MTBDRplus test results: what do indeterminate results actually mean?The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2016
    Article
  18. Article
  19. 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

16 authors at 8 institutions in 2 countries.

Neeraj RaizadaFoundation for Innovative New Diagnostics, New Delhi, India.
K S SachdevaCentral TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi, India.
D S ChauhanNational JALMA Institute for Leprosy and Other Mycobacterial Diseases, Agra, India.
Bharti MalhotraSawai Man Singh Medical College, Jaipur, India.
Kishore ReddyFoundation for Innovative New Diagnostics, New Delhi, India.
P V DaveState TB Cell, Directorate of Health Services, Gujarat, India.
Yamuna MundadeUNITAID, Geneva, Switzerland.
Pranav PatelState TB Cell, Directorate of Health Services, Gujarat, India.
Ranjani RamachandranWorld Health Organization, New Delhi, India.
Ram DasNational JALMA Institute for Leprosy and Other Mycobacterial Diseases, Agra, India.
Rajesh SolankiState TB Cell, Directorate of Health Services, Gujarat, India.
Douglas Fraser WaresGlobal TB Programme, World Health Organization, Geneva, Switzerland.
Suvanand SahuStop TB Partnership, Geneva, Switzerland.
Rick O'BrienFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
C N ParamasivanFoundation for Innovative New Diagnostics, New Delhi, India.
Puneet K DewanWorld Health Organization, New Delhi, India.
Government of Gujarat · INNational JALMA Institute for Leprosy & Other Mycobacterial Diseases · INWorld Health Organization - India · INFoundation for Innovative New Diagnostics · CHGovernment of India · INSawai ManSingh Medical College and Hospital · INUnitaid · CHWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

unlabelledRifampicin (R) and isoniazid (H) are key first-line anti-tuberculosis drugs. Failure to detect resistance to these two drugs early results in treatment failure and poor clinical outcomes. The study purpose was to validate the use of the GenoType MTBDRplus line probe assay (LPA) to detect resistance to R and H in Mycobacterium tuberculosis strains directly from smear-positive sputum samples in India.

methodSmear positive sputum specimens from 320 patients were subjected to LPA and results compared against those from conventional Lowenstein Jensen (LJ) culture and drug susceptibility testing (C&DST). All specimens with discordant R DST results were subjected to either sequencing of the rpoB gene and/or repeat DST on liquid culture (MGIT 960) at a National Reference Laboratory.

resultsSignificantly higher proportion of interpretable results were observed with LPA compared to LJ C&DST (94% vs. 80%, p-value <0.01). A total of 248 patients had both LJ and LPA DST results available; 232 (93.5%) had concordant R DST results. Among the 16 discordant R DST results, 13 (81%) were resolved in agreement with LPA results. Final LPA performance characteristics were sensitivity 96% (CI: 90%-98%), specificity 99% (CI: 95%-99%), positive predictive value 99% (CI: 95%-99%), and negative predictive value 95% (CI: 89%-98%). The median turnaround testing time, including specimen transportation time, on LPA was 11 days as compared with 89 days for LJ C&DST.

conclusionsLPA proved highly accurate in the rapid detection of R resistance. The reduction in time to diagnosis may potentially enable earlier commencement of the appropriate drug therapy, leading to some reduction of transmission of drug-resistant strains.

Indexed as

AdultFemaleHumansIndiaIsoniazidMaleMicrobial Sensitivity TestsMolecular Diagnostic TechniquesMutationMycobacterium tuberculosisRifampinSputumTuberculosis, Multidrug-ResistantIsoniazidRifampin

Identifiers

PMID24586360
PMCPMC3929364
OpenAlexW1971853437

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.