Promise versus reality: Optimism bias in package inserts for tuberculosis diagnostics

Journal of Clinical Microbiology

Volumn 50, Issue 7, 2012, Pages 2455-2461

  Denkinger, Claudia M ^a   Grenier, Jasmine ^b   Minion, Jessica ^c   Pai, Madhukar ^d,e  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^b MCGILL UNIVERSITY   (Canada)

^c UNIVERSITY OF ALBERTA   (Canada)

^d MCGILL UNIVERSITY   (Canada)

^e MCGILL UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BACTERIUM CULTURE; DIAGNOSTIC ACCURACY; DIAGNOSTIC KIT; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERFERON GAMMA RELEASE ASSAY; INTERMETHOD COMPARISON; PACKAGING; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; SEROLOGY; SYSTEMATIC REVIEW; TUBERCULIN TEST; TUBERCULOSIS; VALIDITY; WORLD HEALTH ORGANIZATION;

BACTERIOLOGICAL TECHNIQUES; BIAS (EPIDEMIOLOGY); HUMANS; PRODUCT LABELING; TUBERCULOSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

EID: 84862739597     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.00842-12     Document Type: Article

References (34)

1. Bekelman JE, Li Y, Gross CP. 2003. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 289:454-465.
2. Bwanga F, Hoffner S, Haile M, Joloba ML. 2009. Direct susceptibility testing for multi drug resistant tuberculosis: a meta-analysis. BMC Infect. Dis. 9:67.
3. Cattamanchi A, et al. 2011. Interferon-gamma release assays for the diagnosis of latent tuberculosis infection in HIV-infected individuals: a systematic review and meta-analysis. J. Acquir. Immune Defic. Syndr. 56:230-238.
4. Centers for Disease Control and Prevention (CDC). 2009. Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. MMWR Morb. Mortal. Wkly. Rep. 58:7-10.
5. Chang K, et al. 27 February 2012. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. J. Infect. 64:580-588.
6. Chang KC, Leung CC. 2010. Systematic review of interferon-gamma release assays in tuberculosis: focus on likelihood ratios. Thorax 65:271-276.
7. Cobelens F, et al. 2012. On behalf of the Evidence for Scale-up Group. Which new diagnostics for tuberculosis, and when? J. Infect. Dis. 205(Suppl 2): S191-S198.
8. Dheda K, van Zyl Smit R, Badri M, Pai M. 2009. T-cell interferongamma release assays for the rapid immunodiagnosis of tuberculosis: clinical utility in high-burden vs. low-burden settings. Curr. Opin. Pulm. Med. 15:188-200.
9. Diel R, Loddenkemper R, Nienhaus A. 2010. Evidence-based comparison of commercial interferon-gamma release assays for detecting active TB: a meta-analysis. Chest 137:952-968.
10. Dinnes J, et al. 2007. A systematic review of rapid diagnostic tests for the detection of tuberculosis infection. Health Technol. Assess. 11:1-196.
11. Flores LL, et al. 2011. Systematic review and meta-analysis of antigen detection tests for the diagnosis of tuberculosis. Clin. Vaccine Immunol. 18:1616-1627.
12. Greco S, Girardi E, Navarra A, Saltini C. 2006. Current evidence on diagnostic accuracy of commercially based nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis. Thorax 61:783-790.
13. Grenier J, et al. 2012. Widespread use of serological tests for tuberculosis: data from 22 high-burden countries. Eur. Respir. J. 39:502-505.
14. Kalantri S, Pai M, Pascopella L, Riley L, Reingold A. 2005. Bacteriophage-based tests for the detection of Mycobacterium tuberculosis in clinical specimens: a systematic review and meta-analysis. BMC Infect. Dis. 5:59.
15. Leung E, Minion J, Benedetti A, Pai M, Menzies D. 2011. Microcolony culture techniques for tuberculosis diagnosis: a systematic review. Int. J. Tuberc. Lung Dis. 16:16-23.
16. Ling DI, Flores LL, Riley LW, Pai M. 2008. Commercial nucleic-acid amplification tests for diagnosis of pulmonary tuberculosis in respiratory specimens: meta-analysis and meta-regression. PLoS One 3:e1536. doi:10.1371/journal.pone.0001536.
17. Ling DI, Zwerling AA, Pai M. 2008. GenoType MTBDR assays for the diagnosis of multidrug-resistant tuberculosis: a meta-analysis. Eur. Respir. J. 32:1165-1174.
18. Mann G, et al. 2010. Beyond accuracy: creating a comprehensive evidence base for TB diagnostic tools. Int. J. Tuberc. Lung Dis. 14:1518-1524.
19. Metcalfe JZ, et al. 2011. Interferon-{gamma} release assays for active pulmonary tuberculosis diagnosis in adults in low- and middle-income countries: systematic review and meta-analysis. J. Infect. Dis. 204(Suppl 4):S1120-S1129.
20. Minion J, Leung E, Menzies D, Pai M. 2010. Microscopic-observation drug susceptibility and thin layer agar assays for the detection of drug resistant tuberculosis: a systematic review and meta-analysis. Lancet Infect. Dis. 10:688-698.
21. Minion J, et al. 2011. Diagnosing tuberculosis with urine lipoarabinomannan: systematic review and meta-analysis. Eur. Respir. J. 38:1398-1405.
22. Minion J, Pai M. 2010. Bacteriophage assays for rifampicin resistance detection in Mycobacterium tuberculosis: updated meta-analysis. Int. J. Tuberc. Lung Dis. 14:941-951.
23. Morgan M, Kalantri S, Flores L, Pai M. 2005. A commercial line probe assay for the rapid detection of rifampicin resistance in Mycobacterium tuberculosis: a systematic review and meta-analysis.BMCInfect. Dis. 5:62.
24. Pai M, Minion J, Steingart K, Ramsay A. 2010. New and improved tuberculosis diagnostics: evidence, policy, practice, and impact. Curr. Opin. Pulm. Med. 16:271-284.
25. Rutjes AW, Reitsma JB, Vandenbroucke JP, Glas AS, Bossuyt PM. 2005. Case-control and two-gate designs in diagnostic accuracy studies. Clin. Chem. 51:1335-1341.
26. Sester M, et al. 2011. Interferon-gamma release assays for the diagnosis of active tuberculosis: a systematic review and meta-analysis. Eur. Respir. J. 37:100-111.
27. Stall N, et al. 2011. Does solid culture for tuberculosis influence clinical decision making in India? Int. J. Tuberc. Lung Dis. 15:641-646.
28. Steingart KR, et al. 2011. Commercial serological tests for the diagnosis of active pulmonary and extrapulmonary tuberculosis: an updated systematic review and meta-analysis. PLoS Med. 8:e1001062. doi:10.1371/journal.pmed. 1001062.
29. Reference deleted.
30. World Health Organization. 2009. Accessible quality-assured diagnostics - 2009 annual report. WHO, Geneva, Switzerland.
31. World Health Organization. 2011. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. WHO, Geneva, Switzerland.
32. World Health Organization. 2011. Commercial serodiagnostic tests for diagnosis of tuberculosis. WHO, Geneva, Switzerland.
33. World Health Organization. 2008. Molecular line probe assays for rapid screening of patients at risk for multidrug-resistant tuberculosis (MDRTB). WHO, Geneva, Switzerland.
34. World Health Organization. 2011. Noncommercial culture and drug-susceptibility testing methods for screening patients at risk for multidrug-resistant tuberculosis. WHO, Geneva, Switzerland.