Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-30T18:44:43.334Z Has data issue: false hasContentIssue false
  • English
  • Français

Review of Nucleic Acid Amplification Tests and Clinical Prediction Rules for Diagnosis of Tuberculosis in Acute Care Facilities

Published online by Cambridge University Press:  13 July 2015

Amit S. Chitnis ,
J. Lucian Davis ,
Gisela F. Schecter ,
Pennan M. Barry  and
Jennifer M. Flood
Amit S. Chitnis*
Affiliation:
Tuberculosis Control Branch, Division of Communicable Disease Control, Center for Infectious Diseases, California Department of Public Health, Richmond, California
J. Lucian Davis
Affiliation:
Department of Epidemiology of Microbial Diseases, School of Public Health, and Division of Pulmonary, Critical Care, & Sleep Medicine, School of Medicine, Yale University, New Haven, Connecticut
Gisela F. Schecter
Affiliation:
Tuberculosis Control Branch, Division of Communicable Disease Control, Center for Infectious Diseases, California Department of Public Health, Richmond, California
Pennan M. Barry
Affiliation:
Tuberculosis Control Branch, Division of Communicable Disease Control, Center for Infectious Diseases, California Department of Public Health, Richmond, California
Jennifer M. Flood
Affiliation:
Tuberculosis Control Branch, Division of Communicable Disease Control, Center for Infectious Diseases, California Department of Public Health, Richmond, California
*
Address correspondence to Amit S. Chitnis, MD, MPH, 850 Marina Bay Parkway, Building P, 2nd Floor, Richmond, CA 94804 ([email protected]).
Get access Rights & Permissions [Opens in a new window]

Abstract

Tuberculosis (TB) remains an important cause of hospitalization and mortality in the United States. Prevention of TB transmission in acute care facilities relies on prompt identification and implementation of airborne isolation, rapid diagnosis, and treatment of presumptive pulmonary TB patients. In areas with low TB burden, this strategy may result in inefficient utilization of airborne infection isolation rooms (AIIRs). We reviewed TB epidemiology and diagnostic approaches to inform optimal TB detection in low-burden settings. Published clinical prediction rules for individual studies have a sensitivity ranging from 81% to 100% and specificity ranging from 14% to 63% for detection of culture-positive pulmonary TB patients admitted to acute care facilities. Nucleic acid amplification tests (NAATs) have a specificity of >98%, and the sensitivity of NAATs varies by acid-fast bacilli sputum smear status (positive smear, ≥95%; negative smear, 50%–70%). We propose an infection prevention strategy using a clinical prediction rule to identify patients who warrant diagnostic evaluation for TB in an AIIR with an NAAT. Future studies are needed to evaluate whether use of clinical prediction rules and NAATs results in optimized utilization of AIIRs and improved detection and treatment of presumptive pulmonary TB patients.

Infect Control Hosp Epidemiol 2015;36(10):1215–1225

Type
Review Article
Information
Infection Control & Hospital Epidemiology , Volume 36 , Issue 10 , October 2015 , pp. 1215 - 1225
Copyright
© 2015 by The Society for Healthcare Epidemiology of America. All rights reserved 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Cookson, ST, Jarvis, WR. Prevention of nosocomial transmission of Mycobacterium tuberculosis . Infect Dis Clin North Am 1997;11:385–409.CrossRefGoogle ScholarPubMed
2. Jensen, PA, Lambert, LA, Iademarco, MF, Ridzon, R. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep 2005;54:1–141.Google ScholarPubMed
3. Blumberg, HM, Watkins, DL, Berschling, JD, et al. Preventing the nosocomial transmission of tuberculosis. Ann Intern Med 1995;122:658–663.CrossRefGoogle ScholarPubMed
4. LoBue, PA, Catanzaro, A. Effectiveness of a nosocomial tuberculosis control program at an urban teaching hospital. Chest 1998;113:1184–1189.CrossRefGoogle ScholarPubMed
5. Scott, B, Schmid, M, Nettleman, MD. Early identification and isolation of inpatients at high risk for tuberculosis. Arch Intern Med 1994;154:326–330.CrossRefGoogle ScholarPubMed
6. Steingart, KR, Henry, M, Ng, V, et al. Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis 2006;6:570–581.CrossRefGoogle ScholarPubMed
7. Steingart, KR, Ramsay, A, Pai, M. Optimizing sputum smear microscopy for the diagnosis of pulmonary tuberculosis. Expert Rev Anti Infect Ther 2007;5:327–331.CrossRefGoogle ScholarPubMed
8. Wisnivesky, JP, Serebrisky, D, Moore, C, Sacks, HS, Iannuzzi, MC, McGinn, T. Validity of clinical prediction rules for isolating inpatients with suspected tuberculosis. A systematic review. J Gen Intern Med 2005;20:947–952.CrossRefGoogle ScholarPubMed
9. Campos, M, Quartin, A, Mendes, E, et al. Feasibility of shortening respiratory isolation with a single sputum nucleic acid amplification test. Am J Respir Crit Care Med 2008;178:300–305.CrossRefGoogle ScholarPubMed
10. Millman, AJ, Dowdy, DW, Miller, CR, et al. Rapid molecular testing for TB to guide respiratory isolation in the U.S.: a cost-benefit analysis. PLoS One 2013;8:e79669.CrossRefGoogle ScholarPubMed
11. Goncalves, B, Lambert Passos, SR, Borges Dos Santos, MA, de Andrade, CA, Moreira Martins, MF, de Queiroz Mello, FC. Systematic review with meta-analyses and critical appraisal of clinical prediction rules for pulmonary tuberculosis in hospitals. Infect Control Hosp Epidemiol 2015;36:204–213.CrossRefGoogle ScholarPubMed
12. Xpert MTB/RIF Assay [package insert]. Sunnyvale, CA: Cepheid; 2015.Google Scholar
13. Centers for Disease Control and Prevention. Revised device labeling for the Cepheid Xpert MTB/RIF assay for detecting Mycobacterium tuberculosis . MMWR 2015;64:193.Google Scholar
14. Centers for Disease Control and Prevention. Reported tuberculosis in the United States, 2013 . Atlanta, GA: U.S. Department of Health and Human Services; 2014.Google Scholar
15. Tuberculosis Control Branch. Report on tuberculosis in California, 2012. Richmond, CA: California Department of Public Health; 2013.Google Scholar
16. Demlow, SE, Oh, P, Barry, PM. Increased risk of tuberculosis among foreign-born persons with diabetes in California, 2010–2012. BMC Public Health 2015;263.CrossRefGoogle Scholar
17. Shah, NS, Cavanaugh, JS, Pratt, R, et al. Epidemiology of smear-negative pulmonary tuberculosis in the United States, 1993–2008. Int J Tuberc Lung Dis 2012;16:1234–1240.CrossRefGoogle ScholarPubMed
18. Chitnis, AS, Schecter, GF, Cilnis, M, Robsky, K, Flood, JM, Barry, PM. Epidemiology of tuberculosis cases with end-stage renal disease, California, 2010. Am J Nephrol 2014;39:314–321.CrossRefGoogle ScholarPubMed
19. El Sahly, HM, Adams, GJ, Soini, H, Teeter, L, Musser, JM, Graviss, EA. Epidemiologic differences between United States- and foreign-born tuberculosis patients in Houston, Texas. J Infect Dis 2001;183:461–468.CrossRefGoogle ScholarPubMed
20. Manangan, L, Elmore, K, Lewis, B, et al. Disparities in tuberculosis between Asian/Pacific Islanders and non-Hispanic Whites, United States, 1993–2006. Int J Tuberc Lung Dis 2009;13:1077–1085.Google ScholarPubMed
21. Pascopella, L, Kellam, S, Ridderhof, J, et al. Laboratory reporting of tuberculosis test results and patient treatment initiation in California. J Clin Microbiol 2004;42:4209–4213.CrossRefGoogle ScholarPubMed
22. Behr, MA, Warren, SA, Salamon, H, et al. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet 1999;353:444–449.CrossRefGoogle ScholarPubMed
23. Taylor, Z, Marks, SM, Rios Burrows, NM, Weis, SE, Stricof, RL, Miller, B. Causes and costs of hospitalization of tuberculosis patients in the United States. Int J Tuberc Lung Dis 2000;4:931–939.Google ScholarPubMed
24. Thomas, JA, Laraque, F, Munsiff, S, Piatek, A, Harris, TG. Hospitalizations for tuberculosis in New York City: how many could be avoided? Int J Tuberc Lung Dis 2010;14:1603–1612.Google ScholarPubMed
25. Tuberculosis Stays in US Hospitals, 2006. Rockville, MD; US Department of Health and Human Services; 2008. Agency for Healthcare Research and Quality website. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb60.pdf. Accessed August 9, 2014.Google Scholar
26. Marks, SM, Flood, J, Seaworth, B, et al. Treatment practices, outcomes, and costs of multidrug-resistant and extensively drug-resistant tuberculosis, United States, 2005–2007. Emerg Infect Dis 2014;20:812–821.CrossRefGoogle ScholarPubMed
27. Hansel, NN, Merriman, B, Haponik, EF, Diette, GB. Hospitalizations for tuberculosis in the United States in 2000: predictors of in-hospital mortality. Chest 2004;126:1079–1086.CrossRefGoogle ScholarPubMed
28. van der Heijden, YF, Maruri, F, Blackman, A, et al. Fluoroquinolone exposure prior to tuberculosis diagnosis is associated with an increased risk of death. Int J Tuberc Lung Dis 2012;16:1162–1167.CrossRefGoogle ScholarPubMed
29. Marks, SM, Magee, E, Robison, V. Patients diagnosed with tuberculosis at death or who died during therapy: association with the human immunodeficiency virus. Int J Tuberc Lung Dis 2011;15:465–470.CrossRefGoogle ScholarPubMed
30. Nguyen, LT, Hamilton, CD, Xia, Q, Stout, JE. Mortality before or during treatment among tuberculosis patients in North Carolina, 1993–2003. Int J Tuberc Lung Dis 2011;15:257–262.Google ScholarPubMed
31. Horne, DJ, Hubbard, R, Narita, M, Exarchos, A, Park, DR, Goss, CH. Factors associated with mortality in patients with tuberculosis. BMC Infect Dis 2010;10:258.CrossRefGoogle ScholarPubMed
32. Nahid, P, Jarlsberg, LG, Rudoy, I, et al. Factors associated with mortality in patients with drug-susceptible pulmonary tuberculosis. BMC Infect Dis 2011;11:1. doi:1471-2334-11-1.CrossRefGoogle ScholarPubMed
33. Kattan, JA, Sosa, LE, Lobato, MN. Tuberculosis mortality: death from a curable disease, Connecticut, 2007–2009. Int J Tuberc Lung Dis 2012;16:1657–1662.CrossRefGoogle ScholarPubMed
34. Pascopella, L, Barry, PM, Flood, J, DeRiemer, K. Death with tuberculosis in California, 1994–2008. Open Forum Infectious Diseases 2014;1(3):ofu090.CrossRefGoogle ScholarPubMed
35. Bock, NN, McGowan, JE Jr, Ahn, J, Tapia, J, Blumberg, HM. Clinical predictors of tuberculosis as a guide for a respiratory isolation policy. Am J Respir Crit Care Med 1996;154:1468–1472.CrossRefGoogle ScholarPubMed
36. Gaeta, TJ, Webheh, W, Yazji, M, Ahmed, J, Yap, W. Respiratory isolation of patients with suspected pulmonary tuberculosis in an inner-city hospital. Acad Emerg Med 1997;4:138–141.CrossRefGoogle Scholar
37. El-Solh, A, Mylotte, J, Sherif, S, Serghani, J, Grant, BJ. Validity of a decision tree for predicting active pulmonary tuberculosis. Am J Respir Crit Care Med 1997;155:1711–1716.CrossRefGoogle ScholarPubMed
38. Wisnivesky, JP, Kaplan, J, Henschke, C, McGinn, TG, Crystal, RG. Evaluation of clinical parameters to predict Mycobacterium tuberculosis in inpatients. Arch Intern Med 2000;160:2471–2476.CrossRefGoogle ScholarPubMed
39. Wisnivesky, JP, Henschke, C, Balentine, J, Willner, C, Deloire, AM, McGinn, TG. Prospective validation of a prediction model for isolating inpatients with suspected pulmonary tuberculosis. Arch Intern Med 2005;165:453–457.CrossRefGoogle ScholarPubMed
40. Moran, GJ, Barrett, TW, Mower, WR, et al. Decision instrument for the isolation of pneumonia patients with suspected pulmonary tuberculosis admitted through US emergency departments. Ann Emerg Med 2009;53:625–632.CrossRefGoogle ScholarPubMed
41. Rakoczy, KS, Cohen, SH, Nguyen, HH. Derivation and validation of a clinical prediction score for isolation of inpatients with suspected pulmonary tuberculosis. Infect Control Hosp Epidemiol 2008;29:927–932.CrossRefGoogle ScholarPubMed
42. Aguilar, J, Yang, JJ, Brar, I, Markowitz, N. Clinical prediction rule for respiratory isolation of patients with suspected pulmonary tuberculosis. Infectious Diseases in Clinical Practice 2009;17:317–322.CrossRefGoogle Scholar
43. Pegues, CF, Johnson, DC, Pegues, DA, Spencer, M, Hopkins, CC. Implementation and evaluation of an algorithm for isolation of patients with suspected pulmonary tuberculosis. Infect Control Hosp Epidemiol 1996;17:412–418.CrossRefGoogle ScholarPubMed
44. Mylotte, JM, Rodgers, J, Fassl, M, Seibel, K, Vacanti, A. Derivation and validation of a pulmonary tuberculosis prediction model. Infect Control Hosp Epidemiol 1997;18:554–560.CrossRefGoogle ScholarPubMed
45. Nahid, P, Pai, M, Hopewell, PC. Advances in the diagnosis and treatment of tuberculosis. Proc Am Thorac Soc 2006;3:103–110.CrossRefGoogle ScholarPubMed
46. Amplified Mycobacterium Tuberculosis Direct Test [package insert]. San Diego, CA: Gen-Probe Incorporated; 2013.Google Scholar
47. Lin, SY, Rodwell, TC, Victor, TC, et al. Pyrosequencing for rapid detection of extensively drug-resistant Mycobacterium tuberculosis in clinical isolates and clinical specimens. J Clin Microbiol 2014;52:475–482.CrossRefGoogle ScholarPubMed
48. Centers for Disease Control and Prevention. Availability of an assay for detecting Mycobacterium tuberculosis, including rifampin-resistant strains, and considerations for its use—United States, 2013. MMWR 2013;62:821–827.Google Scholar
49. Centers for Disease Control and Prevention. Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. MMWR 2009;58:7–10.Google Scholar
50. Sarmiento, OL, Weigle, KA, Alexander, J, Weber, DJ, Miller, WC. Assessment by meta-analysis of PCR for diagnosis of smear-negative pulmonary tuberculosis. J Clin Microbiol 2003;41:3233–3240.CrossRefGoogle ScholarPubMed
51. Greco, S, Rulli, M, Girardi, E, Piersimoni, C, Saltini, C. Diagnostic accuracy of in-house PCR for pulmonary tuberculosis in smear-positive patients: meta-analysis and metaregression. J Clin Microbiol 2009;47:569–576.CrossRefGoogle ScholarPubMed
52. Greco, S, Girardi, E, Navarra, A, Saltini, C. Current evidence on diagnostic accuracy of commercially based nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis. Thorax 2006;61:783–790.CrossRefGoogle ScholarPubMed
53. Chang, K, Lu, W, Wang, J, et al. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. J Infect 2012;64:580–588.CrossRefGoogle ScholarPubMed
54. Steingart, KR, Schiller, I, Horne, DJ, Pai, M, Boehme, CC, Dendukuri, N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2014;1:CD009593.Google Scholar
55. Rapid implementation of the Xpert MTB/RIF diagnostic test: technical and operational 'how-to'; practical considerations. Geneva, Switzerland: WHO; 2011. World Health Organization website. http://www.tbevidence.org/tbevidence_old_site_files/documents/policies/WHO%20Rapid%20Implementation%20of%20Xpert.pdf. Accessed April 29, 2015.Google Scholar
56. Catanzaro, A, Perry, S, Clarridge, JE, et al. The role of clinical suspicion in evaluating a new diagnostic test for active tuberculosis: results of a multicenter prospective trial. JAMA 2000;283:639–645.CrossRefGoogle ScholarPubMed
57. Piersimoni, C, Nista, D, Zallocco, D, Galassi, M, Cimarelli, ME, Tubaldi, A. Clinical suspicion as a primary guidance to use commercial amplification tests for rapid diagnosis of pulmonary tuberculosis. Diagn Microbiol Infect Dis 2005;53:195–200.CrossRefGoogle ScholarPubMed
58. Lim, TK, Mukhopadhyay, A, Gough, A, et al. Role of clinical judgment in the application of a nucleic acid amplification test for the rapid diagnosis of pulmonary tuberculosis. Chest 2003;124:902–908.CrossRefGoogle ScholarPubMed
59. Lim, TK, Gough, A, Chin, NK, Kumarasinghe, G. Relationship between estimated pretest probability and accuracy of automated Mycobacterium tuberculosis assay in smear-negative pulmonary tuberculosis. Chest 2000;118:641–647.CrossRefGoogle ScholarPubMed
60. Friedrich, SO, Rachow, A, Saathoff, E, et al. Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment. Lancet Respir Med 2013;1:462–470.CrossRefGoogle ScholarPubMed
61. Boyles, TH, Hughes, J, Cox, V, Burton, R, Meintjes, G, Mendelson, M. False-positive Xpert(R) MTB/RIF assays in previously treated patients: need for caution in interpreting results. Int J Tuberc Lung Dis 2014;18:876–878.CrossRefGoogle Scholar
62. Lippincott, CK, Miller, MB, Popowitch, EB, Hanrahan, CF, Van, RA. Xpert MTB/RIF assay shortens airborne isolation for hospitalized patients with presumptive tuberculosis in the United States. Clin Infect Dis 2014;59:186–192.CrossRefGoogle ScholarPubMed
63. Marks, SM, Cronin, W, Venkatappa, T, et al. The health-system benefits and cost-effectiveness of using Mycobacterium tuberculosis direct nucleic acid amplification testing to diagnose tuberculosis disease in the United States. Clin Infect Dis 2013;57:532–542.CrossRefGoogle ScholarPubMed
64. Chaisson, LH, Roemer, M, Cantu, D, et al. Impact of GeneXpert MTB/RIF assay on triage of respiratory isolation rooms for inpatients with presumed tuberculosis: a hypothetical trial. Clin Infect Dis 2014;59:1353–1360.CrossRefGoogle ScholarPubMed
65. Taegtmeyer, M, Beeching, NJ, Scott, J, et al. The clinical impact of nucleic acid amplification tests on the diagnosis and management of tuberculosis in a British hospital. Thorax 2008;63:317–321.CrossRefGoogle Scholar
66. Banerjee, R, Allen, J, Lin, SY, et al. Rapid drug susceptibility testing with a molecular beacon assay is associated with earlier diagnosis and treatment of multidrug-resistant tuberculosis in California. J Clin Microbiol 2010;48:3779–3781.CrossRefGoogle ScholarPubMed
67. Davis, JL, Kawamura, LM, Chaisson, LH, et al. Impact of GeneXpert MTB/RIF on patients and tuberculosis programs in a low-burden setting. a hypothetical trial. Am J Respir Crit Care Med 2014;189:1551–1559.CrossRefGoogle Scholar
68. Cordeiro-Santos, M, Trajman, A, Cobelens, F, et al. Tuberculosis infection control: potential benefit of a new rapid tuberculosis test in a human immunodeficiency virus/AIDS reference hospital. Infect Control Hosp Epidemiol 2014;35:1206–1207.CrossRefGoogle Scholar
69. Luetkemeyer, A, Firnhaber, C, Kendall, M, et al. Xpert MTB/RIF versus AFB smear to determine respiratory isolation of US TB suspects. In: Conference on Retroviruses and Opportunistic Infections; February 23–26, 2015; Seattle, WA.Google Scholar