Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients with Suspected Tuberculosis from Low and Higher Prevalence Settings

Anne F. Luetkemeyer, Cynthia Firnhaber, Michelle A. Kendall, Xingye Wu, Gerald H. Mazurek, Debra A. Benator, Roberto Arduino, Michel Fernandez, Elizabeth Guy, Pamela Johnson, Beverly Metchock, Fred Sattler, Edward Telzak, Yun F. Wang, Marc Weiner, Susan Swindells, Ian M. Sanne, Diane V. Havlir, Beatriz Grinsztejn, David Alland

Research output: Contribution to journalArticle

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Abstract

The Xpert MTB/RIF (Xpert) assay is a rapid nucleic acid amplification test widely used in settings of high tuberculosis prevalence to detect tuberculosis as well as rpoB mutations associated with rifampin resistance. Data are needed on the diagnostic performance of Xpert in lower-prevalence settings to inform appropriate use for both tuberculosis detection and the need for respiratory isolation. Methods. Xpert was compared to 2 sputum samples, each evaluated with acid-fast bacilli (AFB) smear and mycobacterial culture using liquid and solid culture media, from participants with suspected pulmonary tuberculosis from the United States, Brazil, and South Africa. Results. Of 992 participants enrolled with evaluable results, 22% had culture-confirmed tuberculosis. In 638 (64%) US participants, 1 Xpert result demonstrated sensitivity of 85.2% (96.7% in participants with AFB smear-positive [AFB+] sputum, 59.3% with AFB smear-negative [AFB-] sputum), specificity of 99.2%, negative predictive value (NPV) of 97.6%, and positive predictive value of 94.9%. Results did not differ between higher-and low-prevalence settings. A second Xpert assay increased overall sensitivity to 91.1% (100% if AFB+, 71.4% if AFB-), with specificity of 98.9%. In US participants, a single negative Xpert result predicted the absence of AFB+/culture-positive tuberculosis with an NPV of 99.7%; NPV of 2 Xpert assays was 100%, suggesting a role in removing patients from airborne infection isolation. Xpert detected tuberculosis DNA and mutations associated with rifampin resistance in 5 of 7 participants with rifampin-resistant, culture-positive tuberculosis. Specificity for rifampin resistance was 99.5% and NPV was 98.9%. Conclusions. In the United States, Xpert testing performed comparably to 2 higher-tuberculosis-prevalence settings. These data support the use of Xpert in the initial evaluation of tuberculosis suspects and in algorithms assessing need for respiratory isolation.

Original languageEnglish (US)
Pages (from-to)1081-1088
Number of pages8
JournalClinical Infectious Diseases
Volume62
Issue number9
DOIs
StatePublished - May 1 2016

Fingerprint

Pulmonary Tuberculosis
Bacillus
Tuberculosis
Acids
Rifampin
Sputum
Nucleic Acid Amplification Techniques
Mutation
South Africa
Brazil
Culture Media
DNA
Infection

Keywords

  • HIV/tuberculosis coinfection
  • Xpert MTB/RIF
  • nontuberculous mycobacteria
  • respiratory isolation
  • tuberculosis diagnosis

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients with Suspected Tuberculosis from Low and Higher Prevalence Settings. / Luetkemeyer, Anne F.; Firnhaber, Cynthia; Kendall, Michelle A.; Wu, Xingye; Mazurek, Gerald H.; Benator, Debra A.; Arduino, Roberto; Fernandez, Michel; Guy, Elizabeth; Johnson, Pamela; Metchock, Beverly; Sattler, Fred; Telzak, Edward; Wang, Yun F.; Weiner, Marc; Swindells, Susan; Sanne, Ian M.; Havlir, Diane V.; Grinsztejn, Beatriz; Alland, David.

In: Clinical Infectious Diseases, Vol. 62, No. 9, 01.05.2016, p. 1081-1088.

Research output: Contribution to journalArticle

Luetkemeyer, AF, Firnhaber, C, Kendall, MA, Wu, X, Mazurek, GH, Benator, DA, Arduino, R, Fernandez, M, Guy, E, Johnson, P, Metchock, B, Sattler, F, Telzak, E, Wang, YF, Weiner, M, Swindells, S, Sanne, IM, Havlir, DV, Grinsztejn, B & Alland, D 2016, 'Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients with Suspected Tuberculosis from Low and Higher Prevalence Settings', Clinical Infectious Diseases, vol. 62, no. 9, pp. 1081-1088. https://doi.org/10.1093/cid/ciw035
Luetkemeyer, Anne F. ; Firnhaber, Cynthia ; Kendall, Michelle A. ; Wu, Xingye ; Mazurek, Gerald H. ; Benator, Debra A. ; Arduino, Roberto ; Fernandez, Michel ; Guy, Elizabeth ; Johnson, Pamela ; Metchock, Beverly ; Sattler, Fred ; Telzak, Edward ; Wang, Yun F. ; Weiner, Marc ; Swindells, Susan ; Sanne, Ian M. ; Havlir, Diane V. ; Grinsztejn, Beatriz ; Alland, David. / Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients with Suspected Tuberculosis from Low and Higher Prevalence Settings. In: Clinical Infectious Diseases. 2016 ; Vol. 62, No. 9. pp. 1081-1088.
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abstract = "The Xpert MTB/RIF (Xpert) assay is a rapid nucleic acid amplification test widely used in settings of high tuberculosis prevalence to detect tuberculosis as well as rpoB mutations associated with rifampin resistance. Data are needed on the diagnostic performance of Xpert in lower-prevalence settings to inform appropriate use for both tuberculosis detection and the need for respiratory isolation. Methods. Xpert was compared to 2 sputum samples, each evaluated with acid-fast bacilli (AFB) smear and mycobacterial culture using liquid and solid culture media, from participants with suspected pulmonary tuberculosis from the United States, Brazil, and South Africa. Results. Of 992 participants enrolled with evaluable results, 22{\%} had culture-confirmed tuberculosis. In 638 (64{\%}) US participants, 1 Xpert result demonstrated sensitivity of 85.2{\%} (96.7{\%} in participants with AFB smear-positive [AFB+] sputum, 59.3{\%} with AFB smear-negative [AFB-] sputum), specificity of 99.2{\%}, negative predictive value (NPV) of 97.6{\%}, and positive predictive value of 94.9{\%}. Results did not differ between higher-and low-prevalence settings. A second Xpert assay increased overall sensitivity to 91.1{\%} (100{\%} if AFB+, 71.4{\%} if AFB-), with specificity of 98.9{\%}. In US participants, a single negative Xpert result predicted the absence of AFB+/culture-positive tuberculosis with an NPV of 99.7{\%}; NPV of 2 Xpert assays was 100{\%}, suggesting a role in removing patients from airborne infection isolation. Xpert detected tuberculosis DNA and mutations associated with rifampin resistance in 5 of 7 participants with rifampin-resistant, culture-positive tuberculosis. Specificity for rifampin resistance was 99.5{\%} and NPV was 98.9{\%}. Conclusions. In the United States, Xpert testing performed comparably to 2 higher-tuberculosis-prevalence settings. These data support the use of Xpert in the initial evaluation of tuberculosis suspects and in algorithms assessing need for respiratory isolation.",
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AU - Wu, Xingye

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AU - Metchock, Beverly

AU - Sattler, Fred

AU - Telzak, Edward

AU - Wang, Yun F.

AU - Weiner, Marc

AU - Swindells, Susan

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AU - Grinsztejn, Beatriz

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