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Evaluation of the Xpert MTB/RIF Performance on Tissues: Potential Impact on Airborne Infection Isolation at a Tertiary Cancer Care Center

  • Tracy McMillen (a1), Shauna C. Usiak (a2), Liang Hua Chen (a1), Luz Gomez (a1), Peter Ntiamoah (a3), Meera R. Hameed (a3), Indre Budvytiene (a4), Niaz Banaei (a4), Mini Kamboj (a2) (a5) and N. Esther Babady (a1) (a5)...
Abstract
OBJECTIVES

In this study, we sought to evaluate the performance of the Xpert MTB/RIF (Cepheid) assay for the detection of Mycobacterium tuberculosis (MTB) complex DNA on fresh and formalin-fixed, paraffin-embedded (FFPE) tissue specimens from oncology patients in an area with a low prevalence of tuberculosis. We also aimed to retrospectively assess the potential impact of Xpert MTB/RIF on the duration of airborne infection isolation (AII).

SETTING

A 473-bed, tertiary-care cancer center in New York City.

DESIGN

A total of 203 tissue samples (101 FFPE and 102 fresh) were tested using Xpert MTB/RIF, including 133 pulmonary tissue samples (65.5%) and 70 extrapulmonary tissue samples (34.5%). Acid-fast bacilli (AFB) culture was used as the diagnostic gold standard. The limit of detection (LOD) and reproducibility were also evaluated for both samples types using contrived specimens. The potential impact of the Xpert MTB PCR assay on tissue samples from AII patients on AII duration was retrospectively assessed.

RESULTS

Using the Xpert MTB/RIF for fresh tissue specimens, the sensitivity was 50% (95% CI, 1.3%–98.7%) and the specificity was 99% (95% CI, 94.5%–99.9%). For FFPE tissue specimens, the sensitivity was 100% (95% CI, 63.1%–100%) and the specificity was 98.3% (95% CI, 95.5%–100%. The LOD was 103 colony-forming units (CFU)/mL for both fresh and FFPE tissue specimens, and the Xpert MTB/RIF was 100% reproducible at concentrations 10 times that of the LOD. With an expected turnaround time of 24 hours, the Xpert MTB PCR could decrease the duration of AII from a median of 8 days to a median of 1 day.

CONCLUSIONS

The Xpert MTB/RIF assay offers a valid option for ruling out Mycobacterium tuberculosis complex (MTBC) on tissue samples from oncology patients and for minimizing AII resource utilization.

Infect Control Hosp Epidemiol 2018;39:462–466

Copyright
Corresponding author
Address correspondence to N. Esther Babady, PhD, D (ABMM), Clinical Microbiology Service, Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, 327 East 64th Street, CLM 522, New York, New York (BabadyN@mskcc.org).
Footnotes
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PREVIOUS PRESENTATION. The results of this study were presented in part at the 2016 American Society of Microbiology Microbe Meeting on June 20, 2016, in Boston, Massachusetts.

Footnotes
References
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1. US Food and Drug Admistration. New data show test can help physicians remove patients with suspected TB from isolation earlier. FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434226.htm. Published 2015. Accessed January 10, 2018.
2. Luo, RF, Scahill, MD, Banaei, N. Comparison of single-copy and multicopy real-time PCR targets for detection of Mycobacterium tuberculosis in paraffin-embedded tissue. J Clin Microbiol 2010;48:25692570.
3. Babady, NE, Buckwalter, SP, Hall, L, Le Febre, KM, Binnicker, MJ, Wengenack, NL. Detection of Blastomyces dermatitidis and Histoplasma capsulatum from culture isolates and clinical specimens by use of real-time PCR. J Clin Microbiol 2011;49:32043208.
4. Garcia-Basteiro, AL, Ismail, MR, Carrilho, C, et al. The role of Xpert MTB/RIF in diagnosing pulmonary tuberculosis in post-mortem tissues. Sci Rep 2016;6:20703.
5. Moure, R, Torres, M, Martin, R, Alcaide, F. Direct detection of Mycobacterium tuberculosis complex in clinical samples by a molecular method based on GenoQuick technology. J Clin Microbiol 2012;50:20892091.
6. Polepole, P, Kabwe, M, Kasonde, M, et al. Performance of the Xpert MTB/RIF assay in the diagnosis of tuberculosis in formalin-fixed, paraffin-embedded tissues. Int J Mycobacteriol 2017;6:8793.
7. Scott, LE, Beylis, N, Nicol, M, et al. Diagnostic accuracy of Xpert MTB/RIF for extrapulmonary tuberculosis specimens: establishing a laboratory testing algorithm for South Africa. J Clin Microbiol 2014;52:18181823.
8. Vadwai, V, Boehme, C, Nabeta, P, Shetty, A, Alland, D, Rodrigues, C. Xpert MTB/RIF: a new pillar in diagnosis of extrapulmonary tuberculosis? J Clin Microbiol 2011;49:25402545.
9. Moure, R, Martin, R, Alcaide, F. Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. J Clin Microbiol 2012;50:513515.
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Infection Control & Hospital Epidemiology
  • ISSN: 0899-823X
  • EISSN: 1559-6834
  • URL: /core/journals/infection-control-and-hospital-epidemiology
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