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ORIGINAL RESEARCH ARTICLE
Year : 2017  |  Volume : 6  |  Issue : 1  |  Page : 87-93

Performance of the Xpert MTB/RIF assay in the diagnosis of tuberculosis in formalin-fixed, paraffin-embedded tissues


1 Department of Biomedical Sciences, University of School of Medicine, Lusaka, Zambia
2 University of and University College London Medical School (UNZA-UCLMS) Research and Training Programme, University Teaching Hospital, Lusaka, Zambia
3 Department of Pathology and Microbiology, University Teaching Hospital, Lusaka, Zambia
4 University of Zambia and University College London Medical School (UNZA-UCLMS) Research and Training Programme, University Teaching Hospital; Institute for Infectious Diseases, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
5 Norwich Medical School, University of East Anglia, Norwich, United Kingdom
6 National TB and Leprosy Control Programme, Ministry of Community Development, Mother and Child Health, Lusaka, Zambia
7 Department of Infection, Division of Infection and Immunity, University College London; National Institute for Health Research Biomedical Research Centre at UCL Hospitals, London, United Kingdom

Correspondence Address:
Pascal Polepole
University of Zambia School of Medicine, Department of Biomedical Sciences, P O BOX 30784, Lusaka 10101
Zambia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2212-5531.201892

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Objective/Background: Extrapulmonary tuberculosis (EPTB), which accounts for 10%–40% of the global burden of TB, with the highest incidence in Sub-Saharan Africa, is strongly associated with human immunodeficiency virus infection. Diagnosing EPTB is challenging, and recently, there has been a concerted effort to evaluate the latest molecular diagnostics for diagnosing TB in a range of specimen types. The Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, USA) is one such technology, which simultaneously detects Mycobacterium tuberculosis and rifampicin resistance. Our objective was to evaluate the accuracy of the Xpert MTB/RIF assay for the diagnosis of EPTB and detection of rifampicin resistance in routinely processed formalin-fixed, paraffin-embedded (FFPE) tissues, compared with histological detection of TB as the gold standard. Methods: A convenience set of 100 biobanked FFPE tissues, including lymph nodes (n = 64), male genital tract tissue (n = 10), abdominal tissue (n = 8), female genital tissue (n = 5), breast tissue (n = 5), synovial tissue (n = 4), skin (n = 2), tongue tissue (n = 1), and thyroid (n = 1), from routine cases of clinically suspected EPTB admitted to the University Teaching Hospital, Lusaka, Zambia, were analyzed using the Xpert MTB/RIF assay and in-house polymerase chain reaction (PCR) assay targeting IS6110, in parallel with Ziehl–Neelsen (ZN) staining, against histology as the gold standard. Results: Some 66% of specimens had histological evidence of TB infection. ZN staining was positive for TB in 8% of cases, and Xpert MTB/RIF was positive for TB in 25% of cases. Taking histology as the gold standard, the sensitivity and specificity were as follows: In lymph tissue the accuracy of the Xpert MTB/RIF assay was 41% (95%CI 27-57), not significantly better than ZN or the in-house PCR assay. In non-lymph tissue the sensitivity of the in-house PCR assay was 82% (95%CI: 56%-95%), significantly higher than the Xpert MTB/RIF assay (P = 0.004). The Xpert MTB/RIF assay indicated rifampicin resistance in just three cases. Conclusion: The Xpert MTB/RIF assay is potentially a useful tool for the diagnosis of TB in routine FFPE tissues.


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