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      Diagnostic accuracy of Xpert MTB/RIF for extrapulmonary tuberculosis specimens: establishing a laboratory testing algorithm for South Africa.

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          Abstract

          South Africa implemented Xpert MTB/RIF as the initial diagnostic test for pulmonary tuberculosis (TB). Xpert MTB/RIF's accuracy for diagnosing extrapulmonary tuberculosis (EPTB) was investigated. EPTB specimens (n = 7,916) from hospitalized patients received over a 6-month period at a high-throughput TB referral laboratory in Johannesburg were investigated. Large-volume specimens were centrifuged, tissue biopsy specimens homogenized, and all specimens checked for growth of contaminating bacteria on blood agar. Contaminated samples received NALC-NaOH (N-acetyl-l-cysteine-sodium hydroxide) decontamination prior to liquid culture. Residual specimens (volumes > 1 ml) after inoculation of culture (n = 1,175) were tested using the Xpert MTB/RIF sputum protocol. Using culture as the reference, Xpert MTB/RIF's overall sensitivity was 59% (95% confidence interval [95% CI], 53% to 65%) and specificity was 92% (CI, 90% to 94%), with the highest sensitivities of 91% (95% CI, 78% to 97%) for pus, 80% (95% CI, 56% to 94%) for lymph node aspirates, and 51% (95% CI, 44% to 58%) for fluids (ascitic, 59%; pleural, 47%). A difference in sensitivities was noticed between specimens classified as having a thick (87% [95% CI, 76% to 94%]) versus clear (watery) (48% [95% CI, 36% to 61%]) appearance. This was unchanged with traces of blood (52% [95% CI, 44% to 60%]) or precentrifugation (57% [95% CI, 28% to 82%]) among clear specimens. Xpert MTB/RIF generated an additional 124 specimen results that were contaminated by Mycobacterial Growth Indicator Tubes (MGIT; 10.5%) and diagnosed rifampin (RIF) resistance earlier (9.6% [25/260]). Xpert MTB/RIF's performance on EPTB specimens provides very promising results and should be considered for incorporation into national TB guidelines. Xpert MTB/RIF is less affected by contaminating bacteria and reduces laboratory labor and diagnostic delay compared to traditional methods.

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          Author and article information

          Journal
          J Clin Microbiol
          Journal of clinical microbiology
          American Society for Microbiology
          1098-660X
          0095-1137
          Jun 2014
          : 52
          : 6
          Affiliations
          [1 ] Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa lesley.scott@nhls.ac.za.
          [2 ] National Health Laboratory Service, South Africa Division of Clinical Microbiology and Infectious Diseases; University of the Witwatersrand, Johannesburg, South Africa.
          [3 ] Division of Medical Microbiology, Department of Clinical Laboratory Sciences and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa National Health Laboratory Service, South Africa.
          [4 ] Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
          [5 ] National Health Laboratory Service, National Priority Program, Johannesburg, South Africa.
          [6 ] Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa National Health Laboratory Service, National Priority Program, Johannesburg, South Africa.
          Article
          JCM.03553-13
          10.1128/JCM.03553-13
          4042800
          24622091
          a8397289-5421-4940-8ecf-b09bae67a95e
          Copyright © 2014, American Society for Microbiology. All Rights Reserved.
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