PMID- 24622091 OWN - NLM STAT- MEDLINE DCOM- 20150105 LR - 20220408 IS - 1098-660X (Electronic) IS - 0095-1137 (Print) IS - 0095-1137 (Linking) VI - 52 IP - 6 DP - 2014 Jun TI - Diagnostic accuracy of Xpert MTB/RIF for extrapulmonary tuberculosis specimens: establishing a laboratory testing algorithm for South Africa. PG - 1818-23 LID - 10.1128/JCM.03553-13 [doi] AB - 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. CI - Copyright (c) 2014, American Society for Microbiology. All Rights Reserved. FAU - Scott, Lesley Erica AU - Scott LE AD - 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. FAU - Beylis, Natalie AU - Beylis N AD - National Health Laboratory Service, South Africa Division of Clinical Microbiology and Infectious Diseases; University of the Witwatersrand, Johannesburg, South Africa. FAU - Nicol, Mark AU - Nicol M AD - 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. FAU - Nkuna, Gloria AU - Nkuna G AD - Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa. FAU - Molapo, Sebaka AU - Molapo S AD - National Health Laboratory Service, National Priority Program, Johannesburg, South Africa. FAU - Berrie, Leigh AU - Berrie L AD - National Health Laboratory Service, National Priority Program, Johannesburg, South Africa. FAU - Duse, Adriano AU - Duse A AD - National Health Laboratory Service, South Africa Division of Clinical Microbiology and Infectious Diseases; University of the Witwatersrand, Johannesburg, South Africa. FAU - Stevens, Wendy Susan AU - Stevens WS AD - 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. LA - eng GR - U2G PS001328/PS/NCHHSTP CDC HHS/United States GR - 3U2GPS0001328-04/PHS HHS/United States GR - PEPFAR/PEPFAR/United States PT - Evaluation Study PT - Journal Article PT - Research Support, U.S. Gov't, P.H.S. DEP - 20140312 PL - United States TA - J Clin Microbiol JT - Journal of clinical microbiology JID - 7505564 RN - 0 (Antitubercular Agents) RN - VJT6J7R4TR (Rifampin) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - *Algorithms MH - Antitubercular Agents/pharmacology MH - Bacteriological Techniques/*methods MH - Body Fluids/microbiology MH - Child MH - Child, Preschool MH - Drug Resistance, Bacterial MH - Female MH - Humans MH - Infant MH - Infant, Newborn MH - Lymph Nodes/microbiology MH - Male MH - Middle Aged MH - Molecular Diagnostic Techniques/*methods MH - Rifampin/pharmacology MH - Sensitivity and Specificity MH - South Africa MH - Tuberculosis/*diagnosis MH - Young Adult PMC - PMC4042800 EDAT- 2014/03/14 06:00 MHDA- 2015/01/06 06:00 PMCR- 2014/12/01 CRDT- 2014/03/14 06:00 PHST- 2014/03/14 06:00 [entrez] PHST- 2014/03/14 06:00 [pubmed] PHST- 2015/01/06 06:00 [medline] PHST- 2014/12/01 00:00 [pmc-release] AID - JCM.03553-13 [pii] AID - 03553-13 [pii] AID - 10.1128/JCM.03553-13 [doi] PST - ppublish SO - J Clin Microbiol. 2014 Jun;52(6):1818-23. doi: 10.1128/JCM.03553-13. Epub 2014 Mar 12.