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Performance of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis and rifampin resistance in a low-incidence, high-resource setting.
PLoS One. 2017; 12(10):e0186139.Plos

Abstract

Performance of the Xpert MTB/RIF assay, designed to simultaneously detect Mycobacterium tuberculosis complex (MTBC) and rifampin (RIF) resistance, has been well documented in low-resource settings with high TB-incidence. However, few studies have assessed its accuracy in low TB incidence settings. We evaluated the performance of Xpert MTB/RIF using clinical sputum specimens routinely collected from suspect pulmonary TB patients over a 4-year time period in San Diego County, California. Xpert MTB/RIF results were compared to acid-fast bacilli (AFB) smear microscopy, mycobacterial culture, and phenotypic drug susceptibility testing (DST). Of 751 sputum specimens, 134 (17.8%) were MTBC culture-positive and 2 (1.5%) were multidrug-resistant (MDR). For the detection of MTBC, Xpert MTB/RIF sensitivity was 89.6% (97.7% and 74.5% in smear-positive and -negative sputa, respectively) and specificity was 97.2%; while AFB smear sensitivity and specificity were 64.9% and 77.8%, respectively. Xpert MTB/RIF detected 35 of 47 smear-negative culture-positive specimens, and excluded 124 of 137 smear-positive culture-negative specimens. Xpert MTB/RIF also correctly excluded 99.2% (121/122) of nontuberculous mycobacteria (NTM) specimens, including all 33 NTM false-positives by smear microscopy. For the detection of RIF resistance, Xpert MTB/RIF sensitivity and specificity were 100% and 98.3%, respectively. Our findings demonstrate that Xpert MTB/RIF is able to accurately detect MTBC and RIF resistance in routinely collected respiratory specimens in a low TB-incidence setting, with comparable performance to that achieved in high-incidence settings; and suggest that under these conditions the assay has particular utility in detecting smear-negative TB cases, excluding smear-positive patients without MTBC disease, and differentiating MTBC from NTM.

Authors+Show Affiliations

Division of Preventive Medicine, University of California, San Diego, California, United States of America.Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, California, United States of America.Tuberculosis Control and Refugee Health Program, County of San Diego Health and Human Services Agency, San Diego, California, United States of America.Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, California, United States of America.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29016684

Citation

Rice, Jason P., et al. "Performance of the Xpert MTB/RIF Assay for the Diagnosis of Pulmonary Tuberculosis and Rifampin Resistance in a Low-incidence, High-resource Setting." PloS One, vol. 12, no. 10, 2017, pp. e0186139.
Rice JP, Seifert M, Moser KS, et al. Performance of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis and rifampin resistance in a low-incidence, high-resource setting. PLoS One. 2017;12(10):e0186139.
Rice, J. P., Seifert, M., Moser, K. S., & Rodwell, T. C. (2017). Performance of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis and rifampin resistance in a low-incidence, high-resource setting. PloS One, 12(10), e0186139. https://doi.org/10.1371/journal.pone.0186139
Rice JP, et al. Performance of the Xpert MTB/RIF Assay for the Diagnosis of Pulmonary Tuberculosis and Rifampin Resistance in a Low-incidence, High-resource Setting. PLoS One. 2017;12(10):e0186139. PubMed PMID: 29016684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis and rifampin resistance in a low-incidence, high-resource setting. AU - Rice,Jason P, AU - Seifert,Marva, AU - Moser,Kathleen S, AU - Rodwell,Timothy C, Y1 - 2017/10/09/ PY - 2017/05/03/received PY - 2017/09/26/accepted PY - 2017/10/11/entrez PY - 2017/10/11/pubmed PY - 2017/10/25/medline SP - e0186139 EP - e0186139 JF - PloS one JO - PLoS One VL - 12 IS - 10 N2 - Performance of the Xpert MTB/RIF assay, designed to simultaneously detect Mycobacterium tuberculosis complex (MTBC) and rifampin (RIF) resistance, has been well documented in low-resource settings with high TB-incidence. However, few studies have assessed its accuracy in low TB incidence settings. We evaluated the performance of Xpert MTB/RIF using clinical sputum specimens routinely collected from suspect pulmonary TB patients over a 4-year time period in San Diego County, California. Xpert MTB/RIF results were compared to acid-fast bacilli (AFB) smear microscopy, mycobacterial culture, and phenotypic drug susceptibility testing (DST). Of 751 sputum specimens, 134 (17.8%) were MTBC culture-positive and 2 (1.5%) were multidrug-resistant (MDR). For the detection of MTBC, Xpert MTB/RIF sensitivity was 89.6% (97.7% and 74.5% in smear-positive and -negative sputa, respectively) and specificity was 97.2%; while AFB smear sensitivity and specificity were 64.9% and 77.8%, respectively. Xpert MTB/RIF detected 35 of 47 smear-negative culture-positive specimens, and excluded 124 of 137 smear-positive culture-negative specimens. Xpert MTB/RIF also correctly excluded 99.2% (121/122) of nontuberculous mycobacteria (NTM) specimens, including all 33 NTM false-positives by smear microscopy. For the detection of RIF resistance, Xpert MTB/RIF sensitivity and specificity were 100% and 98.3%, respectively. Our findings demonstrate that Xpert MTB/RIF is able to accurately detect MTBC and RIF resistance in routinely collected respiratory specimens in a low TB-incidence setting, with comparable performance to that achieved in high-incidence settings; and suggest that under these conditions the assay has particular utility in detecting smear-negative TB cases, excluding smear-positive patients without MTBC disease, and differentiating MTBC from NTM. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/29016684/Performance_of_the_Xpert_MTB/RIF_assay_for_the_diagnosis_of_pulmonary_tuberculosis_and_rifampin_resistance_in_a_low_incidence_high_resource_setting_ L2 - https://dx.plos.org/10.1371/journal.pone.0186139 DB - PRIME DP - Unbound Medicine ER -