Performance Characteristics of the Cepheid Xpert MTBRIF Test in a Tuberculosis Prevalence Survey 英文参考文献.docVIP

PerformanceCharacteristicsoftheCepheidXpertMTB/ RIFTestinaTuberculosisPrevalenceSurvey SusanE.Dorman1*,VioletN.Chihota2,JamesJ.Lewis2,3,MaunankShah1,DavidClark2,AlisonD.Grant3, GavinJ.Churchyard2,3,4,KatherineL.Fielding3 1Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America, 2Aurum Institute for Health Research, Johannesburg, South Africa, 3LondonSchoolofHygieneandTropicalMedicine,London,UnitedKingdom,4SchoolofPublicHealth,UniversityofWitwatersrand,Johannesburg,SouthAfrica Abstract Background: Xpert MTB/RIF (‘‘Xpert’’) is a molecular test for detection of Mycobacterium tuberculosis (MTB) in sputum. Performancecharacteristicshavebeenestablishedforitsuseduringpassivetuberculosis(TB)casedetectioninsymptomatic TB suspects, but Xpert performance has not been assessed in other settings. Objectives were to determine Xpert performanceandcostsinthecontextofaTBprevalencesurvey. Methodology/Principal Findings: This was a diagnostic sub-study of a TB prevalence survey conducted in gold mining companies in South Africa. Sputa (one per participant) were tested using smear microscopy, liquid culture (reference comparator),andXpert.Costswerecollectedusinganingredientsapproachandanalyzedusingapublichealthprogram perspective.6893participantsprovidedasputumspecimen.187/6893(2.7%)werepositiveforMTBinculture,144/6893 (2.1%) werepositive for MTB byXpert, and91/6893 (1.3%) werepositive for acid fastbacilli by microsocopy. Sensitivity, specificity, positive predictive value, and negative predictive value for detection of MTB by Xpert were 62.6% (95% confidenceinterval[CI]55.2,69.5),99.6%(99.4,99.7),81.3%(73.9,87.3),and98.9(98.6,98.8);agreementbetweenXpertand culture was 98.5% (98.2, 98.8). Sensitivity of microscopy was 17.6% (12.5, 23.9). When individuals with a history of TB treatmentwereexcludedfromtheanalysis,Xpertspecificitywas99.8(99.7,99.9)andPPVwas90.6(83.3,95.4)fordetection ofMTB.Forthetestingscenarioof7000specimenswith2.7%ofspecimensculturep