Skip directly to site content Skip directly to page options Skip directly to A-Z link


Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting People
														Search

		Submit


Tuberculosis (TB)


Section Navigation
			
			CDC Home


Facebook
        Twitter
        LinkedIn
        Syndicate





Report of Expert Consultations on Rapid Molecular Testing to Detect Drug-Resistant Tuberculosis in the United States										Related Pages
										Recommendations
CDC should develop a system with sufficient testing capacity to enable molecular DR testing for one AFB smear-positive or NAA-positive respiratory specimen or one *M. tuberculosis* culture from each TB patient or TB suspect andspecimens or isolates from persons that the local or state TB Control Program designates as high priority for testing.
CDC should evaluate existing molecular DR testing services to identify best practices.
CDC should use a phased approach to implementing a universal molecular DR testing service.
CDC should immediately establish an interim service to provide molecular DR testing for persons at high-risk of having MDR TB and those deemed high priority by the local TB program. CDC is encouraged to explore using supplements to existing cooperative agreements to provide sufficient new funds to existing, proficient molecular DR testing laboratories to allow them to expand their capacities to meet this need. The interim service could serve as a pilot project to inform the development of a universal molecular DR testing service.
CDC should establish and fund regional laboratories to provide molecular DR testing for state and local TB programs. Funds in the current TB Elimination Cooperative Agreements should not be redirected to the molecular DR testing program. The molecular DR testing laboratories should
coordinate molecular DR testing services with the medical consultation and training services of the TB Regional Training and Medical Consultation Centers (RTMCCs),
provide six-day-a-week service,
use validated molecular methods to detect rifampin and isoniazid resistance,
implement molecular DR testing for anti-TB drugs other than rifampin and isoniazid (e.g., fluoroquinolones) as the tests are developed and validated,
report results electronically within two business days of specimen receipt,
report detection of drug resistance in specimen or isolate by telephone to facilitate prompt action by the program and clinician,
ensure notification of appropriate individuals (e.g., local program, laboratory, clinician) of the need for expedited testing of rifampin-resistant samples for susceptibility to first-line and second-line anti-TB drugs, and
participate in an external quality assurance program.
CDC should work with TB partners and state and local TB programs and laboratories to identify and overcome potential obstacles and barriers to implementing a regional molecular DR testing service, such as local regulations regarding out-of-state testing, certification of laboratories, reporting requirements, and need for memoranda of agreement.
CDC and partners should develop clear policies and standard operating procedures for referring specimens to the molecular DR testing laboratories.
CDC should develop and fund a process for shipping *M. tuberculosis* cultures to the molecular DR testing laboratories.
CDC should develop and fund a process for shipping specimens to the molecular DR testing laboratories for TB laboratories or programs that can not afford the cost of shipping.
CDC should coordinate, and possibly integrate, activities of the molecular DR testing and genotyping laboratories to avoid unnecessary duplication of efforts and shipment of isolates.
CDC should work with partners to develop external quality assurance, proficiency testing, and rechecking programs for the molecular DR testing service.
CDC should develop a robust process for monitoring and evaluating the performance of the molecular DR testing laboratories. This should include post-market surveillance to determine the performance, cost, and benefit of the molecular DR tests as performed in a regional testing service.
CDC should work with partners to develop protocols to analyze discrepancies in the results of molecular DR and conventional tests. CDC should collect data on and investigate discrepancies to better understand the performance of molecular and conventional DS testing.
CDC, NTCA, and APHL should convene a work group to develop guidelines, templates, and models for programs to use in developing their systems to access the molecular DR testing service and receive reports.
CDC should work with partners such as APHL and NTCA to assess training needs, develop training materials, and establish an education program for TB control officials, laboratorians, clinicians, and policy makers on the appropriate use and interpretation of molecular DR tests for TB.
CDC should work with partners such as APHL and NTCA to develop a process for providing guidance, technical assistance, and consultation on clinical, programmatic, and laboratory aspects of the appropriate use and interpretation of molecular DR tests for TB in the United States.
CDC should develop a broader evidence base to support changes in recommendations and practices and investigate the economic implications of molecular DR testing.
CDC should develop and promote a research agenda for molecular DR testing for TB.
CDC should work with private- and public-sector partners to increase the number and types of molecular DR tests, commercial sources, FDA-approved tests, and validated tests.
CDC and FDA should encourage manufacturers to develop molecular DR tests for TB and submit to FDA for review and approval.
CDC should assist manufacturers with regulatory quality trials of molecular DR tests aimed at receiving FDA approval.
CDC should establish a repository of well-characterized isolates for use in developing, evaluating, and validating molecular DR tests for TB.
CDC should disseminate the panel report and any resulting CDC recommendations in multiple media, in order to reach clinicians, TB control officials, laboratorians, regulatory agencies, policy makers, and other TB partners. This may include publication in scientific or medical journals or MMWR, posting on the CDC website, use of electronic mail lists, and direct distribution to key stakeholders.
CDC should monitor and evaluate the implementation of the recommendations. CDC should periodically, perhaps annually, provide progress reports to ACET.
							
					
						Page last reviewed:  September 1, 2012					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


About CDC
					Contact Us
					800-232-4636
 Facebook Twitter Instagram LinkedIn Youtube Pinterest Snapchat
 CONTACT CDC
				Contact Us
							Call 800-232-4636
							Email Us
			ABOUT CDC
				About CDC
							Jobs
							Funding
			POLICIES
				Accessibility
							External Links
							Privacy
							Policies
							No Fear Act
							FOIA
							OIG
							Nondiscrimination
							Vulnerability Disclosure Policy
			CONNECT WITH US
				Facebook
								Twitter
								Instagram
								LinkedIn
							Youtube
								Pinterest
								Snapchat
								Email
			LANGUAGES
				Español
							繁體中文
							Tiếng Việt
							한국어
							Tagalog
							Русский
							العربية
							Kreyòl Ayisyen
							Français
							Polski
							Português
							Italiano
							Deutsch
							日本語
							فارسی
							English


U.S. Department of Health & Human Services
			Accessibility
			External Links
			Privacy
			Policies
			No Fear Act
			FOIA
			Nondiscrimination
			OIG
			Vulnerability Disclosure Policy
			USA.gov


Exit Notification / Disclaimer Policy Close
 Links with this icon  indicate that you are leaving the CDC website. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website.
				Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.
				You will be subject to the destination website's privacy policy when you follow the link.
				CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Website Disclaimers
 Cancel Continue