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Report of Expert Consultations on Rapid Molecular Testing to Detect Drug-Resistant Tuberculosis in the United States										Related Pages
										Appendix 3
Figure 1: Flow Chart of Steps in a Molecular Drug-Resistance Testing Service
Figure 2: Reflex Testingimage icon
Steps in Molecular Drug-Resistance Testing
Before initiating a program for molecular drug susceptibility testing, each jurisdictional TB program must decide how to accomplish the steps below and develop any necessary protocols for
determining which TB suspects and patients get molecular DR testing (i.e., establish selection criteria) and which types of specimens to test,
authorization of molecular DR testing for TB suspects and patients
shipment of specimens and isolates to molecular DR testing laboratory
reporting of molecular DR test results
reflex testing for rifampin-resistant samples
discrepant result analysisIt is anticipated that as part of developing this service, a work group of CDC, NTCA, and APHL representatives will develop guidelines, models, and templates for these steps and protocols.
A TB suspect or patient presents for evaluation:
Local health care provider or TB program
evaluate TB suspect or patient, determine if molecular DR testing is warranted; consult with TB program or TB experts as necessary
if required, obtain permission from the TB program to request a molecular DR test for a TB suspect or patient,
obtain specimen
complete submission form. The submission form should indicate if this is a new suspect or patient that has not previously had a sample sent for molecular DR testing.
submit to lab for processing, AFB smear microscopy, and culture and possible submission to molecular DR testing laboratory
if approved by the TB program, assign a unique identifier, properly package, and submit non-processed specimen to the molecular DR testing laboratory. Ensure that a specimen has been sent for microscopy and culture
Local laboratory
receive specimen, assign identifier, enter data into laboratory information system
process specimen in accord with local requirements
Specimens which are processed and cultured at a local laboratory
digest, decontaminate, concentrate, AFB smear microscopy, inoculate media
store remnants of the processed specimen for possible shipment to molecular DR testing laboratory
if cultures are to be tested, confirm that the culture contains AFB
Specimens handled at laboratories that only do AFB smear microscopy
process, AFB smear microscopy
refer specimen to full-service laboratory for isolation and drug susceptibility testing
store remnants of the processed specimen for possible shipment to molecular DR testing laboratory
If AFB-positive or NAA positive (specimen or culture),
Confirm or obtain approval of the TB program to submit to molecular DR testing laboratory
Package sample and ship to molecular DR testing laboratory in accord with local policies
If AFB-negative, ship to molecular DR testing laboratory ONLY if requested to do so by TB program
Molecular DR testing laboratory
accession sample, enter data into a laboratory information management system.
process sample for molecular DR testing
non-processed specimens: digest, recover bacteria, lyse bacteria , prepare molecular DR test substrate. Note: AFB smear microscopy should be performed to aid in the interpretation of the Molecular DR test result.
processed specimens: recover bacteria, lyse bacteria, prepare molecular DR test substrate
cultures: recover bacteria, lyse bacteria, prepare molecular DR test substrate
conduct molecular DR testing
[one or two step test: detect *M. tuberculosis* then molecular DR test or combined detection and molecular DR testing]
include appropriate positive and negative controls
if inhibitors detected or suspected, conduct appropriate follow-up testing
if results are indeterminate, conduct appropriate follow-up testing
review result, prepare report using standardized language, and sign out
report result in accord with TB program instructions
recipients of report to be determined by TB program
report rifampin-susceptible results electronically
report rifampin-resistant results by phone and electronically
store residual sample for potential follow-up testing
Recipient of report
if necessary, ensure all involved parties are promptly informed of result and act upon the result
if rifampin resistance detected, initiate reflex testing
testing to include expedited conventional DS testing for 1st and 2nd line drugs
testing to be done at a proficient laboratory identified by program
compare molecular and conventional DS results, report and discrepancies to TB Control program
Health care provider/clinician
receive report, incorporate results into case management decisions
obtain result of conventional drug susceptibility testing
compare molecular and conventional DS results, report and discrepancies to TB Control program
— conventional tests considered the gold standard for isoniazid and rifampin
							
					
						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


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