Tuberculosis
- Topics
- Basic TB Facts
- Treatment
- Testing & Diagnosis
- TB & HIV Coinfection
- Infection Control & Prevention
- Drug-Resistant TB
- TB in Specific Populations
- African-American Community
- Correctional Facilities
- Table of Contents
- Introduction
- Strengthen TB Information Systems and Program Assessment
- Strengthen TB Environmental Controls and Isolation Practices
- Provide More Comprehensive and Timely Screening and Diagnostic Evaluations
- Develop and Strengthen Contact Investigation Protocols
- Increase HIV Counseling and Testing
- Increase Staff Training
- Strengthen Collaboration Between Health Departments and Jails
- International Travelers
- Pregnancy
- Disaster Responders
- Children
- Vaccines & Immunizations
- Laboratory Information
- Drug Susceptibility Testing
- The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TB
- Rapid Molecular Testing to Detect Drug-Resistant TB in the US
- Executive Summary
- Introduction
- Background on Tests for Molecular Detection of DR
- General Considerations and Principles for a Molecular DR Testing Service�
- Possible Scenarios and Scope of Testing for a Molecular DR Testing Service
- Research Needs
- General Recommendations of the Expert Panel
- Communication Plan for the Report
- Recommendations
- References
- Panel Members and CDC Participants
- Appendix 1
- Appendix 2
- Appendix 3
- Interim Laboratory Biosafety Guidance for XDR Mycobacterium tuberculosis strains
- Molecular Detection of Drug Resistance (MDDR)
- Research
- TB Epidemiologic Studies Consortium
- Background
- Infrastructure
- Research Projects
- Publications
- Meetings
- Directory
- TBESC Committee Members
- Translating Research into Practice (TRIP)
- Contact TBESC
- Prospective Evaluation of Immunogenetic and Immunologic Markers for Susceptibility to Tuberculosis Infection and Progression from M. Tuberculosisinfection to active TB
- Zero Tolerance for Pediatric TB
- Models for Incorporating HIV Counseling, Testing, and Referral into Tuberculosis Contact Investigations
- Prevalence of Latent TB Infection Among High Risk Populations in the United States
- Regional Capacity-Building in Low-Incidence Areas
- Use of Network Analysis Methods to Characterize M. tuberculosis Transmission Patterns Among Women and Other High-Risk Populations
- An Analysis of Molecular Epidemiology of Multi-Drug Resistant M. tuberculosisin the United States
- Missed Opportunities for TB Prevention in Foreign-Born Population in the United States and Canada
- New Model for Assessing TB Surveillance and Action Performance and Cost
- Addressing TB Among African Americans in the Southeast: Identifying and Overcoming Barriers to Treatment Adherence for Latent TB Infection and TB Disease
- Assessing the TB Knowledge, Attitudes, Beliefs, and Practices Among Private Providers Serving Foreign-born Populations at Risk for TB
- Factors Associated with Acceptance of, Adherence to and Toxicity From Treatment for Latent TB Infection and Pilot Study of Treatment for Latent TB Infection Effectiveness
- Culturally Appropriate TB Educational Materials for Leaders and Staff of Hispanic Service Organizations
- Enhancing TB Programs� Capacity for Self-Evaluation: Testing New Tools and Developing an Evaluation Toolkit
- African Refugee Women�s Health Improvement Project
- Evaluation of the TK Medium: A New Rapid Solid Culture System for Tuberculosis
- Evaluation of New Interferon-y Release Assays in the Diagnosis of Latent TB Infection in Health Care Workers
- Request for Proposal
- TB Trials Consortium
- Behavioral & Social Science Research
- TB Epidemiologic Studies Consortium
- Data & Statistics
- Education & Training
- Resources for TB Programs
- Publications & Products
- Fact Sheets
- General
- Fact sheets - Spanish
- TB - General Information
- The Difference Between Latent TB Infection and Active TB Disease
- Diferencia entre la infección de tuberculosis latente y enfermedad de tuberculosis activa
- A Global Perspective on TB
- Tuberculosis Information for Employers in Non-Healthcare Settings
- Bovine Tuberculosis in Humans
- Tuberculosis Information for International Travelers
- TB Can Be Treated
- Exposure to TB
- TB and HIV/AIDS
- You Can Prevent TB
- Testing for TB
- Tuberculosis: informaci�n general
- Diferencia entre la infecci�n de tuberculosis latente y enfermedad de tuberculosis activa
- Informaci�n sobre la tuberculosis para los viajeros internacionales
- Exposición a la tuberculosis
- Usted puede prevenir la tuberculosis
- La tuberculosis puede ser tratada
- Tuberculosis y VIH/SIDA
- Usted puede prevenir la tuberculosis
- Pruebas para detectar la tuberculosis
- Data & Statistics
- A Global Perspective on TB
- Trends in Tuberculosis – United States
- The Revised Report of Verified Case of Tuberculosis
- The National Tuberculosis Indicators Project (NTIP)
- National Tuberculosis Indicators Project (NTIP): Frequently Asked Questions
- TB Genotyping
- TB Genotyping Information Management System (TB GIMS)
- Drug-Resistant TB
- Multidrug-Resistant Tuberculosis (MDR TB)
- Extensively Drug-Resistant Tuberculosis (XDR TB)
- CDC’s Role in Preventing Extensively Drug-Resistant Tuberculosis (XDR TB)
- Tuberculosis multirresistente (MDR)
- Tuberculosis extremadamente resistente (XDR)
- El papel de los CDC en la prevenci�n de la tuberculosis extremadamente resistente (XDR)
- Infection Control & Prevention
- TB in Specific Populations
- Tuberculosis Information for Employers in Non-Healthcare Settings
- Tuberculosis in Minorities
- Tuberculosis Information for International Travelers
- TB and HIV/AIDS
- Recommendations for Human Immunodeficiency Virus (HIV) Screening in Tuberculosis (TB) Clinics
- Treatment of Drug-Susceptible Tuberculosis Disease in HIV-Infected Persons
- Tuberculosis in Blacks
- Tuberculosis and Pregnancy
- Tuberculosis y embarazo
- Treatment
- TB Can Be Treated
- Treatment of Latent TB Infection
- Treatment of Latent Tuberculosis Infection: Maximizing Adherence
- Treatment Options for Latent Tuberculosis Infection
- Treatment of Drug-Resistant Tuberculosis
- Treatment of Drug-Susceptible Tuberculosis Disease in Persons Not Infected with HIV
- Treatment of Drug-Susceptible Tuberculosis Disease in HIV-Infected Persons
- Tratamiento de la infecci�n de tuberculosis latente
- Testing & Diagnosis
- TB Can Be Treated
- Testing for TB
- Recommendations for Human Immunodeficiency Virus (HIV) Screening in Tuberculosis (TB) Clinics
- Interferon-Gamma Release Assays (IGRAs)
- Tuberculin Skin Testing
- Diagnosis of Tuberculosis Disease
- Targeted Tuberculin Testing and Interpreting Tuberculin Skin Test Results
- Prueba cutánea de la tuberculina
- Diagnóstico de la tuberculosis activa
- Vaccines & Immunizations
- General
- Guidelines
- Guides & Toolkits
- Core Curriculum
- Self-Study Modules
- Report of Verified Case of Tuberculosis (RVCT)
- Forging Partnerships to Eliminate TB
- Understanding the TB Cohort Review Process
- Latent Tuberculosis Infection: A Guide for Primary Health Care Providers
- Effective TB Interviewing for Contact Investigation
- Mantoux Tuberculin Skin Testing Products
- Ethnographic Guides
- Newsletters
- Pamphlets, Brochures, Booklets
- Posters
- Mantoux Tuberculin Skin Test Wall Chart
- World TB Day
- Afiches
- 2011 Poster (English)
- 2011 Poster (Spanish)
- 2010 Poster (English)
- 2010 Poster (Spanish)
- 2008 Poster (English)
- 2008 Poster (Spanish)
- 2006 Poster (English)
- 2004 Poster (English)
- 2004 Poster (Spanish)
- 2003 Poster (English)
- 2003 Poster (Spanish)
- 2003 Now is the Time Poster (English)
- 2003 Now is the Time Poster (Spanish)
- Think TB
- Stop TB
- Reports & Articles
- Morbidity and Mortality Weekly Reports (MMWRs)
- Contact Investigations
- Control and Elimination
- Data & Statistics
- Drug-Resistant Tuberculosis
- Infection Control & Prevention
- Laboratory
- TB in Specific Populations
- Foreign-Born
- High-Risk Settings
- Homeless
- International
- Occupational Groups
- Travel
- TB & HIV
- Testing & Diagnosis
- Treatment
- LTBI Updates
- Vaccines & Immunizations
- World TB Day
- DTBE Authored Journal Articles
- Tuberculosis Laboratory Aggregate Reports
- Morbidity and Mortality Weekly Reports (MMWRs)
- Slide Sets
- Core Curriculum
- Self-Study Modules
- Prevention and Control of Tuberculosis in Correctional and Detention Facilities
- Guidelines for Preventing the Transmission of M. TB in Health care Settings
- Investigation of Contacts of Persons with Infectious TB
- Text-Only version
- Introduction
- Decisions to Initiate a Contact Investigation
- Investigating the Index Patient and Sites of Transmission
- Assigning Priorities to Contacts
- Diagnostic and Public Health Evaluation of Contacts
- Medical Treatment for Contacts with LTBI
- When to Expand a Contact Investigation
- Communicating Through the News Media
- Data Management and Evaluation of Contact Investigations
- Confidentiality and Consent in Contact Investigations
- Staff Training for Contact Investigations
- Contact Investigations in Special Circumstances
- Source-Case Investigations
- Cultural Competency and Social Network Analysis
- Resources
- Epidemiology of Pediatric Tuberculosis in the United States
- Text-Only version
- Introduction
- Pediatric TB Cases by Age and Race
- Pediatric TB Cases by Origin of Birth
- Pediatric Cases, Percentages and Rates by States
- Pediatric TB Cases by Case Verification Criterion and Site of Disease
- Pediatric TB Cases in Specific Groups
- Pediatric TB Cases Case Completion
- Slide 1
- Slide 2
- Slide 3
- Slide 4
- Slide 5
- Slide 6
- Slide 7
- Slide 8
- Slide 9
- Slide 10
- Slide 11
- Slide 12
- Slide 13
- Slide 14
- Slide 15
- Slide 16
- Slide 17
- Slide 18
- Slide 19
- Slide 20
- Slide 21
- Slide 22
- Slide 23
- Slide 24
- Slide 25
- Slide 26
- Slide 27
- Slide 28
- Slide 29
- Slide 30
- Slide 31
- Treatment of TB
- Targeted Tuberculosis Testing and Treatment of Latent Tuberculosis Infection
- CD Roms
- Electronic Tools & Resources
- Web-Based Courses & Webinars
- Fact Sheets
- Global TB
- Events
- Links
- About Us
- Mission Statement and Activities
- Organization Chart
- Advisory Groups
- Federal TB Task Force
- Table of Contents
- Executive Summary
- Introduction
- Chronology in the Development of This Report
- Strategies for Maintaining Control of TB
- Strategies for Accelerating the Decline of TB
- Activities for Developing New Tools
- Global U.S. Actions
- Assessing the Impact of Actions Taken
- Federal TB Task Force Members and Others Involved in the Development of This Report
- Glossary
- References
- Federal TB Task Force Roster
- Table of Contents
- Executive Summary
- Introduction
- How to Eliminate TB? – The IOM Report
- Why Eliminate TB? – Rationale for Elimination
- Who Will Lead? – CDC's Response
- Goal I: Maintain control of TB
- Goal II: Accelerate the decline
- Goal III: Create new tools
- Goal IV: Reduce the global burden of TB
- Goal V: Summon and sustain support
- Goal VI: Track progress
- References
- Federal TB Task Force
- Funding
Report of an Expert Consultation on the Uses of Nucleic Acid Amplification Tests for the Diagnosis of Tuberculosis
General Considerations
- Optimum patient care and public health must be cornerstones of the recommendations.
- Many TB suspects are seen initially by less experienced clinicians who may delay specific treatment until laboratory results confirm the diagnosis. On the assumption that, generally, knowledge and skills for TB diagnosis will remain stable or deteriorate, the laboratory will play an increasingly critical role in reducing delays in the initiation of TB treatment.
- NAA testing has significant potential added value for clinicians and TB control officials.
- Earlier diagnosis leads to earlier initiation of treatment, a reduced period of infectiousness, and improved patient outcomes.
- Earlier notification of TB cases to public health authorities should permit public health interventions sooner and may engage a TB expert sooner in the care of the TB patient.
- Earlier detection of M. tuberculosis bacteria in sputum specimens can facilitate earlier infection control (respiratory isolation) decisions.
- Earlier differentiation of AFB-smear positive specimens containing M. tuberculosis from those containing other mycobacteria can eliminate unnecessary contact investigations.
- Prompt confirmation of tuberculosis may help avoid inappropriate empirical use of fluoroquinolones as monotherapy of pneumonias, a practice which is suspected to lead to development of tuberculosis resistant to fluoroquinolones.
- NAA tests have limitations, and caution must be taken when interpreting NAA test results.
- The FDA-approved NAA tests for TB have slightly less sensitivity than culture-isolation methods, and the 15% to 20% of U.S. TB cases that are reported with negative culture results may also have negative NAA test results. Thus, a negative NAA test result does not exclude the diagnosis of TB.
- Sputum specimens (up to 20% in some studies) may contain inhibitors that prevent or reduce amplification to cause false-negative NAA test results, although inhibitors rarely cause false-negative NAA test results in smear-positive specimens (<3% of samples).
- Several sporadic or systematic errors can cause false-positive NAA test results.
- Costs and funding issues
- Only FDA-approve d or laboratory-validated analyte specific reagent (ASR) tests are eligible for Medicare or Medicaid reimbursement.
- The FDA-approved tests are
- a substantial added cost to the laboratory;
- additional tests that augment but do not replace any current laboratory test;
- labor intensive, technically demanding, and not suitable for automation; and
- susceptible to end-product contamination and amplification inhibition.
- NAA tests can provide substantial savings
- for the patient (earlier diagnosis, improved outcomes, reduced health-care costs)
- for the health care provider (definitive diagnosis earlier, focused diagnostic testing, optimum patient care);
- for the hospital (less potential for nosocomial transmission, briefer period of respiratory isolation if TB is excluded); and
- for the public health program (interrupt transmission earlier, abbreviated period for transmission, focused contact investigations).
- Turnaround time (TAT) must be as brief as possible to maximize benefits of NAA testing. The key TAT is the interval from specimen collection to time that the laboratory report is communicated to the health care provider.
- Good communication between laboratorians, health care providers, and public health officials is critical to optimizing the benefits of NAA testing. Standard language or statements to include in laboratory reports of NAA test results are needed.
- Education of laboratorians, clinicians, health care providers, TB controllers, and policy makers on the appropriate use and interpretation of NAA tests for the diagnosis of TB will be essential.
- For general medical care and public health systems, a single, simple algorithm for NAA testing is preferred. Some special circumstances, such as infection control and inpatient medical care, may require separate algorithms.
- There are only two FDA-approved tests which may be impractical for use by laboratories with a small volume of testing.
- Analyte Specific Reagent (ASR) tests for detecting M. tuberculosis bacteria (e.g., real-time PCR assays) with excellent sensitivity, specificity, speed, and ease-of-use have been recently independently developed, validated, and implemented in a variety of laboratories.
- Home-brew tests themselves are not regulated by the FDA, but the components (ASRs) that compose them may be regulated if purchased from a manufacturer. ASRs used in home-brew tests for TB are classified as Class III medical devices by the FDA (21 CFR 864.4020) and must be cleared or approved by FDA before they can be marketed in the United States (21 CFR 864.4020)
- Laboratories developing and performing home-brew tests as a diagnostic service are required to meet CLIA high-complexity certification requirements, to comply with CLIA quality control requirements, and to establish the performance of the in-house test following CLIA regulations.
- The ordering of home-brew tests that are developed using ASRs is limited under section 520(e) of the Federal Food, Drug and Cosmetic Act to physicians and other persons authorized by applicable State law to order such tests.
- The laboratory that develops and performs a home-brew test using an ASR is required to inform the ordering person of the test result by appending to the test report the statement: “This test was developed and its performance characteristics determined by (Laboratory Name).” It has not been cleared or approved by the U.S. Food and Drug Administration. ” (21 CFR 809.30(e))
- Cost efficiency, rapid turnaround time, and expertise could be enhanced by establishing high-volume regional laboratories offering molecular tests.
- Sufficient information is available for making recommendations for respiratory specimens.
- Further research is needed before specific recommendations can be made on the use of NAA testing in the diagnosis of TB in children who cannot produce sputum and in the diagnosis of extrapulmonary TB, although there is much anecdotal evidence of the utility of such testing in individual cases.
Contact Us:
- Centers for Disease Control and Prevention
Division of Tuberculosis Elimination (DTBE)
1600 Clifton Rd., NE
MS E10
Atlanta, GA 30333 - 800-CDC-INFO
(800-232-4636)
TTY: (888) 232-6348 - New Hours of Operation
8am-8pm ET/Monday-Friday
Closed Holidays - cdcinfo@cdc.gov