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
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- 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 Expert Consultations on Rapid Molecular Testing to Detect Drug-Resistant Tuberculosis in the United States
Possible scenarios and scope of testing for a molecular DR testing service
A phased approach to developing and implementing a molecular DR testing service would be prudent. In the initial phase, testing might be offered for TB patients or suspects at high-risk of having MDR TB and situations deemed high priority by the program (judicious use testing). A long-range goal should be to offer testing for all TB patients and suspects (universal testing). In addition to molecular DR tests, the resources of the molecular DR laboratory might be leveraged to provide other services for state and local TB programs and laboratories. The scope of any additional service, such as NAA testing for detection or culturing or second-line drug susceptibility testing, must be clearly defined and adequately funded.
Judicious use testing would concentrate on testing (a) samples for which the test result would alter case management or TB Control decisions, outbreak or contact investigations, preventive therapy in immunocompromised contacts, infection control, or Do Not Board lists; (b) samples from persons at risk of having drug-resistant TB (persons exposed to an MDR-TB case, from a population with a high rate of MDR TB, or failing or having failed therapy with first-line anti-TB drugs); and (c) respiratory specimens or isolates that can not be tested easily with conventional methods (non-viable specimens; mixed or contaminated cultures). Given that there are 100 to 150 new cases of MDR-TB reported to CDC each year and many new TB cases are persons from populations with a high prevalence of MDR TB, one would estimate that a judicious use molecular DR testing program would entail the testing of about 2500 samples per year. One or two regional molecular DR testing laboratories would be needed. The estimated cost of this is $300,000 to $400,000 plus the cost of shipping (~$70,000) and initial equipment.
Universal testing would involve molecular DR testing one AFB smear-positive or NAA-positive respiratory specimen or one M. tuberculosis culture from each TB patient or TB suspect. About 5000 AFB-smear positive pulmonary TB cases were reported to CDC in 2007. An approximately equal number of patients were AFB-smear positive due to the presence of non-tuberculous mycobacteria (NTM) in the respiratory specimen. About 7,400 pulmonary and ~3000 extrapulmonary culture-confirmed TB cases were reported to CDC in 2007. Thus, universal testing would entail testing 10,000 to 20,000 samples per year. Up to four regional molecular DR testing laboratories would be needed to handle this work load. The estimated cost of a universal molecular DR testing service is 1.2 million to $2 million dollars plus the cost of shipping ($250,000 to $500,000) and initial equipment.
Variations of the molecular DR testing options described above may allow CDC to address the needs of programs for NAA testing for detection as well as molecular DR testing. However, linking NAA testing for detection with molecular DR testing must be carefully thought through to determine if it is a cost-effective, reliable approach to providing molecular DR testing services to state and local TB programs.
- Option 1: only samples shown to be NAA-positive for TB would be accepted by the molecular DR testing laboratory. In this case, universal testing would involve 7000 to 9000 samples because NAA tests detect 70% to 90% of pulmonary TB cases that are ultimately culture confirmed. This approach (a) would delay sample submission to the molecular DR testing laboratory by 1–2 days, although a positive NAA result at the local laboratory might prompt earlier initiation of therapy; (b) would increase the cost of the molecular DR testing service to the TB program to include the cost of NAA testing at the local laboratory; (c) might complicate the submission process for private- and public-sector laboratories and programs that do not have access to NAA testing, although this requirement might be an incentive for local laboratories to offer NAA testing; and (d) might reduce shipping costs if leftover DNA from the NAA testing were shipped. If NAA testing were required prior to submission, a phased implementation of this requirement would be essential to ensure that all programs have access to molecular DR testing when needed, perhaps by allowing programs to submit samples from patients meeting the judicious use criteria.
- Option 2: the molecular DR testing laboratory would conduct NAA testing for detection as well as molecular DR testing. For AFB-smear positive specimens, the available molecular DR tests can reliably detect M. tuberculosis DNA, so a separate test for detection is not needed. For AFB-smear negative samples, an optimized NAA test for detection could be coupled with a molecular DR test to increase reliability of the molecular DR test. However, the performance of molecular DR tests with AFB-smear negative, NAA positive specimens is not known. This approach would (a) provide access to NAA testing for detection to local and state TB programs; (b) increase the cost of the molecular DR testing service to include the cost of NAA tests for detection; (c) allow use of a specimen processing method optimized for molecular DR testing; and (d) require strict criteria for submitting AFB-smear negative specimens to avoid inappropriate ordering of NAA tests for patients who are unlikely to have TB.
For any of the scenarios, a phased approach would be prudent. At a minimum, it would be essential to provide molecular DR testing services for TB patients or suspects at high-risk of having MDR TB and those deemed high priority by the program. This could be accomplished by providing sufficient new funding to existing, proficient molecular DR testing laboratories to expand their capacities to meet this need. If done through supplements to existing cooperative agreements, this might be done quickly. Such an interim service could serve as pilot projects and would allow time to (a) compare the performances and costs of currently available tests and select one or more for use in the molecular DR testing service; (b) assess and overcome potential obstacles and barriers to a regional approach to diagnostic testing such as local regulations regarding out-of-state testing, reporting requirement, and need for memoranda of agreement; (c) develop a strategy to coordinate or integrate services provided by the molecular DR testing and genotyping laboratories to avoid unnecessary duplication of efforts and shipment of isolates; (d) develop a strategy for implementing the molecular DR testing service to include informing potential service users of the availability of the service, how to access the service, and the appropriate use and interpretation of molecular DR tests for TB; (e) design a molecular DR testing service to meet the needs of local and state TB control programs; and (f) develop, compete, and award a contract to provide the services.
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