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TB FAQS

TB Diagnostics: Top 10 FAQs By Test Developers. Useful resources for each question are now available on our website. Publications Related to This Site. 2014 Diagnostics by Design, Panel Discussion. The Value Chain for Diagnostics: Concept to Product to Implementation. Based on input from 25 companies and test developers, these are the most critical questions of relevance to test developers and companies wanting to develop TB diagnostic technologies. Useful resources for each question have been posted.

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TB FAQS | tbfaqs.org Reviews
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TB Diagnostics: Top 10 FAQs By Test Developers. Useful resources for each question are now available on our website. Publications Related to This Site. 2014 Diagnostics by Design, Panel Discussion. The Value Chain for Diagnostics: Concept to Product to Implementation. Based on input from 25 companies and test developers, these are the most critical questions of relevance to test developers and companies wanting to develop TB diagnostic technologies. Useful resources for each question have been posted.
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2 credits
3 related links
4 resources posted
5 latest news
6 target product profiles
7 product development support
8 product validation support
9 regulation
10 policy
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TB FAQS | tbfaqs.org Reviews

https://tbfaqs.org

TB Diagnostics: Top 10 FAQs By Test Developers. Useful resources for each question are now available on our website. Publications Related to This Site. 2014 Diagnostics by Design, Panel Discussion. The Value Chain for Diagnostics: Concept to Product to Implementation. Based on input from 25 companies and test developers, these are the most critical questions of relevance to test developers and companies wanting to develop TB diagnostic technologies. Useful resources for each question have been posted.

INTERNAL PAGES

tbfaqs.org tbfaqs.org
1

Scale-Up | TB FAQS

http://www.tbfaqs.org/scale-up

Once a product has been validated, registered and put on the market, and once policy endorsements are obtained, what are the challenges for uptake and scale-up in high burden countries? Which validated tests have been successfully scaled-up, what were reasons for the success, and how long did it take to reach scale? How do country level policy makers make decisions on technologies to scale-up? If some tests have not been scaled-up even after policy endorsements, why? Dr Madhukar Pai, MD, PhD. TB Burden A...

2

TB Burden And Treatment Landscape | TB FAQS

http://www.tbfaqs.org/tb-burden-and-treatment-landscape

TB Burden And Treatment Landscape. TB Burden And Treatment Landscape. TB BURDEN AND TREATMENT LANDSCAPE. What is the global burden of TB (including latent TB, TB/HIV and MDR/XDR-TB) and what is the current and future TB treatment landscape? What is the current burden and predictions for future, disease distribution (highest burden countries), current and future patient demographics, and trends over the next 5-10 years? What is the treatment landscape today and for the next 5-10 years?

3

Regulation | TB FAQS

http://www.tbfaqs.org/regulation

What are the regulatory requirements for TB diagnostics, both in-country and globally? What is required for the registration of new diagnostics in the major, high TB burden countries? Will multiple regulatory approvals be necessary? What will it cost? Is there a pathway to get simultaneous approvals from multiple regulatory agencies? How critical is FDA approval for global markets and what will it take to get FDA approval? Dr Madhukar Pai, MD, PhD. McGill University, Montreal.

4

Product Validation Support | TB FAQS

http://www.tbfaqs.org/product-validation-support

What kind of validation is required for a new TB diagnostic in order to enter the market and where can companies get support for such validation? How many validation studies will be required to introduce a new TB diagnostic? Are test accuracy studies adequate, or clinical impact studies required? How much geographical diversity is needed for the clinical trials and validation? What validation studies were required for, and conducted by Cepheid to bring their TB test to market? Dr Madhukar Pai, MD, PhD.

5

Current Diagnostics Landscape And Pipeline | TB FAQS

http://www.tbfaqs.org/current-diagnostics-landscape-and-pipeline

Current Diagnostics Landscape And Pipeline. Current Diagnostics Landscape And Pipeline. CURRENT DIAGNOSTICS LANDSCAPE AND PIPELINE. What is the current testing landscape for TB (including latent TB and DST), and what diagnostics are in the pipeline? What is the level of access to current TB diagnostics? What TB diagnostic tests are currently on the market, and what products are likely to enter the market in the near future? Which tests are currently included in policy recommendations and widely used?

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LINKS TO THIS WEBSITE

tbevidence.org tbevidence.org

WHO Policies | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/who-policies

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? WHO Policy Statement on Xpert MTB-RIF, Update. 2014. [Link]. WHO Xpert MTB/RIF implementation manual. 2014. [Link]. WHO Commercial serodiagnostic tests for diagnosis of tuberculosis. 2011. [Link]. WHO Use of liquid medium for c...

tbevidence.org tbevidence.org

SOP & Package Inserts | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/resource-center/sop-package-inserts

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? SOP & Package Inserts. Nucleic Acid Amplification Tests (NAAT). Rapid Tests for MDR-TB. Antigen Tests for TB. Collection of Studies on TB Culture and DST Methods. IUATLD, 2000 - Download [Link]. Quality Smear Preparation for AFB.

tbevidence.org tbevidence.org

Events | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/events-2

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? Diagnostics Innovation in China: Bringing TB and HIV Molecular Diagnostics to Market. 25-26 September, 2012. Shanghai, China. [Link]. 43rd Union World Conference on Lung Health. Advanced TB Diagnostic Research – Montréal. 28-30...

tbevidence.org tbevidence.org

Guideline Development | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/resource-center/guideline-development

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? Clinical Practice Guidelines We Can Trust:. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines - Download [Link]. WHO Process for New Policies on TB Diagnostics. WHO Handbook for Guideline Development.

tbevidence.org tbevidence.org

Scientific blueprint | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/resource-center/scientific-blueprint

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? Proudly powered by WordPress.

tbevidence.org tbevidence.org

Algorithms | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/resource-center/algorithms

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? The Online TST/QFT Interpreter, Version 2.0 beta. McGill University and Montreal Chest Institute, Canada - Download [Link]. McGill University and Montreal Chest Institute, Canada - Download [Link]. Proudly powered by WordPress.

tbevidence.org tbevidence.org

Books Monograph and Reports | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/resource-center/books-monograph-and-reports

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? Books Monograph and Reports. Mycobacteriology Laboratory Manual, 2014- Download [Link]. Tuberculosis Laboratory Safety Manuel - Download [Link]. Towards Lab-Free Tuberculosis Diagnosis. TAG, TBHIV, ICL - Download [Link]. WHO, W...

tbevidence.org tbevidence.org

What is evidence-based TB diagnosis? | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/what-is-evidence-based-tb-diagnosis

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? What is evidence-based TB diagnosis? And development of research agendas. Recognizing the growing importance of evidence-based TB diagnosis and policy making, the Stop TB Partnership’s New Diagnostics Working Group.

tbevidence.org tbevidence.org

Training Material | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/resource-center/training-material

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? Laboratory Biosafety and Quality. Mantoux Tuberculin Skin Test Training Materials Kit. Centers for Disease Control and Prevention - Download [Link]. Mantoux Tuberculin Skin Testing Training Guide. RIT, Japan - Download [Link].

tbevidence.org tbevidence.org

Credits | Evidence-Based tuberculosis Diagnosis

http://tbevidence.org/credits-2

A comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics. Collection of Studies on TB Culture and DST Methods. Books Monograph and Reports. SOP & Package Inserts. Specimen Banks and databases. What is evidence-based TB diagnosis? Madhukar Pai, Andy Ramsay, Karen Steingart. Proudly powered by WordPress.

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TB FAQS

TB Diagnostics: Top 10 FAQs By Test Developers. Useful resources for each question are now available on our website. Publications Related to This Site. 2014 Diagnostics by Design, Panel Discussion. The Value Chain for Diagnostics: Concept to Product to Implementation. Based on input from 25 companies and test developers, these are the most critical questions of relevance to test developers and companies wanting to develop TB diagnostic technologies. Useful resources for each question have been posted.

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