TB Path to Innovation

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TB was first identified in 460 BCE by 1882 Hippocrates and initially named Robert Koch “phthisis,” which means “consumption” discovered TB in Greek. Throughout history, using the microscope 1895 TB has had many names, including Development “white plague.” However, since Dr. of chest x-ray diagnostic 1907 Koch’s discovery, “tuberculosis” became Tuberculin skin the more common medical term. test developedp 1921 BCG vaccine BCG initially proved iintroducedntr a resounding success, reducing mortality from TB 1936 Solid culture first by in vaccinated 90% used to identify TB children. However, BCG does not prevent primary infection or reactivation 1943 of latent TB. First anti-TB drug discovered: Streptomycin 1952 First anti-TB regimen used: Streptomycin, PAS, isoniazid Monotherapy- (single-drug regimen) 19631963 resistant mutations began to Rifampin and appear within a few months of Capreomycin discovered the introduction of the drug Streptomycin. It was soon demon- 19741974 strated that this problem could British Medical Research be overcome by treating TB with Council trials added Rifampin and Pyrazinamide a combinationcom of twtwo or three drugs. Emergence Emergence 19801980 of TB-HIV of MDR-TB* Liquid culture developed co-infection* 19941994 Directly Observed Treatment, David Rochkind Short-course (DOTS) uberculosis Progra USAID’s T m Began 19981998 In Rifapentine c re approved d a ia s g in Emergence n g o p s of XDR-TB* 20092009 t ip ic e iLED microscope, line s l in probe assay developed a e n d fo v a r c n c ew 20102010 in e d GeneXpert XpeXpert MTB/RIF rapid test for c ru TB rreceives CE IVD marketing an g d s, MTB/RIF®M assay id at is a newne molecular test that es can detdetect TB and mutations 20112011 associassociated with Rifampicin New drug development approach: CPTR (critical path to TB [drug] regimens) <2hrs resistresistance in fewer than 2 hoursho with far greater aaccuracycc than smear 20122012 microscopy. FDA approves Bedaquiline, the first new anti-TB drug since Rifapentine in 1998 APPROVED 20142014 Clinical trials begin on PaMZ, the 3-drug cocktail that could shorten treatment for TB, including MDR-TB One Day We Hope to Have... A tool that can diagnose TB and MDR TB within 24 hours for children, adults, and HIV-infected individuals A shorter treatment regimen that can cure TB in 10 days or less that will also work with antiretroviral drugs A vaccine that can prevent new TB infections or recurrences of the disease *NOTES: MDR-TB: Multidrug-resistant tuberculosis, TB-HIV: Tuberculosis and HIV Co-infection, XDR-TB: Extensively drug-resistant tuberculosis.

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The T-SPOT.TB Test Frequently Asked Questions
General tuberculosis information T-SPOT.TB Test description and Frequently asked performance questions T-SPOT.TB Test performance characteristics T-SPOT.TB advantages over tuberculin skin test T-SPOT.TB test results T-SPOT.TB methodology Screening control programs Contact investigations References References Table of contents General tuberculosis information Tuberculosis: Definition, infection and disease 1. What is the scale of the TB problem? 2. How is TB spread? 3. What is TB infection (Latent Tuberculosis Infection “LTBI” or “latent TB”)? 4. What is TB disease (“active TB”)? 5. Are certain groups of individuals at an increased risk of exposure to Mycobacterium tuberculosis? 6. Are certain individuals at an increased risk of progressing from latent TB infection to TB disease? 7. How important is treatment for TB disease? 8. Why is the treatment period for TB disease so long? 9. How important is treatment for TB infection (“LTBI” or “latent TB”)? TB detection 10. Is there a test for the detection of TB infection (“LTBI” or “latent TB”)? • Tuberculin Skin Test (TST) • Interferon-Gamma Release Assays (IGRA) 11. Is there a test for the detection of TB disease (“active TB”)? 12. What are the limitations of the TST? Bacille Calmette-Guérin (BCG) vaccination 13. What is the BCG vaccination? T-SPOT.TB test description and performance 14. What is the intended use of the T-SPOT.TB test? 15. Why does the T-SPOT.TB test measure interferon-gamma? 16. Does the T-SPOT.TB test differentiate between latent TB infection and TB disease? 17. What data is there to support the T-SPOT.TB test in clinical use? 18.
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Faqs 1. What Is a 2-Step TB Skin Test (TST)? Tuberculin Skin Test (TST
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Prior Tuberculin Skin Testing Does Not Boost Quantiferon-TB Results in Paediatric Contacts
REFERENCES 4 Aaron SD, Vandemheen KL, Fergusson D, et al. Tiotropium 1 Suissa S, Ernst P, Vandemheen KL, Aaron SD. in combination with placebo, salmeterol, or fluticasone– Methodological issues in therapeutic trials of COPD. Eur salmeterol for treatment of chronic obstructive pulmonary Respir J 2008; 31: 927–933. disease: a randomized trial. Ann Intern Med 2007; 146: 2 Sin DD, Wu L, Anderson JA, et al. Inhaled corticosteroids 545–555. 5 Wedzicha JA, Calverley PM, Seemungal TA, et al. The and mortality in chronic obstructive pulmonary disease. prevention of chronic obstructive pulmonary disease exacer- Thorax 2005; 60: 992–997. bations by salmeterol/fluticasone propionate or tiotropium 3 Calverley PM, Anderson JA, Celli B, et al. Salmeterol and bromide. Am J Respir Crit Care Med 2008; 177: 19–26. fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356: 775–789. DOI: 10.1183/09031936.00030508 Prior tuberculin skin testing does not boost QuantiFERON-TB results in paediatric contacts To the Editors: children were evaluated with TST and QFT-GIT. At the first visit, 63 (77.8%) contacts were QFT-GIT negative, eight (9.9%) We read with interest the paper by LEYTEN et al. [1], which were QFT-GIT positive and 10 (12.3%) had an undetermined appeared in the June 2007 issue of the European Respiratory QFT-GIT. Of those initially negative children, only one became Journal (ERJ). LEYTEN et al. [1] showed that prior tuberculin skin QFT-GIT positive after TST. The mean IFN-c antigen-specific 1 tests (TST) do not induce false-positive QuantiFERON -TB production did not change 11 weeks after skin testing (ESAT-6/ Gold in-tube (QFT-GIT) assay results when evaluated in the CFP-10/TB7.7 difference -0.030 IU?mL-1,p50.281).
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Screening and Treatment Recommendations for People Exposed to Multidrug Resistant TB All people at increased risk of tuberculosis (TB) infection should be screened for TB infection per United States Preventive Services Task Force [1] and Centers for Disease Control and Prevention guidelines [2]. This document provides specific guidance for screening and post- screening management of all people who have been identified through public health investigations as having been exposed to multidrug resistant tuberculosis (MDR TB). Recommendations for symptomatic contacts, children less than 5 years of age and those who are highly immunocompromised (see step 1B) are different from other groups. Step 1: Initial Screening A. Assess contacts for symptoms of active TB disease ▪ Cough lasting 3 weeks or longer ▪ Contacts reporting cough of less than 3 weeks duration at the time of screening should have follow-up to determine if the cough has resolved. If they have a persistent cough for greater than or equal to 3 weeks, further evaluation is indicated. ▪ Hemoptysis (coughing up blood) ▪ Chest pain ▪ Night sweats ▪ Fevers or chills ▪ Unintentional weight loss ▪ Loss of appetite ▪ Fatigue B. Obtain a medical history including prior TB screening and TB treatment information ▪ Contacts with prior positive tuberculin skin test (TST) or interferon-gamma release assay (IGRA) results (documentation of previous testing is recommended) do not need a new TST or IGRA performed; they should be considered to have a positive TB screening test. In the event a person with a past positive TST or IGRA has a new TST or IGRA performed and it is negative, the significance of the new screening test is uncertain.
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