TUBERCULOSIS CONTROL PROGRAMME

PRESENTED BY DR.PRIYANKA PHONDE.

INTRODUCTION TO TUBERCULOSIS
Tuberculosis, MTB or TB a common and in many cases lethal infectious disease caused by various strains of mycobacterium, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body. It is spread through the air when people who have an active MTB infection cough, sneeze, or otherwise transmit their saliva through the air Most infections in humans result in an asymptomatic, latent infection, and about one in ten latent infections eventually progresses to active disease, which, if left untreated, kills more than 50% of its victims.

HISTORY OF TUBERCULOSIS
Dr. Robert Koch discovered the tuberculosis bacillus.

Tubercular decay has been found in the spines of Egyptian mummies. Tuberculosis has been present in humans since antiquity. The earliest detection of Mycobacterium tuberculosis is in the remains of bison dated 18,000 years before. Whether tuberculosis originated in cattle and then transferred to human.

Pictured: Egyptian mummy in the British Museum

VARIOUS TYPES OF TUBERCULOSIS

Pulmonary tuberculosis Tuberculosis (TB) will not cause any symptoms until the infection has reached the lungs. As the bacteria are very slow moving, the condition develops very slowly. Your symptoms might not begin until many years after you were initially exposed to the bacteria. Symptoms of pulmonary TB include: a persistent cough that brings up thick phlegm, which may be bloody breathlessness, which is usually mild to begin with and gradually gets worse weight loss lack of appetite a high temperature of 38C (100.4F) or above extreme tiredness a sense of feeling unwell

Extra pulmonary tuberculosis (TB)

TB infection can spread from the lungs to other parts of the body. TB infections that occur outside the lungs are known as extrapulmonary TB. Extrapulmonary TB is more common in people with weakened immune systems particularly people with an HIV infection.

A TB infection can spread to: lymph nodes that are near the lungs (lymph node TB) bones and joints (skeletal TB) the digestive system (gastrointestinal TB) the bladder and reproductive system (genitourinary TB) the nervous system (central nervous system TB) Cardiac Tuberculosis Scrofula Adrenal Tuberculosis

Causes, incidence, and risk factors

Pulmonary tuberculosis (TB) is caused by the bacteria Mycobacterium tuberculosis (M. tuberculosis). You can get TB by breathing in air droplets from a cough or sneeze of an infected person. This is called primary TB. In the United States, most people will recover from primary TB infection without further evidence of the disease. The infection may stay asleep or inactive (dormant) for years. However, in some people it can reactivate. Most people who develop symptoms of a TB infection first became infected in the past. However, in some cases, the disease may become active within weeks after the primary infection. The following people are at higher risk for active TB: Elderly Infants People with weakened immune systems, for example due to AIDS, chemotherapy, diabetes, or certain medications Your risk of contracting TB increases if you: Are in frequent contact with people who have TB Have poor nutrition Live in crowded or unsanitary living conditions The following factors may increase the rate of TB infection in a population: Increase in HIV infections poor environment and nutrition The appearance of drug-resistant strains of TB

TESTS FOR TUBERCULOSIS

Examination may show: Clubbing of the fingers or toes (in people with advanced disease) Enlarged or tender lymph nodes in the neck or other areas Fluid around a lung (pleural effusion) Unusual breath sounds (crackles) Tests may include: Biopsy of the affected tissue (rare) .CBC,ESR Chest CT scan Interferon-gamma blood test such as the QFT-Gold test to test for TB infection Sputum examination and cultures Thoracentesis Tuberculin skin test Chest x-ray Acid-fast stain Bronchoscopy Coughing up blood Disseminated tuberculosis Gastric culture Hemoglobinuria Mediastinoscopy with biopsy Meningitis tuberculous Mycobacterial culture Open pleural biopsy Pleural fluid culture Pleural needle biopsy PPD skin test Pulmonary tuberculosis Routine sputum culture Scrofula Sputum stain for mycobacteria Synovial biopsy Thoracic CT

How does a doctor diagnose Tuberculosis?

TB can be diagnosed in several different ways, including chest X-rays, analysis of sputum, and skin tests. Sometimes, the chest X-rays can reveal evidence of active tuberculosis pneumonia. The X-rays may show scarring (fibrosis) or hardening (calcification) in the lungs. Examination of the sputum on a slide (smear) under the microscope can show the presence of the tuberculosis-like bacteria. Bacteria of the Mycobacterium family Tuberculin skin tests include the Tine test and the Mantoux test, also known as the PPD (purified protein derivative) test.

Treatment
The most commonly used drugs include: Isoniazid(H) Rifampin(R) Pyrazinamide(Z) Ethambutol(E) Other drugs that may be used to treat TB include: Amikacin Moxifloxacin Streptomycin Is there a vaccine against tuberculosis? Bacille Calmette Gurin, also known as BCG, is a vaccine given throughout many parts of the world. It is derived from an atypical l Mycobacterium but offers some protection from developing active tuberculosis, especially in infants and children.

CATEGORY

TYPE OF PATIENT
New sputum smear+ve,or ve,new extrapulmonary other TB cases
Sputum smear +ve relapse,sputum smear+ve faiture,sputum smear positive Rx after default DISCONTINUED

*MEDICINE GIVEN
2H3,R3,E3,Z3 + 4H3 R3

DURATION OF COLOUR OF FOLLOW-UP TREATMENT TREATMENT SPUTUM BOX EXAMINATION

IP-2MONTHS CP-4 MONTHS RED 2,4,6 MONTHS

CAT-1

CAT-2

2S3 H3 R3 3E3 Z3 + 1H3 R3 E3 Z3 + 5H3 R3 E3

IP-3MONTHS CP-5 MONTHS

BLUE

3,5,8 MONTH

CAT-3 CAT-4

MDR

6(9) Km Ofx (lvx)EtoCs Z E/18 Ofx (Lvx)E to Cs E

IP-6-9 Mnths Cp-18-24 mnths

3,4,5,6,7,9,12, 15,18,21,24 months

What is drug-resistant TB?

Drug-resistant TB (TB that does not respond to drug treatment) has become a very serious problem in recent years in certain populations. For example, INH-resistant TB is seen among patients from Southeast Asia. The presence of INHlike substances in the cough syrups in that part of the world may play a role in causing the INH resistance. However, the major reason for the development of resistance is poorly managed TB care. This can result from poor patient inappropriate dosing or prescribing of medication, poorly formulated medications or an inadequate supply of medication. Multidrug-resistant tuberculosis (MDR-TB) refers to organisms that are resistant to at least two of the first-line drugs, INH and Rifampin. More recently, extensively (extremely) drug resistant tuberculosis (XDR-TB) has emerged. These bacteria are also resistant to three or more of the second-line treatment drugs.

What is multidrug-resistant tuberculosis (MDR TB)? Multidrug-resistant TB (MDR TB) is TB that is resistant to at least two of the best anti-TB drugs, isoniazid and rifampicin. These drugs are considered first-line drugs and are used to treat all persons with TB disease. What is extensively drug resistant tuberculosis (XDR TB)? Extensively drug resistant TB (XDR TB) is a relatively rare type of MDR TB. XDR TB is defined as TB which is resistant to isoniazid and rifampin, plus resistant to any fluoroquinolone and at least one of three injectable second-line drugs (i.e., amikacin, kanamycin, or capreomycin). Because XDR TB is resistant to first-line and secondline drugs, patients are left with treatment options that are much less effective. XDR TB is of special concern for persons with HIV infection or other conditions that can weaken the immune system. These persons are more likely to develop TB disease once they are infected, and also have a higher risk of deaths. How does drug resistance happen? Resistance to anti-TB drugs can occur when these drugs are misused or mismanaged. Examples include when patients do not complete their full course of treatment; when health-care providers prescribe the wrong treatment, the wrong dose, or length of time for taking the drugs; when the supply of drugs is not always available; or when the drugs are of poor quality. Who is at risk for getting MDR TB? Drug resistance is more common in people who: do not take their TB medicine regularly do not take all of their TB medicine as told by their doctor or nurse develop active TB disease again, after having taken TB medicine in the past come from areas of the world where drug-resistant TB is common have spent time with someone known to have drug-resistant TB disease

How can MDR TB be prevented? The most important thing a person can do to prevent the spread of MDR TB is to take all of their medications exactly as prescribed by their health care provider. No doses should be missed and treatment should not be stopped early. Patients should tell their health care provider if they are having trouble taking the medications. If patients plan to travel, they should talk to their health care providers and make sure they have enough medicine to last while away. Health care providers can help prevent MDR TB by quickly diagnosing cases, following recommended treatment guidelines, monitoring patients response to treatment, and making sure therapy is completed. Another way to prevent getting MDR TB is to avoid exposure to known MDR TB patients in closed or crowded places such as hospitals, prisons, or homeless shelters. If you work in hospitals or health-care settings where TB patients are likely to be seen, you should consult infection control or occupational health experts. Ask about administrative and environmental procedures for preventing exposure to TB. Why is XDR TB so serious? Because XDR TB is resistant to the most powerful first-line and second-line drugs, patients are left with treatment options that are much less effective and often have worse treatment outcomes. XDR TB is of special concern for persons with HIV infection or other conditions that can weaken the immune system. These persons are more likely to develop TB disease once they are infected, and also have a higher risk of death once they develop TB disease.

TB Burden in India Tuberculosis (TB) remains the number one killer infectious disease affecting adults in developing countries. The 1990 World Health Organization (WHO) report on the Global Burden of Disease ranked TB as the seventh most morbidity-causing disease in the world, and expected it to continue in the same position up to 2020. . In 1993, the WHO declared TB as a global emergency. The situation is more complicated when one considers countries such as India where India accounts for one-third of the global TB burden, with 1.8 million developing the disease each year and nearly 0.4 million dying due to TB annually.

Preface Tuberculosis (TB) is a disease that has severely affected communities and nations The disease has brought untold miseries to generations and even today, when newer modalities for diagnosis and treatment of TB have made the disease curable, people are suffering and dying from the disease. During 2004, it was estimated, about nine million new cases of TB occurred globally. India contributes a fifth of these cases, i.e., about 1.8 million, of which 0.8 million are new sputum-positive infectious cases. Nearly 400,000 estimated deaths occur annually due to tuberculosis. The National TB Control Programme (NTCP) was started in 1962, using the District TB Centre model. In 1992, the Government of India, together with the World Health Organization (WHO) and the Swedish International Development Agency (SIDA), reviewed the national programme and concluded that it suffered from managerial weaknesses, inadequate funding, over-reliance on x-ray, non-standard treatment regimens, low rates of treatment completion, and lack of systematic information on treatment outcomes. In 1993, WHO declared TB a global emergency and devised the Directly Observed Treatment - Short Course (DOTS) strategy and recommended that all countries adopt this strategy. The strategy is built on five pillars, viz, political commitment and continued funding for TB control programmes, diagnosis by sputum smear examinations, uninterrupted supply of high quality anti-TB drugs, drug intake under direct observation, and accurate recording and reporting of all registered cases.. The Revised National TB Control Programme (RNTCP) was launched in India in 1997, The World Bank acknowledged that the DOTS strategy was the most economical health intervention and agreed to provide credit assistance for the RNTCP, initially for the coverage of 271 million population, later revised to cover 730 million population. Presently, other bilateral and multilateral agencies, Danish International Development Agency (DANIDA), Department for International Development (DFID), US Agency for International Development (USAID), Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria (GFATM) and Global Drug Facility (GDF), are providing invaluable support to the programme.

Tuberculosis Control in India.

The History of Tuberculosis Control in India.

The Four Decades Prior to Tuberculosis Control Programmes Establishment of Sanatoria and TB Clinics TB Association of India: The first concerted effort towards TB control in the country was through the organization of the King George V thanksgiving fund in 1929. The TB Association of India was established on February 23, 1939. Government Initiatives Mass BCG Campaign: The mass BCG campaign started in 1951, and in addition to the 65 million children vaccinated, 165 million tuberculin tests were administered. This gave first indications that the TB problem in rural areas could be as large as that found in the urban areas Three Decades of the National TB Control Programme Development of the National TB Control Programme :The available tools for the control of TB consisted of BCG vaccination for prevention, chest radiography and sputum microscopy for case finding, and chemotherapy for treatment. 1959, the National TB Institute (NTI) was established in Bangalore With the availability of Rifampicin, the reintroduction of Pyrazinamide and the success of the six-month short-course chemotherapy (SCC) regimens in clinical trials, it was possible to reduce the treatment duration from 12 down to six months.

The Revised National Tuberculosis Control Programme

Genesis of the Revised National TB Control Programme Despite the NTP being in existence since 1962, no appreciable change in the epidemiological situation of TB in the country had been observed. The HIV-AIDS epidemic and the spread of multi-drug resistance TB were threatening to further worsen the situation. In view of this, in 1992, GoI, with WHO and SIDA reviewed the TB situation and the performance of the NTP. The observations revealed that the NTP, though technically sound, suffered from managerial weaknesses, inadequate funding, an over-reliance on x-ray for diagnosis, had frequent interrupted supplies of drugs, and low rates of treatment completion. To rectify these lacunae, The Revised National TB Control Programme (RNTCP) thus formulated, adopted the internationally recommended Directly Observed Treatment Short-course (DOTS) strategy, as the most systematic and cost-effective approach to revitalize the TB control programme in Indialth services; an uninterrupted supply of good quality anti-TB drugs; effective and patient-friendly treatment The objectives of the RNTCP are . To achieve at least 85 percent cure rate among the new smear-positive cases initiated on treatment, and thereafter a case detection rate of at least 70 percent of such cases. The RNTCP builds on the strengths and achievements of the NTP, as the NTP had created an extensive infrastructure for TB control with a network of more than 446 District TB Centre, 330 TB clinics and more than 47,600 TB beds. The RNTCP decentralizes the supervision and managerial responsibility through the creation of a sub-district level supervisory team, comprising a Senior Treatment Supervisor (STS), a Senior TB Lab Supervisor (STLS) and a designated Medical Officer-TB Control (MOTC), catering to a population of approximately 5,00,000, microscopy centres which cater to 1,00,000 population with quality microscopy equipment and trained personnel. A decentralized financial management system was also put in place by creating state and district TB control societies. To maintain an uninterrupted supply of quality anti-TB drugs, distribution, monitoring and quality assurance procedures have been streamlined successfully.

DOTS
The WHO-recommended Directly Observed Treatment, Short Course (DOTS) strategy was launched formally as Revised National TB Control programme in India in 1997 after pilot testing from 19931996. DOTS is the most effective strategy available for controlling TB. The five key components of DOTS are Political commitment to control TB Case detection by sputum smear microscopy examination among symptomatic patients; Patients are given anti- TB drugs under the direct observation of the health care provider/community DOT provider; Regular, uninterrupted supply of anti-TB drugs; and Systematic recording and reporting system that allows assessment of treatment results of each and every patient and of whole TB control programme. The new stop TB strategy was recommended internationally by WHO. The components of the new stop TB strategy are the following: Pursue High quality DOTS expansion and enhancement Address TB/HIV, MDR-TB and other challenges Contribute to health system strengthening Engage all health care providers Empower people with TB, and communities Enable and promote research

GOALS AND OBJECTIVES OF RNTCP

Goals and Objectives for TB control in India up to 2015 Goal: The goal of the TB control Programme is to decrease mortality and morbidity due to TB and cut transmission of infection until TB ceases to be a major public health problem in India. Objectives: The objective of TB control Programme is to achieve and maintain cure rate of at least 85% in new sputum positive pulmonary TB patients, and to achieve and maintain detection of at least 70% of such cases. Involvement of Other Sector: NGOs: Private practitioners: Medical colleges TB/HIV coordination activities Training Quality assurance of sputum microscopy

Treatment under RNTCP

Treatment groups Type of patient Regimen Intensive Phase (IP) Continuation Phase (CP)

New (Cat I)

New Sputum smear2H3R3Z3E3 positive New Sputum smearnegative New Extra-pulmonary New Others

4H3R3

Previously Treated (Cat II)

Smear-positive 2H3R3Z3E3S3/ relapse Smear-positive failure 1H3R3Z3E3 Smear-positive treatment after default Others

5H3R3E3

Surveillance of Drug Resistance in India

Types Drug resistance in TB may be broadly classified as primary and acquired. Drug resistance in a patient who has never received anti-TB treatment previously is termed as primary resistance. Acquired resistance is that which occurs as a result of specific previous treatment. The term initial resistance is used to indicate primary resistance and resistance among patients whose history of previous chemotherapy is not known. Causes Factors related to the development of drug resistance include: Inadequate or inefficient administration of effective treatment; poor case holding; use of sub-standard drugs; inadequate or irregular drug supply; ignorance of healthcare workers , interruption of chemotherapy due to side effects; availability of anti-TB drugs without prescription; illiteracy; low socio-economic status of patients laboratory delays in identification and susceptibility testing of M. tuberculosis isolates Detection The conventional methods of isolation, identification and indirect drug susceptibility testing of M. tuberculosis usually require eight to10 weeks. Although they are most widely used, the long waiting period in obtaining results by these methods may delay the initiation of proper treatment, resulting in the patient transmitting drug-resistant infection in the community. In recent years, several new methods have been reported for reducing the time interval between the collection of the specimen and the receipt of results to three weeks or less. However, these methods require considerable technical expertise and financial inputs in a routine laboratory setup in disease.

Extrapulmonary Tuberculosis: Management and Control

Diagnosis and Treatment of EPTB under the RNTCP

Category of Treatment Category I

Type of Patient New sputum smear-positive pulmonary TB (PTB) Seriously ill** new sputum smear-negative PTB Seriously ill** new EPTB Sputum smear-positive relapse Sputum smear-positive failure Sputum smear-positive treatment after default Others*** New sputum smear-negative PTB , New EPTB, not seriously ill

Regimen* 2H3R3Z3E3 + 4H3R3

Category II

2S3H3R3Z3E3+1H3R3Z3E3+ 5H3R3E3

Category III

2H3R3Z3+4H3R3

Facts and Figures about Paediatric Tuberculosis Of total case prevalence, paediatric TB is estimated to account for about 10 percent. Females are more susceptible to develop the disease. Extrapulmonary TB is noticeably high in children. Diagnosis is difficult in paediatric patients. Detection of smear-positivity increases with age, and smear positive to negative ratio in adolescents closely matches with that of adults.

Pediatric Tuberculosis:

The RNTCP and Medical Colleges

The major activities to be undertaken by the medical colleges themselves include: 1) Training/teaching of RNTCP amongst: _ Faculty members; _ Undergraduates and postgraduates ; _ Residents and Interns; and _ Paramedical staff (laboratory technicians and nursing staff). 2)Engagement with the RNTCP 3)Advocacy of the RNTCP 4) Conduct Operational Research on relevant topics to RNTCP

Public-Private Mix in the Revised National TB Control Programme

In the earlier days of the RNTCP, the concept of Public-Private Mix (PPM) had mainly considered only the collaboration between the national TB programme and the private health sector, through the involvement of private hospitals and Private Practitioners (PPs). It is now conceived as a strategy to diagnose and treat TB patients reporting to all sectors of health care under the DOTS strategy. PPM has been defined by WHO as strategies that link all entities within the private and public sectors (including health providers in other governmental ministries) to the national.

TB-HIV Co-infection: A Lethal Combination

Impact of TB on HIV and HIV/AIDS Control Programme. TB is one of the most common treatable infectious HIV-related disease . Untreated TB shortens the survival of patients with HIV infection. TB accelerates the progression of HIV, as observed. Worldwide TB is the leading cause of death. Late TB diagnosis contributes to increased death rates. In order to contain the deadly duo of HIV-TB, it is, therefore, essential that the HIV and TB control programmes work closely together. National Action Plan for Joint TB-HIV Coordination Sensitisation of key policy-makers to address the importance of TB-HIV co-infection. Joint Training Programme for service providers involved in RNTCP and NACP by VCCTCc-DMCdcoordination Sensitisation of NGOs and PPs working for NACP and RNTCP Infection control measures Information, Education, and Communication Treatment services for tuberculosis and HIV Monitoring and evaluation of coordination of both the programmes

Diagnostic Needs and Status of New Diagnostic Tools for Tuberculosis

Diagnostic Needs of High TB Prevalence Countries Replacement for smear Replacement for culture Screening test drug resistance detection Recent Advances in Diagnostics Smear Microscopy Culture Radiometric BACTEC 460 TB method: MGIT 960 (Mycobacteria Growth Indicator Tube): MB/BacT system: Microscopic observation of broth culture Septi-check AFB method: Micro colony detection on solid media: Rapid Identification of Mycobacterium Isolates Analysis of lipid: Probe-based identification: Sherlock mycobacteria identification system (SMIS): PCR restriction enzyme analysis DNA chips:

The Role of IEC in the RNTCP

Health Communication Health Promotion Health Education Objectives Achieved through IEC A greater appreciation of the TB control programme by policy-makers and other stakeholders Increased level of information about the disease, its curability, standard diagnostic and treatment regime among patients and providers Popularizing the fact that TB is curable, by using cured patients to motivate others Making TB services more accessible to the marginalised sections of society women, tribal and other marginalised groups through awareness generation, and the promotion of health seeking behavior Greater collaboration with private health care providers by popularizing availability of good quality diagnostic and treatment under the RNTCP; Greater involvement of other sectors by ensuring referral to government health centres and also ensuring their involvement in diagnosis and treatment of patients; Ensuring completion of treatment by patients by increasing their knowledge about the disease and their treatment, and also by creating patient-friendly environments; and Making DOTS a familiar name among different target audiences so that there is an immediate association of the term DOTS with TB and its cure.

Target Groups
The target audiences that are to be addressed through the RNTCP IEC activities have been divided into three groups: _ Patients, their Families and the General Public _ Health Providers (Public and Private) Policy-makers, Opinion Leaders, Stakeholders

Media Options
The issues concerning TB do not vary greatly across the country, despite economic and sociocultural differences, though language and the medium of communication and preference of the medium would vary across the states and districts. The Centre focuses on mass media for the dissemination of messages about TB, targeted at opinion leaders, patients, the public at large and health providers, both public and private. Advocacy effort are targeted at the opinion leaders, other major stakeholders, NGOs, medical colleges and other partners in the programme.

Planning 12th Five Year Plan (2012-2017) Universal Access: Reaching the Unreached the New Vision of RNTCP

RNTCP has implemented most of the additional components of the WHO Stop TB strategy including TB/HIV, management of drug resistant TB, engagement of NGO and Private sectors, Infection control and Operational Research. The twin objectives of RNTCP (70% case detection rate and 85% treatment success rate) have been achieved for the past 4 years. There is evidence on the effectiveness of the RNTCP DOTS programme on significantly decreasing the burden of TB . The vision of the Government of India is for a Tbfree India with reduction of the burden of the disease In particular, by end- 2015, the programme aims to achieve the following targets: Early detection and treatment of at least 90% of estimated TB cases in the community, including HIV-associated TB; Initial screening of all re-treatment smear positive TB patients for drug-resistant TB and provision of treatment services for MDR-TB Offer of HIV Counseling and testing for all TB patients and linking HIV-infected TB patients to HIV care and support Successful treatment of at least 90% of all new TB patients, and at least 85% of all previouslyt reated TB patients; Extend RNTCP services to patients diagnosed and treated in the private sector

Monitoring and Evaluation System

Level Frequency of review Peripheral Health Institutions (PHIs) & Designated Microscopy Centres (DMCs) Tuberculosis Unit (TU) MO i/c PHI/DMC conducts a meeting of all the staff involved in RNTCP and reviews their activities weekly.

MO-TC reviews the activities of STS/STLS at least fortnightly.

District Level

DTO reviews the monthly activity reports of all MOTCs, STS and STLS within the district during monthly district level review meetings. CMO and DM also review the programme on a regular basis.
State level review meetings are held every quarter and chaired by Secretary (Health)/DHS. STO also reviews the monthly activity reports of DTOs within the states. Recommendations of all the evaluations and the actions taken are discussed at the meeting. CTD conducts review meetings of STOs twice in a year. All important issues covering technical performance, administrative and managerial issues, manpower resources, logistics and financial issues, are reviewed.

State Level

National Level

Stop TB Strategy
All components of new Stop TB Strategy are incorporated in RNTCP. These are: Pursue quality DOTS expansion and enhancement, by improving the case finding are cure through an effective patient-centred approach to reach all patients, especially the poor. Address TB-HIV, MDR-TB and other challenges, by scaling up TB-HIV joint activities, DOTS Plus, and other relevant approaches. Contribute to health system strengthening, by collaborating with other health programmes and general services Involve all health care providers, public, nongovernmental and private, by scaling up approaches based on a public-private mix (PPM), to ensure adherence to the International Standards of TB care. Engage people with TB, and affected communities to demand, and contribute to effective care. This will involve scaling-up of community TB care; creating demand thorugh context-specific advocacy, communication and social mobilization. Enable and promote research for the development of new drugs, diagnostic and vaccines. Operational Research will also be needed to improve programme performance.

Challenges for the Future

Additional technical progress is still needed to refine, simplify and improve the performance of new TB diagnostics, and to adapt them to the laboratory conditions found in developing countries. _ Epidemiological and operational research is needed to develop algorithms optimizing the use of alternative diagnostics. _ Objective evaluation of the analytic and clinical performance of assays. _ Pilot studies of new tests in TB programme conditions. _ Operational research determining the local factors affecting use of specific tests. _ Establishment of an international process that compares performance of diagnostics under expert consensus criteria. _ Research is needed to support models predicting the impact of early diagnosis on morbidity, mortality, disease transmission, and ultimately on TB control. _ Laboratories and clinical services need to be strengthened concomitantly with the development of new tools, to ensure optimal use of both existing and new tests.