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World Health Organization
TB Case Definitions
Module 4 – March 2010
Project Partners
Funded by the Health Resources and Services Administration (HRSA)
Module Overview
TB Case Definitions Categories for
Classifying TB Cases• Site of Disease
• Bacteriologic Result
• HIV Status
• History of Prior Treatment
TB Case Registration Groups
Learning Objectives
Objectives: At the end of this presentation,participants will be able to:
Define TB cases utilizing the World Health Organization case definitions for tuberculosis
State the four key features important to classifying TB cases
Categorize TB cases utilizing the World Health Organization registration groupings
TB Case Definitions
Why do we define and categorize TB cases?
Purpose of TB Case Definitions
Correct categorization of patients before starting treatment for TB is essential:• for proper patient registration and case notification
• to select the appropriate treatment regimen
• to standardize the process of data collection for TB control
• to evaluate the proportion of cases according to site, bacteriology, and treatment history
• for cohort analysis of treatment outcomes
• to accurately monitor trends and evaluate the effectiveness of TB programs
TB Case Definitions
Tuberculosis suspect — Any person who presents with symptoms or signs suggestive of TB (e.g., a cough of long duration, > 2 weeks)
Case of tuberculosis• a definite case of TB (defined next slide) or • diagnosed by a health worker with the plan to treat
with a full course of anti-TB treatment
Any person started on TB treatment should be recorded as a case. Incomplete “trial” TB treatment should not be given as a method for diagnosis
TB Case Definitions (2)
Definite case of tuberculosis: A patient with M. tuberculosis complex identified from a clinical specimen by culture or newer method (e.g., nucleic acid amplification, molecular beacon or line probe assays)
In countries where M. tuberculosis cannot routinely be identified, a pulmonary case with one or more initial sputum smears positive for acid-fast bacilli (AFB) is also considered a “definite” case
Categories for Classifying TB Cases
TB Case Classifications
TB cases are also classified according to:
1. Anatomical site of TB disease
2. Bacteriologic results (including drug resistance)
3. History of previous TB treatment
4. HIV status of the patient
Anatomical Site of Disease
Pulmonary Tuberculosis (PTB): Refers to disease involving the lung parenchyma• A patient with both pulmonary and extra-
pulmonary TB constitutes a case of PTB
• Miliary TB is classified as PTB because there are lesions in the lungs
Anatomical Site of Disease (2)
Extra-pulmonary Tuberculosis (EPTB): Refers to TB disease of organs other than the lungs. Therefore the following constitute a case of EPTB:• Tuberculous intrathoracic lymphadenopathy
(mediastinal and/or hilar)
• Tuberculous pleural effusion, without radiographic abnormalities in the lungs
• Extrathoracic TB
Anatomical Site of Disease (3) Diagnosis of EPTB should be based on a
decision to treat with a full course along with:• One culture-positive specimen; or• Histological specimen; or• Strong clinical evidence consistent with active
EPTB and a decision to treat with a full course of anti-TB treatment
Where several EPTB sites are involved, the case definition depends on the site representing the most severe form of disease
Classify as PTB if both pulmonary and extra-pulmonary sites involved
Bacteriologic Result
Includes smear, culture and newer methods for identification of M. tuberculosis
Defining the AFB smear result is important :• to identify smear-positive cases = most
infectious; most likely to transmit TB to others
• to identify sputum smear-negative cases, especially HIV positive persons
• to record, report, and evaluate program performance
Bacteriologic monitoring for treatment response is most practical in smear-positive patients
Bacteriologic Result (2)
Pulmonary TB: Sputum smear-positive
Where there is a functional EQA system:• A patient with one or more sputum
specimens that are AFB smear-positive is considered a PTB case
Bacteriologic Result (2)
Pulmonary TB: Sputum smear-positive
Where there is not yet a functional EQA system, then one of the following apply at treatment start:• > 2 sputum specimens are AFB smear-positive; or
• at least 1 sputum specimen is AFB smear-positive and radiographic abnormalities consistent with active PTB are present and determined by a clinician; or
• at least one sputum specimen is AFB smear-positive plus culture is positive for M. tb
Bacteriologic Result (3)
Pulmonary TB: Sputum smear-negative
At least 2 sputum specimens are negative for AFB at start of treatment
No specimen is smear positive
Obtain TB culture for all smear-negative cases
Bacteriologic Result (4)
Pulmonary TB: Sputum smear-negative
Defined as:
1. Smear-negative but culture-positive for M.tb; or
2. Meet the following criteria:• decision by a clinician to treat with a full course of
anti-tuberculosis chemotherapy, and
• radiographic abnormalities consistent with active PTB, and either: laboratory or strong clinical evidence of HIV infectionor no response to a course of broad-spectrum non-TB
antibiotics (if HIV-negative or status unknown)
Bacteriologic Result (5)
Pulmonary TB: Smear not done
PTB cases without smear results are no longer classified as smear-negative!
Classify as “smear not done” on the TB Register and annual survey
ISTC Standard 3: Extrapulmonary Specimens
For all patients suspected of having extrapulmonary TB, appropriate specimens from the suspected sites of involvement should be obtained for microscopy, culture and histopathological examination.
Bacteriologic Result (6)
International Standards for Tuberculosis Care, 2009
HIV Status
Determining and recording HIV status for TB cases is critical for:• Making treatment decisions• Monitoring trends• Assessing program performance
The 2006 updated TB Register and TB Treatment Card include dates for:• HIV testing• Co-trimoxazole initiation• ART initiation
History of Previous TB Treatment
A case should be defined according to whether or not the patient has previously received TB treatment in order to:
• Identify patients at increased risk of acquired drug resistance
• Provide epidemiological monitoring of the TB epidemic and program performance at regional and country levels
TB Case Registration Groups
TB Case Registration Groups
New case: A patient who has never had treatment for TB or who has taken anti-tuberculosis drugs for less than 1 month
Previously Treated case: A patient who has received a month or more of anti-TB drugs in the past (with positive or negative bacteriology)• Case is further classified by outcome of most
recent course of treatment
No “chronic” category
TB Case Registration Groups (2)
Relapse: A patient previously treated for TB who has been declared cured or treatment completed, and is diagnosed with bacteriologically positive TB (smear, culture or newer means of identifying M.tb)
Treatment after Failure: A patient who is started on a re-treatment regimen after having failed previous treatment
Treatment after Default: A patient who returns to treatment following interruption of treatment for > 1 month and is positive bacteriologically
Previously treated cases
TB Case Registration Groups (3)
Transfer in: A patient who has transferred from another TB register to continue treatment
Other: All cases that do not fit the previous definitions. This includes:• Previous treatment history is unknown• Previously treated, but outcome is unknown• Returned to treatment with:
• smear-negative PTB• bacteriologically negative EPTB
TB Case Registration
Activity
Summary
Every TB patient should be assessed for the four key features of case definition so they can be classified correctly and begin treatment
Every TB patient should have TB case registration group determined prior to initiation of TB treatment