STS: TB Diagnosis and Case finding

National Tuberculosis Elimination Programme (NTEP) strives for all presumptive TB patients to be microbiologically confirmed. Under NTEP, the acceptable methods for microbiological diagnosis of TB are: 

Rapid diagnostic molecular test: Rapid molecular tests that use techniques like NAAT are very specific. They amplify the genomic material in the patient sample and hence enhances detection

• Nucleic Acid Amplification Test (NAAT) e.g., GeneXpert, TrueNat

  

  Figure: Genxpert Machine for CBNAAT

  

  Figure:  Truenat Machine

• Line Probe Assay

Microscopy is a TB diagnostic technology that utilizes the acid-fastness property of Mycobacterium tuberculosis to visualize it under a microscope. Results of sputum smear microscopy can either be smear-negative, or smear-positive (with various grades). 

Advantages:

• It is currently the most accessible and cheapest TB diagnostic test available under National TB Elimination Programme (NTEP) in India.
• It has the shortest turnaround time for diagnosis.
• It has high specificity. 

Limitations:

• Low sensitivity. It becomes positive only when more than 5000 bacilli/ml of sample are present. Hence, cases would be missed in early disease, or when an inappropriate biological specimen is provided, where bacterial load in sputum is less.
• It is unable to differentiate between M. tuberculosis and Non-tuberculous Mycobacteria (NTM). This is predominantly an issue in geographies with lower burden.

There are two types of microscopies used in NTEP: Ziehl-Neelsen (ZN) Microscopy and Fluorescence Microscopy (FM). These vary in the type of stain and microscope used. FM is newer of the two types and is currently recommended for use over ZN.

Resources

• WHO Policy Statement - Fluoresence Light-emitted Microscope for the Diagnosis of TB, 2010.

Cartridge Based Nucleic Acid Amplification Test (CBNAAT) is a rapid molecular diagnostic test. It is used for diagnosis of Tuberculosis (TB) and Rif-resistant Tuberculosis (RR-TB) in NTEP. Results are obtained from unprocessed sputum samples in about 2hours which helps in early detection and treatment of TB patients. 

India has vast number of CBNAAT laboratories which are utilized for TB/RR-TB detection and Universal Drug Susceptibility Testing (UDST) under the National TB Elimination Program (NTEP).  

Figure: CBNAAT Cartridge and Machine in Use (Image courtesy: USAID supported Challenge TB Project)

The CB-NAAT system detects DNA sequences specific for Mycobacterium tuberculosis complex and rifampicin resistance by Polymerase Chain Reaction (PCR). It concentrates Mycobacterium tuberculosis bacilli from sputum samples, isolates genomic material from the captured bacteria by sonication and subsequently amplifies the genomic DNA by PCR. The process identifies clinically relevant rifampicin resistance-inducing mutations in the RNA polymerase beta (rpoB) gene in the Mycobacterium tuberculosis genome in a real-time format using fluorescent probes called molecular beacons.

Video: Cartridge-Based Nucleic Acid Amplification Test [CBNAAT] - GeneXpert Technology 

Resources

• Training Module (1-4) for Program Managers and Medical Officers, NTEP, MoHFW, 2020.
• India TB Report 2021, National TB Elimination Program (NTEP), MoHFW, 2021.

Assessment Questions

Truenat is an indigenous rapid molecular test platform that is currently under use in NTEP for diagnosis of TB and Rif Resistance. It is a platform utilising real-time Polymerase Chain Reaction (PCR) technology built into micro-PCR chips.

Testing on Truenat involves three components:

1. Workstation (consisting of 2 devices)
   • Trueprep AUTO Universal Cartridge-based Sample Prep Device for the automated extraction and purification of DNA
   • Truelab Real-time micro PCR Analyzer for performing real-time PCR. It is available as 1 (Uno), 2 (Duo) or 4 (Quattro) chip ports.
2. Cartridge and Chip
3. Reagent kits (Sample Pre-treatment and Prep kits)

Figure: Truenat  Source: MolBio Products.

Test results for MTB detection and Rif Resistance has a turn around time of 1-2 hours. Depending on the micro-PCR chips used various tests can be performed using Truenat. Truenat MTB micro-PCR chips detect Mycobacterium tuberculosis bacteria for TB diagnosis. Truenat MTB RIF micro-PCR chip is used as a reflex test to detect resistance to Rifampicin (RIF), the first-line drug for TB treatment

Truenat has many advantages. Truenat is designed to be mobile and is battery operated (~8 hours on full charge). It can be deployed in peripheral laboratories and microscopy centres with minimal or no added facilities and hence it is more point-of-care. Biosafety requirements are similar to smear microscopy. However, it is multi staged and partially automated, requiring the presence of a Lab Technician through out the test.

Resources

1. Truenat MTB Kit Insert.
2. Trueprep AUTO Universal Cartridge-based Sample Prep Device.
3. Practical Guide to Implementation of Truenat Tests for the Detection of TB and Rifampicin-resistance, 2021.

Assessment

Line Probe Assay (LPA) is a rapid molecular test available at centralised laboratories.

The assay is based on Polymerase Chain Reaction (PCR) that can simultaneously detect Mycobacterium tuberculosis complex as well as drug sensitivity to anti-TB drugs.

Figure 1: The GenoType MTBDRplus Molecular LPA Procedure; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Advantages of LPA

• Rapid molecular test. (Turnaround time: 3-5 days)
• Highly sensitive and specific.
• Performed directly from sputum smear-positive specimens and on isolates of M. tuberculosis complex grown from smear-negative and smear-positive specimens.
• Detects multiple gene mutations in anti-TB drugs.
  • First-line LPA detects mutations to rifampicin and isoniazid
  • Second-line LPA detects mutations to fluoroquinolones and aminoglycosides.
• Suitable for low and high-throughput labs.

Disadvantages of LPA

• Cannot be used as a point-of-care test.
• Requires appropriate laboratory infrastructure, equipment and biosafety precautions.
• Different rooms (DNA extraction, pre-amplification, amplification, post-amplification/ hybridization) are required to perform different steps (Figure 2).
• Requires trained manpower to perform tests and interpret test results.
• Stringent internal quality control is required to prevent contamination.

Figure 2: Amplification (A) and Post-amplification Laboratory (B) for LPA; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Resources

• Guidelines for PMDT in India, 2021.
• Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Assessment

Culturing TB Bacilli is well known and historic method for detection/ confirmation of Tuberculosis. It is a highly sensitive and specific phenotypic test; it can detect even a few viable bacilli in the sample (Upto 10 Colony Forming Units- CFUs). TB bacilli multiply in the culture and form colonies of TB bacilli which can are easily be identified.

Based on the growth media used Culture is divided in to two types, Solid and Liquid Culture methods. Types Culture:

• Solid Culture on Lowenstein Jensen media : Historic gold standard culture test. Results take usually upto 2 months (60 days).
• Modern Liquid culture systems: (e.g. BACTEC MGIT 960, BacT Alert or Versatrek etc.) Results take usually up to 42 days. 

Uses

1. Solid culture is the gold standard diagnostic test for TB. But it is not used for the purpose of TB diagnosis due to the long turn around time of 2 months. It is largely used for research purposes where it is used as the baseline test on which the sensitivity and specificity of other tests are calculated.
2. Liquid Culture is being used for follow-up monitoring of patients on drug resistant TB treatment to detect treatment failure. Liquid culture is also used for long term follow up patients who have successfully completed treatment to detect recurrence.
3. Liquid culture is used as a previous step to grow bacilli and obtain isolates prior to Drug Susceptibility Testing.
4. Liquid cultures are also used in TB prevalence surveys for its high sensitivity and specificity

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India 2021

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Culture Drug Susceptibility Testing (CDST) is a growth-based phenotypic method used to check the susceptibility of Mycobacterium tuberculosis strains to various first and second line anti-TB drugs. Mycobacterial resistance to a particular drug is identified if there is growth observed in culture in presence of that drug.

In NTEP CDST is the standard method to detect resistance in samples of patients who have tested positive on followup. While CDST is possible on both Solid and Liquid culture, currently, the NTEP utilizes only liquid culture as a method for DST, due to faster Turn around times.

CDST testing services are available under NTEP in designated, specialized laboratories called CDST Labs both in public and private sector. Currently there are 80 such laboratories (60 certified for First Line and 49 for Second line drugs). Such designated laboratories are subject to regular external quality assessment, often by the National Reference Laboratory at that region.

Quality assured DST to R, H, Z, Mfx, Lfx, Lzd, Am, Km and Cm are available across the country. 

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.
• Training Manual for Mycobacterium tuberculosis Culture & Drug Susceptibility Testing, NTEP, 2009.
• RNTCP Laboratory Network Overview, CTD, 2009.

NTEP laboratory network is comprising of National Reference Laboratories (NRLs), state level Intermediate reference laboratories (IRLs), Culture & Drug Susceptibility Testing (C & DST) laboratories and peripheral level laboratories. Peripheral level laboratories consist of  designated microscopy centres (DMCs) and NAAT labs.

NTEP has a quality assured laboratory network for bacteriological examination of sputum in a 3-tiered system.

Figure: Laboratory network of NTEP

Resources:

• TB India Report 2021

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The National Reference Laboratories (NRLs) constitute the third tier of the National Tuberculosis Elimination Programme (NTEP) laboratory network hierarchy. 

They provide quality assurance and certification services for the Culture and Drug Susceptibility Testing (C&DST) labs and coordinate with the World Health Organisation (WHO) Supranational Reference Laboratory (SNRL) network.

There are six designated NRLs which are delineated in the figure below.

Image

Figure: Six National Reference Laboratories under NTEP in India

NIRT, Chennai, in addition to being one of the NRLs is also one of the WHO designated SNRLs for the Southeast Asia Region.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• NTEP Laboratory Network: Overview.

Some Culture and Drug Susceptibility Test (C&DST) laboratories host an Intermediate Reference Laboratory (IRL) under the National TB Elimination Programme (NTEP). 

There is at least one IRL per state at an identified location, usually in a secondary or tertiary level public health facility. There are 34 IRLs in India.

The IRLs are responsible for:

• Undertaking training on laboratory technologies for district and field level staffs
• Conducting on-site evaluation visits to districts for sputum microscopy at least once a year
• Undertaking panel testing of Senior TB Laboratory Supervisors (STLS) at each district linked to it
• Ensuring the proficiency of staff performing National Tuberculosis Elimination Programme (NTEP) smear microscopy activities by providing training to laboratory technicians and STLS

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• NTEP Laboratory Network: Overview.

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Under the National Tuberculosis Elimination Programme (NTEP), many labs are established at the regional level within states for providing Culture and Drug Susceptibility Testing (C&DST) facilities for presumptive TB/DRTB and for TB/DRTB patients. C&DST laboratories are mostly located in intermediate reference laboratories (IRLs) or medical colleges. There are 42 C&DST laboratories established under the programme in different geographies. Dedicated human resources are provided for the laboratories under the programme. Districts are linked with laboratories for providing facilities for Culture and DST using: Phenotypic Methods (Solid – Lowenstein Jensen (LJ), and Liquid Culture – Mycobacteria Growth Indicator Tube (MGIT)) Genotypic technology (Line Probe Assay (LPA) and Cartridge Based Nucleic Acid Amplification Test (CBNAAT))

Figure: Culture and Drug Susceptibility Testing (C&DST) facility, Source: The Foundation For Innovative New Diagnostics (FIND)

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021
• Training Modules (1-4) for Programme Managers and Medical Officers; New Delhi, India: Central TB Division, July 2020

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The National Tuberculosis (TB) Elimination Program (NTEP) has a network of Nucleic Acid Amplification Tests (NAAT) laboratories coupled with Designated Microscopy Centers (DMCs) to form the backbone of the diagnostic component of TB services.

Nucleic Acid Amplification Tests (NAAT) laboratories includes Cartridge-based NAAT (CBNAAT) and TrueNat tests. These tests detect tuberculosis as well as rifampicin resistance and are more sensitive than smear microscopy.

Functions of Nucleic Acid Amplification Test (NAAT) Laboratories:

1. Acting as a hub for collection of samples from public and private health facilities (spokes)
2. Universal Drug Susceptibility Testing (UDST) to rule out rifampicin resistance among confirmed TB patients
3. Timely provision of NAAT test result to the TB patient, medical officer of the concerned health facility and NTEP staff for related actions
4. Acting as a sample dispatch center for the Culture DST laboratory for subsequent processing of samples for first-line line probe assay (LPA) and second-line drug resistance testing utilizing second line LPA and liquid culture DST
5. Recording and reporting including digitization of diagnostic process from collection to test result in NTEP Nikshay portal and Laboratory Information Management System
6. Management of supplies and logistic associated with laboratory logistic (CBNAAT cartridges and TrueNAT chips) and reporting any additional requirement thereof
7. Supporting the quality assurance activities undertaken by District or Intermediate Reference Laboratory under NTEP
8. Support health system in carrying out special drives for vulnerable and at-risk population and their testing directly by CBNAAT (slum population, diabetic population, smoker, malnourished people, patients of silicosis and kidney dialysis etc.)

Resources

• RNTCP Technical and Operational Guidelines for TB Control in India, 2016.
• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, 2021.

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Functions and Integrated Services of the DMC

• Testing of Sputum samples by Microscopy.
• Request/ referral for microscopy or Nucleic Acid Amplification Test (NAAT) or Culture and Drug Susceptibility Test (C&DST) or Chest X-ray (CXR) or Tuberculin Skin Test (TST) is generated at the PHI-DMC, as well as follow-up tests.
• Maintain consumables and logistics required for testing/ packaging and transport.
• Maintain TB laboratory registers for recording and reporting.
• Notify every TB patient in Nikshay at the earliest and update information of patients on comorbidity, treatment adherence, treatment outcome, contact investigation and TB Preventive Treatment (TPT).
• Biomedical waste management for the waste generated at DMCs.
• A DMC is required to participate in the External Quality Assurance system(EQA) of NTEP to ensure standardized quality diagnostic testing. 

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

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To increase access to diagnostic services, NTEP has a provision for sputum collection centres in areas where the health facility is not equipped with key requirements to conduct sputum microscopy, molecular tests, drug susceptibility testing or follow up examinations.

Sputum collection centres are dedicated locations where sputum samples are collected, packaged and then transported to nearby TB diagnostic centres. It could be attached to any near-by health-facility as well.

Requirements of a Sputum Collection Centre

To function as sputum collection centres, the following is essential:

• Linkage/ mapping (time and distance) to testing laboratory
• Availability of adequate number of sputum cups and falcon tubes, logistics for sample packaging and transport
• Identification of open areas for sputum collection
• Staff trained in NTEP guidelines on sputum collection, sample packaging and transport, complete and correct documentation of laboratory request form, and infection control practices
• Feasibility and financial measures required for sample transport
• Inclusion of local volunteers, courier services, sample transportation under National Health Mission Free Diagnostic Services or other mechanisms as decided by the state/district
• Availability of Information, Education and Communication (IEC) material, training modules, and job-aids
   

 Sputum collection centres are established in:

• Ayushman Bharat Health and Wellness Centres/Sub-centres
• Urban primary health centres
• Tribal, hilly, desert and difficult-to-reach areas of the country

Resources

• Training Modules for Programme Managers and Medical Officers
• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres
• Mycobacteriology Laboratory Manual, GLI Initiative, 2014

Assessment:

Screening for active tuberculosis (TB) a process to filter out people who are less likely to have TB, from a group. Screened positive people are likely to have TB and are confirmed subsequently using a TB diagnostic test. This will allow finite diagnostic testing resources to be used on the remaining.

Screening in TB may be performed ​using simple field tools (4 Symptom complex) and tests such as Chest X-ray, or a combination of both. ​Combination of both is the most effective, but is often not applied due to the practical difficulties in making a chest X-ray conveniently available.

Screening is an integral part of any general case finding effort. It is also applied systematically in specific situations.

1. At health care facilities (intensified case finding): Here those visiting are screened using the 4 symptom complex, often at the point of entry to the facility. Those screened positive may be fast-tracked to TB Diagnostic testing.
2. In vulnerable populations in active case finding efforts: Here the entire population identified for active case finding are screened using the pre-decided protocols by going door to door. 

Resources

• Systematic Screening for Active Tuberculosis; Principles and Recommendations, WHO 2013.
• National Strategic Plan for Tuberculosis Elimination 2020–2025.

People who have been exposed to patients with infectious TB are known as TB contacts; they constitute a high-risk group for TB. Case finding investigation contributes to the early detection of TB cases, and results in identifying a significant number of additional patients.

Figure: Approaches to Tuberculosis Case Finding

Active case-finding requires systematic screening and clinical evaluation of populations who are at high risk of developing TB, such as people living in slums, tribal areas, congregate settings, persons who are household contacts of TB cases

Resources:

• Assessing TB Case-Finding

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Systematic screening of all individuals of a defined population is known as active case finding.  It is applied outside of health facilities at the community level by the health system.

Objective of ACF is to:

1. identify cases early, initiate prompt treatment, reduce risk of poor treatment outcomes and reduce risk of further transmission of TB
2. to provide access to diagnosis services to populations that would have been otherwise unreached

It is effort intensive and is recommended only in population groups where there is estimated high case load. In NTEP, ACF is recommended only to be performed in Key / vulnerable population.

ACF can also be clubbed with suitable ACSM campaigns to create awareness about the signs and symptoms and about TB in the target population/ community. It can also be combined with other health activities/ campaigns (such as Pulse Polio/ Leprosy screening/ population based screening for NCDs) for increased efficiency.

Resources

1. Training Modules for Programme Managers and Medical Officers.
2. Active TB Case Finding, Guidance Document.
3. WHO recommendations for Systematic Screening for Active Tuberculosis

Assessment

Passive case finding is essentially where the patient self reports to the health care provider with symptoms. This requires that affected individuals are aware of their symptoms, have access to health facilities, and are evaluated by health workers or volunteers who recognise the symptoms of TB and link those individuals for TB testing services.

This approach to case finding has the least effort and cost and is a minimum expectation. In a Peripheral Health Institution (PHI), it is estimated that about 2-3% of new adult outpatients are symptomatic that require referral for TB diagnosis (presumptive TB cases).

Passive case finding may miss TB patients if :

1. The disease is mild/ transient.
2. Access to healthcare is poor.
3. Health providers do not have an adequate index of suspicion and are unable to reliably link respiratory symptoms to TB. 

Resources

1. Training Modules for Programme Managers and Medical Officers.

Assessment

Intensified Case Finding (ICF) is a case finding approach between Active and Passive approaches. Here individuals coming in contact with the health system through any activity are screened actively for symptoms of TB and referred for testing.

This approach brings the benefit of active case finding approach by active screening for TB symptoms, but does limit the extensive effort required by restricting to only those people who has some or the other healthcare problem. This approach is considered for people attending a healthcare facility.

Some examples of ICF are screening for TB symptoms and referral for testing in:

• all cases attending an HIV clinic.
• among children with malnourishment who attend a nutrition clinic.
• all mothers attending the antenatal clinics

Resources

1. Technical and Operational Guidelines.
2. Assessing TB Case Finding.

Assessment

Bidirectional screening is a method to identify cases in diseases which have predisposition to each other or has a significant influence on each other. For example TB and HIV, where having HIV increases risk of developing TB and cases with TB would have poor outcomes if co-infected with HIV.

Screening for TB is done through four-symptoms complex based screening or through Chest X-ray. Screening for the linked disease is carried out as per the policies of the corresponding health program.

Bi-directional screening policies are implemented by various disease control programs. For example, with NTEP the following disease control efforts implement a bidirectional screening policy:

1. HIV through NACO 
2. COVID19 
3. Diabetes Mellitus (DM) through NPCDCS
4. Tobacco  through National Tobacco Control Program

Both programs monitor bidirectional screening, referral and testing as per their own policies.

Resources

1. National Strategic Plan for TB Elimination.

Assessment

Why important, how is it done,

It is crucial to make an effort for microbiological confirmation in presumptive Extrapulmonary Tuberculosis (EPTB) cases. Appropriate specimens from the Extrapulmonary (EP) site are collected and, depending on the specimen type and availability of facilities, the specimens are sent for:

• Cartridge-based Nucleic Acid Amplification Testing (CBNAAT)
• Culture and Drug Susceptibility Testing (C&DST) for M. tuberculosis 
• Histopathological examination

The diagnostic algorithm (see the figure below) to be followed for EPTB cases depends on 2 main factors:

1. Availability of appropriate specimens from the EP site
2. Availability of CBNAAT (preferred test)

Figure: Diagnostic Algorithm of EPTB

• If an appropriate specimen from the EP site is available, specimens from the presumed sites of involvement must be tested with CBNAAT.
• CBNAAT detects MTB and RIF status and helps to identify microbiologically confirmed EPTB cases.
• If CBNAAT is not available, the specimen is sent for Liquid Culture (LC) at the C&DST lab. If the LC is positive, it is identified as a microbiologically confirmed EPTB case.
• If there is high clinical suspicion of TB even after a negative culture result, other diagnostic tools are used to clinically diagnose EPTB (usually with a specialist). If these tests indicate TB, they may be treated as clinically diagnosed EPTB or else arrive at an alternate diagnosis.

Clinical Diagnosis of EP-TB

If an appropriate specimen from the EP site is not available, in the presence of high clinical suspicion of TB, other modalities of diagnosis are used in consultation with a specialist. If with other diagnostic modalities, TB diagnosis still cannot be established, the specialist may explore an alternate diagnosis. 

A clinical diagnosis of EPTB is made if a consultative decision is made to treat with a full course of anti-TB drugs in spite of the situations listed above. Chest X-ray (CXR), ultrasonography, Computerised Tomography (CT) scan, Magnetic Resonance Imaging (MRI) and biochemical examinations are supporting tests that can be used to help arrive at a diagnosis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Technical Operational Guidelines, Chapter 3: Case Finding and Diagnosis Strategy, NTEP.

Assessment

​

All children with persistent fever with/without cough for two or more weeks; close contact with TB patients in the last 2 years; unexplained sudden weight loss or signs of malnutrition despite good nutrition, should be subjected to Chest X-ray (CXR).

1) If the CXR is normal, the child should be checked for signs of Extrapulmonary TB (EPTB) and referred for detailed investigations to higher centres in case of any symptoms.

2) If the CXR is suggestive of TB, the child should be subjected to a sputum test/ gastric aspiration / induced sputum for Mycobacterium tb (MTB) testing.

               - If the report is MTB positive, the child is microbiologically confirmed for TB and should be further tested for Rifampicin (Rif)-resistance and treated accordingly for Drug-sensitive (DS)/ Drug-resistant (DR) TB, based on Rif results.

               - If the report is MTB negative, look for significantly enlarged peripheral lymph nodes and also repeat the sputum test with a good sample and refer to a higher centre if required.

3) If the CXR displays non-specific shadows prescribe antibiotics (amoxiclav/ amoxicillin) if not already taken. Do not prescribe quinolones or linezolid and review the shadow and symptoms.

4) If CXR displays pleural effusion send the pleural fluid for examination at Nucleic Acid Amplification Testing (NAAT) lab as well for cytology and biochemical examinations.

              - If pleural fluid turns out MTB positive at the NAAT, treat as per guidelines

              - If the pleural fluid is MTB negative, but is a straw-coloured exudative effusion, treat the child as clinically diagnosed probable TB.

Image

Figure: Diagnostic Algorithm for Paediatric TB; Source: Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis, 2022.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis, ICMR, MoHFW, GoI, CTD, 2022.
• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, CTD, MoHFW, GoI, 2021.

Assessment

Drug-resistant TB (DR-TB) diagnosis is predominantly based on laboratory diagnosis. Presumptive-TB/ DR-TB is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

The vision of National TB Elimination Programme (NTEP) is to provide early diagnosis to all persons with any form of DR-TB through Universal Drug Susceptibility Testing (UDST).

All diagnosed TB patients are eligible for a NAAT test to know their Rifampicin sensitivity status. The integrated diagnostic algorithm for diagnosis of TB offers upfront Nucliec Acid Amplification Test (NAAT) for diagnosis of TB to vulnerable population. Among other eligible groups for NAAT are: non-responders to treatment and contacts of DR-TB patients are also offered upfront NAAT.

Rapid identification of DR-TB is achieved by using a combination of NAAT (CBNAAT/ Truenat) followed by sequential testing by first- and second-line Line Probe Assay (LPA) and Liquid Culture (LC) and Drug Susceptibility Testing (DST) for specific drugs as described below:

• When Rifampicin resistance is not detected by NAAT, the patient is offered First-line (FL) LPA.FL-LPA provides information on Isoniazid resistance.
• For Rif resistance/Inh resistance cases, SL-LPA  is done and it provides information on resistance to Levofloxacin, Moxifloxacin and Amikacin.
• For all Rif resistance cases, LC and DST is done for Pyrazinamid, Moxifloxacin (if resistance detected by LPA), Linezolid, Clofazimine*, Bedaquiline* and Delamanid*.

(* when available)

Resources

• Guidelines for PMDT in India, 2021.

Assessment

Check

All childhood TB patients’ sputum and other relevant samples (e.g. gastric aspirate, induced sputum, bronchoscopic lavage, lymph node aspiration, CSF, tissue biopsies etc.) should be subjected to genotypic or the phenotypic Drug Susceptibility Tests (DSTs). Based on the bacteriological confirmation, the child should be treated for DS/DR TB as required.

But in cases where the child’s DST is unknown, the source patient’s DST should be considered.

If the source is a known DS TB, treat the child for DS TB. If the child responds poorly to the DS TB treatment consult the pediatrician and re attempt the necessary investigations.

If the source patient is a known DR TB patient, consult with the pediatrician and re-attempt DST on an appropriate specimen from the child and treat as per the child’s DST (if the report is conclusive), if not then treat the child as DR TB after the source patient.

If the source patient’s DST status is not known perform DST on the child’s and the source patient’s specimen and treat the child as per the DST of the child or the source patient, whichever report is conclusive.

Pediatric TB patients should be presented to and discussed with a DR-TBC Committee (including the pediatrician) to decide the treatment.

Image

Figure:  Diagnostic Algorithm for Paediatric DR-TB; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India,2021, CTD, MoHFW, India, p39. 

Abbr: DR-TB: Drug-resistant TB; DS-TB: Drug-sensitive TB; NAAT: Nucleic Acid Amplification Test; MGIT: Mycobacterium Growth Indicator Tube; DST: Drug Susceptibility Testing; DRT: Drug Resistance Testing; BAL: Bronchoalveolar Lavage.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis.

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Assessment

Based on the site of disease, Tuberculosis can be classified as-

1. Pulmonary tuberculosis (PTB) refers to any microbiologically confirmed or clinically diagnosed TB involving the lung parenchyma or the tracheo-bronchial tree.
2. Extra Pulmonary tuberculosis (EPTB) refers to any microbiologically confirmed or clinically diagnosed TB involving organs other than the lungs such as pleura, lymph nodes, intestine, genitourinary tract, joint and bones, meninges of the brain etc. 

Note: Miliary TB is classified as PTB because there are lesions in the lungs. A patient with both pulmonary and extra-pulmonary TB should be classied as a case of Pulmonary TB.

• New case - A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new case. 
• Previously treated patients have received 1 month or more of anti-TB drugs in the past. They could be further classified as:
• Recurrent TB case - A TB patient previously declared as successfully treated(cured/treatment completed) and is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. 
• Treatment After failure patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment.  
• Treatment after loss to follow-up A TB patient previously treated for TB for 1 month or more and was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB case 
• Other previously treated patients are those who have previously been treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented. 
• Transferred In: A TB patient who is received for treatment in a Tuberculosis Unit, after registered for treatment in another TB unit is considered as a case of transfer in.
• Transferred Out : A patient who has been transferred to another recording and reporting unit and whose treatment outcome is unknown.

Resources:

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021 
• WHO Consolidated Guidelines on Tuberculosis: Module 4-Treatment: Drug resistant TB Treatment, 2020

On the basis of diagnosis, Tuberculosis (TB) can be classified into 2 main types:

1. Microbiologically confirmed TB
2. Clinically diagnosed TB

Microbiologically Confirmed TB

• Microbiologically confirmed TB refers to a presumptive TB case from which a biological specimen is positive for acid-fast bacilli/ Mycobacterium tuberculosis on smear microscopy, culture, or on a rapid diagnostic molecular test (such as Cartridge-based Nucleic Acid Amplification Test (CBNAAT)/ Truenat).
• All such diagnosed cases should be notified at the source, regardless of whether TB treatment has started.

Clinically Diagnosed TB

• Clinically diagnosed TB refers to a presumptive TB case that is not microbiologically confirmed but has been diagnosed with active TB by a clinician who has decided to give the patient a full course of anti-TB treatment.
• This definition includes cases diagnosed on the basis of X-ray abnormalities or suggestive histology or extrapulmonary cases without laboratory confirmation.
• Clinically diagnosed cases subsequently found to be microbiologically positive (before or after starting treatment) should be reclassified as microbiologically confirmed.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Definitions and Reporting Framework for Tuberculosis, WHO, 2013.

Assessment

Active Case Finding (ACF) is a provider-initiated activity with the primary objective of detecting TB cases early by active case finding in targeted groups and to initiate treatment promptly.

• It can target people who anyway would have sought health care with or without symptoms or signs of TB and also people who do not seek care.
• Increased coverage can be achieved by focusing on clinically, socially and occupationally vulnerable populations.
• ACF activities in a campaign mode will create mass awareness about the signs and symptoms in general population

Objective of ACF campaign activities- Reaching the unreached in a campaign mode to enhance TB case finding

Figure 1: Objectives of active case finding

Beyond TB disease, screening can also identify individuals who are eligible for and would benefit from TB preventive treatment (TPT) once TB disease is ruled out, thus further averting future incident TB.

General process is as below:

Figure 2: ACF campaign general process

Resources

1. WHO consolidated guidelines on tuberculosis: Module 2: Screening, Systematic screening for TB disease;WHO 2021
2. India TB Report 2022, Central TB Division, MoHFW 2022
3. Active TB Case Finding- Guidance document, Central TB Division & DGHS, MoHFW 2017

Assessment:

Mapping of vulnerable population is a pre-requisite for conducting an efficient ACF campaign. It involves understanding the population characteristics, identifying and enumerating and mapping the target population. 

Guidelines for mapping

• Identify & map high risk/ vulnerable populations in the local area with the following guidance. If additional information is available locally, it can be used for the prioritisation of target groups.

Figure 1: Schematic map for house to house survey of identified vulnerable population

• Without proper mapping, there is a high chance of missing cases. The success of the active TB case finding campaign relies on how good the mapping is.

Resources

• Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017.

Assessment

Active case-finding (ACF) approaches bring essential TB services closer to the community. It has high potential for improving TB case detection and reach people with TB currently missed by the health system. To maximize gains from ACF, it is important that the interventions are planned in advance. 

Planning for ACF includes identifying the right target population/area, designing the intervention, finding the right implementing partners, training of workforce, microplanning for daily activities, logistics, ensuring that the complete pathway of care is followed, reporting and recording.

Steps involved in planning for ACF

1. Identification of population based on:

a. increased risk for TB eg: prisoners, miners, urban slums, co-morbidities like HIV, diabetes etc.

b. those with limited access to health services eg: migrants, homeless, tribal, live in hard to reach areas etc.

2. Identification of stakeholders including district and sub-district TB program staff, non-government organizations, community based organizations, community health workers to support with ACF activities

3. Strengthening the health system e.g. training of staff, ensuring sufficient lab supply and lab technicians. Staff trainings should be done to eliminate gaps in knowledge about TB, cough hygiene, infection control measures, conducting screening, collecting quality sputum, transporting sputum or referring people with presumptive TB to the health facility/laboratory, TB testing, data collection, data entry 

4. Microplanning for ACF includes:

a. when and where to conduct ACF-day, time, duration, methodology-camp, door-to-door, community gatherings, home visits, place of work etc

b. availability of trained manpower, team composition, logistics and consumables

c. screening and diagnostic algorithm to be used

d. number of screenings and tests done per day

e. accessibility and linkage with TB testing laboratories, use of mobile van with CXR, CBNAAT/Truenat 

f. laboratory workload to accommodate additional testing due to ACF

g. laboratory turn around time, availability of test reports for clinical management 

h. advocacy on ACF activities with the target population, pre-sensitization meetings, addressing perceived risks of TB screening and diagnosis (e.g. job loss, loss of income)

i. data collection tools (paper based, smartphones, tablets etc.), TB notification, recording and reporting

Resources

1. Systematic screening for active tuberculosis: an operational guide (http://www.who.int/tb/publications/ systematic_screening/en/)

2. Experience of active tuberculosis case finding in nearly 5 million households in India (Prasad BM, Satyanarayana S, Chadha SS, Das A, Thapa B, Mohanty S, et al. Public Health Action. 2016;6(1):15–8. doi:10.5588/pha/15/0035)

3. Community-wide screening for tuberculosis in a high-prevalence setting (Marks GB, Nguyen NV, Nguyen PTB, et al. N Engl J Med 2019; 381: 1347-57)

Assessment

A targeted approach is considered as an appropriate public health response to identify the hidden cases of TB in the communities. In this regard the National TB Elimination Programme (NTEP) expects that 110,000 per million vulnerable population (11%) should be mapped for community-based screening and >90% of the mapped target vulnerable population should be screened for symptoms of TB.

Mapping of target population from the identified vulnerable population helps the programme to screen out the persons into: 1) those who are at high risk of progression to active TB disease; 2) those who are eligible for TB preventive treatment 3) Enhance the cost-effectiveness of the programme

Following are various methods for identifying and mapping the target population from the vulnerable population:

• Tuberculosis symptom screening

• Sputum testing

• Chest X-ray

Various modalities used to conduct mapping of target population from the identified vulnerable population under the ACF campaign are:

a) House-to-house TB symptom interviews through community volunteers

• Relatively minimal costs

• Needs community awareness session as a pre requisite before conducting ACF

• May be affected by self and perceived stigma

• Community volunteers may require monetary/ no monetary incentives.

b) Door-to-door Sputum collection / sputum drop-off clinics

• Has the potential for higher yield of TB cases

• Involvement of Trained TB staff is required for appropriate collection of sputum

• The sputum has to be non-contaminated in order to avoid compromising the results.

c) Conducting Camps in prisons, migrant localities, old age homes and other such institutional settings

• Accessible to the population who are at high risk but otherwise have limited access to TB testing services

• Essential to detect TB early and stop the spread of infection in such institutional settings.

• Requires skilled TB staff in such settings

d) Mobile vans equipped with X-ray units and Truenat machines

• Feasible yet resource-intensive modality

• Requires skilled staff to handle the testing

• Requires resources - electricity, internet, computer/ tablet etc.

Image

Resource 

• Optimizing active case finding for tuberculosis, Implementation lessons from South-East Asia, World Health Organization,2021.

• Burugina Nagaraja, S.; Thekkur, P.; Satyanarayana, S.; Tharyan, P.; Sagili, K.D.; Tonsing, J.; Rao, R.; Sachdeva, K.S. Active Case Finding for Tuberculosis in India: A Syntheses of Activities and Outcomes Reported by the National Tuberculosis Elimination Programme. Trop. Med. Infect. Dis. 2021, 6, 206. https://doi.org/10.3390/ tropicalmed6040206

Assessment

A good screening algorithm should have the following characteristics:

• High specificity (to reduce the number of false positives, ideally around 70%)
• High sensitivity (to reduce the number of false negatives, ideally around 90%)
• Low Number Needed to Screen (NNS)
• Low cost
• Rapid and simple to apply
• High client acceptability

The algorithm should be optimised so that the maximum number of cases can be detected with available resources.

Usually verbal screening using  symptom complex (4S) are used. However ACF campaigns targeting high risk populations (household contacts, elderly homes etc.)can consider using X ray also as a screening tool. Chest X ray helps in picking up sub-clinical TB cases also which will be usually missed through verbal screening of symptoms.   

A more sensitive test like NAAT is preferred over sputum microscopy in ACF campaigns as the cases will be in early stage and may be missed by testing using Microscopy.

References

• Optimising Active Case Finding – Implementation Lessons from South-East Asia. WHO SEAR, 2021.
• WHO Consolidated Guidelines on Tuberculosis – Module 2: Screening, WHO, 2021.
• High-priority Target Product Profiles for New Tuberculosis Diagnostics: Report of a Consensus Meeting, 28–29 April 2014, Geneva, Switzerland. Geneva: World Health Organisation, 2014.

Assessment

1. Financial Resources

• Financial resources for ACF may be procured from the Centre/State or through local Private Provider Support Agencies (PPSA). When the funds for ACF are procured from the centre, it should be included under a separate budget head (DSTB Pool) under PIP. 
• Each team would be eligible for an incentive of INR 500 for every new case of TB diagnosed and put on treatment under this activity OR as per approvals in the Programme Implementation Plan (PIP) in the National Programme Coordination Committee (NPCC) of the respective state or as approved by the state National Health Mission (NHM). 
• Each state should ensure that local travel arrangements from the general health system are made available for the field visits by the team, supervisory visits, etc.
• Allowances to ensure Travel Allowance (TA)/ Dearness Allowance (DA) and refreshments as per entitlement are to be made from the respective source of salary for the field teams and supervisory teams.

2. Consumables

Logistics for an ACF campaign include:

a. IEC materials: Appropriate IEC materials are to be designed and printed in the local language. A prototype of the same will be shared with states from the CTD. IEC material printing/ distribution should be completed by two weeks before the start of field activities.

b. Additional logistics for testing:

• Additional slides, laboratory reagents, sample transport boxes, X-ray films, CBNAAT cartridges,  falcon tubes (minimum 1000 per 1 lakh population) should be procured and supplied to health staff for collecting sputum samples from the eligible symptomatic at least two weeks before the start of field activities. Boxes for sputum sample transport should be provided to the health staff for carrying samples to DMCs.
• Additional sputum examination request forms needed – 500 per 1 lakh population

c. Recording and reporting forms: All recording and reporting formats requirement assessment is to be done by DTOs three weeks before the start of field activities

3. Human resource

Human resource for ACF is required for the following:

a. Field activities: House-to-house visits, symptom screening, sputum collection and transport to the Designated Microscopy Centre (DMC).

• One field visit team will comprise two members - one health worker from National TB Elimination Programme (Senior Treatment Supervisor (STS)/ Senior TB Lab Supervisor (STLS)/ TB Health Volunteer (TB-HV)) or a partner organisation (NGO outreach worker) or general health services (Auxiliary Nurse Midwife (ANM)/ Multipurpose Worker (MPW)/ Multipurpose Healthcare Supporters (MPHS) and one Accredited Social Health Activist (ASHA) or community volunteer. The states should decide on the team composition based on available resources and the population to be covered (as obtained from vulnerability mapping).
• House-to-house visits by health workers should involve community leaders, panchayat members particularly the women members, religious leaders and other local influencers like medical practitioners, local moneylenders, grocery shop owners, popular teachers, prominent youth, etc.
• Local community members/ influencers must accompany search teams during house-to-house visits in such areas, especially during revisit to houses.

b. Testing additional sputum samples for Mycobacterium tuberculosis (MTB): Laboratory technicians of the linked DMC and Cartridge-based Nucleic Acid Amplification Test (CBNAAT) labs should be well-informed about the increase in workload and recording of information during ACF activities. 

c. Supervision and Monitoring of ACF activities: Supervision and monitoring of the campaign are done at various levels under the leadership of designated officers. It is  required during the preparatory phase as well as the implementation phase of the campaign.The list of observers along with the districts/ blocks/ urban areas allotted must be shared with Central TB Division (CTD).

• Village level - Medical Officer of Primary Health Centre (PHC)/ Community Health Centre (CHC)/ Urban Health Centre (UHC)
• Block level - Block Medical Officer (BMO)/ Block Health Officer (BHO)
• District level - District TB Officer (DTO)
• State level - State TB Officer (STO)
• Regional level – Regional Directors of the Regional Office of Health and Family Welfare (ROH&FW) will be in charge of supervising activities in their respective states.
• National level - One national level officer for each state will be nominated by CTD to supervise and monitor activities including field visits to the states prior to and during the campaign.

References

• Active TB Case Finding Guidance Document, Central TB Division, Ministry of Health and Family Welfare, 2017.

Assessment

Microplanning for ACF Campaign

A microplan is a detailed plan of action in terms of human resources, materials, money and time. A good microplan ensures that the health intervention reaches each individual beneficiary and is crucial to the success of the activity. For Active Case Finding (ACF), microplanning is performed at the health facility level and collated at the block, district and state levels. Training for the same is given to concerned personnel during state, district and block level meetings prior to the campaign. Microplan at PHI, Block, District and State levels should be ready at least 15 days prior to the initiation of field activities.

Microplanning is done with respect to:

I. Advocacy, Communication and Social Mobilization (ACSM)

 A comprehensive IEC plan should be made with communication material for mass media, mid-media and print media to reach out up to the remotest village in advance.

II. Logistics

• Microplan should include planning additional consumables required for the campaign
• It includes additional slides, laboratory reagents, sputum cups, falcon tubes, sample transport boxes, X-ray films, Cartridge-based Nucleic Acid Amplification Test (CBNAAT) cartridges, etc. Additional sputum containers (minimum 1000 per lakh population) will be procured and supplied to health staff for collecting sputum sample from the eligible symptomatic two weeks before the start of field activities
• Linkages of Peripheral Health Institute (PHI) areas with Designated Microscopy Centre (DMC), X-ray facilities, CBNAAT lab, Extra Pulmonary (EP) sample collection and EP testing should be included in the planning up-front. 
• Laboratory technicians of the linked DMC and CBNAAT labs should be well informed about the increase in workload and recording of information during ACF activities.

III. Field activities including human resources

• Maps prepared for other campaigns like Pulse Polio, Leprosy Case Detection Campaign (LCDC), etc. must be used while planning. If maps are not available with local bodies, search team members and supervisors should be sent to the area before the ACF campaign, in order to become familiar with the area and develop maps. 
• The number of houses to be covered each day should be mentioned in the microplan. This number may vary from day to day depending upon the geographical situation of the area planned to be covered by the team on a particular day. 
• Teams of two persons each should go house-to-house. Out of the two members in each team, one should be a local volunteer (including Accredited Social Health Activist (ASHA)).
• Each team should be allocated clear-cut, well-demarcated areas clearly mentioning the starting and ending points, identifiable with landmarks; for each day of House to House (h-t-h) activity.
• In special areas, one additional person from the local community, where the team will be working, should accompany the team. 
• Human resources required for covering the mapped vulnerable population during field activities should be calculated and recorded.
• For planning and implementation purposes, urban areas should be divided into smaller planning units based on municipal wards or assemblies, or by roads or prominent landmarks. Each such unit should be put under the charge of a medical officer or nodal officer.
• Involvement of the local community, leaders, health officials, municipal bodies and their staff is essential in planning.
• Local staff is familiar with the layout of the urban areas and their inputs are vital for planning and supervision of house-to-house activities.

Execution of Microplan

The ACF campaign is executed as per the microplan and supervision is done with reference to the microplan

The House to House (h-t-h) survey is done for 2 weeks

A survey team consisting of 2 persons - one NTEP staff/ partner organization staff/ General Health services staff and one local volunteer / ASHA worker. They go from house to house in the mapped vulnerable areas/ key population groups and screen individuals for symptoms of TB. After screening, the eligible population for sputum examination includes: Persistent cough for ≥2 weeks, Fever for ≥2 weeks, Significant weight loss (>5% weight loss over last 3 months), Presence of blood in sputum any time during the last 6 months, Chest pain in the last one month, History of Anti-TB Treatment (previous/ current). If any one of these is present, a sputum cup or falcon tube is given to them and a sputum sample is collected. Sputum samples thus collected are transported to a designated lab using the sample transport system existing in the area. testing using smear microscopy/CBNAAT will be done for all symptomatic persons as per the state policy. Those who are microbiologically confirmed to be positive should be initiated on treatment within 2 days. Additionally, the team will look for other symptoms/diseases also. If person is having any symptoms or other ill health, s/he will be referred for evaluation by a Medical Officer for further management, if needed. Field Activity Report will be submitted by each health staff on a daily basis to the Medical Officer of the Peripheral Health Institution

Resources

• Active TB Case Finding – Guidance Document, 2017, Central TB Division, MoHWF, New Delhi.
• Active Case Finding for Tuberculosis in India: A Syntheses of Activities and Outcomes Reported by the National Tuberculosis Elimination Programme, Burugina Nagaraja S et al, Trop Med Infect Dis., 2021.

Assessment

Vulnerability mapping and Microplanning are 2 important activities of Active Case Finding which precede field activities. Vulnerable populations should be mapped and recorded in prescribed formats from health facility level onwards. Mapping data from PHI are consolidated at Block level, those at Block level are consolidated at district level and those at district level are consolidated at state level. Data from mapping formats is used for microplanning. Microplanning forms the basis of field activities. Microplans are also consolidated at subsequent levels. During supervision and monitoring, it is important to assess the activities with respect to the microplan. 

The recording formats for ACF include:

1. Formats for mapping - Health Facility Level, Block Level, District Level and State Level                     

2. Formats for microplanning - Manpower, Logistics, Field Activity

FORMATS FOR MAPPING

Mapping details should also be entered in Ni-kshay under the section shown below:

Image

Fig: Ni-kshay section for reporting various ACF activities

FORMATS FOR MICROPLANNING

Based on the requirement obtained from the mapping exercise, microplanning is done with respect to human resource, logistics and field activities

Human Resource Planning Form

Field activities are captured in Form 1 & 2 of the ACF. The data from field activities are compiled at the PHI level and submitted to the District and State using google sheets at present. Although there is no specific mechanism to demarcate the presumptive TB patients and the confirmed (clinical and microbiological) TB cases in Ni-kshay, States follow different mechanism including marking in the Laboratory register as ACF testing and sending a separate sheet to the district in paper format.

Reference: 

1. Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017 

Assessment:

Field supervision of Active Case Finding (ACF) is needed during both the preparatory phase and the implementation phase. Supervisory teams should be formed at the National, State, District, Block and Peripheral Health Institute (PHI) levels.

Field supervision during the preparatory phase: 

The Field Supervisors should: 

• Attend District and Block Coordination Committee meetings.
• Review the micro plan and check whether all components are present. 
  • All geographical areas have been included. 
  • Team composition is appropriate – all house-to-house teams have at least one Accredited Social Health Activist (ASHA) and at least one Non-government Organisation (NGO) worker and at least one National TB Elimination Programme (NTEP) field staff. 
  • Sensitisation training to detect the cases has been planned for all ASHAs and field staff. 
  • Workload of teams in terms of houses to be covered/ day has been rationalised.  
  • Areas requiring special attention have been identified and plans developed.
  • Information, Education and Communication (IEC)/ social mobilisation plans have been developed and documented. 

Field supervision during the implementation phase: 

• All officers should again visit their allotted districts/ blocks/ urban areas during the implementation phase to assess the quality as well as the completeness of coverage of the area through house-to-house visits. 
• Field Activity Report will be submitted by each health staff on a daily basis to the Medical Officer of PHI. The Field Activity reports from all health staff will be analysed and appropriate action will be taken by the Medical Officer of PHI and these reports will be combined and a report will be prepared and submitted to Block Medical Officer (BMO) on daily basis. 
• Ensure a mechanism of daily feedback from the observers to the block and district control rooms to facilitate immediate corrective action at all levels. Tracking the cascade of care is a useful tool for assessing quality. (Cascade of care: Track No. of people targeted, no. of people screened out of targeted, no. of presumptive TB identified out of screened, no. of presumptive TB patients examined out of identified, no. of presumptive TB completely evaluated {like smear-negative patients examined with chest X-ray and Cartridge-based Nucleic Acid Amplification Test (CBNAAT), no. of TB patients diagnosed out of examined, no. of TB patients put on treatment out of those diagnosed.})
• Qualitative and quantitative assessment of the ACF campaign activity from observers should be utilised for long-term corrective actions like problems faced by ASHAs & Frontline Workers (FLWs) during the campaign, review of micro-plans etc. or immediate corrective actions like repeating the activity in an area where a significant number of uncovered houses are found after completion of the activity. 

The Progress indicators and quality indicators for ACF should be monitored by the supervisory team while on field visit.

Resources

• Active TB Case Finding Guidance Document, CTD, DGHS, MoHFW, 2017.

Assessment

Monitoring should be an integral part of the Active Case Finding (ACF) interventions. It is accomplished by a strong data collection system enacted through a programme-based ACF data and recording in Nikshay.

Monitoring activities for ACF interventions broadly cover the number screened, number of presumptive TB cases based on symptoms or chest X-ray findings, samples collected for testing, samples transported for testing, samples tested, microbiologically and clinically diagnosed TB cases, TB notification and treatment initiation.

Monitoring Against the ACF Plan

1. Monitor the Number Needed to Screen (NNS), i.e., the number needed to be screened based on current TB symptoms, past history of TB, comorbidities, other socio-economic factors, etc. 

2. Monitor the Number Needed to Test (NNT) which helps understand the efficiency of diagnostic testing and the efficiency of screening for presumptive TB.

3. Monitor the yield of ACF activities, i.e., TB cases found and compare the yield of different screening and testing methods (X-ray, smear, Nucleic Acid Amplification Test (NAAT)).

4. Monitor whether there was an additional increase in TB notification of bacteriologically confirmed TB cases compared to the previous year (or in comparison to a control district).

• Monitor notification trends, treatment outcomes and mortality (TB prevalence should decrease over years based on repeated ACF in the same population).

5. Monitor engagement of National TB Elimination Programme (NTEP) staff, non-governmental organisations, community volunteers and the private sector in ACF activities.

Monitoring Against the Cascade of Care

1. Monitor the proportion of people with presumptive TB who provide sputum.

2. Monitor linkage to health facilities, sample collection, transportation and tests done.

3. Monitor drop-outs between screening and diagnosis, dropouts between diagnosis and treatment.

4. Monitor public health action provided to notified TB cases.

Resources

• Optimizing Active Case Finding for Tuberculosis, 2021. 
• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.

Assessment

The ACF campaign has to be reported for documentation, monitoring and evaluating the performance of the activity and guiding the policy decisions. 

The various formats used for reporting of performance of Active Case Finding (ACF) activities are as follows:

1. Field activity daily report

• Submitted by each health staff on a daily basis to the Medical Officer of Primary Health Centre (PHC)/ Community Health Centre (CHC)/ Urban Health Centre (UHC).

Table 1: Format for field activity daily report

2. ACF activity reporting by Health Facility

• The Field Activity reports from all health staff will be analysed and appropriate action will be taken by Medical Officer of PHC/ CHC/ UHC.
• These reports are combined and a report will be prepared as per the following format and submitted to Block Medical Officer (BMO)/ Block Health Officer (BHO) on daily basis.

Table 2: Format for ACF activity by health facility

At the block level reports from all the reporting units will be compiled in the below format and sent to the District on a daily basis.

3. ACF activity reporting by Block/ Town/ City

Table 3: Format for ACF activity reporting by block/ town/ city

And at the district level, reports from all blocks are to be compiled in the format below, and the consolidated report should be sent to the State.

4. ACF activity reporting by District

Table 4: Format for ACF activity reporting by district

5. ACF activity reporting by State

Table 5: Format for ACF activity reporting by state

• State TB Officer (STO) would be responsible for the overall coordination and implementation of campaign activities and reporting in the State/ UT.
• Data entry of district-level reports in electronic format will be ensured by District TB Officer (DTO) on a daily basis after the field activity is completed. Nikshay has a section on active case finding where the mapping of target population and reporting of various activities can be done.

Fig 1: Nikshay section for reporting various ACF activities

Resources

• Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017.

Assessment