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  • Laboratory Hierarchy and Network

    Content

    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

     

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  • NAAT Labs and their role

    Content

    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.)

     

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  • Functions of a Designated Microscopy Centres [DMC]

    Content

    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. 

     

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  • Sputum Collection centres

    Content

    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

     

    Assessment:

    Question Answer 1 Answer 2 Answer 3 Answer 4 Correct answer Correct explanation Page id Part of Pre-test Part of Post-test
    Under NTEP, where are sputum collection centres established to increase access to diagnostic services?  Tribal areas Ayushman Bharat health and wellness centres Difficult-to-reach areas All of the above 4 To increase access to diagnostic services, sputum collection centres are established in Ayushman Bharat health and wellness centres, Urban health centres, tribal, hilly, desert and difficult-to-reach areas of the country.   Yes Yes