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AFB-M.Tb detection (M.Tb/NTM Detection) by CBNAAT Tissue

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Report in 48Hrs

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nofastingrequire

No Fasting Required

Details

Detects TB in tissue biopsies; distinguishes NTM.

2,6643,806

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AFB-M.Tb Detection (M.Tb/NTM Detection) by CBNAAT Tissue

  • Section 1: Why is it done?
    • Test Overview: This test detects Mycobacterium tuberculosis (M.Tb) and Non-tuberculous Mycobacteria (NTM) in tissue samples using Cartridge-Based Nucleic Acid Amplification Test (CBNAAT), also known as GeneXpert MTB/RIF. It combines acid-fast bacillus (AFB) detection with rapid molecular identification.
    • Primary Indications:
    • • Detection of tuberculosis in tissue samples from suspected cases • Identification of drug-resistant tuberculosis (particularly rifampicin resistance) • Differentiation between M.Tb and non-tuberculous mycobacteria • Investigation of granulomatous lesions and chronic infections • Diagnosis of extrapulmonary tuberculosis (lymph nodes, bone, soft tissue) • Confirmation of mycobacterial infection in immunocompromised patients • Rapid screening when TB is clinically suspected
    • Timing and Circumstances:
    • • Performed on tissue samples obtained via biopsy or surgical specimens • Used when conventional AFB smear microscopy results are inconclusive • Part of initial diagnostic workup for patients with clinical signs of TB • Results typically available within 2 hours of sample processing • Can be used in both initial diagnosis and follow-up after treatment initiation
  • Section 2: Normal Range
    • Result Interpretation:
    • • Negative/Not Detected: No M.Tb or NTM detected in the tissue sample • Positive/Detected: M.Tb identified in the tissue sample • Rifampicin Resistance: Present (resistant) or Absent (susceptible)
    • Normal/Reference Values:
    • • Normal Result: Negative (No TB detected) • Abnormal Result: Positive (TB detected) • Units: Qualitative result (Positive/Negative) • Cycle Threshold (Ct) Value: When reported, higher Ct indicates lower bacterial load (semi-quantitative measure)
    • Ct Value Categories:
    • • Low Ct (16-22): High bacterial load • Medium Ct (22-28): Medium bacterial load • High Ct (28-40): Low bacterial load • No Ct Value Reported: Negative for TB
  • Section 3: Interpretation
    • Positive Result Interpretation:
    • • Indicates confirmed M.Tb infection in the tissue sample • Presence of viable or non-viable mycobacterial DNA • Supports diagnosis of tuberculosis at that anatomical site • If rifampicin resistance detected: Indicates MDR-TB (multidrug-resistant TB), requires second-line drug therapy • Low Ct values suggest higher bacterial burden and greater infectivity
    • Negative Result Interpretation:
    • • M.Tb not detected in this tissue sample • Does not completely rule out TB if clinical suspicion is high • May occur with inadequate sample quantity/quality • Possible in early-stage disease with low bacterial load • May require repeat sampling or culture confirmation • Consider clinical context and other diagnostic findings
    • Factors Affecting Results:
    • • Sample quality and adequacy • Time elapsed between sampling and processing • Proper storage conditions of tissue • Site of tissue collection (different sites have different yields) • Stage of disease progression • Antibiotic therapy prior to sampling • Immunological status of patient • Presence of inhibitors in tissue samples
    • Clinical Significance:
    • • Test has ~95-98% sensitivity and ~99% specificity for M.Tb detection • Faster than culture methods (results in 2 hours vs 2-8 weeks) • Particularly valuable in HIV-positive patients with disseminated TB • Helps identify drug-resistant strains early for appropriate treatment • Positive result warrants initiation of anti-tuberculous therapy • Negative result does not exclude TB; correlate with clinical and radiological findings
  • Section 4: Associated Organs
    • Primary Organ Systems Involved:
    • • Respiratory System (lungs and bronchi) - most common site • Lymphatic System (lymph nodes) - frequent in extrapulmonary TB • Skeletal System (bone and spine) - in spinal TB (Pott's disease) • Integumentary System (skin and soft tissues) • Central Nervous System (meninges) - TB meningitis • Gastrointestinal System (intestines, peritoneum) • Genitourinary System (kidneys, bladder, reproductive organs)
    • Diseases and Conditions Associated with Abnormal Results:
    • • Active Tuberculosis (pulmonary and extrapulmonary) • Multidrug-Resistant TB (MDR-TB) - especially with rifampicin resistance detection • Extensively Drug-Resistant TB (XDR-TB) • Tuberculous Lymphadenitis - lymph node involvement • Spinal Tuberculosis (Pott's Disease) - vertebral involvement • Tuberculous Meningitis - central nervous system involvement • Abdominal/Peritoneal Tuberculosis • Cutaneous Tuberculosis • Tuberculous Osteomyelitis • Disseminated/Miliary Tuberculosis
    • Complications of Abnormal Results:
    • • Progressive organ damage if untreated • Potential transmission to close contacts • Development of drug-resistant strains with delayed treatment • Immunosuppression complications in HIV co-infected patients • Tissue necrosis and abscess formation • Systemic spread leading to disseminated disease • Increased morbidity and mortality rates • Treatment-related complications if drug resistance not identified • Potential for relapse if inappropriate therapy used
  • Section 5: Follow-up Tests
    • Additional Tests for Positive Results:
    • • Culture and Drug Sensitivity Testing (DST) - gold standard confirmation and resistance patterns • Extended drug resistance testing (e.g., second-line drug resistance) • TB DNA sequencing for comprehensive resistance profiling • Sputum AFB smear microscopy - if pulmonary involvement suspected • Chest X-ray/CT imaging - to assess extent of disease • HIV testing - to identify co-infection status • Liver function tests (LFTs) - baseline before antituberculous therapy • Renal function tests - for dose adjustment of TB medications
    • Additional Tests for Negative Results:
    • • Tissue culture for mycobacteria - if clinical suspicion remains high • Repeat tissue biopsy/sampling - if inadequate sample quality • AFB smear microscopy of tissue - additional microscopic confirmation • Histopathological examination - to identify granulomas and exclude other pathologies • TB-LAMP (Loopmediated isothermal amplification) - alternative molecular method • PCR-based testing on tissue - alternative amplification method • Assessment for non-tuberculous mycobacteria (NTM) - consider alternative diagnosis
    • Monitoring During Treatment:
    • • Monthly sputum smear microscopy (for pulmonary TB) during first 2 months • Radiological follow-up at 2-3 months and end of treatment • Monthly liver function monitoring on isoniazid/rifampicin • Regular clinical assessment for treatment response • End-of-treatment culture to confirm cure • Follow-up CBNAAT if clinical deterioration occurs • Audiometry if using ototoxic second-line drugs (aminoglycosides) • Post-treatment surveillance for relapse
    • Complementary Related Tests:
    • • TB-SPOT test / Interferon-Gamma Release Assay (IGRA) - for latent TB detection • TST (Tuberculin Skin Test/Mantoux test) - hypersensitivity response • CXR (Chest X-ray) - imaging for pulmonary manifestations • CT/MRI - for specific organ involvement assessment • Complete Blood Count - baseline and monitoring • CD4 count - in HIV-positive patients for prognostication • NAA testing on sputum/body fluids - if appropriate specimens available
  • Section 6: Fasting Required?
    • Fasting Requirement:
    • NO - Fasting is NOT required for this test as it is performed on tissue samples obtained via biopsy or surgery, not blood samples.
    • Sample Collection Requirements:
    • • Tissue samples are obtained through sterile biopsy procedures or surgical specimens • Sample should be collected in sterile containers • No special fasting or dietary restrictions needed • Patient may eat and drink normally before tissue collection procedure • If general anesthesia is planned for biopsy, follow pre-operative fasting guidelines (typically 6-8 hours)
    • Pre-Procedure Preparations:
    • • Discontinue antibiotic therapy if possible (at least 24 hours before sampling when feasible) • Avoid antimycobacterial drugs prior to sampling if diagnostic confirmation needed • Inform physician of any ongoing medications • Provide informed consent for biopsy procedure • Remove jewelry, dentures, or metallic objects if imaging is part of procedure • Wear comfortable, loose-fitting clothing for easy access to biopsy site
    • Sample Handling and Processing:
    • • Tissue samples must be sent to laboratory promptly (preferably within 2 hours) • Store samples at room temperature (do NOT freeze unless instructed) • Use sterile, leak-proof containers • Label samples with patient identification, date, time, and specimen site • Include clinical information about suspected diagnosis • Avoid contamination of sample • Follow laboratory's specific transportation guidelines
    • Special Instructions:
    • • Notify laboratory if patient is immunocompromised or HIV-positive • Inform of any recent antibiotic or antituberculous therapy • Provide relevant clinical history for accurate interpretation • If procedure involves anesthesia, follow anesthesia fasting guidelines • Arrange for someone to accompany patient if conscious sedation is used • Plan for adequate recovery time after biopsy procedure • Follow post-procedure wound care instructions provided by physician

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