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

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Report in 48Hrs

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No Fasting Required

Details

Detects TB and differentiates NTM in sputum.

₹2,664₹3,806

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AFB-M.Tb Detection (M.Tb/NTM Detection) by CBNAAT Sputum - Comprehensive Guide

  • Why is it done?
    • Test Purpose: CBNAAT (Cartridge Based Nucleic Acid Amplification Test) detects Mycobacterium tuberculosis (M.Tb) and non-tuberculous mycobacteria (NTM) in sputum samples using rapid molecular techniques. It identifies acid-fast bacilli (AFB) and determines drug resistance status.
    • Primary Indications: Suspected tuberculosis infection; Screening patients with respiratory symptoms (persistent cough >2-3 weeks); Evaluation of HIV-positive patients with respiratory symptoms; Monitoring treatment response in TB patients
    • Clinical Circumstances: Patients with cough, fever, night sweats, weight loss; Contact with confirmed TB cases; Immunocompromised patients; Patients with chest X-ray findings suggestive of TB; Healthcare workers with respiratory symptoms
    • Advantages of CBNAAT: Rapid results (2 hours); High sensitivity and specificity; Simultaneous detection of M.Tb and rifampicin resistance; WHO-recommended first-line diagnostic tool; Suitable for resource-limited settings
  • Normal Range
    • Normal Result: NEGATIVE (Not Detected); Indicates absence of M.Tb or NTM DNA in the sputum sample
    • Abnormal Results: POSITIVE (Detected); Indicates presence of M.Tb or NTM DNA
    • Result Categories: M.Tb DETECTED with RIFAMPICIN RESISTANCE DETECTED; M.Tb DETECTED with RIFAMPICIN RESISTANCE NOT DETECTED; NTM DETECTED; NEGATIVE/NOT DETECTED
    • Cycle Threshold (Ct) Values: HIGH LOAD: Ct <21 (Excellent); MEDIUM LOAD: Ct 21-27 (Good); LOW LOAD: Ct 28-37 (Marginal); VERY LOW/NEGATIVE: Ct >37 or No Ct value
    • Interpretation Guide: NEGATIVE = TB unlikely (though cannot completely exclude if high clinical suspicion); POSITIVE = TB confirmed (patient requires anti-TB treatment); RIFAMPICIN RESISTANCE = Multi-Drug Resistant TB (MDR-TB), requires second-line drugs
  • Interpretation
    • M.Tb DETECTED (with Rifampicin Resistance NOT Detected): Patient has active pulmonary TB; Likely drug-susceptible TB; Standard first-line anti-TB therapy (RIPE: Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) should be initiated; Patient is infectious and requires isolation; Respiratory precautions recommended
    • M.Tb DETECTED (with Rifampicin Resistance Detected): Patient has Multi-Drug Resistant TB (MDR-TB); Resistant to Rifampicin and typically Isoniazid; Requires second-line anti-TB drugs (fluoroquinolones, injectable agents); Prolonged treatment duration (20 months vs 6 months); Higher mortality and morbidity risk; Strict isolation and infection control measures essential; Requires specialist TB care
    • NTM DETECTED: Non-tuberculous mycobacteria (e.g., M. avium, M. kansasii) detected; May indicate NTM disease or colonization; Requires further identification and drug susceptibility testing; Clinical context essential for management; Generally less contagious than M.Tb; Usually affects immunocompromised patients
    • NEGATIVE/NOT DETECTED: No M.Tb or NTM DNA detected in sample; Does not absolutely exclude TB (sensitivity ~98%); Negative result with high clinical suspicion may warrant repeat testing; Consider smear microscopy, culture, or chest X-ray; Patient unlikely to be infectious if negative
    • Factors Affecting Results: Sample quality (adequate sputum vs saliva); Patient cooperation during collection; Timing of sample (early morning preferred); Number of bacilli in specimen; Prior anti-TB treatment; Technical issues during amplification; Presence of inhibitors in sample
    • Clinical Significance of Ct Values: Very LOW Ct (<16) = Very high bacterial load, highly infectious; LOW Ct (16-21) = High bacterial load, significant infectivity; MODERATE Ct (22-28) = Moderate bacterial load; HIGH Ct (29-37) = Low bacterial load, minimal infectivity
    • Test Performance: Sensitivity: 98% (pulmonary TB); Specificity: >99%; Positive Predictive Value: High in high-prevalence settings; Negative Predictive Value: High but not 100%; Can detect rifampicin resistance with 95% accuracy
  • Associated Organs
    • Primary Organ System: Respiratory System - Specifically the lungs; M.Tb primarily affects the alveoli in pulmonary tissue
    • Secondary Organs Affected: Lymph nodes (hilar and mediastinal); Pleura (TB pleurisy); Bronchi (bronchial stenosis); Upper airway structures
    • Extrapulmonary Manifestations: Central Nervous System: TB meningitis; Skeletal System: Pott's disease (spinal TB), joint TB; Urogenital System: Renal TB, genitourinary TB; Gastrointestinal System: TB peritonitis, intestinal TB; Cardiovascular System: TB pericarditis; Hepatic System: TB hepatitis
    • Diseases Associated with Abnormal Results: Active Pulmonary TB; Latent TB Infection; Drug-Susceptible TB; Multi-Drug Resistant TB (MDR-TB); Extensively Drug-Resistant TB (XDR-TB); TB/HIV Co-infection; NTM Lung Disease; Cavitary TB disease
    • Complications of Untreated/Resistant TB: Massive hemoptysis; Spontaneous pneumothorax; Respiratory failure; Acute Respiratory Distress Syndrome (ARDS); Sepsis and septic shock; Death (if untreated); Disseminated TB with multi-organ involvement
    • Risk Factors for Severe Disease: HIV/AIDS (CD4 <50); Diabetes mellitus; Chronic kidney disease; Malnutrition; Immunosuppressive therapy; Alcohol abuse; Smoking; Delayed diagnosis
    • Clinical Manifestations: Productive cough (>3 weeks); Hemoptysis; Chest pain; Dyspnea; Fever; Night sweats; Weight loss; Fatigue; Malaise
  • Follow-up Tests
    • If CBNAAT is POSITIVE: Sputum Smear Microscopy (for infectivity assessment); Culture (for drug susceptibility testing); Chest X-Ray (to assess extent of disease); HIV testing; Complete Blood Count; Liver and Renal Function Tests; Drug Susceptibility Testing (DST) for all TB cases
    • If CBNAAT is NEGATIVE (High Clinical Suspicion): Repeat CBNAAT on consecutive days; AFB Smear Microscopy (Ziehl-Neelsen staining); Culture on Lowenstein-Jensen or MGIT medium (Gold standard); Chest X-Ray; CT Thorax (if high suspicion persists); Consider bronchoscopy with BAL (Bronchoalveolar Lavage) if accessible TB suspected
    • If Rifampicin Resistance DETECTED (MDR-TB): Fluoroquinolone Susceptibility Testing; Second-line injectable drug DST; Isoniazid DST; Extended Drug Susceptibility Testing (for XDR-TB assessment); Culture confirmation; Genetic testing for specific resistance mutations; Chest imaging to assess severity
    • If NTM DETECTED: Species identification (MALDI-TOF mass spectrometry or 16S rRNA sequencing); NTM-specific drug susceptibility testing; Clinical correlation with imaging; Repeat isolation to confirm disease vs colonization; Immunological assessment in immunocompromised patients
    • During Anti-TB Treatment (Monitoring): Sputum Smear Microscopy: At weeks 2, 4, 6, 8, and 24 of treatment; CBNAAT/Culture: To assess treatment response; Baseline and periodic Liver Function Tests (LFT); Baseline and periodic Renal Function Tests; Blood glucose monitoring (especially in diabetics); Audiometry (if on injectable drugs); Line probe assay or sequencing for genetic resistance confirmation
    • After Treatment Completion: Sputum examination (to confirm cure); Chest X-Ray (to document resolution); Clinical assessment; Follow-up at 3, 6, 12 months post-treatment; Regular sputum check if symptoms persist; TB preventive therapy assessment for contacts
    • Complementary Diagnostic Tests: AFB Culture (confirms diagnosis, allows DST); Tuberculin Skin Test (TST/Mantoux); Interferon-Gamma Release Assays (IGRA) - QuantiFERON Gold; Biomarkers (LAM antigen, ADA levels); Imaging studies (CT, HRCT for complications)
  • Fasting Required?
    • Fasting Requirement: NO - Fasting is NOT required for this test
    • Sample Collection Requirements: Early morning sputum sample preferred (higher bacilli concentration); Collect in sterile container; Minimum 5 mL of sputum (not saliva); Patient should cough deeply from lungs; Label with patient identification; Process within 4 hours or refrigerate at 2-8°C
    • Pre-Test Instructions: Patient can eat and drink normally before test; NO fasting period required; Avoid mouth rinse or gargling immediately before sample collection; Adequate hydration recommended to produce sputum; Morning sample preferred; Instruct patient on proper sputum collection technique
    • Medications: No medications need to be withheld; Routine medications can be taken as usual; Anti-TB medications (if already started) do not interfere with test validity; Continue all other prescribed medications
    • Sample Quality Considerations: Sputum should be purulent/mucoid; Saliva alone is NOT acceptable; If adequate sputum cannot be produced, consider inducing sputum with hypertonic saline nebulization; Alternative samples: Bronchial aspirate, gastric lavage (in children), pleural fluid; Reject samples that are not properly labeled or obviously contaminated
    • Specimen Storage and Transport: Process immediately if possible; If delay unavoidable, store at 2-8°C for up to 24 hours; Transport in sealed, leak-proof container; Maintain biosafety precautions (specimen infectious); Room temperature transport acceptable if processing within 4 hours
    • Safety Precautions: Patient must be counseled on respiratory etiquette (cover mouth when coughing); Collection area should be well-ventilated; Healthcare workers should use appropriate PPE (N95 mask, gloves, gown); Handle as potentially infectious material; Follow institutional biosafety protocols

How our test process works!

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