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AFB-M.Tb Detection with 1st line drug resistance (Rifampicin and Isoniazid resistance) by CBNAAT

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Detects TB DNA and resistance to rifampicin & isoniazid.

₹3,752₹5,360

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AFB-M.Tb Detection with 1st Line Drug Resistance (Rifampicin and Isoniazid Resistance) by CBNAAT

  • Why is it done?
    • To detect Mycobacterium tuberculosis (M.tuberculosis) bacteria and identify resistance to first-line anti-tuberculosis drugs, specifically rifampicin and isoniazid, which are critical for treatment planning
    • To diagnose tuberculosis in patients with symptoms such as persistent cough, fever, night sweats, weight loss, and chest pain
    • To identify drug-resistant tuberculosis (MDR-TB) cases early, enabling prompt initiation of appropriate second-line therapy
    • To screen patients suspected of having tuberculosis, including those with HIV co-infection, who are at higher risk for MDR-TB
    • To monitor treatment response and detect treatment failure in tuberculosis patients
    • To provide rapid results (2 hours) compared to traditional culture methods (2-8 weeks), enabling timely clinical decision-making
    • Typical timing: Performed when TB is clinically suspected or confirmed, and during initial diagnosis to guide treatment selection
  • Normal Range
    • Normal Result: MTB NOT DETECTED (Negative)
    • Abnormal Result: MTB DETECTED (Positive)
    • Drug Resistance Status: Reported as either 'RIF Resistant' (Rifampicin), 'INH Resistant' (Isoniazid), or 'RIF and INH Resistant' (MDR-TB), or 'No Resistance Detected' (Drug-Susceptible TB)
    • Units: Qualitative (Positive/Negative for MTB; Susceptible/Resistant for drug resistance)
    • Interpretation Guide:
    • MTB NOT DETECTED = No tuberculosis infection detected; patient likely does not have active TB
    • MTB DETECTED + Susceptible = Tuberculosis present, treatable with standard first-line drugs
    • MTB DETECTED + RIF Resistant = Rifampicin-resistant TB; requires modified treatment regimen
    • MTB DETECTED + INH Resistant = Isoniazid-resistant TB; second-line drugs may be required
    • MTB DETECTED + RIF and INH Resistant = Multidrug-resistant TB (MDR-TB); requires second-line therapy with fluoroquinolones and injectable agents
  • Interpretation
    • Positive MTB, Drug-Susceptible: Patient has active tuberculosis infection without resistance to standard first-line drugs (isoniazid and rifampicin). Standard 6-month treatment regimen with HRZE (Isoniazid, Rifampicin, Pyrazinamide, Ethambutol) is appropriate.
    • Positive MTB, Rifampicin-Resistant: Patient has TB with resistance to rifampicin, indicating at least MDR-TB. Immediate escalation to second-line therapy is required. Fluoroquinolones and injectable agents (amikacin, capreomycin) should be considered. Extended treatment duration (20-24 months) is typical.
    • Positive MTB, Isoniazid-Resistant: Patient has isoniazid-resistant TB. Treatment regimen must be modified, typically substituting isoniazid with ethambutol or other agents. Requires close monitoring and possible addition of second-line drugs depending on severity and epidemiology.
    • Positive MTB, Both RIF and INH Resistant (MDR-TB): Confirmed multidrug-resistant tuberculosis. This is a serious condition requiring second-line therapy including fluoroquinolones (e.g., moxifloxacin, levofloxacin), injectable agents (amikacin, capreomycin, streptomycin), and other agents. Treatment duration is typically 20-24 months. Notify public health authorities. Isolate patient to prevent transmission.
    • Negative MTB: No M.tuberculosis detected in the specimen. TB is unlikely, but clinical correlation is essential. Negative results do not definitively exclude TB, especially in low bacillary load cases or early disease. Repeat testing may be indicated if clinical suspicion remains high.
    • Factors Affecting Results:
    • Specimen quality and adequacy (sputum volume, contamination)
    • Timing of specimen collection (best in early morning sputum)
    • Bacillary load (number of bacteria in specimen)
    • Stage of disease (early/late TB may have lower sensitivity)
    • HIV co-infection status (may affect sensitivity)
    • Prior TB treatment history
    • Presence of atypical mycobacteria (may cross-react but rare)
    • Clinical Significance:
    • CBNAAT (Cartridge-Based Nucleic Acid Amplification Test) is WHO-recommended as the first-line diagnostic test for TB diagnosis and MDR-TB detection, with 98% sensitivity and 99% specificity for MTB detection, and 95% sensitivity for rifampicin resistance
    • Early detection of drug resistance enables timely modification of therapy, reducing treatment failure rates and preventing transmission of resistant strains
    • Results directly impact treatment selection, duration, and outcomes
    • MDR-TB requires intensive therapy with potential for serious adverse effects and longer treatment duration
  • Associated Organs
    • Primary Organ Systems:
    • Respiratory system (lungs, bronchi, trachea) - Most common site of TB infection
    • Lymph nodes - Frequently affected in TB
    • Central nervous system - TB meningitis is a severe complication
    • Bone and joints - Causes Poncet's disease and spinal TB
    • Gastrointestinal tract - TB can affect stomach and intestines
    • Urinary system and kidneys - TB can cause genitourinary TB
    • Liver - Can be involved in miliary TB and hepatotoxicity from drugs
    • Common Associated Conditions:
    • Pulmonary tuberculosis (PTB) - Most common form
    • Extrapulmonary tuberculosis - Affects organs outside lungs
    • Multidrug-resistant tuberculosis (MDR-TB)
    • Extensively drug-resistant tuberculosis (XDR-TB)
    • HIV/TB co-infection
    • Tuberculosis meningitis
    • Miliary tuberculosis - Disseminated form
    • Latent tuberculosis infection (LTBI)
    • Potential Complications from Abnormal Results:
    • Treatment failure due to inadequate therapy for drug-resistant TB
    • Progressive pulmonary disease leading to lung cavitation and fibrosis
    • Disseminated/miliary TB affecting multiple organs
    • TB meningitis with high mortality rate
    • Transmission of resistant strains to close contacts
    • Respiratory failure and hemoptysis
    • Adverse drug effects from second-line anti-TB medications
    • Mortality without appropriate treatment
  • Follow-up Tests
    • If MTB NOT DETECTED:
    • Repeat CBNAAT or AFB sputum smear microscopy if clinical suspicion remains high
    • Chest X-ray to evaluate for TB and alternative diagnoses
    • Culture and drug susceptibility testing (DST) if AF B positive smears present
    • Tuberculin skin test (TST) or Interferon-gamma release assay (IGRA) for latent TB
    • If MTB DETECTED (Drug-Susceptible):
    • Initiate standard first-line anti-TB therapy (HRZE regimen)
    • Monthly sputum smear microscopy to monitor treatment response (weeks 2, 4, 6, 8, 16, 20, 24)
    • Liver function tests (LFTs) at baseline and month 1-2 (to monitor for hepatotoxicity from isoniazid and rifampicin)
    • Complete blood count (CBC) to establish baseline
    • HIV testing (all TB patients should be tested)
    • Chest X-ray at 2-3 months to assess radiological response
    • If MTB DETECTED (RIF and/or INH Resistant - MDR-TB):
    • Immediate referral to MDR-TB specialist center
    • Culture and phenotypic/genotypic drug susceptibility testing (DST) to determine resistance to second-line drugs
    • HIV testing (critical for MDR-TB management)
    • Baseline audiogram (to monitor for ototoxicity from injectable agents like amikacin)
    • Comprehensive metabolic panel including liver and kidney function (second-line drugs are nephrotoxic and hepatotoxic)
    • Baseline ophthalmologic examination (for ethambutol-related optic neuritis if used)
    • Electrocardiogram (ECG) if fluoroquinolones planned (QT prolongation risk)
    • Monthly sputum smear microscopy during intensive phase
    • Monthly monitoring of liver function, serum creatinine, electrolytes, and hemoglobin
    • Repeat audiometry at 2 months and end of treatment if injectable agents used
    • Chest X-ray at 2-3 months and end of initial phase to assess radiological response
    • General Follow-up for All TB Patients:
    • Contact tracing and testing of household members and close contacts
    • Directly observed therapy (DOT) monitoring
    • Nutritional assessment and support
    • Adherence counseling
    • Post-treatment follow-up for at least 1-2 years to monitor for relapse
  • Fasting Required?
    • Fasting: NOT REQUIRED
    • Specimen Type: Sputum (expectorated sample)
    • Patient Preparation Instructions:
    • Collect 2-5 mL of sputum (not saliva) in a sterile, sealable container provided by the laboratory
    • Best collection time is early morning, as overnight accumulation yields higher bacillary load
    • Patient should rinse mouth with water before collection to reduce saliva contamination
    • Deep cough to expectorate sputum from lungs, not throat
    • Alternative methods if unable to produce sputum: induced sputum using hypertonic saline nebulization, gastric aspiration (early morning), or bronchoscopy
    • Send specimen to laboratory immediately or refrigerate if delay is unavoidable (within 24 hours)
    • Avoid use of preservatives unless required by local laboratory protocol
    • Precautions During Collection:
    • Health care workers should use appropriate personal protective equipment (N95 mask, gloves)
    • Collection in well-ventilated areas or booths to minimize TB transmission
    • Patient should cover mouth with tissue during coughing
    • Medications to Avoid/Considerations:
    • No specific medications need to be avoided before CBNAAT testing
    • However, if patient is already on anti-TB therapy, inform the laboratory for result interpretation (may affect detection)
    • Anti-cough medications should not be used 30 minutes before collection
    • Test Timing and Frequency:
    • Can be performed at any time (no need for fasting or special timing)
    • Results available within 2 hours
    • Can be repeated if initial test is indeterminate or negative despite high clinical suspicion

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