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AFB-M.Tb Detection with Rifampicin resistance by CBNAAT Tissue

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PCR detection of TB in biopsy with rifampicin resistance.

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AFB-M.Tb Detection with Rifampicin Resistance by CBNAAT Tissue - Comprehensive Guide

  • Section 1: Why is it done?
    • Test Purpose: This test detects Mycobacterium tuberculosis (M.Tb) in tissue samples using CBNAAT technology and simultaneously identifies rifampicin resistance, which is a marker of multidrug-resistant tuberculosis (MDR-TB).
    • Primary Indications: Diagnosis of extra-pulmonary tuberculosis in tissue samples (lymph nodes, bone, synovium, pericardium, meninges); confirmation of TB in immunocompromised patients; suspected drug-resistant tuberculosis; monitoring treatment response in tissue-based infections.
    • Clinical Circumstances: When tissue biopsy is performed for suspected TB; during diagnostic workup of chronic inflammation; evaluation of persistent lymphadenopathy; assessment of joint, bone, or lymph node involvement; when TB is suspected but sputum samples are negative or unavailable.
    • CBNAAT Advantage: Cartridge-based nucleic acid amplification test provides rapid detection (approximately 2 hours) with high sensitivity and specificity for both TB detection and rifampicin resistance in a single test.
  • Section 2: Normal Range
    • Normal/Negative Results: "MTB Not Detected" and "Rifampicin susceptibility: Not applicable" - indicates absence of M.Tb DNA in the tissue sample.
    • Positive Results: "MTB Detected" with either "Rifampicin Resistant" (RIF-R) or "Rifampicin Susceptible" (RIF-S) status - indicates presence of M.Tb and its susceptibility pattern.
    • Indeterminate Results: "MTB Not Detected" with error flag or "Probe check incomplete" - indicates test failure requiring repeat testing.
    • Units and Interpretation: Qualitative test reported as positive/negative; Cycle threshold (Ct) values may be reported for internal quality control; lower Ct values indicate higher bacterial loads; no quantitative values are clinically reported.
  • Section 3: Interpretation
    • MTB Detected + Rifampicin Susceptible (RIF-S): Confirms active tuberculosis infection in tissue with standard drug susceptibility; patient is susceptible to conventional TB treatment; typically responsive to first-line antituberculosis therapy (RIPE: Rifampicin, Isoniazid, Pyrazinamide, Ethambutol).
    • MTB Detected + Rifampicin Resistant (RIF-R): Indicates multidrug-resistant TB (MDR-TB); resistance to rifampicin is strongly associated with isoniazid resistance; requires second-line anti-TB drugs (fluoroquinolones, injectable agents); higher treatment complexity and potential adverse effects; requires extended treatment duration (18-20 months).
    • MTB Not Detected: Absence of M.Tb in tissue sample; does not exclude TB if clinical suspicion is high; may indicate: low bacterial load below detection limit, inadequate sample quality, non-TB causes of inflammation, or early/late stage disease.
    • Factors Affecting Results: Sample quality and quantity; degree of tissue preservation; prior antituberculosis therapy; immunosuppression status; bacterial load variation; presence of inhibitory substances in tissue.
    • Clinical Significance: Rapid identification of TB and drug resistance enables prompt initiation of appropriate therapy; prevents unnecessary use of first-line agents in RIF-R cases; improves treatment outcomes; reduces transmission risk; guides public health interventions.
  • Section 4: Associated Organs
    • Primary Organ Systems: Lymphatic system (lymph nodes - most common); musculoskeletal system (bones, joints, synovium); cardiovascular system (pericardium); nervous system (meninges); genitourinary system (kidneys, endometrium); gastrointestinal tract (peritoneum); integumentary system (skin).
    • Diseases Associated with Abnormal Results: Extrapulmonary tuberculosis (EPTB); tuberculous lymphadenitis; Pott's disease (spinal TB); tuberculous arthritis; tuberculous meningitis; tuberculous pericarditis; genitourinary TB; abdominal TB; cutaneous TB; drug-resistant TB; MDR-TB.
    • Complications Associated with Positive Results: Tissue necrosis and abscess formation; structural damage (bone erosion, joint destruction); neurological damage (paraplegia in spinal TB); cardiac dysfunction (in pericarditis); renal failure (in genitourinary TB); disseminated disease; sepsis; delayed diagnosis complications; treatment resistance and prolonged morbidity.
    • Rifampicin Resistance Implications: Significantly increased risk of treatment failure; prolonged infectious period; higher mortality rates; increased risk of acquired additional drug resistances; need for more aggressive and prolonged therapy; greater morbidity from untreated disease.
  • Section 5: Follow-up Tests
    • Recommended Follow-up Tests if MTB Detected: Chest X-ray to assess for pulmonary involvement; sputum AFB microscopy if pulmonary disease suspected; AFB culture for drug susceptibility testing (DST) confirmation; CT/MRI imaging of affected tissue sites; TB screening of close contacts.
    • Mandatory Tests if Rifampicin Resistant: Line probe assay (LPA) for confirmation of RIF-R and detection of isoniazid resistance; culture-based DST for comprehensive drug susceptibility profile; fluoroquinolone susceptibility testing; injectable agent susceptibility testing; repeat CBNAAT on second specimen for confirmation.
    • Baseline Tests Before Initiating Treatment: Liver function tests (AST, ALT, bilirubin); renal function tests (creatinine, BUN); baseline audiometry if using aminoglycosides; baseline vision assessment if using ethambutol; HIV status; baseline radiological imaging of involved organ.
    • Monitoring During Treatment: Repeat imaging at 2-4 weeks, 2-3 months, and end of treatment; clinical response assessment monthly; repeat sputum/tissue culture at 2 months to assess treatment response; liver and renal function monitoring monthly for first 3 months; adverse event monitoring.
    • Post-Treatment Monitoring: Follow-up imaging 6-12 months post-treatment; clinical assessment for relapse signs; repeat CBNAAT or culture if symptoms recur; long-term monitoring for MDR-TB patients (up to 2 years); surveillance for drug-related complications.
  • Section 6: Fasting Required?
    • Fasting Requirement: NO - Fasting is not required for this test.
    • Sample Collection Method: This test uses tissue samples obtained through biopsy procedures, not blood samples. Fasting status does not affect tissue-based diagnostics.
    • Patient Preparation Requirements: Tissue biopsy procedures may require pre-procedure fasting (typically 4-6 hours) if anesthesia will be used; patient should follow specific instructions from the proceduralist; normal diet and hydration can be maintained unless general anesthesia planned; routine medications typically continued unless specifically instructed otherwise.
    • Medications: Anticoagulants (warfarin, DOACs) should be managed per proceduralist guidelines; antiplatelet agents may require adjustment; prior antituberculosis therapy does not affect test validity; immunosuppressive medications do not require interruption; always inform physician of all current medications.
    • Pre-Biopsy Instructions: Consult proceduralist regarding specific fasting requirements based on anesthesia type; arrange for someone to accompany patient if sedation planned; sign informed consent; report all allergies; inform of bleeding disorders or current anticoagulation; avoid strenuous activity day of procedure.

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