Rapid automated molecular detection of M. tuberculosis complex and rifampicin resistance directly from sputum and other specimens.
Tuberculosis remains a leading infectious killer. Smear microscopy is fast but insensitive; culture is sensitive but takes weeks. Rapid molecular testing closes the gap between suspicion and treatment, and simultaneously screens for rifampicin resistance — the gateway to detecting MDR-TB.
TB is caused by Mycobacterium tuberculosis complex. Pulmonary disease presents with chronic cough, fever, night sweats and weight loss; extrapulmonary disease can affect nodes, pleura, bone, meninges and other sites. Drug-resistant TB (MDR: resistant to at least isoniazid and rifampicin; XDR: additional fluoroquinolone and second-line injectable resistance) demands entirely different regimens.
Smear microscopy misses a large fraction of cases, cannot distinguish MTB from other mycobacteria, and says nothing about drug resistance. Conventional culture and DST can take 4–8 weeks.
The modern TB pathway combines smear microscopy, rapid molecular tests (Xpert MTB/RIF), liquid culture (MGIT), line probe assays for extended resistance, phenotypic DST and — in selected cases — whole genome sequencing.
Xpert MTB/RIF delivers simultaneous TB detection and rifampicin-resistance screening in about 2 hours, directly from the specimen, enabling same-day treatment decisions while culture-based confirmation proceeds.
Sterile container · Cap: White
Additive: None
Volume: 3–5 mL
Collect early-morning deep-cough sample for mycobacterial testing.
Validated target list: data to be updated. Please contact ID Labs for the current configuration.
| Characteristic | Value | Source |
|---|---|---|
| Detection | M. tuberculosis complex DNA plus rpoB rifampicin-resistance region | Manufacturer Specification |
| Published performance | In the multicentre NEJM 2010 evaluation (Boehme et al.), Xpert MTB/RIF showed high sensitivity and specificity for TB detection and rifampicin resistance — these are published study figures, not ID Labs validated performance. | Published Scientific Evidence |
| Analytical / clinical performance | Performance characteristics: please contact ID Labs — data to be updated. | ID Labs Validated Performance |
Use as an initial rapid test in presumptive TB per WHO algorithms. Positive rifampicin-resistance results should trigger confirmatory culture, LPA/phenotypic DST and expert review.
| Smear vs GeneXpert vs LPA vs MGIT vs WGS | |||||
|---|---|---|---|---|---|
| Feature | Smear microscopy | GeneXpert | LPA | MGIT culture | WGS |
| Turnaround | Hours | ≈ 2 hours | 1–2 days | Days–weeks | Days–weeks |
| Detects TB | AFB only (not species-specific) | Yes — MTB complex | Yes — MTB complex | Yes — viable growth | Yes — from isolate/DNA |
| Resistance information | None | Rifampicin (rpoB) | INH + RIF (+ second-line with FL/SL LPA) | Full phenotypic DST | Comprehensive genotypic prediction |
| Viability | No | No | No | Yes | Yes (isolate) |
Boehme CC, Nabeta P, Hillemann D, et al.
New England Journal of Medicine · 2010 · Vol 363 · (11) · pp. 1005–1015
Multicentre evaluation of the Xpert MTB/RIF assay demonstrating rapid, sensitive detection of tuberculosis and rifampicin resistance directly from sputum, compared with smear microscopy and culture.
World Health Organization
WHO Guidelines · 2021 (updated)
WHO recommendations on rapid molecular diagnostics for TB, including Xpert MTB/RIF and line probe assays, and their place within diagnostic algorithms. These are international guidelines; they do not constitute ID Labs validated performance data.
Cochrane Database of Systematic Reviews · 2021
Curated peer-reviewed / authoritative reference. Open the source link for the full text.
World Health Organization · 2017
Curated peer-reviewed / authoritative reference. Open the source link for the full text.
Molecular detection of M. tuberculosis complex with first-line (isoniazid, rifampicin) and second-line drug-resistance mutations by reverse hybridisation.
Automated liquid culture of mycobacteria with phenotypic drug susceptibility testing — the reference pathway for confirming viable TB and defining resistance.
Panel configuration, specimen logistics and turnaround details on request.
Information on this page is educational and does not replace professional clinical judgment. Performance values are labelled by source (ID Labs Specification / ID Labs Validated Performance / Manufacturer Specification / Published Scientific Evidence). Molecular results must be correlated clinically and, where appropriate, confirmed by culture and phenotypic susceptibility testing.
