Tuberculosis

Line Probe Assay (LPA) for TB

Molecular detection of M. tuberculosis complex with first-line (isoniazid, rifampicin) and second-line drug-resistance mutations by reverse hybridisation.

Method
PCR + reverse hybridisation (strip-based)
Turnaround
1–2 days (data to be updated)
Specimen
Sputum
Sample volume
Data to be updated

Why This Test Matters

MDR-TB requires rapid recognition. LPA extends molecular resistance testing beyond rifampicin to isoniazid (katG, inhA) and — with second-line LPA — fluoroquinolones and injectables, within days rather than weeks.

Clinical Background

Isoniazid and rifampicin are the backbone of first-line TB therapy; resistance to both defines MDR-TB. Rapid genotypic profiling shortens the time to an appropriate regimen.

The Diagnostic Challenge

Current Diagnostic Methods

How the ID Labs Test Helps

LPA identifies MTB complex and the commonest resistance-conferring mutations directly from smear-positive specimens or cultured isolates, enabling earlier regimen adjustment.

How the Test Works

  1. 01Specimen or isolate
  2. 02DNA extraction
  3. 03Multiplex PCR of resistance regions (rpoB, katG, inhA)
  4. 04Reverse hybridisation to membrane probes
  5. 05Band-pattern interpretation
  6. 06Report

Test Methodology

MethodologyPCR + reverse hybridisation (strip-based)
TechnologyLine probe assay
InstrumentData to be updated
DetectionStrip hybridisation of amplified resistance-gene regions

Specimen Information

Sputum

Collection
Deep cough specimen into a sterile wide-mouth container after rinsing the mouth.
Minimum volume
1 mL
Recommended
3–5 mL
Transport
2–8 °C
Storage
2–8 °C
Stability
Data to be updated
Rejection criteria
Saliva-only samples (watery, no purulent material).

Specimen Container

Sputum Container (Wide-mouth, Sterile)

Sterile container · Cap: White

Additive: None

Volume: 3–5 mL

Collect early-morning deep-cough sample for mycobacterial testing.

Targets / Analytes / Organisms

Validated target list: data to be updated. Please contact ID Labs for the current configuration.

Technical Performance

CharacteristicValueSource
Analytical / clinical performancePerformance characteristics: please contact ID Labs — data to be updated.ID Labs Validated Performance

Clinical Utilization

Advantages

  • Rapid molecular resistance profile for first-line drugs
  • WHO-recommended for rapid detection of INH and RIF resistance
  • Applicable to isolates and smear-positive specimens

Limitations

  • Detects only the mutations covered by the probes — phenotypic DST remains necessary
  • Lower sensitivity in smear-negative specimens
  • Genotypic resistance and phenotypic resistance are related but not always identical
  • Does not replace culture

Publications & Scientific Evidence

WHO Consolidated Guidelines on Tuberculosis: Module 3 — Diagnosis: Rapid Diagnostics for Tuberculosis Detection

World Health Organization

WHO Guidelines · 2021 (updated)

GuidelineExternal link only

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.

GenoType MTBDRplus and MTBDRsl for detection of TB drug resistance: diagnostic accuracy

Scientific Reports (Nature) · 2015

Clinical ValidationExternal link only

Curated peer-reviewed / authoritative reference. Open the source link for the full text.

Evaluation of line probe assays (MTBDRplus/MTBDRsl) in clinical specimens

Frontiers in Microbiology · 2018

Clinical StudyExternal link only

Curated peer-reviewed / authoritative reference. Open the source link for the full text.

Related Tests & Technologies

Discuss this test with our scientific team

Panel configuration, specimen logistics and turnaround details on request.

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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.