Infectiology Diagnostic


Minimal containment requirements
High sensitivity



PATHFAST™ TB LAM Ag test is a product for in vitro diagnostic use with the PATHFAST™ automated analyser for the quantitative measurement of lipoarabinomannan (LAM) in human sputum. PATHFAST™ TB LAM Ag test is intended to be used:

  • as an aid to the diagnosis of TB
  • by laboratory technician, nurse or physician
  • in a hospital or clinical laboratory setting.

The PATHFAST™ TB LAM Ag test procedure is based on a chemiluminescent enzyme immunoassay and MAGTRATION*. All required components for performing the testing are packed in one reagent cartridge.

By loading PATHFAST™ TB LAM Ag cartridge into the in vitro diagnostic system PATHFAST™, the quantification of LAM can be accurately measured within 17 minutes.

LAM is a 17.5 kDa glycolipid present in the mycobacterial cell wall [6] . LAM can be detected in the sputum of TB patients, and LAM concentration correlates well with the score of smear microscopy and time to detect of a culture


Benefits of choosing PATHFAST™ TB LAM Ag test

PATHFAST™ TB LAM Ag test stands out with many benefits for TB treatment monitoring due to its numerous competitive advantages.

  • Minimal containment requirements: It doesn't demand high-level biosafety containment (e.g. BSL3 lab), making it ideal for resource-limited settings.
  • Ease of use: Its straightforward operation that requires minimal training, streamlining workflow.
  • Quantitative precision: It provides quantitative results allowing for a deeper understanding of TB treatment efficacy.
  • High sensitivity: It detects lower LAM concentrations, enabling TB treatment monitoring also in patients with low bacterial loads.
  • Swift results: With a turnaround time of less than an hour, it expedites clinical decision-making.
  • Data-driven decisions: Its quantitative nature enables tracking of LAM concentration changes over time.
  • Cost-effective: Considering its speed and accuracy, it offers a cost-effective solution for TB management.
  • Could serve as a Point-of-Care test: The test shows potential for use as a point-of-care test, possibly bringing TB diagnosis and treatment monitoring closer to patients in primary care facilities and clinics.
  • Reagents “all in one”: Once the sample preparation is done, no water supply & drain system and no extra washing buffer & substrate bottles needed.

The highly precise, fast and compact chemiluminescence immunoassay analysis system

PATHFAST™ TB LAM Ag test utilizes advanced technology to detect and quantify LAM which is a specific component in the cell wall of M. tuberculosis in patient sputum samples. LAM is released during active TB infection. The test uses special antibodies that create a visible signal to indicate TB treatment success. The PATHFAST™ analyzer employs a technology involving magnetic particles in a pipette tip. During the test, the sample interacts with specific antibodies and magnetic particles. After removing unwanted substances, a chemiluminescent substance (CDP-star) is added. The brightness produced during the test is used to calculate the LAM concentration in the sample.


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Sensitivity (CI)* 88.8%
Specificity (CI)* 100%
PPV 100%/td>
NPV 69%
NPV Likelyhood Ratio (+) +Oo

Analytical sensitivitys

Limit of blank (LoB): 3.03 pg/mL
Limit of detection (LoD): 6.67 pg/mL
Limit of quantitation (LoQ): 7.44 pg/mL (C.V. 20%)


Five sputum-based QC samples at different levels of LAM (133, 3354, 30247, 45514, 53627 pg/mL) were serially diluted and measured. The recovery rate against the theoretical value was within 85% to 118% up to 53627 pg/mL.

Assay range: 10 - 50000 pg/mL

The assay range was set from the results of LoQ and linearity..

High dose hook effect

A sputum-based QC sample at a concentration of approximately 10000000 pg/mL was serially diluted and measured. There was no high dose hook effect for the samples with LAM values up to 10000000 pg/mL.