Alere Determine™ TB LAM Ag

Posted by admin on April 28th, 2014

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Rapid Rule-in TB-HIV Co-infection

Now there is a new advantage to help detect active Tuberculosis (TB) in the HIV community. The Alere Determine™ TB LAM Ag test empowers you, at the point-of-care, to screen for active TB in HIV positive patients, providing results in just minutes.

This novel rapid test detects the LAM antigen (lipoarabinomannan) in urine samples, assisting you in your TB screening to rule-in sooner than traditional methods and enabling earlier treatment for your patient.

Product exclusively available for export to select markets.

SKU: 7D2740 Category:

Description

Benefits

  • The Alere Determine™ TB LAM Ag test empowers you, at the point-of-care, to screen for active TB in HIV positive patients, providing results in just minutes.
  • Offers optimal performance in HIV positive patients with advanced immunosuppression.
  • A useful tool for detecting sputum smear negative patients.
  • Diagnose both pulmonary and extra pulmonary TB from one convenient urine sample.
  • Enhanced power comes through combination with methods such sputum smear microscopy or the Xpert® MTB/RIF test.
  • Uses unprocessed urine as the validated sample type.
  • An antigen (Ag) detection test, and detects the LAM antigen.
  • LAM, lipoarabinomannan, is a structurally important component of the outer cell wall of mycobacteria that is shed from metabolically active or degrading cells, is cleared by the kidney and detectable in urine.
  • Results in 25 minutes.

Specifications

Ordering Information

Product name Product code
Alere Determine™ TB LAM Ag ( x 100 ) 7D2740


Product Information

Method Lateral flow
Time to results 25 mins.
Storage conditions 2 – 30°C
Shelf life 9 months
Sample type Urine (unprocessed)
Kit contents 100 test units

Reference Scale Card

Package Insert


Performance

Specificity1 > 98%
Sensitivity1
Sensitivity

(%)

CD4 cell count

(cells/µL)

4.0% ≥ 200
39.0% < 200
45.7% < 150
51.7% < 100
66.7% < 50

 

References

1. Lawn SD, Kerkhoff AD, Vogt M, Wood R. Diagnostic accuracy of a low-cost, urine antigen, point-of-care screening assay for HIV-associated pulmonary tuberculosis before antiretroviral therapy: a descriptive study. Lancet Infect Dis. 2012 Mar;12(3):201-9.