Clearview TB ELISA
Clearview TB ELISA is a revolutionary
urine-based test that improves the speed in detecting the disease
amongst HIV patients and can play a crucial role in slowing the
spread of Tuberculosis (TB) across the developing world.
Traditional sputum smear tests for TB incur considerable
limitations when used as a primary diagnostic test with sensitivity
ranging between 40%-60% and falling to as low as 20% in patients
who are also HIV infected.1
Clearview TB ELISA uses antibodies specific to
the mycobacteria antigen lipoarabinomannan (LAM) which forms part
of the TB cell wall. The elevated levels of the LAM antigen in the
urine of TB/HIV patients provides a specific diagnostic target.
Clearview TB ELISA clinical trial data shows
that by directly testing for LAM antigen, over 80% sensitivity is
obtained in patients that are HIV
positive.2
In clinical trials Clearview TB ELISA displayed
over 90% specificity in healthy
controls.2
The use of urine also offers the clinician the advantage of a
sample material which is safer and far less invasive than
conventional sputum sample collection.
Clearview TB ELISA is a breakthrough step
towards offering healthcare professionals the tools needed to aid
in the diagnosis of TB in HIV co-infected patients:
- Higher detection rate than the sputum smear test in
HIV/TB populations
- Detects the presence of the active TB antigen
- User-friendly
- Rapid
- Robust
Procedure
Clearview TB ELISA is an enzyme-linked
immunosorbent assay (ELISA) based system that qualitatively detects
the presence of lipoarabinomannan (LAM) antigen of mycobacteria in
human urine as an aid in the diagnosis of mycobacterial infection
in patients with HIV.
*See the Clearview
TB ELISA package insert for complete
instructions.
References
-
Diagnostics for Tuberculosis: Global Demand
and Market Potential. World Health Organization, 2006.
2. See Package Insert