Background: Decreasing tuberculosis (TB) mortality is constrained by diagnostic and treatment delays. The World Health Organization (WHO) recently actively recommended the point-of-care Alere Determine Lipoarabinomannan Ag assay (AlereLAM) to assist in the diagnosis of tuberculosis in specific HIV-infected outpatients. Objectives:The primary objective of this study was to compare time to ambulatory TB treatment in HIV-infected adults with CD4 ≤ 100 cells/μL before and after ('primary comparison groups') availability of AlereLAM. In pre-specified subgroups, we prospectively assessed AlereLAM-positive prevalence.Method: Clinicians prospectively performed AlereLAM in HIV-infected adults with TB symptoms and either CD4 ≤ 100 cells/μL or 'seriously ill' criteria. In a retrospective arm of equal duration, clinicians retrospectively collected data on HIV-infected adults with CD4 ≤ 100 cells/μL who initiated TB treatment.Results: A total of 115 prospectively eligible adults (of whom 55 had CD4 ≤ 100 cells/μL) and 77 retrospectively eligible patients were included. In the primary comparison groups, the retrospective and prospective arms had similar age and sex distribution. With availability of AlereLAM, the time to TB treatment decreased from a median of 4 to 3 days ( p = 0.0557). With availability of AlereLAM, same-day TB treatment initiation rose from 9.1% to 32.7% ( p = 0.0006). In those with CD4 ≤ 100 only, those with 'seriously ill' criteria only, and in those meeting either, or both, of these criteria, AlereLAM was positive in 10.5%, 21.9%, 34.8% and 48.4% respectively. Conclusion:Availability of AlereLAM led to more patients initiating same-day TB treatment. Using both CD4 ≤ 100 and 'seriously ill' criteria gave the greatest yield. Results of this study have informed local policy design.
Introduction: In outpatients, the World Health Organization recommends that the urine Alere Determine-tuberculosis lipoarabinomannan (AlereLAM) should be used to support the diagnosis of tuberculosis (TB) in people living with HIV (PLHIV) with CD4 counts ≤ 100 cells/µL or with signs of being ‘seriously ill’. There is a risk of a false-positive AlereLAM in disseminated non-tuberculous mycobacterial (NTM) infections and it may be difficult to differentiate a single infection (either Mycobacterium tuberculosis or NTM) from dual infection.Patient presentation: We report three patients, enrolled in an operational study assessing AlereLAM use in an outpatient setting, who had advanced HIV (all CD4 20 cells/µL) and strongly positive (grade 4+) AlereLAM results in whom Mycobacterium avium or kansasii were later cultured from blood or urine and sputum.Management and outcome: Based on positive AlereLAM results, all three were initiated on TB treatment. One died before NTM infection was detected. Two were managed for dual infection (TB and NTM) but died within two years.Conclusion: Tuberculosis remains a leading cause of death and a disproportionate number of these deaths occur in PLHIV. Tuberculous treatment should be initiated based on a positive AlereLAM result, and this should be followed by additional testing to confirm the diagnosis of TB and to obtain drug susceptibility results. In those not responding to TB treatment where the only positive result was an AlereLAM, an alternative or additional diagnosis of NTM infection should be considered, particularly in patients with a very low CD4 count.
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