Taye T Balcha1,2, Niclas Winqvist1,3, Erik Sturegård4, Sten Skogmar1, Anton Reepalu1, Zelalem H Jemal5, Gudeta Tibesso6, Thomas Schön7,8, Per Björkman1. 1. Infectious Disease Research Unit, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden. 2. Ministry of Health, Addis Ababa, Ethiopia. 3. Regional Department of Infectious Disease Control and Prevention, Malmö, Sweden. 4. Clinical Microbiology, Regional and University Laboratories, Region Skåne, Malmö, Sweden. 5. Oromia Regional Health Bureau, Addis Ababa, Ethiopia. 6. Columbia University Mailman School of Public Health, International Center for AIDS Care and Treatment Programs- Ethiopia, Addis Ababa, Ethiopia. 7. Department of Medical Microbiology, Faculty of Health Sciences, Linköping University, Linköping, Sweden. 8. Department of Clinical Microbiology and Infectious Diseases, Kalmar County Hospital, Kalmar, Sweden.
Abstract
OBJECTIVE: To assess the diagnostic performance of urine lipoarabinomannan (LAM) detection for TB screening in HIV-positive adults in Ethiopia. METHODS: Testing for LAM was performed using the Determine TB-LAM lateral flow assay on urine samples from participants in a prospective cohort with baseline bacteriological categorisation for active TB in sputum. Characteristics of TB patients with regard to LAM status were determined. Participants were followed for 6 months to evaluate survival, retention in care and incident TB. RESULTS: Positive LAM results were found in 78/757 participants. Among 128 subjects with definite (confirmed by culture and/or Xpert MTB/RIF) TB, 33 were LAM-positive (25.8%); the respective figure for clinically diagnosed cases was 2/20 (10%). Five of the remaining 43 LAM-positive individuals had died during the 6-month follow-up period, whereas 38 remained in care without clinical signs of TB. The overall sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 25.8%, 92.9%, 42.3% and 86.0%, respectively. Among TB patients, LAM positivity was associated with higher WHO clinical stage, lower body mass index (BMI), CD4 cell and haemoglobin levels, and with increased mortality. A combination algorithm of urine LAM testing and sputum smear microscopy detected 49 (38.2%) of definite TB cases; among those with CD4 count ≤100 cells/mm3 , this proportion was 66.7%. CONCLUSIONS: The performance of urine LAM testing for TB detection was poor in this population. However, this was improved among subjects with CD4 count ≤100 cells/mm3 . In combination with sputum microscopy urine, LAM could be considered for targeted TB screening in this subgroup.
OBJECTIVE: To assess the diagnostic performance of urine lipoarabinomannan (LAM) detection for TB screening in HIV-positive adults in Ethiopia. METHODS: Testing for LAM was performed using the Determine TB-LAM lateral flow assay on urine samples from participants in a prospective cohort with baseline bacteriological categorisation for active TB in sputum. Characteristics of TBpatients with regard to LAM status were determined. Participants were followed for 6 months to evaluate survival, retention in care and incident TB. RESULTS: Positive LAM results were found in 78/757 participants. Among 128 subjects with definite (confirmed by culture and/or Xpert MTB/RIF) TB, 33 were LAM-positive (25.8%); the respective figure for clinically diagnosed cases was 2/20 (10%). Five of the remaining 43 LAM-positive individuals had died during the 6-month follow-up period, whereas 38 remained in care without clinical signs of TB. The overall sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 25.8%, 92.9%, 42.3% and 86.0%, respectively. Among TBpatients, LAM positivity was associated with higher WHO clinical stage, lower body mass index (BMI), CD4 cell and haemoglobin levels, and with increased mortality. A combination algorithm of urine LAM testing and sputum smear microscopy detected 49 (38.2%) of definite TB cases; among those with CD4 count ≤100 cells/mm3 , this proportion was 66.7%. CONCLUSIONS: The performance of urine LAM testing for TB detection was poor in this population. However, this was improved among subjects with CD4 count ≤100 cells/mm3 . In combination with sputum microscopy urine, LAM could be considered for targeted TB screening in this subgroup.
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