Table 3 Further research that is needed regarding the Determine TB-LAM assay
Focus of research | Goal | Studies needed |
|---|---|---|
Assay and samples | Understanding the assay | Determine mechanisms by which LAM enters urine. Further clarify the host and pathogen factors associated with LAM antigenuria |
| Â | Assess any batch to batch variation of the assay | To determine manufacturing quality control of the test strips |
| Â | Improve diagnostic accuracy | Research and development to identify means to improve sensitivity and specificity Studies to assess and enhance reproducibility of interpreting test strips |
| Â | Assess impact of conditions of sample storage | Determine the effect of duration of urine storage at room temperature and any impact of freeze-thaw cycles on diagnostic accuracy |
| Â | Assess impact of urine contamination | Assess impact of contamination of urine samples on specificity |
Diagnostic accuracy and assay utility | Assess diagnostic accuracy | More studies are needed to very carefully assess the sensitivity and specificity in different geographical locations in appropriate clinical populations (advanced HIV, ambulatory vs hospitalized, adults vs children) using appropriate diagnostic gold standard. Assess for any association between reduced specificity and non-tuberculous mycobacteria or other coinfections/co-morbidity |
| Â | Use by health care workers at point-of-care | Assess feasibility and acceptability of running and reading the test-strips at point-of-care by non-laboratory trained health-care workers |
| Â | Incorporation in diagnostic algorithms | Operational research to assess feasibility and utility of incorporating in different diagnostic algorithms |
Impact and cost | Impact assessment | Assess the impact on time to diagnosis, time to starting TB treatment, morbidity and mortality and programme efficiency |
| Â | Cost-effectiveness | Assess cost-effectiveness in different settings |