Table 3.
Research, development, and implementation questions for future urine Lipoarabinomannan (LAM) Tests. POC: point of care.
| Research and development questions | |
| 1 | What concentrations of LAM need to be detected to meet TPP sensitivity in HIV-negative populations? |
| 2 | Can sensitive, specific, low-cost, simple, and rapid platform alternatives be developed that substantially improve POC detection compared to conventional lateral-flow assays? |
| 3 | Which of the currently available antibodies yield the best performance in immunoassays? |
| 4 | What simple and POC-amenable specimen processing steps would improve the availability for detection or increase the concentration of LAM in clinical samples? |
| 5 | Are multiple molecular species of LAM present in clinical specimens, implying the need for polyclonal antibodies or multiple sets of monoclonal antibodies? |
| 6 | What purified LAM antigen preparations best mimic what is found in patient samples? |
| 7 | What is the molecular structure of LAM released from M. tuberculosis in vivo? |
| Implementation and public health impact questions | |
| Patient-related questions | |
| 8 | What is the target population and distribution? Which populations will benefit from this tool? Which populations could eventually benefit? |
| 9 | How much more impact will a next-generation test have on mortality risk reduction? |
| 10 | Can LAM tests be used to monitor treatment adherence and/or completion? |
| 11 | What are the diagnostic yields of LAM tests alone and in combination with smear microscopy or Xpert? |
| Operational and health systems questions | |
| 13 | What is the intended level of healthcare facility and user level of training required? |
| 14 | How much time is saved by using this tool versus other standard-of-care tools? |
| Policy and access questions | |
| 15 | What global institutions, technical experts, and financing organizations are considered key influencers in the global market for this product? How are we engaging with them? |
| 16 | What are the early-adopter countries that may drive product uptake and expansion? Which countries are potential new markets for next-generation LAM tests? |
| 17 | How will next-generation LAM tests integrate into current WHO guidelines and TPPs for TB detection? |