TAG 2010 Pipeline Report
The next edition of the Pipeline Report will include a more detailed survey of diagnostics appropriate to low resource settings. Here we look at the qualities required from a point-of-care test to be useful and two initiatives that appear to be close to emerging from the pipeline.
Requirements for Point-of-Care Tests Point-of-care refers to a test that can be conducted in the same facility where a patient receives his/her treatment and other care. In rural areas many patients have to travel vast distances to reach testing facilities and then return to get their results. There is considerable loss to follow up from people who do not return for their test results. These technologies need to be quick and easy to use and interpret, that work with a finger-prick blood sample or other non-venous sample and have a simple read out. They need to be appropriate to settings without sophisticated laboratories, where electricity and running water cannot be guaranteed. They need to perform in hot, humid or dusty environments and have a long shelf life. They need to be used and maintained by health workers without advanced technical skills.
The CD4 Initiative Point-of-Care CD4 Test The CD4 Initiative, at Imperial College, was established in 2005. The Initiative came about through a substantial activist push from Gregg Gonsalves, and a generous grant from the Gates Foundation.5 Led by principal investigator Dr Hans-Georg Batz and project manager Dr Stephen Reid, their objective is to develop new, low-cost, rapid point-of-care tests to measure CD4 counts, which are suitable for use in rural areas of low-income countries. The initiative set out to produce tangible results in four years, which is a very ambitious timescale to develop this type of product. The project began by establishing a set of predetermined specifications: • • • • • • 26
Simple and robust Semi-quantitative, minimum cut off of 250 cells/mm3 Stable at 40oC for 12 months Quality assurance material to check correct functioning of test Use of finger-prick blood/other non-venous blood sample Simple to perform, few steps and <2 hours training required