UNITAID. World Health Organization (June 2013).
This report reviews current and emerging diagnostic platforms and developing technologies for point of care (POC) use - for CD4, viral load, and early infant diagnosis (EID) diagnostic tests - and assesses whether they meet the World Health Organization's "ASSURED" criteria (Affordable, Sensitive, Specific, User-friendly, Robust/Rapid, Equipment-free, and Deliverable to those in need). Many effective laboratory-based platforms are available for the three diagnostic tests, and various POC assays and platforms are in development, which may reduce costs, improve access for hard-to-reach-populations, and decrease loss-to-follow-up. Three POC CD4 tests are available. Others, including a disposable test, are expected to be on the market within two years. Access to viral load testing is inadequate in most resource-limited counties because of high costs, limited laboratory capacity, and transportation problems. ASSURED-certified viral load testing at the POC would decrease infrastructure and training costs. Only one assay is currently available, but many platforms and assays are in development, and one may be released in 2013. EID tests (which can also be performed on viral load platforms) have improved, but access is not universal. In addition to the viral load test platforms in development, at least two EID-specific POC assays are in progress, with one potential release in 2013. In addition, new platforms for high-volume testing are emerging. In conclusion, a country-specific mix of centralized, high-volume testing and POC diagnostics will likely be the most effective way to ensure access to these tests in resource-limited settings.