Expensive and technically complex diagnostics for CD4, HIV viral load and early infant diagnosis (EID) have put appropriate staging, treatment monitoring and infant diagnosis out of reach for many patients in resource-limited settings. The World Health Organization (WHO)/UNAIDS Treatment 2.0 Initiative emphasises the essential role that cheaper and simplified diagnostic tools, especially point-of-care (POC) technologies, must play in efforts to further expand access to treatment. POC tests, defined as diagnostic testing at or near the site of patient care, brings the test conveniently and immediately near or to the patient. This increases the likelihood that the patient, physician, and care team will receive the results quicker, which allows for immediate clinical management decisions to impact patient care. In resource-limited settings, POC testing has the potential to significantly impact health care delivery and to address the challenges of health disparities.
New POC platforms for CD4, HIV viral load and EID are on the horizon and will become available over the next few years. However, many promising new POC tests are currently delayed at the market entry stage due to the burden of variable and lengthy country registration procedures and the requirements for clinical trials in almost every country in which manufacturers wish to market their assays. Partners, manufacturers, and donors also recognise the need for innovative technologies that will help countries achieve sustainable universal access to treatment to capitalise on the preventive benefit of antiretroviral therapy.
This generic protocol aims to provide a standardised approach and procedures for multicentre prospective evaluations of the clinical performance and operational characteristics of POC CD4 tests for the purpose of obtaining regulatory approval and for programmatic uptake considerations.
A multicentre approach will allow for accurate and reliable evaluation of the POC device’s performance in the population of intended use and will reduce the need for each laboratory or country to perform independent evaluations of the same POC devices. In turn, this will accelerate the availability and widespread implementation of POC testing in resource limited regions.