The need for standardization in laboratory networks.

Expanding health care services for HIV, tuberculosis, and malaria has increased the demand for affordable and reliable laboratory diagnostics in resource-limited countries. Many countries are responding by upgrading their public laboratories and introducing new technology to provide expanded testing services into more regions. This expansion carries the risk of increasing the diversity of an already highly diverse technology and testing platform landscape, making it more difficult to manage laboratory networks across different levels of the health care system. To prevent this trend, countries are recommended to implement policies and guidelines that standardize test menus, technology, platforms, and commodities across multiple laboratories. The benefits of standardization include rational prioritization of resources for capacity development and more efficient supply chain management through volume-based price discounts for reagents and instrument service. Procurement procedures, including specification, prequalification, and contract negotiation, need to align with the standardization policies for maximum benefit. Standardization should be adhered to irrespective of whether procurement is centralized or decentralized or whether carried out by national bodies or development partners.

Challenges in implementing CD4 testing in resource-limited settings.

The scale-up of HIV antiretroviral therapy in recent years has led to a rapid increase in CD4 and CD4% count capacity to meet the diagnostic needs of staging and monitoring disease progression and treatment efficacy in adults and infants. The speed of implementation of this technology has been unrivalled in recent years and has met challenges with technology selection, laboratory infrastructure development, human resource limitations, cost-effectiveness, instrument maintenance, and ensuring testing access and quality. The lessons learned from dealing with these challenges have helped strengthen existing laboratory systems for other diagnostics. They may also facilitate the implementation of new diagnostics in future.