Early Infant Diagnosis: Logistics

This report assesses the cost of point-of-care (POC) GeneXpert technology for early infant diagnosis (EID) and viral load (VL) compared with conventional platforms in Zimbabwe. Three cost-analyses were conducted based on a retrospective study and simulations: (1) a simple cost analysis of the initial investment (capital cost); (2) a cost-efficiency analysis (cost/ output); and (3) a cost-effectiveness analysis (cost/ outcomes). This report outlines the results—cost of initial investment, running cost per test, simulated costs per test, and cost-effectiveness.

This 2017 presentation provides an overview of PEPFAR’s viral load/in vitro diagnostic technology scale up strategy—the network approach. It highlights procurement challenges and product selection considerations as well as challenges associated with forecasting and maintenance. The presentation also reviews point-of-care integration considerations and provides recommendations for laboratory procurement.

This presentation provides an overview of the 2017 WHO guidance for procurement of in vitro diagnostics (IVD) and related laboratory items and equipment. The overview includes roles and tips for users, procurers of IVDs, manufacturers, and national regulatory authorities.

Poorly conducted procurement has a huge programmatic impact if stability of products and allowable shelf life for labile reagents are not foreseen as part of the procurement process. This WHO guidance aims to highlight the necessary factors to consider when procuring in vitro diagnostic medical devices (IVDs) and other laboratory items.

This study demonstrated how public-private partnerships (PPP) can be used to address key gaps and strengthen laboratory systems. The BD-PEPFAR PPP established standardized, streamlined specimen logistics, using the Ethiopian Postal Service Enterprise to support a laboratory network. Training laboratory and postal service personnel, ensuring an adequate supply of standard specimen transport materials, improving physical specimen logistics, addressing laboratory safety, mentoring facility staff, using geographic information system (GIS) software and geographic positioning system (GPS) devices, and monitoring and evaluating the specimen referral network resulted in increased referring sites and decreased turnaround times for ART-related monitoring. This planned and structured approach to improving specimen referral enhanced access to quality laboratory services.

This ASLM 2016 poster presents site mapping and an innovative model of hub/spoke as an approach to optimizing the EID network in Lesotho.

This ASLM 2016 poster discusses site selection for platform placement to integrate point-of-care technologies into national EID networks. Early infant diagnosis data from 7,979 heath facilities across all nine UNITAID POC EID project countries was evaluated for EID demand.

This ASLM 2016 presentation describes a stepwise approach to site and platform selection and site preparation towards readiness for point-of-care EID introduction in nine countries.

This AIDS 2016 presentation describes Global Fund efforts to provide a range of credible, cost-effective, competitive options with more transparent pricing and contracting—accessible to all—and highlights the online Viral Load and EID Selection and Procurement Tool. A table with suppliers (July 2016) and their testing products and regulatory status is included.

This ICASA 2015 presentation emphasizes that with conventional EID, many test results are never received by the infant or caregiver and outlines POC HIV EID (and viral load) products— available and pipeline—and next stage POC technologies.