Perspectives on Introduction and Implementation of New Point-of-Care Diagnostic Tests

Abstract

In recent years, there has been significant investment from both the private and public sectors in the development of diagnostic technologies to meet the need for human immunodeficiency virus (HIV) and tuberculosis testing in low-resource settings. Future investments should ensure that the most appropriate technologies are adopted in settings where they will have a sustainable impact. Achieving these aims requires the involvement of many stakeholders, as their needs, operational constraints, and priorities are often distinct. Here, we discuss these considerations from different perspectives representing those of various stakeholders involved in the development, introduction, and implementation of diagnostic tests. We also discuss some opportunities to address these considerations.

Novel techniques and future directions in molecular diagnosis of malaria in resource-limited settings

“…The need for training in performing a diagnostic test, in terms of both initial training and ongoing proficiency training and evaluation, is a chronically underestimated component of the implementation of POC diagnostic tests. A test that is easy to use and allows less skilled workers to perform it is systematically misunderstood as obviating the need for training and continuous monitoring of user capacity [52].…”

HIV point-of-care diagnostics: meeting the special needs of sub-Saharan Africa

“…Unmet needs in HIV diagnosis could be seen firstly in the lack of simple, affordable, quick, accurate, equipment-free, and reliable POC options for early infant diagnosis and for viral load measurement [4,12,43]; equally important, however, is the gap created by the poorly defined implementation logistic system in RLS [75].…”

“…A range of perceived barriers to successful implementation of evolving POC technologies may include economic, regulatory, and policy-related factors [75,78,79]; implementation plans should therefore devise strategies to overcome these perceived hurdles. Regulatory affairs agencies in subSaharan African countries need to ensure that performance evaluation of emerging POC kits are carried out locally prior to the registration of such products.…”

“…Also, POC implementation programs require viable business models to ensure sustainability and affordability in low-income countries [75]. These strategies may include designing economic structures to strengthen private-public sector partnership.…”

Multicenter Feasibility Study To Assess External Quality Assessment Panels for Xpert MTB/RIF Assay in South Africa

“…The South African experience to date has highlighted several areas for program strengthening realized during the national phased implementation, including the need for improved technical and clinical training, the need for laboratory information systems for data management, and the need for quality system components such as an external quality assessment (EQA) program, to name a few (1,2). The quality system needs to encompass the preanalytical, analytical, and postanalytical processes to ensure ongoing test quality, and an EQA program is one of the internationally recognized tools for this purpose (3,4). In this context for Xpert MTB/RIF, a panel must require intact Mycobacterium tuberculosis that can be processed outside a biosafety level 3 (BSL3) (or even BSL2) laboratory infrastructure.…”