Abstract

Bacterial blood stream infections (BSI) are a common cause of mortality and morbidity globally. As the causative agents and the resulting treatment decisions vary, near-patient testing and surveillance tools are necessary to monitor bacterial causes and resistance to antimicrobial agents. The gold standard to identify BSIs is blood culture (BC), a methodology not widely available in resource-limited settings. The aim of the study was to map out a target product profile of a simplified BC system (SBCS) to inform product development efforts. To identify the desired characteristics of a SBCS, we enlisted a small group of specialists working in Africa and Asia. Questions were used to understand challenges and how these constraints inform system requirements. The specialists were infectious disease physicians, public health/clinical microbiologists, clinical researchers, and technology experts with different geographical backgrounds. All suggested that BC should ideally be available at the district hospital level. Many of the same operational challenges, such as limited availability of culture bottles, electricity and internet connectivity, profuse dust, the lack of ambient temperature control, and human capacity constraints were identified across the different regions. BCs, although the accepted gold standard for diagnosis of BSIs, are not widely available outside of reference/research centers in Africa and Asia. To extend the reach of this important tool, it is crucial to engage product developers and academic research partners to develop accessible alternatives.

Highlights

  • The World Health Assembly and World Health Organization (WHO) have recognized sepsis as a global public health priority [1]

  • To inform the target product profile (TPP) characteristics related to test results, we discussed how blood culture (BC) results were reported in each facility (Table 1)

  • Interviewees unanimously expressed an interest in automated AST information from an integrated simplified BC system, which was included as the desired characteristic

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Summary

Introduction

The World Health Assembly and World Health Organization (WHO) have recognized sepsis as a global public health priority [1]. Sepsis is a major worldwide health and economic burden [2] and it has been estimated that there are 31 million cases of sepsis per year worldwide with 6 million patient deaths [1]. Blood culture is an essential laboratory procedure that can influence the treatment of patients with sepsis [4]. Results of blood cultures (BCs) play a critical role in informing regional empiric therapy guidelines and the tracking of antimicrobial susceptibility trends and patterns [2]. BC was pioneered in the early and mid-20th century [5] with minor later improvements in the method due to the automated detection of positive BCs [6]. New technologies were developed to enable more rapid identification of pathogens and detection of resistance markers from positive

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