Book Description

Circulation of monkeypox virus globally has increased demand for diagnostics, prompted rapid development of commercial kits, and driven expansion of networks of laboratories and health facilities offering diagnosis. However, a clear need for more simplified, automated and/or accessible assays remains, including those that can enable testing at decentralized sites outside the laboratory. In response, to increase access to quality-assured, accurate and affordable mpox (monkeypox) diagnosis, an expert consultation process has been initiated, resulting in the drafting of two target product profiles (TPPs): 1. Tests used for diagnosis within health care settings and laboratories (TPP1). 2. Tests used as an aid to diagnosis by detecting orthopoxvirus (OPXV) antigens, which are amenable to decentralized use, including in the community (TPP2). Generally speaking, a TPP is a planning tool for the development of health products. The primary target audience of the TPPs are manufacturers, suppliers, and researchers developing new assays. Additionally, countries and agencies evaluating and/or selecting assays for procurement and use for mpox (monkeypox) testing across both urban and rural environments, especially in settings with constrained resources, may benefit from the criteria and information presented. The TPPs are intended as a strategic reference document for comparison and transparency. The criteria lay out some of the characteristics that are most relevant to inform the expeditious development of tests that address the greatest and most urgent public health need according to WHO. As is the case with all WHO TPPs, it is recognized that access, equity, and affordability are integral parts of the innovation process and need to be considered at all stages, not just after a product is developed.