Public consultation: Target Product Profiles for tests used for diagnosis of mpox (monkeypox)

Since early May 2022, cases of mpox (monkeypox) – caused by infection with monkeypox virus (MPXV) – have been reported from countries that have not previously reported cases, and continue to be reported in West and Central African countries. This is the first time that many mpox cases and clusters have been reported concurrently across multiple countries in widely disparate geographical areas. On 23 July 2022, mpox was declared a public health emergency of international concern (PHEIC) by the WHO, accelerating the global response, with the goal to stop the multi-country outbreak.

Increased circulation of MPXV 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, there remains a clear need for more simplified, automated and/or accessible assays, including those that can enable testing at more decentralized sites outside of the laboratory.

Target Product Profiles

The World Health Organization (WHO) is developing two target product profiles (TPPs) for diagnosis of mpox, aiming to inform and encourage technological advancements and enable assay development, as follows:

TPP 1: tests used for mpox diagnosis within health care settings and laboratories

TPP 2: tests used as an aid to mpox diagnosis by targeting orthopoxvirus antigen(s), that are amenable to decentralized use, including in the community

The goal of these TPPs is to promote development of technologies that could increase access to quality-assured, accurate and affordable mpox diagnosis, thus supporting global response efforts to stop transmission and link affected individuals to appropriate care and services.