Democratizing molecular diagnostics and building national capacity through open reagents and open PCR

Abstract Access to affordable, quality-assured molecular diagnostics remains uneven across low- and middle-income countries (LMICs). The COVID-19 pandemic showed how dependent many national testing networks were on a small number of closed platforms. Open PCR platforms and openly distributable assays filled much of that gap, but much of the capacity deployed during the pandemic has since gone unused. Session 16 of the WHO Hub for Pandemic and Epidemic Intelligence Innovation Forum, co-hosted with the Clinton Health Access Initiative (CHAI), examined how open reagents and open PCR are being adopted, financed and sustained within national health systems. Contributions came from CHAI, two tuberculosis laboratory experts from India speaking in a personal capacity, the National Public Health Laboratory of Cameroon, Huwel Lifesciences and Thermo Fisher Scientific. Examples included the validation of open PCR kits for tuberculosis within India's national programme, local manufacturing of reagents and kits, and Africa CDC's evaluation and listing of open PCR assays during the mpox and Ebola outbreaks. The common message was that the technology has been shown to work. The remaining challenges are to position it within national diagnostic networks, to validate assays rapidly when new pathogens emerge, and to keep platforms and staff in routine use between emergencies.