In-house Test Development for Molecular Detection of SARS-CoV-2

December 17, 2020

ASLM and Foundation for Innovative New Diagnostics (FIND) have produced a guide on how to develop and validate in-house RT-PCR tests for SARS-CoV-2. This guidance is essential, particularly in settings with limited diagnostics, including low- and middle-income countries (LMIC) where diagnostics are not immediately available during a pandemic. During the current COVID-19 pandemic the much needed testing reagents or kits for the commercial molecular diagnostic platforms are backlogged, unavailable or unaffordable. Test manufacturers can meet only a small fraction of the global demand for their products. These aforementioned factors hinder efforts for aggressive and sustained testing, which is the cornerstone of the test-trace-isolate strategies. Development of RT-PCR tests ‘in-house’ to detect emerging pathogens is one strategy that can help to mitigate some of the challenges associated with relying on test kits produced elsewhere in the world. Ultimately, the ability to develop and validate tests ‘in-house’ positions a laboratory to respond more quickly to outbreaks of emerging pathogens than it would be able to if it were reliant on commercial assay development and approval. This resource is intended for national laboratories, university laboratories, and private laboratories with established molecular biology capabilities. The information contained in the resource will also provide a roadmap for the creation and validation of new molecular diagnostic tests for other emerging pathogens as well. Throughout the guide, key considerations are highlighted, including constraints of resource-limited laboratories, requirements for good molecular biology practices including quality control (QC) and quality assurance (QA). The guide is available in English, French and Portuguese.