Roadmap to create diagnostic tests available in English, French and Portuguese.
This document provides guidance on the development of a new, in-house, real-time RT-PCR test for SARS-CoV-2 aimed at laboratories which have established molecular biology capabilities.
The information – available in English, French and Portuguese – will also provide a roadmap for the creation of new molecular diagnostic tests for other emerging pathogens.
It acknowledges the constraints of resource-limited laboratories, and outlines requirements for good molecular biology practices, including quality control and quality assurance.
Steps to success
When a new virus such as SARS-CoV-2 emerges, laboratories rely on time-tested methods of developing diagnostic tests when commercial assays are unavailable.
These LDTs are rarely perfect on the first attempt.
Ideally, these tests continue to develop and gain validation until formally certified for in vitro diagnostic use by a regulatory body.
Most LDTs do not progress to the point of formal certification for use. However, they should still be held to the highest standard of quality possible to mitigate the health and economic impacts of the emerging disease and help protect vulnerable populations.
