How to validate Laboratory Developed Test for COVID-19 detection in a clinical setting

April, 2021. At the upcoming webinar, Lumex Instruments’ client, 1Care Diagnostics, will share their insights and experience about Laboratory Developed Test (LDT) validation for CLIA-certified lab setting.

While working on the LDT, 1Care Diagnostics used microchip-based real-time PCR technology for COVID-19 detection in saliva samples developed by Lumex Instruments. The system is based on PCR analyzer AriaDNA, and it uses a pre-loaded microchip kit with the US CDC recommended primers & probes lyophilized in the microchip.

The high-speed real-time PCR on a microchip brings a lot of advantages for COVID-19 testing. The method provides sensitive, affordable, and fast diagnostics due to 10 times fewer reagents and consumables, low sample volume, and short analysis time. Moreover, thanks to its small footprint, low energy consumption, and ease of use, PCR analyzer AriaDNA is ready to be deployed as a point-of-analysis network.

1CareDiagnostics – one out of a hundred CLIA-certified labs across the USA licensed to use their Emergency Use Authorization (EUA) to perform COVID-19 testing. During this webinar, Gabriel Martinez, our guest speaker from 1Care Diagnostic, will talk about the process of LDT validation, equipment set-up, and sample preparation and demonstrate examples and results of the clinical trial.