Ultra-High-Throughput SARS-CoV-2 Testing Platform

In early 2020, as testing for the SARS-CoV-2 pandemic lagged due to a scarcity of qualified collection devices (both swabs and viral transport media), laboratory instrumentation, and even plastic consumables, Quantigen and its collaborators set out to develop an ultra-high-throughput system that could process 100,000 CoV samples per day with minimal cost-per-sample or risk of supply interruptions. 

First, we validated the use of non-invasive anterior nares collections using a simple, inexpensive, and mass-producible spun polyester swab. These data were subsequently used by the FDA in expanding its guidance for appropriate sample collection. 

Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs | FDA

Click here to read the full FDA news release

Next, we validated the stability of dry swab storage (i.e., absent VTM) for up to 72 hours when exposed to either unusually cold or hot temperatures – data which we have since published, and which has been cited numerous times by groups submitting their own EUA proposals to the FDA. 

Finally, in collaboration with Audere, Quantigen performed a usability study for the HealthPulse@home COVID-19 Specimen Collection Kit, which established real-world feasibility of at-home, self-collected samples using swabs transported dry and in the absence of temperature controls.

Key collaborators:

• Bill and Melinda Gates Foundation
  (primary sponsor)
• Corteva Agriscience
• SteriPack
• Audere
• U.S. Cotton
• The Everett Clinic,Part of Optum