The current SARS-CoV-2 pandemic has created an urgent need for rapid point-of-care diagnostic tools. Many of these tests are being developed and are achieving FDA approval. In the face of a sweeping pandemic, assays should require no specialized equipment and should have rapid and easy-to-read visual results. Researchers in Constance Cepko’s lab at Harvard Medical School have developed a novel assay that involves a fast and easy sample preparation protocol and yields results in under an hour with excellent sensitivity. The team hopes to collaborate with industrial partners to leverage both the sensitivity and ease of deployment of the technology to roll out the test in highly resource-constrained environments.

The innovation is based on the reverse-transcription loop-mediated isothermal amplification (RT-LAMP) technique from New England Biolabs. The team has developed a robust RT-LAMP primer set that enables highly sensitive detection of the SARS-CoV-2 virus genome that induces a strong colorimetric reaction. Because of the strength of this color change, point-of-care LAMP-based diagnostics do not require specialized or expensive detection instruments.

In addition to improvements on the assay, the team has also optimized sample preparation to further increase sensitivity from a media sample as small as 0.5mL. Sample preparation is performed in a single tube in a matter of minutes and requires only three buffers, an inexpensive pulse-spin mini-centrifuge, and a 65°C heat block, allowing for ease of application by medical personnel at point-of-care institutions.