New Clinical Diagnostic Test for COVID-19

An in-house assay developed by Rockefeller University performs better than FDA-authorized nasal and oral swab tests, reveals a new study published in the journal PLoS ONE.

Rockefeller university developed an in-house assay to identify positive cases within the community during the early days of the pandemic when commercial COVID tests were less.

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‘DRUL saliva test conducted at home is emerging as new clinical diagnostic test for COVID-19.’

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“This research confirms that the test we developed is sensitive and safe,” says Darnell, the Robert and Harriet Heilbrunn professor and head of the Laboratory of Molecular Neuro-Oncology.

The DRUL test offered several advantages such as safe, efficient test taken at home and sent to the lab in transport medium that kills virus on contact.

The assay used only off-the-shelf reagents so it was inexpensive, costing around $2 per test. (By comparison, Medicare is currently paying up to $100 for every commercial test conducted). The test was also comfortable by providing a sample in a matter of spitting in a cup.

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The data from this study, which was previously submitted to New York State as part its approval process, shows that DRUL test in most cases outperforms the widely used tests for COVID-19.

Researchers first assessed DRUL’s limit of detection—how many viral copies the test could catch per volume of fluid. The test succeeded in detecting a single viral particle in one microliter of saliva, a figure comparable to that of the most sensitive assays.

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Next, in a direct challenge, they compared 162 results from volunteers who received both a swab and a saliva test. Predictably, almost all came back negative but four samples that were negative or indeterminate on the swab test were positive on the DRUL assay.

Since it was approved as a clinical diagnostic test in New York State, DRUL has been widely used on campus, first with select essential employees and then as a weekly screening programme for children of employees.

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Over 65,000 tests have been performed using the DRUL assay at Rockefeller, and the test has become a standard weekly screen for all of Rockefeller’s on-campus employees.

Other groups have implemented the test as well, including scientists at the Howard Hughes Medical Institute research campus, Stop COVID-19, and New York City’s integrated healthcare system.

Source-Medindia