SUNY Upstate Medical Develops Clarifi COVID-19 Test: FDA Ranked #1 Saliva Test & 6th Worldwide for Sensitivity

SUNY Upstate Medical Develops Clarifi COVID-19 Test: FDA Ranked #1 Saliva Test & 6th Worldwide for Sensitivity

SUNY Upstate Medical was recently congratulated by New York’s Gov. Andrew W. Cuomo for developing what is positioned as the number one ranking COVID-19 saliva test by the U.S. Food and Drug Administration (FDA) for detecting the virus in its earliest stages. This test, known as Clarifi COVID-19, was developed by Upstate Medical and a start-up Quadrant Biosciences. Identified by the FDA as one of the most sensitive COVID-19 tests, regardless of type, it now ranks 6th worldwide in detecting the virus, according to Upstate Medical’s news release. Economical and easy to use, the virus test has purportedly aided the New York university system in identifying cases at the earliest stages of the virus.

TrialSite offers a brief breakdown concerning this SUNY Upstate COVID-19 test.

What class of test does the Clarifi COVID-19 test fall under?

The saliva test

What has the FDA’s review of this test revealed about Clarifi COVID-19 test?

The FDA found that this test has the best (lowest) limit of detection (LoD)at 600 copies of the virus per milliliter. According to the recent Upstate Medical news, the FDA’s recent published results reveal this particular test is the highest ranked saliva test coupled with one of the top sensitivity levels of any COVID-19 test.

Why are tests that can test with lower LoDs important?

Because they are able to detect infections at the earliest stages when individuals may be infectious, but asymptomatic. This is important because individuals infected with SARS-CoV-2, the virus behind COVID-19, become contagious starting at about day 3 to day 5 yet still may show no visible signs of illness (e.g. asymptomatic).

Where does the Clarifi COVID-19 Test rank in terms of sensitivity?

It is the sixth most sensitive test –according to Upstate Medical News only five other tests are more sensitive.

Why is sensitivity of test so important?

Because tests with greater sensitivity help limit the diffusion of the pathogen.

How fast can the test produce results?

Within 48 hours.

What has been the extent of usage at SUNY?

The Clarifi COVID-19 test has been used throughout the fall semester on SUNY campuses for regular, mandatory testing of students, faculty and staff. Already SUNY has conducted 580,805 tests this fall with a positive rate of 0.52%.

Currently, Upstate Medical is now as the capacity to conduct 200,000 tests per week.

Is testing going on beyond the boundaries of SUNY?

Yes. Recently SUNY, Upstate Medical and Albany International airport announced a partnership to test airport employees starting Friday, December 11. Passengers will follow later this month.

What is the recent ‘pooled surveillance testing’?

SUNY has been able to conduct more than 200,000 tests weekly this semester thanks to a series of major breakthroughs at SUNY Upstate Medical. Both the New York State Department of Health and FDA gave approval for an individual saliva swab test developed by Upstate Medical and Quadrant Biosciences. By combining this groundbreaking individual saliva swab test with Upstate Medical’s state-approved pooled testing protocol

What is Quadrant Biosciences background?

Founded in 2011 and based in Syracuse, New York, this venture has raised $10 million in investment capital according to Crunchbase. Now employing about 50, Quadrant Biosciences works with top academic institutions, medical researchers and engineers to translate breakthrough findings into thoughtfully developed and scientifically sound assessment applications. They promote two evolutionary advancements, including 1) head injury assessment and 2) autism detection.

SUNY Upstate Background

Part of the State University of New York (SUNY) system, this public college and university system represent the largest such higher education system in the United States. SUNY Upstate Medical is the only academic medical center in Central New York state. The region’s largest employer, the university’s educational mission is anchored by its four colleges, including 1) Medicine, 2) Nursing, 3) Health Professions and 4) Graduate Studies.

Prominent Biomedical Research

SUNY Upstate biomedical research enterprise focuses on the most prevalent human diseases, from cancer and diabetes to heart disease. The research apparatus’ mission centers on capitalizing on expertise in structural, molecular and systems biology to accelerate new medicinal and diagnostic breakthroughs. Upstate’s research enterprise now involves a $40+ million budget.

Care & Economy

The Upstate University Health System serves 1.8 million people, often the most seriously ill and injured. Upstate Medical powered the Central New York economy injecting approximately $2.3 billion into circulation.

Who was the lead scientist on this project for Upstate Medical?

Frank Middleton, PhD 

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