NEW BRUNSWICK, NJ — Researchers at Rutgers say they have developed a test that can specifically identify the omicron variant of coronavirus.
Rutgers announced the news Tuesday. According to the school, this is a molecular PCR test that can correctly identify all the known variants of the virus, including alpha, beta/gamma, delta and omicron.
All of those have been named "variants of concern" by the Centers for Disease Control and World Health Organization.
The Rutgers test has not yet been approved by the Food & Drug Administration, and Rutgers just published their findings last Friday, Jan. 21, in this study in a medical journal. Their study has also not been peer reviewed. Still, Rutgers said it is now working to obtain rapid approval from the New Jersey Department of Health to use the new test on patients in New Jersey.
If approved, this test could be a game changer. That's because many of the current tests that are considered to be the gold standard in diagnosing COVID — the molecular PCR tests — are unable to confirm the omicron variant. The omicron variant is also the variant that can evade vaccine protection.
The test was developed in the laboratory of Dr. David Alland, director of theand the . Padmapriya Banada was the project leader.
Dr. Alland and his team say their test is 100 percent sensitive and has correctly identified each variant in clinical trials they've done at Rutgers. Banada says it does this by identifying genetic mutations of the virus.
The test can find virus particles in a nasal swab or saliva, she said. The test looks at the RNA extracted from someone's saliva or nose.
The test uses special probes called “sloppy molecular beacons” that are particularly good at detecting mutations in organisms that mutate frequently, such as viruses.
“Our approach is unusually flexible in being able to detect unanticipated mutations,” Dr. Alland said. “We had recently improved an older version that could detect the delta variant, but when omicron appeared, we suspected it would be able to specifically identify this variant as well. We are happy to find that our testing shows that we were correct.”
Banada explained the Rutgers Genomics lab (Rutgers Institute of Genomic Medicine) is submitting the test for state Dept. of Health approval as a "laboratory developed test," or LDT. As per this document from the FDA, LDTs do not require FDA clearance or approval before use.
There are no photos available of the new test.
They say that if used widely in the general public, their test would be very helpful because it would help determine the correct type of antibody therapy and potentially help identify patients at high risk for severe COVID-19.
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