Indian-origin team develops test to spot corona infection in 2 hrs

An Indian-origin team of researchers led by Dr RavindraKolhe from Georgia-based Augusta University has developed a novel, accuratecoronavirus test that can tell patients in if they are infected within abouttwo hours, instead of waiting typically days to hear from remote testingfacilities.

The team at the Georgia Esoteric and Molecular (GEM)laboratory at the Medical College of Georgia’s Department of Pathology, AugustaUniversity, said the lab would also like to test samples from outside theimmediate area when requested, but those details are still being worked out.

   

At the moment, the test is for patients whose samples aretaken at the Augusta University’s Health System.

“We want patients and physicians in our community tohave timely access to information that will ultimately benefit us all byhelping limit spread of the virus,” said Kolhe, director of the Lab andvice chair for translational research in the MCG Department of Pathology.

“More rapid identification of individuals who areinfected will help ensure they get help as needed and that the risk of exposureto others is significantly reduced,” Kolhe added.

The GEM Lab team includes Dr Ashis Mondal, lab supervisor;Kimya Jones, lab manager; research associates Sudha Ananth and Yasmeen Jilani;postdocs Drs. Pankaj Ahluwalia, Nikhil Sahajpal and Meenakshi Ahluwalia; andmolecular pathology fellow Dr. Allan Njau.

“We completed our COVID-19 assay validation on Sundayand immediately submitted the documentation to the FDA for theirapproval,” said Kolhe.

“This was a nonstop 90-hour effort by the phenomenalteam in the GEM lab to develop this test, but we all felt a commitment to ourcommunity to make this test available here,” he added.

While Food and Drug Administration approval is pending forthe new test, the FDA released new guidance this week that its approval is nolonger required for COVID-19 testing in a CLIA-certified laboratory like theGEM Lab.

“As we have all seen in the news, identifyingindividuals infected with this virus within a few hours and initiating thequarantine protocol can have a huge impact on infection spread and potentiallypatient outcomes,” Kolhe informed.

“We are now running tests around the clock”.

To quickly meet demand, the GEM Lab team is now workingaround the clock to increase their testing capacity, which started at 72 testsin a 24-hour period and which they want to expand to 500 in coming weeks.

The new test, which works on the Luminex ARIES laboratoryplatform, is based on modified testing recommendations from the Centers forDisease Control and Prevention (CDC), and focuses on two unique genetic markersfor the virulent virus.

“For testing, we are looking at a conserved region thatis unique for coronavirus 2019, has not been changed in this virus and isfundamental to its survival,” informed Kolhe.

The two genetic markers, N1 and N3 are DNA sequences thatare distinctive points of variation that can be used to identify a human or adisease.

“The biggest game changer in this is the turnaroundtime for patients because we are able to provide the test locally,” saidKolhe.

“We want to identify patients with a high viral loadand who can spread the virus rapidly,” he added.

Until now, a patient sample from the Augusta area would betaken, put on a plane to a reference lab, where it may take three to four hoursto process.

“The GEM Lab team has worked 24/7 to completevalidation and implementation in absolutely record time,” said Dr AmynRojiani, chair of the MCG Department of Pathology.

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