Advanced Viral Diagnostics Tool Moves Closer to Widespread Use

Today's clinical diagnostic tools primarily focus on identifying specific, known pathogens. These targeted assays, like the PCR and antigen tests widely used during health crises such as the COVID-19 pandemic, are crucial for diagnostics. However, they are inherently reactive and usually come into play once an outbreak is already underway. Next-generation sequencing (NGS) provides a broader range of pathogen detection but lacks the sensitivity of targeted assays. To overcome this, an advanced NGS-based screening and surveillance system named VirCapSeq-VERT was launched in 2015. This system is capable of detecting any virus that could infect humans, whether previously identified or not, with enhanced sensitivity and speed compared to other NGS platforms. The latest iteration of VirCapSeq has now been validated and reported in the Journal of Clinical Microbiology.

Developed by scientists at the Center for Infection and Immunity (CII) at Columbia University Mailman School of Public Health (New York, NY, USA), VirCapSeq has been utilized globally in research to study acute and chronic disease outbreaks and conduct surveillance in humans, domestic animals, and wildlife. Recently, the CII collaborated with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the platform's development as a viral diagnostic tool, aiming to strengthen U.S. readiness for future outbreaks and enhance capabilities in infectious disease diagnostics. In 2022, the technology received approval from New York State to be employed in detecting nucleic acids from both DNA and RNA viruses in plasma, and the following year, approval was extended to nasal swabs for diagnosing systemic and respiratory infections. CII researchers expect the technology to be routinely used in hospitals soon.

The validation study, part of CII’s regulatory application to New York State, focused on evaluating VirCapSec's detection sensitivity, consistency, and repeatability. The study also assessed its ability to identify various viruses in co-infections and examined its accuracy and precision in real-world clinical conditions. The results were impressive: VirCapSeq-VERT achieved a clinical sensitivity of 99% and a clinical specificity of 100%. Moreover, it identified co-infections with clinically significant viruses that were not detected by the standard comparator assays used for the initial diagnostic testing.

“VirCapSeq is the only sequencing technology with regulatory approvals that has the broad range coverage of unbiased high throughput sequencing with significantly greater sensitivity in the detection and identification of all vertebrate viruses, including new and emerging species,” said Vishal Kapoor, MS, deputy director for laboratory medicine at the CII. “This technology can help identify novel viral threats early on in a public health emergency with the potential to contain outbreaks and prevent pandemics.”

“Our technology is poised to transform precision medicine, giving caregivers the ability to quickly pinpoint the cause of an infection so as to guide treatment,” added W. Ian Lipkin, MD, John Snow Professor of Epidemiology and the CII director. “At the same time, this diagnostic tool will be a boon for public health by providing information on viruses circulating in a community.”

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