One Test Can Identify Almost All Infections
A new genomic test has been developed that can detect multiple pathogens with a single analysis, offering the potential for quicker and more accurate disease diagnosis.
Researchers have created a genomic test capable of identifying almost any infectious pathogen in the human body.
The test, as per a ten-year study conducted at the University of California–San Francisco (UCSF) and published in Nature Medicine, has shown an 86 percent success rate in diagnosing neurological infections.
Additionally, a study published on the same day in Nature Communications revealed that the test has over 90 percent accuracy in detecting respiratory viruses compared to PCR tests, the current gold standard diagnostic tests.
This FDA-recognized test can enhance care for neurological infections like meningitis and encephalitis and expedite the identification of new viral pandemic threats.
How the Technology Works
Unlike most tests that can only detect a limited number of pathogens at a time, this new test can identify all pathogens present by analyzing the genetic material in the patient sample.
This also enables the test to assess the quantity of different pathogens in the sample, predicting disease severity and aiding in quickly pinpointing the target pathogen.
Initially developed to analyze cerebrospinal fluid (CSF) using metagenomic next-generation sequencing (mNGS), the technology has been utilized on numerous patients with unexplained neurological symptoms.
A study in Nature Communications described how researchers have mechanized the mNGS process to identify pneumonia-causing pathogens in respiratory fluid.
A 1-Test Catch-All
This innovation is highly valuable for neurological diseases where rare or unknown pathogens present diagnostic challenges, potentially affecting patient outcomes due to delays in diagnosis.
Dr. Charles Chiu, professor at UCSF and senior study author, described the technology as deceptively simple in a press statement, emphasizing how it streamlines the diagnostic and treatment process by replacing multiple tests with a single one.
The test has already demonstrated significant impact, aiding in diagnosing an elusive infection in a young Wisconsin boy in a timely manner.
Over a period of seven years, nearly 5,000 CSF samples were examined by the UCSF team, with over 14 percent showing infections, and the new test correctly identifying the pathogen 86 percent of the time.
Chiu highlighted the superiority of the mNGS test compared to other tests for neurologic infections in the press release.
Future Developments
The technology is evolving, particularly in respiratory testing.
While the current CSF test involves numerous steps and takes several days, the new respiratory version aims for faster results within 12 to 24 hours, offering same-day or next-day outcomes.
Both studies indicate that the mNGS test can swiftly detect respiratory viruses likely to cause pandemics, such as SARS-CoV-2, even with minimal virus quantities present.
The CSF and respiratory mNGS tests have received breakthrough device designation from the FDA, facilitating collaboration with FDA specialists to address any premarket review challenges.
