New rapid test could accelerate hepatitis C diagnosis and treatment
Point-of-care tool delivers HCV RNA results in about 15 minutes
Researchers in the U.S. have developed a rapid point-of-care test that detects active hepatitis C infection by identifying HCV RNA, with results available in about 15 minutes, which could allow some patients who test positive to begin treatment the same day.
“We were able to develop a diagnostic test that can be performed at the point of care during a patient’s clinical visit, which could enable same-day diagnosis and treatment in support of HCV elimination efforts,” Sally McFall, PhD, a professor at Northwestern University who led the development of the test, said in a university news story.
McFall and colleagues are hopeful their new test could play a role in the World Health Organization (WHO)’s goal to eliminate viral hepatitis, including hepatitis C, as a public health problem by 2030.
“Ultimately, the implementation of this assay could significantly accelerate progress toward WHO HCV elimination targets, by expanding access, reducing delays in diagnosis, and strengthening link to curative therapies,” the researchers wrote.
WHO’s goal has been shown to be achievable, with Taiwan announcing it has met the WHO criteria for eliminating hepatitis C as a public health problem, ahead of the 2030 global target.
How the 15-minute hepatitis C test was developed and tested
The development and validation of the 15-minute point-of-care test for hepatitis C viral RNA were described in the study “Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid PCR System,” published in The Journal of Infectious Diseases. The work was funded by several U.S. National Institutes of Health (NIH) grants.
HCV is a blood-borne virus, spread primarily through blood-to-blood exposure. It infects the liver and causes liver inflammation, known as hepatitis. Most people infected with HCV develop a chronic or long-lasting infection, which can set the stage for fatal complications such as liver failure and cancer.
Available treatments can cure chronic hepatitis C in nearly all cases, but treatment can only be given once someone is diagnosed. The current standard for diagnosing hepatitis C is a two-step process.
A person’s blood is first tested for antibodies against the virus, which indicate past exposure. If that test is positive, the sample is then tested for HCV RNA, a type of genetic material whose presence confirms an active infection.
A major drawback of this two-step process is that it takes a long time, often requiring people to return for multiple clinic visits before a diagnosis is confirmed. This raises the odds that some people testing positive for hepatitis C will miss appointments or otherwise fall through the cracks, meaning they don’t get a diagnosis that could be lifesaving.
There is one Food and Drug Administration-approved, Clinical Laboratory Improvement Amendments-waived point-of-care test for hepatitis C in the U.S., but results can take up to about an hour to generate, which may exceed the length of a typical clinical visit. As a result, patients with positive results may need to return for follow-up care, increasing the risk that some people with hepatitis C are lost to follow-up.
Adapting rapid PCR technology for hepatitis C detection
Scientists at Northwestern had previously collaborated with Minute Molecular Diagnostics (now a wholly owned subsidiary of Nuclein, LLC) to create the DASH Rapid PCR System, a platform designed for rapid detection of viral genetic material.
PCR, short for polymerase chain reaction, is a technology used in standard-of-care tests to detect HCV RNA. The researchers adapted the DASH platform to create a rapid point-of-care PCR test for hepatitis C.
To evaluate the new test, collaborators at Johns Hopkins University used the DASH platform to analyze 97 clinical specimens (77 positive and 20 negative) from 40 people participating in an ongoing NIH-funded longitudinal study.
Results showed the test achieved 100% positive percent agreement and 100% negative percent agreement with standard testing, with results available in as little as about 15 minutes.
The scientists noted that further validation is needed to confirm the test’s performance when used in real-world point-of-care settings, but said it could become a valuable tool for expanding access to hepatitis C diagnosis and treatment.
“This test could revolutionize HCV care in the U.S. and globally by dramatically improving diagnosis, accelerating treatment uptake and enabling more people to be cured faster,” said Claudia Hawkins, MD, one of the study’s authors and the director of the Havey Institute for Global Health’s Center for Global Communicable and Emerging Infectious Diseases at Northwestern. “By reducing delays and simplifying testing pathways, it has the potential to save millions of lives from the devastating liver-related complications of untreated HCV.”
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