Northwestern Scientists Develop 15-Minute Hepatitis C Test Enabling Same-Day Treatment

Scientists at Northwestern University查看公司主页 have developed the fastest diagnostic test for hepatitis C virus查看药品详情 (HCV), delivering results to patients in just 15 minutes—up to 75% faster than other rapid HCV tests. The breakthrough technology could enable same-day diagnosis and treatment initiation, potentially transforming care for a disease that affects an estimated 50 million people globally and causes approximately 242,000 deaths annually.

The research, published December 10 in The Journal of Infectious Diseases, addresses a critical bottleneck in hepatitis C (搜索)搜索该疾病 care. While the infection is curable with an 8- to 12-week course of medication, treatment rates remain low partially due to lack of affordable and easily accessible diagnostic tests.

Revolutionary Speed for Point-of-Care Testing

The new test utilizes the DASH® (Diagnostic Analyzer for Specific Hybridization) PCR platform, originally developed at Northwestern University查看公司主页 to detect COVID-19 from nasal swab samples. The hepatitis C (搜索)搜索该疾病 version uses whole blood specimens, demonstrating the platform's flexibility across different sample types and pathogens.

"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," said corresponding author Sally McFall, co-director of the Center for Innovation in Global Health Technologies at Northwestern University查看公司主页 McCormick School of Engineering.

Current hepatitis C (搜索)搜索该疾病 diagnosis follows a two-step process. An initial antibody test determines if the patient was exposed to the virus, and if positive, a second PCR test detects viral RNA (搜索)搜索该靶点 to confirm active infection. Healthcare workers typically send PCR samples to central laboratories, requiring days or weeks for results and necessitating patient return visits. While the FDA has approved one other point-of-care HCV test, results still require 40 to 60 minutes—much longer than typical clinical appointments.

Independent Validation Confirms Accuracy

To validate the test's performance, Northwestern scientists shipped DASH® analyzers and HCV cartridges to collaborators at Johns Hopkins University查看公司主页. The independent evaluation using 97 clinical specimens confirmed 100% agreement when compared to commercial platforms, establishing the test's reliability for clinical use.

"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 study co-author Dr. Claudia Hawkins, 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."

Supporting Global Elimination Goals

The rapid diagnostic could play a critical role in the World Health Organization查看公司主页's ambitious goal to eliminate HCV by 2030. Chronic hepatitis C infection (搜索)搜索该疾病 leads to cirrhosis (搜索)搜索该疾病 and liver cancer (搜索)搜索该疾病, making early detection and treatment crucial for preventing these potentially fatal complications.

The research represents a collaboration between engineering and infectious disease faculty at Northwestern University查看公司主页. The study received support from multiple National Institutes of Health grants, including funding from the National Cancer Institute, National Institute of Biomedical Imaging and Bioengineering, and National Institute of Allergy and Infectious Disease.

The technology is being commercialized by Nuclein, LLC (搜索)搜索该词条, with McFall serving as one of the original inventors of the DASH platform and holding stock in the company.