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Researchers develop one-step urine test for screening HCV
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SAN FRANCISCO — Researchers from University of California Irvine have developed a one-step urine-based test effective for screening and diagnosing hepatitis C virus infection that may reduce costs, according to a poster presentation at The Liver Meeting 2015.
“Our novel HCV antigen test system has significantly improved sensitivity and specificity over current tests,” Ke-Qin Hu, MD, director, hepatology services, H.H. Chao Comprehensive Digestive Disease Center School of Medicine, University of California Irvine, said in a press release. “Importantly, for the first time, we can use urine specimens for one-step screening and diagnosing of HCV infection. Finding a more convenient, easy-to-use and cost-effective screening alternative is imperative, because HCV is significantly underscreened and under-diagnosed.”
Ke-Qin Hu
Using their novel test system, HCV-Ags EIA assay, developed for one-step screening and diagnosing of viremic HCV infection, Hu and his colleague Wei Cui, MD, analyzed urine samples from 128 patients without renal disease and 27 patients with chronic kidney diseases, to determine if the test results were consistent with serum HCV RNA PCR, the current standard test to confirm viremic HCV infection.
Among 35 urine samples from 20 patients without HCV and 15 patients with resolved HCV, the researchers observed a 100% concordance with serum HCV RNA PCR results, ie, 100% specificity of the HCV-Ags EIA for viremic HCV infection.
In 93 urine samples from patients with HCV, the HCV-Ags EIA assay showed a 100% sensitivity rate for detecting active or viremic infection. This was not affected by renal dysfunction or hemodialysis, according to the abstract.
After urine samples were diluted, the lowest detection limit of the HCV-Ags EIA assay was equivalent to HCV RNA at approximately 50 IU/mL. In addition, the optical density measurements of the urine samples from the HCV-Ags EIA test were correlated to the corresponsive serum HCV RNA load.
According to the release, current blood-based HCV tests require two steps and can cost more than $200 in the U.S.
“The ability to detect infection using urine rather than blood avoids needle stick and blood sample collection, greatly reduces the cost and necessary clinical infrastructure for screening and diagnosis, helping to promote widespread adoption of the test on a global scale,” Hu said.
The researchers concluded: “The present study demonstrates for the first time that HCV-Ags can be reliably detected in urine specimens as a one-step diagnostic test for all HCV genotype infections. Our HCV-Ags EIA eliminates the need for a blood specimen, establishes a diagnosis of active HCV infection in a single, noninvasive step, and would increase the capacity of global screening for pangenotypic infections more cost-effectively.”
Hu noted that the technology has now been licensed to DiligenMed Inc.– by Melinda Stevens
Reference:
Hu K-Q, et al. Abstract 1785. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.
Disclosures: The researchers report no relevant financial disclosures.
Editor's note: This article has been updated with clarifications to the data.