Development of an ultrasensitive, rapid and portable nucleic acid based test for detection of acute Hepatitis C Virus infection at the point-of-care.

NIH RePORTER · ALLCDC · R43 · $306,992 · view on reporter.nih.gov ↗

Abstract

Hepatitis C Virus (HCV) infections are on the rise in the US and the world. Nearly 4 million people in the United States have HCV infection, half of which will progress to chronic HCV infection. HCV infections often go undiagnosed and untreated due to limited screening, lack of accessible testing options for primary care settings and loss to follow-up. Undiagnosed and untreated HCV infections can lead to adverse health outcomes and result in extremely high direct medical costs. Chronic infections when untreated can cause liver damage, cirrhosis, liver cancer and in some cases death. HCV RNA is detectable in whole and capillary blood specimens and infections are effectively treatable with antiviral drugs. The USPTF now recommends HCV screening for all adults between the ages of 18 and 79 years. Despite the seriousness of the health outcomes mentioned above, testing levels remain low and loss to follow-up rates remain high even amongst those that get the initial screen due to the need for a confirmatory test. In order to stem the growing rate of infections and resulting adverse outcomes, testing rates need to increase followed by reduction in loss to follow-up. The COVID-19 pandemic has enabled primary care in less traditional settings such as retail and promoted the use of telemedicine. This healthcare delivery model is particularly relevant to HCV screenings tests that are plagued by accessibility concerns. Point-of-care tests (POC) that detect anti-HCV antibodies are available but cannot differentiate between active and past infections and are plagued by sensitivity concerns. There is a need for rapid point-of-care confirmatory tests for active HCV infection. A POC test that can accurately detect acute viremia could enable test and treat models. Several POC molecular nucleic acid amplification tests (NAATs) are currently available, however, the majority are not sensitive, have validity issues [7] and are incompatible with complex samples due to lack of genuine sample purification. The only POC platform capable of high sensitivity (Cepheid Xpert) is expensive and is designated moderately complex. Cubit Diagnostics has developed a proprietary sample to results platform that utilizes specific target capture (STC) based sample purification followed by multiplex polymerase chain reaction (PCR). The Cubit platform consists of a disposable cartridge and a reusable dock. The platform is low cost, low footprint, extremely sensitive and can complete a test in 30 minutes. Cubit has developed a SARS- CoV-2, Flu A, Flu B test on this platform and plans to prove the feasibility of its proprietary STC extraction method using blood samples via this application. During this project, bench assays for specific target capture (STC) sample purification and fast polymerase chain reaction (PCR) will be developed for detection of HCV RNA from whole blood. Primers and probes will be designed and reagent formulations optimized to allow for PCR completion in 15 min. Targe...

Key facts

NIH application ID
11007686
Project number
1R43PS005313-01
Recipient
ARETE BIOSCIENCES
Principal Investigator
Sujit Jangam
Activity code
R43
Funding institute
ALLCDC
Fiscal year
2024
Award amount
$306,992
Award type
1
Project period
2025-09-30 → 2026-09-29