WHO prequalifies, OraQuick HCV, the first self-test for hepatitis C virus

In a remarkable feat, we are inching closer to diagnosis and treatment of a life threatening disease. The World Health Organisation (WHO) on Wednesday prequalified the self test against

hepatitis C

. WHO recommended HCV self-testing (HCVST) in 2021, to complement existing HCV testing services in countries. The recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not otherwise test.
“Every day 3500 lives are lost to

viral hepatitis

.

Of the 50 million people living with hepatitis C, only 36% had been diagnosed, and 20% have received curative treatment by the end of 2022,” says Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes. “The addition of this product to the WHO prequalification list provides a safe and effective way to expand HCV testing and treatment services, ensuring more people receive the diagnoses and treatment they need, and ultimately contributing to the global goal of HCV elimination.”

OraQuick HCV self-test

The product, called OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick® HCV Rapid Antibody Test which was initially prequalified by WHO in 2017 for professional use.

It is an immunoassay for the qualitative detection of immunoglobin G (IgG) antibodies to hepatitis C virus (anti-HCV) in oral fluid, fingerstick whole blood, venipuncture whole blood, plasma specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate), and serum (serum separator tube (SST), and from individuals 11 years or older.
It is manually performed and the assay strip contains synthetic peptides and recombinant proteins from the core, NS3, and NS4 regions of the HCV genome (test line) and a goat anti-human IgG (control line) immobilized onto a nitrocellulose membrane.

About hepatitis C

Hepatitis C is a viral infection affecting the liver, primarily transmitted through exposure to infected blood. This virus, identified as HCV, can lead to both acute and chronic forms of hepatitis. Acute hepatitis C often presents with mild symptoms or none at all, making it challenging to diagnose early. However, if left untreated, it can progress to chronic hepatitis C, which may cause severe liver damage over time, including cirrhosis, liver cancer, or liver failure.

The global burden of hepatitis C is significant, with an estimated 71 million people affected worldwide. Risk factors include unsafe injection practices, inadequate sterilization of medical equipment, and transfusion of unscreened blood products.