WHO prequalifies, OraQuick HCV, self-test for Hepatitis C virus

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.

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.

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.