WHO prequalified the OraQuick HCV self-test to enhance hepatitis C diagnosis and treatment. Only 36% of 50 million cases are diagnosed, and 20% treated, according to Dr. Meg Doherty. The 2021 HCVST recommendation complements services, targeting under-tested populations. Unsafe injections and unscreened blood cause 3500 daily deaths, highlighting the need for better diagnosis efforts.
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.
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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.
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