The Amazing Molecular Test for Hepatitis C

Viral Hepatitis C (HCV) is a devastating disease.  It is the number one cause of liver cancer and often leads to the need for a liver transplant.

A national survey found that 1.8 percent of Americans – about 3.9 million – have been infected with HCV, and most – about 3.2 million – are chronically infected, with many showing no signs or symptoms. As many as ¬ 80 percent of HCV infections reported each year are chronic, and some 20 percent of chronic infections progress to cirrhosis (scarring of the liver) over 20 to 30 years.

The FDA has just approved a RealTime PCR test from Abbott to measure the viral load of Hepatitis in the body.  That is tremendous scientific news because now we have a low level way of discovering, and then treating, Hepatitis on a molecular level.  Here’s how:

“With the addition of the HCV assay to its automated m2000 system, Abbott is the only molecular diagnostics supplier in the U.S., to offer viral load assays for HIV, HBV and HCV, and a combination test for chlamydia and gonorrhea, on a single molecular platform,” said Joseph Jacobs, M.D., associate medical director, Abbott Molecular. “This enables laboratories to consolidate sexually transmitted and infectious disease testing to improve workflow and productivity. Also, having a single manufacturer of these tests provides the clinician with a level of assurance of consistency and quality when managing patients.”

The Abbott RealTime HCV test offers precise measurement (quantitation) of HCV in human plasma or serum. It is a highly sensitive HCV viral load test and the only one for which the limit of detection (lowest level of virus that generates a positive result) and the limit of quantitation (lowest exact viral load measurement) are the same, 12 IU/mL. This level of sensitivity enables clinicians to measure very low levels of the HCV virus to gauge success of antiviral drug treatment for eradicating the infection.

On June 12, 2008, I wrote — Federal Punishment of Urban Needle Exchanges — and included this quote about Hepatitis in that article:

Needle exchange programs, which increase the availability of sterile syringes, are an important means of reducing the transmission of HIV infection and other blood-borne diseases such as hepatitis B and C among injection drug users and their often unsuspecting sexual partners and children – the most rapidly growing population of people with HIV. Most needle exchange programs operate on a one-for-one basis, so they also reduce the presence of infected needles in playgrounds, streets, and trash receptacles, thus protecting children, sanitation workers, and others from accidental needle sticks.

If we implement a successful needle exchange program, and if we use PCR for molecular testing of Hepatitis, I’d argue we would be well on our way to identifying and then eradicating this liver eating disease.