14 April 2011
Hepatitis C retesting – HPA Bristol Laboratory
Following the discovery that one of its tests for Hepatitis C could deliver an incorrect negative result in a small number of cases, the Health Protection Agency’s Bristol Laboratory has introduced a new test for the virus and is undertaking a retesting programme.
The new PCR (polymerase chain reaction) test has been adopted following indications that its predecessor PCR test may have given inaccurate results for some samples by not detecting the Hepatitis C virus.
The PCR test is used to see if a patient has an active infection with the Hepatitis C virus. It usually follows a positive antibody test, which can show if someone had an infection in the past, but cannot distinguish between current and past infection.
An expert team looking into the Hepatitis C PCR testing arrangements at Bristol has recommended new tests for at total of 691 people who tested PCR negative for the virus between 1 January 2009 and 1 May 2010, and who were not retested during this period.
Most of these patients come from the former Avon area (Bristol, Bath and North East Somerset, North Somerset and South Gloucestershire), though there are smaller numbers of patients from elsewhere in the South West, as the laboratory offers testing services for the whole of the region. Patients will be invited to discuss the issue and provide a blood sample by GPs, who were written to yesterday.
Dr Isabel Oliver, Regional Director for HPA South West, said: “The HPA keeps its testing technology under regular review, and on this occasion we found that the previous test did not always perform as well as we would have hoped. For more than nine in ten Hepatitis C patients who tested negative with this PCR test, we’re confident the results were correct. But for the remainder, there is a chance that we may not have picked up active infection, so we want to offer them new tests to make sure.
“We are writing to GPs to ask them to invite these specific patients back for a test – those who tested negative for this particular PCR test between 1 January 2009 and 1 May 2010.
“These new blood samples will be tested immediately and GPs advised of the results. If the test result is negative, no further action will be needed. If the result is positive, then patients will be referred to liver specialists for further assessment and possible treatment.
“We can appreciate that this testing offer may cause anxiety for patients, and we’d like to stress how carefully we’ve considered this issue with our local NHS partners. A new, improved test has been installed at the laboratory and there may be some patients who would benefit from it.”
Hepatitis C is a disease that progresses slowly, usually over 15 to 20 years, and treatment is easily available at any point.
Notes for editors
1. Hepatitis means swelling or inflammation of the liver. The most common causes of hepatitis are viral infections. Hepatitis C infection (also known as Hep C or HCV) is one such virus that can cause long-lasting infection and can lead to liver disease.
2. Hepatitis C infection affects different people in different ways: many experience no symptoms at all while others experience extreme tiredness and can feel very unwell. Reported symptoms include fatigue, weight loss, nausea, 'flu like symptoms, problems concentrating, abdominal pain and jaundice.
3. It is estimated that around 15-20% of infected people clear their infections naturally within the first 6 months of infection. For the remainder, hepatitis C is a chronic infection that can span several decades and can be life-long.
4. Hepatitis C is a blood borne virus infection. The virus is spread when blood from an infected person gets into the bloodstream of another. Today, injecting drug use is the most common way to acquire hepatitis C virus infection. The prevalence of chronic hepatitis C infection in England is estimated to be around 0.4%.
5. The best treatment for hepatitis C infection consists of taking two drugs, interferon and ribavirin, and is known as dual or combination therapy. In clinical trials, combination therapy has been shown to be effective for many patients. However, not everybody is suitable for treatment or can tolerate it.
6. The HPA South West lead Laboratory in Bristol introduced a new PCR test for Hepatitis C following the indications that the previous PCR test failed to detect active virus in some patients’ samples. This was due to certain agents in the patients’ blood samples which acted to inhibit the test from working effectively. The new PCR test has improved performance in this area, and is more sensitive.
7. Further information about Hepatitis C is available from the HPA website at http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/HepatitisC/GeneralInformation/hepcGeneralInfo/ or from the Hepatitis C Trust at www.hepctrust.org.uk. The Trust also has a general information helpline on 0845 223 4424.
