Saskatoon Health Region has advised Region physicians that patients may require additional Hepatitis C testing.
“In March of this year, it was discovered that our confirmatory test that we have used since 2012 was based on an older technology and was not meeting an acceptable standard for patient care,” says Dr. Joseph Blondeau, interim Head for Pathology and Laboratory Medicine for Saskatoon Health Region and a clinical microbiologist. “Once we discovered this problem, we immediately ceased this testing. As a result of the review, we have informed physicians that they should consider getting their patients follow-up tests, if they feel that is clinically necessary.”
Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. Testing for hepatitis C virus is a two-step process where a patient’s blood is tested for antibodies, and, if positive, supplemental testing is performed. Though laboratory results are important in providing patient care, the clinical assessment by physicians is key to determining whether a patient has been exposed to the virus and whether or not they require treatment for an active infection.
“We started a large-scale review after we had discovered that between January 1 and April 2015, 26 patients tested positive, but in the end, did not have Hepatitis C,” explains Blondeau. “The false positive results would not have led to inappropriate therapy given supplemental testing is required first. Further analysis indicated the potential for a small number of false negative cases.
The comprehensive review, in the end, showed there was no clear indication as to why 26 false positives occurred. However, it did identify an issue with the test since 2012.
Between January 2012 and April 2015, the region completed about 4,000 tests for Hepatitis C using this older technology. However, the number of patients this represents would be smaller because some patients are tested several times.
“While we know we can’t go back and re-test every time there is change in technology or procedures, we also recognize there is a chance, because of what we learned in our audit, that patients were affected,” says Blondeau. “We felt it was important to share that with physicians and patients and offer follow up testing to those who felt it was still clinically needed. We are sorry for any stress or anxiety this may cause patients.”
Physicians are being notified directly about this. If patients are concerned that this issue may have affected them, they should speak with their health care provider. Saskatoon Health Region and the Saskatchewan Disease Control Laboratory are working closely together to deliver this service.