Hepatitis C reflex testing in Canada: from theory to practice
Hepatitis C testing in Canada can be complicated. Until recently, hepatitis C testing through provincial labs across the country was standard two-step testing. This approach uses two separate blood samples collected at two separate times. The first blood sample is for the screening test that looks for antibodies to the hepatitis C virus. This screening test determines if a person has ever been exposed to the virus. If this test result is positive, a second blood sample is taken to conduct the confirmatory test that looks for the presence of the hepatitis C virus in the blood. This test confirms whether a person currently has a hepatitis C infection or if the infection has been cleared.
A newer approach to hepatitis C testing could be a game changer. It is called reflex testing or “one-step diagnosis”. In Canada, this is a relatively new testing approach that uses blood collected at a single visit to complete the screening and confirmatory tests (as required) at the lab. This means that a person does not need to have blood taken a second time if they test positive for hepatitis C antibodies and require a confirmatory test.
CATIE spoke to two frontline service providers who have access to reflex testing and one who doesn’t, to learn more about their experiences.
More complete and timely follow-up for people affected by hepatitis C
Gisela Macphail, MD, MPH, FRCPC, CUPS Liver Clinic, Calgary, Alberta
When we examined our cascade of care at the CUPS Liver Clinic in 2018, we noted that some people weren’t even aware they had a positive hepatitis C screening test because they either were not seen in follow-up or because the provider seeing them on the next visit was not the same person and didn’t communicate the result. We also noted that many people did not go on to have a confirmatory test, to learn if they currently had the hepatitis C virus infection.
We then made an agreement with the provincial laboratory to do hepatitis C reflex testing on specimens from our clinic. This was a wonderful change, as it allowed for more complete and timelier follow-up with clients. This is especially important as about one in four people spontaneously clears the virus. Many people had been living with the psychological burden of hepatitis C (for example, stigma, knowledge of having a chronic infection that requires treatment to be cured) for years without actually having chronic hepatitis C.
At the CUPS Liver Clinic, reflex testing means that the positive (and negative) confirmatory test results from all providers in the clinic are forwarded to me. I can then do electronic consultations, organize treatment with the Liver Clinic team and treat clients without them needing to physically see me. It has allowed us to reach people who experience barriers to accessing care.
Simplifying the pathway to diagnosis and treatment
Mia Biondi, PhD, NP-PHC, Omega Specialty Nurses, London, Ontario
Ontario is now the only province that does not have a form of hepatitis C reflex testing. Practically speaking, this means that multiple steps need to be taken for confirmatory testing: the provider needs to contact the patient and reach them, send new paperwork to the lab, the patient would need to attend the lab, and then the provider would contact the patient with the confirmatory test results. There are many points in this process where loss to follow-up can occur. These steps are further complicated when an individual does not have a reliable phone, cannot attend the laboratory as a result of the cost of transportation, or has competing life priorities.
Reflex testing would result in a single contact point with the patient to discuss whether or not they currently have a hepatitis C infection. Research shows us that minimizing the number of appointments or tasks that need to be completed prior to hepatitis C treatment can greatly improve treatment uptake for some populations. Furthermore, extensive follow-up will not be feasible in most traditional healthcare settings.
Potential limitations and confusion from the reflex testing process
Lesley Gallagher, RN, Pender Community Health Centre, Vancouver, British Columbia
Although the practice of hepatitis C reflex testing increases pre-treatment efficiency and minimizes time to diagnosis, it can have limitations which may not be well understood by many healthcare practitioners.
Hepatitis C antibodies remain detectable for life, showing that the patient has been exposed to hepatitis C. A patient with hepatitis C antibodies may not have a current hepatitis C infection if they have spontaneously cleared the virus or received treatment and been cured. Therefore, the confirmatory test is needed to determine if the patient currently has hepatitis C.
In my experience working in British Columbia, only the initial positive screening (antibody) test, will automatically trigger a confirmatory viral load test to be run (this is an RNA test in B.C.). The majority of patients I care for have previous positive antibody testing on record. This causes some issues in what is meant to be a streamlined process. If a patient has ever had a positive hepatitis C antibody result in the past, they do not require this test to be repeated.
A healthcare provider who is not familiar with the lab tests for hepatitis C diagnosis (screening versus confirmatory) may rely only on the practice of hepatitis C reflex testing. If a positive confirmatory RNA test is not received after ordering a screening (antibody) test, they will not be prompted to follow up or refer the patient. The healthcare provider may assume the patient does not have hepatitis C. However, if the patient has a previous positive screening (antibody) test on record, the confirmatory RNA test will not be triggered. Therefore, the patient’s current hepatitis C infection status is not known.
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From speaking to people working the front lines, we get a more complete picture of what reflex testing looks like in the real world: what is working and what can be improved. Ultimately, reflex testing reduces barriers to getting a hepatitis C diagnosis and connects people to care so they can get treated and cured of hepatitis C. It makes the process more convenient for the person being tested and reduces the chances of a person not completing a multi-step testing process.
To learn more about hepatitis C reflex testing, see a recent CATIE Blog post on implementation in British Columbia, and an overview of reflex testing in Prevention in Focus.
Romane Close is the knowledge specialist in hepatitis C resource development at CATIE.