Hepatitis C point-of-care testing: What is its impact on testing and linkage to care?

Prevention in Focus PiF 2022 Fall

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Testing is a critical step in the hepatitis C cascade of care: through testing, people with hepatitis C can be diagnosed and linked to hepatitis C treatment services. Testing can also serve as an important part of prevention and education for those at risk of hepatitis C. Innovations in testing can create alternate pathways for diagnosis and linkage to care; point-of-care testing is one such innovation. Point-of-care tests are analyzed at the site where the sample is collected and typically provide results within five to 60 minutes. This article explores what point-of-care testing is, the advantages of point-of-care testing, and how these types of tests can help us increase access to testing while simplifying the hepatitis C cascade of care, supporting Canada in achieving the global goal of hepatitis C elimination by 2030.

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How does hepatitis C testing work in Canada?

Typically, two tests are required to diagnose a hepatitis C infection: a screening test and a confirmatory test. The first test (screening test) looks for hepatitis C virus antibodies and determines if a person has ever had hepatitis C. If the screening test result is positive for hepatitis C antibodies, a second test (confirmatory test) is required to determine whether the person has a current hepatitis C infection. The confirmatory test detects the presence of virus in the blood. In Canada, it is typically an RNA test.

Hepatitis C tests in Canada are conducted on a blood sample. The blood sample can be collected through a standard blood draw by venipuncture, which is the most common way hepatitis C tests are done in Canada, or through blood from a finger prick.

What is point-of-care testing?

A point-of-care test is analyzed at the site where the sample is collected (i.e., the point of care), as opposed to being sent to a laboratory for analysis.1 Typically with point-of-care tests, the testing can be done and the results obtained within a total of five to 60 minutes. For hepatitis C point-of-care testing, a blood sample is taken from a finger prick and tested immediately on site. Some point-of-care tests can provide results within minutes, so the client can be given the result of the test during the same visit. These are often referred to as “rapid point-of-care tests.” Point-of-care tests have been developed to detect hepatitis C antibodies and viral RNA. One point-of-care hepatitis C antibody test has been licensed for use in Canada. One point-of-care hepatitis C RNA test is being used for research purposes in Canada today and will potentially become licensed in the future.

Point-of-care hepatitis C antibody testing: Overview of the OraQuick HCV Rapid Antibody Test

Since 2017, there has been one point-of-care hepatitis C antibody test licensed for use in Canada. Is it called the OraQuick HCV Rapid Antibody Test (manufactured by OraSure Technologies). The OraQuick HCV Rapid Antibody Test is a single-use point-of-care test for hepatitis C antibodies (i.e., determining if a person has ever had hepatitis C) through blood from a finger prick. It is also designed for use with saliva; however, this application of the test is not approved for use in Canada.

The OraQuick HCV Rapid Antibody Test provides results in 20 minutes.2 There is, however, emerging research that the OraQuick HCV Rapid Antibody Test can detect some positive results faster, within five minutes for all individuals with a current hepatitis C infection.3 However, use of the test with this “‘five-minute-rule” is not part of the Health Canada approval.

Accuracy of OraQuick HCV Rapid Antibody Test

The accuracy of a hepatitis C test is measured using sensitivity and specificity. The OraQuick HCV Rapid Antibody Test has a sensitivity of 95.9% or higher when used with finger-prick blood samples.4 This means that if 1,000 people with hepatitis C antibodies were tested, 959 people would correctly test positive and up to 41 people would incorrectly test negative.

The OraQuick HCV Rapid Antibody Test has a specificity of 99% or higher when used with finger-prick blood samples.4 This means that if 1,000 people without hepatitis C antibodies were tested, 990 people would correctly test negative and up to 10 people would incorrectly test positive.

In comparison to standard laboratory-based testing in Canada for hepatitis C antibodies, which have sensitivities and specificities above 99%, there is a slightly higher chance of false-negative results when testing with the OraQuick HCV Rapid Antibody Test.

Point-of-care hepatitis C RNA testing: Overview of the Xpert HCV Viral Load Fingerstick

At the time of publishing, there is no hepatitis C point-of-care RNA test licensed by Health Canada for diagnostic use. However, a company called Cepheid manufactures the Xpert HCV Viral Load Fingerstick, which is being used for research purposes in some programs and services across the country. The Xpert HCV Viral Load Fingerstick is an RNA test that can be used to determine a current hepatitis C infection. Research being done with the Xpert HCV Viral Load Fingerstick may be used to support an application to Health Canada for licensing in the future.

The Xpert HCV Viral Load Fingerstick requires the GeneXpert System, a specialized machine, to analyze the test. The GeneXpert System is available in various sizes, including a machine as small as 16 cm wide and 30 cm tall. To date, Health Canada has licensed point-of-care tests that require the GeneXpert System for the viruses that cause COVID-19, influenza and respiratory syncytial virus infections.

For the Xpert HCV Viral Load Fingerstick, 0.1 mL of blood is collected into a minivette, which is a small tool used to collect blood from a finger prick. The minivette containing the blood sample is transferred to the test cartridge and then analyzed through the GeneXpert System. The Xpert HCV Viral Load Fingerstick provides a quantitative RNA result in just under 60 minutes. Because the test measures the amount of virus in the sample, it can be used for diagnosing a current hepatitis C infection, monitoring treatment and detecting reinfection.5

Accuracy of Xpert HCV Viral Load Fingerstick

The Xpert HCV Viral Load Fingerstick has a sensitivity of about 99% for hepatitis C RNA detection.6 This means that if 1,000 people with current hepatitis C infection were tested, 990 people would correctly test positive and 10 people would incorrectly test negative.

The Xpert HCV Viral Load Fingerstick has a specificity of about 99% for hepatitis C RNA detection.6 This means that if 1,000 people without a current hepatitis C infection were tested, 990 people would correctly test negative and 10 people would incorrectly test positive.

In comparison to standard laboratory-based tests in Canada for hepatitis C RNA, which have sensitivities and specificities above 99%, the Xpert HCV Viral Load Fingerstick demonstrates similar, very high accuracy.

How widely is point-of-care testing for hepatitis C used in Canada?

While the OraQuick HCV Rapid Antibody Test is the only point-of-care test approved for use in Canada, it is not reliably funded in any jurisdiction, making the tests largely inaccessible.7

What are the advantages of point-of-care testing compared with other types of tests?

Testing is a critical step to diagnose and link people with hepatitis C to care and treatment services and can also serve as an important part of prevention services and education. Compared with other types of testing, point-of-care testing has advantages that could reduce some barriers to hepatitis C testing. To achieve elimination of hepatitis C as a public health threat by 2030, advances in hepatitis C testing are required to simplify the hepatitis C cascade of care in Canada.7

Testing can be performed in a variety of locations

Point-of-care tests have the potential to increase the number of people tested because they can be administered and interpreted in non-traditional settings outside of medical and laboratory facilities.8–10 For example, point-of-care tests have been delivered in a variety of settings where people are already accessing services such as pharmacies,11 harm reduction services including needle and syringe programs and supervised consumption sites,12–15 substance use disorder treatment programs,16 prisons,17,18 services that support people experiencing homelessness19 and mobile services.20 Self-contained single-use point-of-care tests such as the OraQuick HCV Rapid Antibody Test can be administered and interpreted during outreach.21

Through delivery in non-traditional settings, point-of-care tests have the potential to engage more individuals, especially those who not do have equitable access to healthcare such as people who use drugs9 and people in remote settings.1,22

The sample can be collected by a range of healthcare and lay providers

Point-of care tests can be administered by a range of healthcare providers including family doctors, nurse practitioners and nurses as well as lay providers such as frontline workers and people with lived and living experience.12,21,22 Benefits of this task-shifting include expanding the availability of testing22 and allowing people with connections to a community (such as an outreach worker, harm reduction worker, social worker or person with lived and living experience) to administer the test. Lay providers who have regular personal contact with clients may see greater uptake in testing from clients because they have well-established relationships.12 Some, but not all, provinces and territories permit lay providers to conduct point-of-care testing.

Test results are available at the same appointment, which can reduce loss to follow-up or delays related to testing

When clients are able to have a blood sample collected and learn their test result within the same encounter, it can be possible to obtain a swift diagnosis, and the emotional burden associated with having to wait for the results can be alleviated.17 This can also simplify the testing process and reduce the number of clinic visits or interactions with service providers related to hepatitis C care that a client will have to have.1,9,10,17,22,23

It is an alternative for people who are unable to provide a venous sample or prefer a finger-prick sample

Since point-of-care tests do not require a blood draw through venipuncture, the tests can be used when the blood draw is a barrier to providing a blood sample. This method is particularly important among people who inject drugs who may experience challenges with venipuncture because of issues with vein health from injection drug use.10,17,22 In addition, members of this community have often had distressing and stigmatizing experiences with healthcare providers, including phlebotomists during blood draws,24 which contributes to reluctance to receive venipuncture.25

There are high rates of acceptance of, and often preference for, finger-prick point-of-care testing over standard venipuncture among people who inject drugs13,26,27 and people entering the prison system.17,18 Studies on point-of-care testing among people who inject drugs have found that a proportion of the study participants declined or could not undergo venipuncture but were able to provide a blood sample from a finger prick. In these studies, a high proportion of the participants who were tested for current hepatitis C infection through finger prick and declined venipuncture were found to have hepatitis C,28 indicating that offering an alternative to venipuncture creates more opportunities for diagnosis and linkage to care for people who inject drugs.

Increasing access to testing and simplifying the hepatitis C cascade of care

Given the advantages that point-of-care testing offers, such as delivering test results at the same encounter and decentralizing testing through offering tests in a variety of locations, it has the potential to increase testing rates. This can in turn increase the rates of diagnosis and linkage to hepatitis C care.

Because access to point-of-care testing is currently limited in Canada, there has been limited research to date examining the impact of point-of-care testing on rates of testing, diagnosis, linkage to care, or treatment in Canada. A randomized controlled trial in Toronto, Ontario, evaluated the impact of peer outreach point-of-care hepatitis C antibody testing with the OraQuick HCV Rapid Antibody Test. The study found that peer outreach workers were able to engage a group of marginalized individuals who were unaware of their hepatitis C antibody status and increase knowledge of their hepatitis C antibody status.21 Although there was a high antibody positivity rate of 39% in this study, receiving point-of-care antibody testing did not increase the likelihood that participants attended a follow-up visit with a centrally located hepatitis C treatment nurse, in comparison with people who were referred by the outreach workers directly to visit a hepatitis C treatment nurse for standard laboratory-based testing.21 Further supports are needed to ensure that people with positive antibody point-of-care test results receive follow-up testing, diagnosis, linkage to care and treatment.16,21,22

International research on the OraQuick HCV Rapid Antibody Test has found that point-of-care antibody testing, followed by RNA testing with a blood-drawn sample in people who test positive for antibodies, can be useful in high-prevalence settings. When an individual can provide the blood sample for the RNA test at the same visit at which they receive a positive antibody point-of-care test result, there are fewer steps required to receive a diagnosis and connect to hepatitis C treatment.12,29

Point-of-care RNA testing has the potential to be used for diagnosis of hepatitis C, fast-tracking people along the cascade of care to linkage and treatment to cure hepatitis C. Research on co-locating point-of-care RNA testing on site at a supervised consumption site in Toronto found a high rate of hepatitis C RNA positivity: 52% of those tested. Of the study participants with hepatitis C infection, 67% were linked to care on site, and of those linked to care, 67% initiated treatment. All clients who received SVR testing (hepatitis C viral load testing to determine treatment success) were cured.14

Research on the integration of point-of-care RNA testing within harm reduction and other services for people who use drugs in Catalonia, Spain, found higher rates of access to treatment and cure, and fewer people lost-to-follow-up, compared with standard laboratory-based testing.30 Additional studies have found high rates of linkage to care13,20 and treatment15,20 among marginalized people through using an antibody point-of-care test first and then offering people with a positive antibody test result a point-of-care RNA test.

Novel ways of increasing access to testing, and linking people to care on the basis of test results, have been explored with success with other point-of-care testing kits, such as for HIV.31 The relative ease of use of point-of-care hepatitis C testing also raises the possibility of hepatitis C self-testing in the future.23,32,33 In a similar way to HIV self-testing, take-home kits for COVID-19 antigen testing, or take-home pregnancy tests, the ability to access a wider range of point-of-care testing modalities in Canada could have a major impact on increased access to testing.

Potential challenges and limitations

A major challenge is the limited access to point-of-care testing across Canada.7 Currently, the tests are not funded by public health or medical systems; access to the tests is typically through private funding or academic centres as part of research. Programs and services will not be able to reliably access or integrate point-of-care tests into their services without public funding. Beyond the two tests discussed in this article, other hepatitis C point-of-care antibody and RNA tests have been developed;8,33 however, they are not available in Canada. Increasing the options for point-of-care tests in Canada and providing public funding for the tests could greatly improve access.7

There are some other challenges and limitations to consider. In many jurisdictions, a duplicate test through the standard laboratory-based processes (i.e., blood is drawn through venipuncture and the blood sample is sent to the public health laboratory) is required to confirm point-of-care test results. Requiring laboratory-based testing to confirm point-of-care test results hinders the ability of point-of-care testing to reduce the number of visits an individual requires to move through the care cascade. However, if point-of-care test results were recognized and accepted by public health and medical systems, without the need for duplicate testing by standard laboratory-based processes to confirm point-of-care test results, point-of-care testing could simplify and speed up the pathway of getting diagnosed with hepatitis C and starting treatment.

Not all point-of-care tests are able to provide immediate results. The Xpert HCV Viral Load Fingerstick point-of-care test has a processing time of about 60 minutes. Research has found that many individuals will not wait 60 minutes to receive their point-of-care RNA test result at the same visit.13 Shortening the wait time for test results, and integrating testing into other healthcare services, may increase the proportion of people who wait for their result.34

Although point-of-care tests are considered relatively simple to administer, some studies have found that a small proportion of Xpert HCV Viral Load Fingerstick tests do not produce a valid result because of low sample blood volume.6,28,35 The Xpert HCV Viral Load Fingerstick assay requires a 0.1 mL sample of blood (about 0.1 grams of blood) collected from a finger prick, which is more than a couple drops of blood. Training on strategies to collect this amount of blood from finger pricks could support the practical administration of these tests.36

Finally, increased access to testing and diagnosis must be accompanied by sufficient capacity of providers to link people to care, offer treatment to cure hepatitis C and provide ongoing support if needed to prevent new infections and reinfections. Services should be offered in stigma-free, trauma-informed, culturally safe environments, tailored to the needs of the communities they are serving.

Implications for service providers

Point-of-care testing for hepatitis C antibodies and RNA is highly accurate and could increase testing uptake. Point-of-care testing can be particularly useful among communities with a higher prevalence of hepatitis C, such as people who use drugs, or people living in remote settings. Point-of-care testing can increase access to testing and simplify the process by enabling providers to conduct the testing and share the results at the same appointment. It also allows for hepatitis C testing in non-traditional settings where people are already accessing services such as harm reduction services, services that support people experiencing homelessness such as shelters or drop-in programs, and mobile services, as well as during outreach.

Service providers will need to consider whether they have access to point-of-care tests and how these test results are integrated into the public health and medical systems. Service providers can consider advocating for public funding of point-of-care testing in their regions and for novel ways to disseminate the tests, to help expand access to testing. Service providers can also consider whether advocating for acceptance of point-of-care test results by the public health and medical systems (so that duplicate testing through standard laboratory-based processes is not required to confirm the point-of-care test results) may be needed to truly simplify the cascade of care and realize the full benefits of point-of-care testing.

Linkage to ongoing supports for preventing hepatitis C infections and reinfections is critical, in addition to linkage to care for hepatitis C treatment for any individual with a positive hepatitis C RNA test.

Related resources

Dried blood spot collection for hepatitis C and HIV testing in Canada

Simplifying the road to hepatitis C diagnosis: Reflex testing in Canada

Hepatitis C: Testing – A section of Hepatitis C: An In-Depth Guide

You can have hepatitis C and not know it – Client resources including a video, poster and postcard

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About the author(s)

Rivka Kushner is CATIE’s manager, national hepatitis C knowledge exchange. She has a master’s of public health in health promotion and previously worked in knowledge exchange related to substance use, workplace health and environmental sustainability.

Externally reviewed by: Bernadette Lettner & Dr. Jordan Feld