Cost-Effectiveness of Point-of-Care HCV RNA Testing in US

Point-of-care testing (POCT) for the diagnosis and treatment of people with HCV has become increasingly practical with the introduction of direct-acting antivirals that have made a cure for HCV routine. However, in order to determine whether or not POCT for HCV RNA testing is cost-effective and thus worthy of being incorporated into the health system, the costs must be weighed against the benefits.

Why It Matters

From Multi-Step Testing to Point-of-Care Testing

The typical process for the diagnosis of hepatitis C involves a multi-step process to confirm the diagnosis of active infection. Many individuals test positive for the hepatitis C antibody and are then referred for an HCV RNA test to confirm active infection. These tests are typically conducted in a laboratory setting and require an additional visit for individuals to receive results and to start treatment. Individuals with unstable housing, those who do not have reliable transportation to and from laboratories for testing, and individuals with competing priorities are among those who may fall out of care between initial screen and confirmatory testing. These individuals and those found to be HCV RNA-positive but not linked to treatment can cause health systems to lose valuable resources as they spend increasing amounts of money treating advanced liver disease and liver cancer instead of curing HCV early with direct-acting antivirals.

Point-of-care HCV RNA testing will have value to improve the cure rate of persons with HCV infection and to reduce the risk of forward transmission of HCV, especially to injection drug users and their sexual partners, by allowing for earlier diagnosis of persons with HCV infection and for patients to be viremic for a shorter period of time. The value of POC RNA testing will be to offset the additional cost of testing and equipment and supplies to use the tests. The value will be expressed in terms of increased cure rates, cases of advanced liver disease and liver cancer prevented, and future medical care and costs for complications and of treatment of chronic HCV infection.

Cost-Effectiveness

Cost-effectiveness analysis represents a language that health systems increasingly use when deciding whether to introduce a new strategy in clinical practice. A test or strategy can be very expensive; however, if it leads to a large number of outcomes, including for example the number of individuals who are cured following single-visit diagnosis and treatment for HCV, the number of cases of advanced liver disease that are averted, the potential future medical costs that are avoided, and the improved health-related quality of life of individuals with chronic HCV, then that test or strategy can be considered cost-effective (and even cost-saving) even when its price is high.

What the Research Says

Studies that cost out POC RNA testing have found that it is both clinically and financially dominant. In a 2026 economic evaluation published in JAMA Network Open, a POC HCV RNA-first strategy was compared with a laboratory-based RNA testing strategy (using a US health care system perspective). Among high-risk populations (those who inject drugs and receive their health care in a variety of community- and clinic-based settings, as well as through emergency departments and through mobile outreach), the POC RNA-first strategy would detect 93.4% of people with active HCV infection, compared with a maximum of 68.7% of people with active HCV infection detected using the traditional approach.

Clinical and Economic Dominance

In closing the diagnostic gap for HCV infected individuals, POC RNA testing will identify more individuals with HCV infection and have the following implications for the health care system:

• Linkage to Care: Improvements ranged from 37.6% to 73.4% across different settings.
• Treatment Initiation: Rates rose by 12.1% to 48.9%.
• Cure Rates (SVR12): Successful treatment outcomes increased by up to 26.4%.

On the other hand, while up-front costs for drugs, for the additional testing, and for equipment for the POC test may be greater, long-term costs will decrease by approximately $3,387 per tested person. That is because forward transmission of the disease will decrease by 16.3% to 53.3% and also because of the huge cost of care to treat late-stage complications of HCV such as cirrhosis and HCC that can be prevented with the POC RNA test.

Who It Affects

Patients

Many people with HCV who have not yet been diagnosed would benefit from POC RNA testing. These individuals may fall out of care between the time of initial screening and the confirmatory test (i.e. laboratory-based RNA test) for several reasons. Individuals who use drugs, have unstable housing, live in rural communities where laboratory-based testing is not readily available, or are involved in the criminal justice system are several examples of individuals who would greatly benefit from a single-visit testing-and-treatment strategy that could result in the individual being cured of their HCV infection years before a diagnosis would have been made and treatment initiated allowing the time for the individual to progress to more advanced stages of liver disease.

Clinicians and Payers

single visit testing and treatment in health care settings, tests, treatment, and clinicians and clinics. All of the above health care settings can benefit from POC HCV RNA testing for single visit testing-and-treatment of patients with HCV. The greatest impact of POC HCV RNA testing for single-visit testing-and-treatment will be in high-prevalence patient populations and in health care settings with a high rate of loss to follow-up of patients diagnosed with HCV. Primary care clinics with good follow-up and same day phlebotomy are an example of a setting where POC RNA testing would be of less value since the test would be used for a single visit of testing-and-treatment as opposed to other health care settings such as harm reduction sites, mobile health care, resource-poor health care and fragmented health care systems where single visit testing-and-treatment would be very valuable for patients with HCV.

Payers and Public Health Departments

Payers and Public Health Departments. The short-term costs to test and purchase equipment and supplies must be weighed against the long-term savings to prevent costly complications of advanced liver disease such as liver failure and liver cancer and need for liver transplant for individuals with HCV infection. POC RNA testing will be an important strategy for public health agencies working to meet HCV elimination goals; however, there will be a need for funding to purchase equipment and supplies on an ongoing basis as well as for training of staff. Reimbursement and capital funding will be important policy issues to be resolved.

What Changes

• Faster diagnosis and treatment initiation: Point-of-care HCV RNA testing reduces the time between screening and confirmation of active infection, enabling same-day counseling and often immediate linkage to antiviral therapy.
• Reduced loss to follow-up in high-risk settings: Clinics that serve people facing transportation, housing, and scheduling barriers are likely to see higher cure rates because fewer patients fall out of the care pathway when testing and treatment steps are combined into a single visit.
• Different budget timing for payers and providers: Healthsystems will need to absorb higher upfront costs for machines, test cartridges, and staff time, while expecting savings later from fewer complications of chronic hepatitis C. That shift may require changes to reimbursement rules, start-up grants, or bundled payments to make adoption feasible.
• Operational and workforce adjustments: Implementing POC RNA testing changes clinic workflows. It creates opportunities to expand roles for nurses, pharmacists, and community health workers in testing and linkage. But it also requires quality control processes, device maintenance, and staff training that many low-resource sites will need support to implement.

A Big Practice Change

An important practice change that can occur in clinics in which POC HCV RNA testing is used is for all patients who test positive for HCV RNA to begin treatment on the same day of testing for HCV RNA. This means that on the same day of testing for HCV RNA, patients and their health care providers will need to make arrangements for patients to pick up prescriptions for DAA. In addition, the test results must be reported to the patient and the results from the test must be monitored and patients followed up with after testing. There will be some clinics in which this process will be relatively straightforward to implement and in others there will be system level issues that must be addressed (e.g.g. prior authorization requirements for DAA, limited DAA access policies, payer restrictions on DAA). Such issues must be identified in order to make a determination regarding whether or not POC HCV RNA testing will be cost effective.

Systemic Implementation

For a number of reasons, the majority of emergency departments (EDs) are not well suited for the adoption of a test-and-treat strategy for the detection and treatment of HCV. EDs lack of infrastructure to support a test-and-treat strategy for the detection and treatment of HCV are several. Nonetheless, many EDs are very high-yield settings for the identification of previously undiagnosed individuals with HCV infection. Thus, the use of a POC RNA test in the ED setting has the potential to save $435 per person within the first year.

Limitations

Cost. Most POC assays and their accompanying instruments cost more up front than sending off a test on a paper slip to a lab for results a few days later. Although no test is 100% sensitive or specific, current RNA-based POC assays are highly sensitive and specific. The value of immediate results to patients and health care providers must be weighed against the up-front costs of the test and the instrument to the program to determine whether even very expensive POC tests are cost-effective for a program with high loss to follow-up between the initial screen and confirmatory testing.

Looking Ahead

However, there are a number of factors that will determine the future use of POC RNA testing. As the number of test cartridges and POC RNA testing platforms being made by manufacturers increases to keep up with demand, the cost per test will decrease. In addition, as there are more tests developed for a variety of diseases, the cost of the equipment to administer these tests will be spread among all of the different programs. Payers, including Medicaid, will need to cover the cost of tests and treatment for people with HCV. In addition, administrative and insurance barriers to DAA drugs for HCV will need to be removed. Finally, as new technologies are developed for the detection of RNA, there will be the potential for less expensive and faster tests that can be used in very resource-poor settings.

Next Steps: Practical Assessment and Evidence-Based Management

In Practice. Estimate the percentage of patients who are lost to follow-up between the time of the screening test with the HCV antibody test and the confirmatory test for HCV RNA. Calculate the number of additional patients who would begin treatment if they were tested and treated in one visit. Decide who will pay for the POC devices and the tests. The payers will calculate the long-term savings to them of preventing the complications of liver disease as opposed to the short-term costs of the tests and devices. The public health officials will decide if the tools for POC RNA testing will help in the elimination of HCV in their community where access to care is the major barrier.

POC HCV RNA testing is not a cure all for testing and treating individuals with HCV infection; however, for many individuals and in many settings, POC HCV RNA testing can be a practical and cost effective strategy to ensure more individuals are cured of HCV infection. POC testing will be particularly useful in many clinical and community-based program settings where individuals fall out of care between the time of a positive antibody test result and confirmatory RNA testing. Importantly, POC testing and same day treatment enable individuals to be cured of HCV infection within a single visit.

Reference

1. Al Rawashdh N, Ferrufino CP, Cheng MM, Doshi SP, Kahn EB. Cost-Effectiveness of Point-of-Care Hepatitis C Virus RNA Testing in the US. JAMA Netw Open. 2026;9(3):e262658. Published 2026 Mar 2. doi:10.1001/jamanetworkopen.2026.2658