Non-risk-based HCV screening at point of care: a prospective pilot

Abstract

Background

Hepatitis C virus (HCV) transmission continues to be a significant problem among high-risk populations and has prompted widespread risk-factor based screening in Australia. Current evidence indicates a higher-than-expected local HCV prevalence in non-high-risk populations, justifying broader screening strategies in support of national HCV elimination efforts. This pilot study evaluated the feasibility and scalability of a non-risk-based point-of-care HCV screening approach with a focus on consumer experience and acceptability.

Methods

Over a 10-month period, individuals attending outpatient and community services were offered point-of-care HCV screening using the Abbott Bioline rapid HCV antibody test. Participants with reactive results received HCV-related education and were referred for confirmatory HCV antibody and RNA testing at local pathology services. Patients with detectable HCV RNA were offered expedited access to the Liver Clinic for assessment and treatment, coordinated by the Liver Clinical Nurse Consultant (CNC).

Results

A total of 1,086 individuals were screened, among whom 1.7% (n = 19) tested positive for HCV antibodies. This is notably higher than the national notification rate of 0.0281% indicating an unrecognised burden of HCV in this population. Among participants, 60.2% reported never having undergone HCV testing before. Consumer satisfaction was highly favourable, with > 95% of patients reporting that the test was easy to complete, and they would recommend it to family and friends. Each patient interaction, including consent, testing, result interpretation, counselling, and documentation, was completed within 20 min. Importantly, the Bioline test did not require laboratory infrastructure or skill set, is easily administered in community or outpatient settings, and delivers immediate results, enabling timely counselling, education, and linkage to care.

Conclusions

This proof-of-concept study demonstrates that non-risk-based opportunistic approach to HCV screening is both acceptable to our community and effective in identifying individuals with previously undiagnosed chronic HCV infection. The approach is scalable, resource-efficient, and represents a viable alternative to traditional, risk-based screening strategies in the context of broader public health efforts toward HCV elimination. Notably, our non-stigmatising “why not?” approach of testing allowed for concomitant education of our consumers and improved awareness of Hepatitis C and other blood-borne viruses.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s12879-026-13187-9.

Background

Hepatitis C virus (HCV) infection remains a significant global health challenge, with an estimated 58 million people living with chronic HCV worldwide and approximately 1.5 million new infections occurring annually [1]. Despite the availability of curative direct-acting antivirals (DAAs), underdiagnosis of chronic HCV remains a major barrier to HCV elimination, particularly in populations with limited access to healthcare or those not routinely screened [2]. In Australia, national efforts are underway to eliminate HCV as a public health threat by 2030, in line with the World Health Organisation (WHO) targets [3]. However, data from New South Wales (NSW) indicates a low detection rate of newly diagnosed HCV cases, with only 13 cases reported per 100,000 population in 2023 [4].

Currently, the Australian guideline for HCV screening is highly targeted and is offered only to high-risk populations: injecting drug users, Indigenous Australians, incarcerated people, and people who have high-risk sexual behaviour. People from culturally and linguistically diverse backgrounds (CALD) are considered a priority group, but there is no systematic screening programme or strategy for this group [5, 6]. Current testing for HCV depends on the enthusiasm, knowledge and time available for health care providers, clinic attendance and willingness of patients to answer risk-based questions without feeling stigmatised about their background and history. This has led to gaps in the implementation of the current testing strategies [7]. There is no systematic programme or strategy to screen people who may have acquired the infection through unsterile medical procedures overseas, blood transfusions before 1990, occupational exposures, cultural practices, previous short-term recreational drug use or vertical transmission. The prevalence of HCV in the general population has also never been assessed, and testing and treatment were never offered on a large scale for the non-targeted public who may not be aware of their HCV status. Hence, HCV testing based only on the presence of risk factors has the potential to miss a considerable number of HCV-positive patients, particularly at a population level [8].

A major hindrance in testing and treatment of HCV is stigma and discrimination. About 71% of people with HCV report that they have experienced stigma and discrimination [9]. Current screening processes, which target the high-risk population, may worsen the existing discrimination and ‘unnormalize’ the testing and treating process. Targeted screening strategies, while effective for high-risk groups, risk excluding individuals unaware of their infection status. Population-based screening models have demonstrated higher HCV detection rates and improved awareness, emphasising the need for broader, less stigmatised approaches to achieve Australia’s 2030 HCV elimination goals. Rapid antibody testing offers a promising solution to enhance HCV case detection by increasing accessibility, reducing stigma, and providing immediate results [10]. Unlike conventional serological tests, rapid tests can be administered at the point of care and require minimal training or equipment, making them suitable for both community-based and outpatient settings [6, 11].

This study aimed to evaluate the feasibility, diagnostic yield, patient acceptability, and operational cost-effectiveness of using the Bioline rapid HCV antibody test in a prospective outpatient cohort. We also assessed the alignment of test outcomes with confirmatory antibody and PCR results and explored potential pathways for sustainable implementation of rapid testing in community health systems.

Methods

Study design and setting

This was a prospective cohort study conducted between March 2024 to January 2025 at the oral health clinic of Westmead Hospital, Outpatient Services at Blacktown Hospital, Community Centres at Blacktown and Mount Druitt, and the Liver Wellness Outreach Service, designed in close consultation with community stakeholders and consumer advocacy groups. The study protocol was reviewed and approved by the Western Sydney Local Health District Human Research Ethics Committee (2023/ETH02042), and written informed consent was obtained from all participants (Clinical Trial number: not applicable). The overarching aim was to evaluate the feasibility, diagnostic yield, and acceptability of implementing point-of-care HCV rapid antibody testing using the Bioline kit (Abbott), while also addressing known barriers to HCV screening, such as stigma, access, and cost.

Participants

Eligible participants were adults aged ≥ 18 years who had the capacity to provide informed consent and had no prior history of testing positive for HCV. Recruitment was voluntary, and individuals were invited to participate during routine outpatient visits. Patients with previously confirmed or treated HCV infection were excluded from the study.

Consumer-driven approach

The study design was underpinned by a strong consumer engagement framework, with consultation with individuals affected by viral hepatitis and community health advocates informing the testing pathway, choice of the rapid antibody test, and design of pre- and post-test surveys. This approach ensured that the study addressed real-world barriers to screening and promoted a destigmatising, patient-centred experience. Emphasis was placed on using a non-invasive, rapid, and non-judgmental testing method to encourage uptake, particularly among those who may not self-identify as high-risk.

Rapid antibody testing and confirmatory testing

The index test was the Abbott BIOLINE™ HCV rapid diagnostic test which is an immunochromatographic assay for detection of anti-HCV antibodies, performed at the point of care according to the manufacturer’s instructions using finger-stick capillary blood. The SD Bioline Rapid Testing System was evaluated and endorsed by the World Health Organisation in the second half of 2019 [12]. The Bioline™ HCV assay has strong diagnostic performance, with sensitivity 96.7% (95% CI 82.8–99.9), specificity 99.8% (95% CI 98.9–100), positive and negative predictive values of 96.7% (95% CI 82.8–99.9) and 99.8% (95% CI 98.9–100), respectively, overall accuracy 99.6% (95% CI 98.6–99.9) [13, 14]. The test was administered by trained healthcare workers, with results available in approximately 20 min. A reactive result indicates the presence of anti-HCV antibodies and therefore previous exposure to HCV, but does not distinguish between resolved and current infection.

Laboratory anti-HCV testing using Roche Elecys assay was used as a reference standard to confirm antibody status. The index test was performed at the point of care on the day of presentation, with samples for confirmatory laboratory testing collected either on the same day or within seven days of the index test. The reference standard for current infection was laboratory-based HCV polymerase chain Reaction (PCR) performed on the Cobas 6800 platform, with detectable RNA defining current viraemic infection. Genotyping was performed for PCR-positive individuals when sample availability permitted. FIB-4 scores were calculated for HCV RNA-positive participants to assess liver fibrosis.

Results

Participation and screening outcomes

This prospective cohort study recruited patients willing to undergo HCV rapid antibody testing using the Bioline kit (Abbott, Gyeonggi, Republic of Korea). The median participant age was 55 years (interquartile range 39–68). Comorbidities among antibody antibody-positive cohort included: type 2 diabetes (n = 2), ischaemic heart disease (n = 1), and arterial hypertension (n = 2). Additional clinical characteristics of HCV antibody-positive patients are detailed in Table 1.

Table 1.

Clinical characteristics of patients reactive to HCV Bioline rapid Antibody Test

Risk factors
Sharing needles	2 (10.5%)
Unsafe tattooing or piercing	0 (0.0%)
Blood or blood product transfusion	0 (0.0%)
Vertical transmission	0 (0.0%)
Household transmission	0 (0.0%)
Unknown	17 (89.5%)
Comorbidities among reactive patients
IHD  T2DM  HTN  Liver diseases  Other (schizophrenia, GORD, asthma)	1 (5.3%) 2 (10.5%) 3 (15.8%) 2 (10.5%) 4 (21.1%)
Ethnicity
Caucasian  Aboriginal  Asian	16 (84.2%) 1 (5.3%) 2 (10.5%)

A total of 1,086 participants were enrolled, with an overall HCV antibody positivity rate of 1.74% (n = 19) (Fig. 1). Participants were not specifically asked about risk factors; however, two participants self-reported injecting drug use during post-test counselling, while the remaining participants did not disclose their mode of transmission.

Fig. 1.

STROBE participant flow outlining approach, screening, test validation and antiviral treatment. Of 2,607 individuals approached, 1,086 were tested and 14 were confirmed HCV antibody positive. Of the 4 RNA positive individuals, 3 achieved SVR12. HCV, hepatitis C virus; RNA, ribonucleic acid; SVR, sustained virological response

Confirmatory HCV antibody testing was performed in 15 patients to validate the results obtained from the Bioline rapid diagnostic test, while 4 patients declined further testing despite follow-up contact attempts Among participants who underwent confirmatory laboratory testing (n = 15), 14 were laboratory anti-HCV positive, yielding a positive predictive value (PPV) of 93.3% for anti-HCV detection (95% CI 68.1%–99.8%). Four participants were confirmed HCV RNA–positive, corresponding to 0.36% (4/1,086) of all individuals screened and 26.7% (4/15) of those with a reactive rapid anti-HCV result who completed confirmatory testing. Of these RNA-positive cases, 50% were identified at Community Centres and 50% at Oral Health Services. Genotyping revealed two cases as HCV genotype 3a and 1a, respectively; genotyping data were unavailable for the remaining two cases. Notably, abnormal FIB-4 values were observed in all four PCR-positive cases.

Testing was primarily conducted at Oral Health (55.6%), followed by the Community Centres (19.1%), the Outpatient services at Blacktown Hospital (13.9%), and the Liver Wellness Programme (11.4%). Among patients who tested HCV antibody positive, 47% were identified through the Liver Outreach Programme, 26% through Oral Health, 15% through the Community centres, and 10% through outpatient clinics.

Pre-and post-test survey

A survey was conducted to evaluate patient motivations for undergoing HCV testing and their perceptions of the testing method. All participants who underwent HCV testing (n = 1,086) completed both the pre-test and post-test questionnaires on the day of testing, resulting in a 100% response rate. The pre-test questionnaire was completed prior to testing, while the post-test questionnaire was completed after test administration while participants were awaiting their results. (Supplementary Data).

Pre-test survey results revealed that 60% of participants were never tested for Hepatitis C in the past (Fig. 2A). Among the participants that had not previously been tested, the primary reason was never having been offered testing (54%) (Fig. 2B).

Fig. 2.

Pre-test survey results. (A) Participants’ self-reported history of HCV testing before point of care testing. (B) Participant’s reasons for not having previously been HCV tested among patients who had not been tested before (n = 1,086). Multiple responses permitted

Post-test surveys demonstrated high patient satisfaction, emphasising the convenience and non-stigmatising nature of the rapid testing approach. The primary reasons for consenting to Bioline™ rapid antibody testing were ease of access, the minimally invasive finger-prick method, and the availability of immediate results (Fig. 3A). Furthermore, 97% of participants reported that the Bioline™ rapid antibody test was “very easy” to perform (Fig. 3.B), while 95% expressed willingness to recommend the test to relatives and friends (Fig. 3C).

Fig. 3.

Post-test survey results. (A) participants’ reported motivations for agreeing to undergo HCV rapid antibody testing. Multiple responses permitted. (B) shows participants’ responses to the question, “How easy was the process for HCV testing today?”. (C) participants’ responses to the question, “Would you recommend the HCV testing to your friends and relatives?”. n = 1,086

Discussion

This study demonstrates the feasibility and acceptability, of using Bioline rapid antibody tests for HCV screening and outlines key operational cost and workflow considerations within a service-attending population. The HCV antibody positivity rate in this non-targeted screening cohort was 1.74%, which is considerably higher than the national notification rate of 0.0281% [4, 15] indicating an unrecognised burden of HCV in this population. Importantly, participants were not pre-selected based on traditional high-risk criteria, suggesting that this rate reflects a true underlying burden of HCV prevalence in the service attending population. Among those who tested antibody positive, 15 underwent confirmatory RNA testing, with 4 cases (0.36% of the total cohort) confirmed as RNA positive. This RNA positivity rate was substantially higher than the state-wide RNA-confirmed notification rate of 0.013% reported in the 2023 New South Wales Hepatitis C Annual Data Report [4], which documented 1,645 RNA-confirmed cases across the population. Notably, this comparison should be interpreted as contextual rather than inferential, because notification rates are surveillance outputs influenced by testing volume, reporting completeness, and case definitions. They are not prevalence estimates and thus cannot be directly compared to the results presented herein. Nonetheless, these results highlight the potential for undiagnosed HCV infection in non-risk-stratified groups and support the expansion of opportunistic screening strategies in community-based and outpatient settings to improve early detection and linkage to care.

This discrepancy highlights the limitations of conventional screening methods and suggests that rapid antibody testing can significantly enhance case detection, particularly among individuals who do not self-identify as high-risk or have limited engagement with traditional healthcare pathways. These findings support broader implementation of rapid HCV screening tools to facilitate early diagnosis and treatment uptake, thereby strengthening public health efforts toward HCV elimination.

Western Sydney, with a population of approximately 1,052,990, includes 16,531 individuals identifying as Aboriginal and Torres Strait Islander peoples and nearly half (499,241) born overseas. Major countries of origin include India, China, the Philippines, South Korea, and Nepal [16]. This diverse demographic context is critical in interpreting the study findings. Among the HCV antibody-positive patients, two were identified as Aboriginal, three were born overseas, and the majority (n = 16) were born in Australia. This distribution challenges the traditional risk-based approach that prioritises testing among individuals from high-prevalence countries or specific high-risk groups. Instead, it underscores the importance of implementing non-risk based, opportunistic testing strategies across diverse healthcare and community settings, in conjunction with risk-based testing approaches [17].

International and local studies support these findings. A population-based screening in Norway (2019) reported an HCV prevalence of 0.2%, with nearly 40% of individuals unaware of their infection status [10]. In NSW, emergency department screening using a computer algorithm to identify eligible patients (born overseas or Indigenous, aged 18–80) revealed an antibody positivity rate of 3.6% and RNA positivity of 1%, with 20% of RNA-positive individuals unaware of their infection [6]. Similarly, a U.S. study found that approximately three-quarters of HCV antibody-positive patients did not belong to any recognised high-risk categories [8]. Another U.S. emergency department study employing an opt-out screening method for all patients aged 18 and above demonstrated that universal screening significantly increased new HCV diagnoses [18]. A retrospective analysis of outpatient presentations in Western Sydney between 2019 and 2021 documented an average HCV prevalence of 0.76%, which is substantially higher than the NSW state-wide RNA-confirmed notification rate of 0.038% during the same period [9]. These findings suggest persistent gaps in current screening approaches, particularly among individuals who may not identify as high-risk or lack regular contact with primary healthcare services.

Our results align with previous research demonstrating the utility of point-of-care HCV testing in improving case detection and linkage to care. For example, Lamoury et al. [19]. reported that point-of-care HCV RNA testing in Australian prison settings significantly improved diagnosis and treatment initiation rates. Grebely et al. [11] showed that HCV core antigen testing at point of care, while slightly less sensitive than RNA testing, offers a practical and cost-effective alternative for diagnosing active infection in low-resource or decentralised settings. Our data extend these findings to community-based outpatient populations, demonstrating high patient satisfaction, streamlined workflow, and immediate results without the need for laboratory infrastructure.

Importantly, nearly all participants in our study found the Bioline test convenient and acceptable, with 97% rating it “very easy” to use and 95% willing to recommend it to others. These figures highlight the test’s potential to overcome common barriers, such as stigma, access limitations, and procedural complexity, that often hinder traditional HCV screening programs.

From a service‑delivery perspective, the point‑of‑care workflow used the Bioline HCV rapid antibody kit (AUD $9.50) and ~ 20 min of staff time per participant. This includes approximately 10 min of Clinical Nurse Consultant Grade 1 & 10-minutes research technical assistant time in a single encounter covering consent, testing, results, counselling, and documentation. For context, conventional laboratory anti‑HCV testing (Medicare Benefits Schedule item 69475) has a base charge of ~ AUD $15.65 in public services and up to AUD $49 for private/overseas patients, excluding consultation time and repeat visits. The Bioline test requires no laboratory infrastructure, is easily administered in community or outpatient settings, and provides immediate results, facilitating timely counselling, education, and linkage to care. This streamlined, single-visit testing pathway enhances accessibility, reduces missed follow-ups, and lowers the overall healthcare burden, particularly in underserved or high-prevalence populations.

This study has several limitations. Considering the prevalence of HCV in Australia and the likelihood of identifying antibody positive individuals, the sample size was small and comprised opportunistic, service-attending participants. Moreover, individuals were enrolled across three sites in Western Sydney, Australia; a geographically and demographically distinct area, which limits representativeness and generalisability of our findings. Indeed, a larger cohort study across multiple sites in Australia (including healthcare and non-healthcare related settings) would provide more broadly relevant information pertaining to HCV prevalence in Australia, and the potential benefits of non-risk-based point of care testing. As an observational implementation study, both selection and implementation biases are possible. Incomplete follow up of anti-HCV reactive participants reduced the precision of our estimates for RNA positivity which reflects current infection. Follow up among anti HCV–reactive participants were incomplete, limiting precise estimates of confirmatory testing, linkage to care, treatment initiation, and SVR12. The screening pathway relied on HCV serology alone; testing for other blood-borne viruses such as hepatitis B virus and human immunodeficiency virus was not integrated because the point-of-care assay used was HCV-specific, limiting diagnostic efficiency and assessment of co-infection. In this service-attending sample, anti-HCV reactivity and RNA positivity were higher than expected when contextualised against routine surveillance notifications; however, notification rates are not prevalence estimates and therefore are not directly comparable with cohort proportions. Finally, the operational costing undertaken was descriptive rather than a formal economic or cost-effectiveness analysis. Downstream outcomes, patient time and travel costs, and sensitivity analyses were not modelled, precluding conclusions regarding scalability or value for money beyond this service-attending pilot.

Conclusion

This study highlights the effectiveness and sustainability of implementing rapid HCV testing within outpatient and community health settings. By addressing gaps in current screening strategies, this model offers a scalable approach to improve HCV detection and treatment uptake. Continued expansion of non-stigmatising, point-of-care testing models is essential to achieving national and global HCV elimination goals.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

CALD

Culturally and Linguistically Diverse Backgrounds

CNC

Clinical Nurse Consultant

DAA

Direct Acting Antiviral

HCV

Hepatitis C virus

NSW

New South Wales

PCR

Polymerase Chain Reaction

WHO

World Health Organisation

Author contributions

Study design: Golo Ahlenstiel, Nishita Jagarlamudi & Jeenat Paulose. Data collection: Jeenat Paulose & Susan Markovic. Data analysis: Golo Ahlenstiel, Scott Read, Jeenat Paulose. Manuscript writing and revision: Jeenat Paulose, Nishita Jagarlamudi, Dmitrii Shek, Susan Markovic, Ian Wong, Scott Read, Jacob George, Josephine Kenny, Kyle Cain, Albert Almir, Alison Derrett, Golo Ahlenstiel.

Funding

This is an investigator- initiated study with no external funding.

Data availability

Data contained within this manuscript is available upon reasonable request.

Declarations

Ethics approval and consent to participate

This retrospective study was conducted in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice. The study has been approved by Western Sydney Local Health District (WSLHD) Human Research Ethics Committee (HREC) with Research Office ID 2023/ETH02042.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.