Implementing a pilot study of COVID-19 self-testing in high-risk populations and remote locations: results and lessons learnt.

BACKGROUND: Rapid antigen-detection tests for SARS-CoV-2 self-testing represent a useful tool for pandemic control and expanding access to community-level case screening. COVID-19 self-tests have been extensively used in high-income countries since 2021; however, their introduction and programmatic implementation in low- and middle-income countries was delayed. We aimed to identify and continuously improve a weekly COVID-19 self-testing model among staff at healthcare facilities and schools. METHODS: This mixed-methods, observational prospective study was conducted in 5 healthcare centres and 24 schools in Georgia, between June and December 2022. The study comprised the integration of COVID-19 self-testing into the national mandatory testing programme for high-risk groups, with primary distribution of self-tests among staff performed weekly, plus secondary distribution to their household members. These use cases were selected because NCDC was seeking to strengthen their already strong weekly testing programme, by investigating self-testing to ease the burden of testing in the healthcare system. Online surveys and semi-structured interviews were used for data collection. RESULTS: In total, 2156 participants were enrolled (1963 female, 72%). At baseline and mid- and end-points, 88%, 97% and 99%, respectively, of participants agreed/strongly agreed they would self-test. Similarly, the majority were willing to report their self-testing results (88%, 98% and 96% at baseline and mid- and end-points, respectively). Weekly reporting of test results to the national COVID-19 database was high during all the implementation. There were 622 COVID-19 positive results reported, and linked to care, from 601 individuals (282 participants and 319 household members). Findings from qualitative interviews showed great satisfaction with self-testing for its convenience, ease of use, trust in the results, no need to travel for diagnostics, and increased perception of safety. CONCLUSIONS: Our findings contribute to the evidence-base regarding self-testing strategies conducted via workplaces and secondary distribution to households. Willingness to perform a COVID-19 self-test increased after implementation. This pilot enhanced pandemic preparedness through expansion of the national self-testing reporting system, development of communications materials, changes in the national legal framework and coordination mechanisms, and improved perceptions around self-care in the community. The lessons learnt can inform operational aspects of the introduction and scale-up of self-care strategies.

COVID-19 self-testing in Nigeria: Stakeholders' opinions and perspectives on its value for case detection.

BACKGROUND: COVID-19 testing coverage is limited in Nigeria. Access to rapid SARS-CoV-2 antigen-detection self-testing kits may help improve the detection of asymptomatic and mildly symptomatic cases and increase the country's low rate of SARS-CoV-2 testing. Before implementing self-testing in Nigeria, assessing the population's perceptions regarding this approach is imperative. In mid-2021, an exploratory cross-sectional qualitative research was conducted to investigate stakeholders' values and preferences for SARS-CoV-2 self-testing in Nigeria. METHODS: In-person and online semi-structured interviews and focus group discussions with healthcare workers, representatives of civil society, and potential implementors of self-testing delivery programs were used to explore values and perceptions around access to conventional provider-initiated COVID-19 testing. Topics included the public's values in relation to SARS-CoV-2 self-testing, the safe and effective use of SARS-CoV-2 self-testing, and likely actions upon receiving a positive SARS-CoV-2 self-test result. A thematic analysis approach was applied. RESULTS: The 58 informants (29 female) reported that Nigeria has limited availability of conventional provider-delivered SARS-CoV-2 testing. While just a few informants were familiar with SARS-CoV-2 self-testing, they generally supported using self-testing as an approach that they felt could assist with early case detection and improve access to testing. Concerns relating to the use of self-testing mainly related to the ability of low-literate individuals to use and interpret the self-tests, the affordability of self-tests, equity of access, and the availability of healthcare system support for those who self-test positive. CONCLUSION: Although the Nigerian public perceive multiple benefits associated with access to SARS-CoV-2 self-testing, the perceived inefficiency of the national health service delivery system may limit the access of users of the kits to psychosocial and clinical support. Nevertheless, in Nigeria, where COVID-19 vaccine coverage is low and the risk of further waves of COVID-19 is high, self-testing may assist in the prompt detection of cases and contribute to halting the spread of the virus.

HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China.

Background: Hepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China. Methods: An observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results: Among 100 participants with median age 27 (interquartile range 23-30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7-64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5-99.4%) and 98% (95%CI: 93.0-99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8-62.1%) or easy (41%, 95%CI: 31.3-51.3%), 76% (95%CI: 66.4-84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3-83.1%) would recommend it to their family and friends. Conclusions: Our findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems.

Diagnostic Accuracy of Point-of-Care HCV Viral Load Assays for HCV Diagnosis: A Systematic Review and Meta-Analysis.

Despite the widespread availability of curative treatment with direct-acting antivirals, a significant proportion of people with HCV remain undiagnosed and untreated. New point-of-care (PoC) HCV RNA assays that can be used in clinical settings may help expand access to testing and treatment. This study aimed to evaluate the diagnostic performance of PoC HCV viral load assays compared to laboratory-based testing. Methods: We searched three databases for studies published before May 2021 that evaluated PoC HCV RNA assays against a laboratory NAT reference standard (Prospero CRD42021269022). Random effects bivariate models were used to summarize the estimates. Stratified analyses were performed based on geographic region, population (PWID, etc.), and specimen type (serum/plasma or fingerstick; fresh or frozen). We used the GRADE approach to assess the certainty of the evidence. Results: A total of 25 studies were eligible. We evaluated five different commercially available viral load assays. The pooled sensitivity and specificity were 99% (95% CI: 98−99%) and 99% (95% CI: 99−100%), respectively. High sensitivity and specificity were observed across different assays, study settings (including LMICs and HICs), and populations. There was a small but statistically significant reduction in sensitivity for fingersticks compared to serum or plasma samples (98% vs. 100%, p < 0.05), but the specificity was similar between frozen and fresh samples. The evidence was rated as moderate-high certainty. Conclusions: PoC HCV viral load assays demonstrate excellent diagnostic performance in various settings and populations. The WHO now recommends using PoC HCV viral load assays as an additional strategy to promote access to confirmatory viral load testing and treatment.

Protocol for a cluster randomised controlled trial of secondary distribution of hepatitis C self-testing within the context of a house-to-house hepatitis C micro-elimination programme in Karachi, Pakistan.

BACKGROUND: Globally, just 21% of the estimated 58 million people living with hepatitis C virus (HCV) know their status. Thus, there is considerable need to scale-up HCV testing if the World Health Organization (WHO) 2030 hepatitis elimination goals are to be achieved. HCV self-testing may assist with this; however, there are currently no data on the real-world impact of HCV self-testing. With an estimated 5% of the general population living with HCV, Pakistan has the second highest HCV burden in the world. This study aims to evaluate the acceptability and impact of home delivery of HCV self-testing for secondary distribution in the context of a house-to-house HCV micro-elimination programme in Pakistan. METHODS: This is a parallel group, non-blinded, cluster randomised trial comparing secondary distribution of HCV self-testing with secondary distribution of information pamphlets encouraging individuals to visit a testing facility for HCV screening. The cluster allocation ratio is 1:1. Clusters will be randomised either to HCV self-testing distributed via study staff or control clusters where information on HCV will be given and the participant will be requested to attend their local hospital for HCV screening. In both clusters, only households with a member who has not yet been screened as part of the larger micro-elimination project will be included. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who a) receive a positive result and are made aware of their status, b) are referred to and complete HCV RNA confirmatory testing, and c) start treatment. Acceptability, feasibility, attitudes towards HCV testing, and cost will also be evaluated. The target sample size is 2,000 participants. DISCUSSION: This study will provide the first ever evidence regarding secondary distribution of HCV self-testing. By comparing HCV self-testing with facility-based testing, we will assess whether HCV self-testing increases the uptake of HCV testing. The findings will inform micro-elimination programmes and determine whether HCV self-testing can enable individuals to be reached who may otherwise be missed. TRIAL REGISTRATION: This study and was registered on clinicaltrials.gov ( NCT04971538 ) 21 July 2021.

A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol.

BACKGROUND: Malaysia has an estimated hepatitis C virus (HCV) prevalence of 1.9% among its adult population and a history of providing HCV treatment in the public sector. In 2019, Malaysia launched a 5-year national strategic plan for viral hepatitis control and has been expanding HCV testing and treatment to the primary care and community levels, while actively engaging key populations in services for hepatitis care. The Ministry of Health (MoH) is seeking to specifically understand how to better target HCV services at men who have sex with men (MSM); HCV self-testing could increase the uptake of HCV testing among this group. METHODS: We aim to integrate HCV antibody self-testing into an existing online platform used for HIV self-testing, to evaluate the acceptability and impact of an online HCV self-testing programme in Malaysia. This is a non-blinded parallel group quasi-randomised superiority study comparing HCV self-testing via an online distribution model with the standard care, which involves attending a clinic for facility-based HCV antibody testing (control, 2:1). Participants will be randomised to either the HCV self-testing via online distribution arm, in which either an oral fluid- or blood-based HCV self-test kit will be mailed to them, or the control arm, where they will be provided with information about the nearest centre with HCV testing. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, attitudes around HCV testing, and cost will also be evaluated. The target sample size is 750 participants. DISCUSSION: This study is one of the first in the world to explore the real-world impact of HCV self-testing on key populations using online platforms and compare this with standard HCV testing services. The outcomes of this study will provide critical evidence about testing uptake, linkage to care, acceptability, and any social harms that may emerge due to HCV self-testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT04982718.

Cost-Effectiveness of a Core Antigen-Based Rapid Diagnostic Test for Hepatitis C.

OBJECTIVES: Hepatitis C virus (HCV) affects 58 million worldwide and > 79% of people remain undiagnosed. Rapid diagnostic tests (RDTs) for HCV can help improve diagnosis and treatment rates. Nevertheless, the high price and infrastructure needed to use current molecular HCV RDT options present a barrier to widespread use-particularly in low- and middle-income countries. We evaluated the performance and cost-effectiveness of a theoretical core antigen (cAg) RDT for HCV viremia confirmation, which requires fewer resources. METHODS: We adapted a previously validated microsimulation model to simulate HCV disease progression and outcomes under different HCV testing algorithms in Georgia and Malaysia. We compared standard of care testing with laboratory-based ribonucleic acid HCV to a cAg-based RDT for HCV confirmation. We simulated a cohort of 10 000 adults in each country, with an HCV-ribonucleic acid prevalence of 5.40% in Georgia and 1.54% in Malaysia. We projected the cumulative healthcare costs, quality-adjusted life-years, and diagnosis coverage rates over a lifetime horizon. RESULTS: Compared with the standard of care testing, the cAg-based RDT would increase quality-adjusted life-years by 270 in Georgia and 259 in Malaysia per 10 000 people. The high diagnosis rate and treatment rate of the cAg-based RDT result in substantial cost savings because of averted HCV sequelae management costs. Cost savings are $281 000 for Georgia and $781 000 for Malaysia. CONCLUSIONS: We found that a cAg-based RDT for HCV could improve the diagnosis rate and result in cost savings. Such a test could have a substantial impact on the feasibility and cost of HCV elimination.

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.

BACKGROUND: Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies. METHODS: Two lots of 13 RDTs were evaluated at 3 laboratories using archived plasma samples from 4 countries (Nigeria, Georgia, Cambodia, and Belgium). HCV status was determined using 3 reference tests according to a composite algorithm. Sensitivity and specificity were evaluated in HIV-infected and HIV-uninfected populations. Operational characteristics were also assessed. RESULTS: In total, 1710 samples met inclusion criteria. In HIV-uninfected samples (n = 384), the majority of RDTs had sensitivity ≥98% in 1 or both lots and most RDTs had specificity ≥99%. In HIV-infected samples (n = 264), specificity remained high but sensitivity was markedly lower than in HIV-uninfected samples; only 1 RDT reached >95%. The majority of HIV-infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Interreader variability, lot-to-lot variability, and rate of invalid runs were low for all RDTs (<2%). CONCLUSIONS: HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status. CLINICAL TRIALS REGISTRATION: NCT04033887.

Home-based hepatitis C self-testing in people who inject drugs and men who have sex with men in Georgia: a protocol for a randomised controlled trial.

INTRODUCTION: Globally, it is estimated that more than three-quarters of people with chronic hepatitis C virus (HCV) are unaware of their HCV status. HCV self-testing (HCVST) may improve access and uptake of HCV testing particularly among key populations such as people who inject drugs (PWID) and men who have sex with men (MSM) where HCV prevalence and incidence are high and barriers to accessing health services due to stigma and discrimination are common. METHODS AND ANALYSIS: This randomised controlled trial compares an online programme offering oral fluid-based HCVST delivered to the home with referral to standard-of-care HCV testing at HCV testing sites. Eligible participants are adults self-identifying as either MSM or PWID who live in Tbilisi or Batumi, Georgia, and whose current HCV status is unknown. Participants will be recruited through an online platform and randomised to one of three arms for MSM (courier delivery, peer delivery and standard-of-care HCV testing (control)) and two for PWID (peer delivery and standard-of-care HCV testing (control)). Participants in the postal delivery group will receive an HCVST kit delivered by an anonymised courier. Participants in the peer delivery groups will schedule delivery of the HCVST by a peer. Control groups will receive information on how to access standard-of-care testing at a testing site. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, and attitudes around HCV testing and cost will also be evaluated. The target sample size is 1250 participants (250 per arm). ETHICS AND DISSEMINATION: Ethical approval has been obtained from the National Centers for Disease Control and Public Health Georgia Institutional Review Board (IRB) (IRB# 2021-049). Study results will be disseminated by presentations at conferences and via peer-reviewed journals. Protocol version 1.1; 14 July 2021. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04961723).

Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt.

BACKGROUND: Self-testing for hepatitis C virus antibodies (HCVST) may be an additional strategy to expand access to hepatitis C virus (HCV) testing and support elimination efforts. We conducted a study to assess the usability and acceptability of HCVST among the general population in a semi-rural, high-HCV prevalence region in Egypt. METHODS: An observational study was conducted in two hospitals in the Nile Delta region. A trained provider gave an in-person demonstration on how to use the oral fluid HCVST followed by observation of the participant performing the test. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Of 116 participants enrolled, 17 (14.6%) had received no formal education. The majority (72%) of participants completed all testing steps without any assistance and interpreted the test results correctly. Agreement between participant-reported HCVST results and interpretation by a trained user was 86%, with a Cohen's kappa of 0.6. Agreement between participant-reported HCVST results and provider-administered oral fluid HCV rapid test results was 97.2%, with a Cohen's kappa of 0.75. The majority of participants rated the HCVST process as easy (53%) or very easy (44%), and 96% indicated they would be willing to use HCVST again and recommend it to their family and friends. CONCLUSION: Our study demonstrates the high usability and acceptability of oral fluid HCVST in a general population. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in both general and high-risk populations.

Acceptability and Usability of HCV Self-Testing in High Risk Populations in Vietnam.

HIV self-testing has emerged as a safe and effective approach to increase the access to and uptake of HIV testing and treatment, especially for key populations. Applying self-testing to hepatitis C virus (HCV) may also offer an additional way to address low coverage of HCV testing and to accelerate elimination efforts. To understand the potential for HCV self-testing (HCVST), an observational study was conducted to assess the acceptability and usability of the OraQuick® HCV Self-Test (prototype) among people who inject drugs (PWID) and men who have sex with men (MSM) in Thai Nguyen, a province in northern Vietnam. A total of 105 PWID and 104 MSM were eligible and agreed to participate in the study. Acceptability, defined as the proportion of participants among eligible subjects who agreed to participate in the study, was 92.9% in PWID and 98.6% in MSM. Compared to MSM, PWID were older (median age: 45 vs. 22 years; p < 0.0001) and had a lower education level (high school and college: 38.1% vs. 100%; p < 0.0001). HCVST usability was high among MSM with fewer observed mistakes, difficulties, or participants requiring assistance (33.7%, 28.8%, and 17.3%, respectively) compared to PWID (62.9%, 53.3%, and 66.7%, respectively; all p < 0.0001)). Inter-reader and inter-operator agreement were good in both groups (Kappa coefficient range: 0.61-0.99). However, the concordance between HCVST and study staff -read or performed HCV testing was lower among PWID than MSM (inter-reader concordance 88.6% vs. 99.0% and inter-operator concordance 81.9% vs. 99%). Overall, HCVST was highly acceptable with moderate to high usability among PWID and MSM in Thai Nguyen. Efforts to provide support and assistance may be needed to optimize performance, particularly for PWID populations and for those who are older and with lower literacy or education levels.

Prospective evaluation of hepatitis C virus antibody detection in whole blood collected on dried blood spots with the INNOTEST® HCV Ab IV enzyme immunoassay.

INTRODUCTION: Dried blood spots (DBS) have potential to improve access to screening for antibodies to hepatitis C virus (HCV). However, although several studies on off-label use of DBS have been performed, to date no HCV antibody serology test is formally approved for use with DBS. This study evaluated the performance of the INNOTEST® HCV Ab IV enzyme immunoassay in paired DBS and plasma samples, to determine whether DBS may be added to the intended use. METHODS: Adults with no history of HCV treatment were prospectively enrolled from two sites in Ukraine. DBS were prepared from fingerstick whole blood (fDBS) and venous whole blood (vDBS) samples. Undiluted and serially diluted DBS and plasma samples were tested. RESULTS: Samples from 149 HCV positive and 151 HCV negative participants were included. Sensitivity and specificity of the INNOTEST® HCV Ab IV assay were both 100 % (95 % confidence intervals 95.7-100) for samples collected on fDBS or vDBS compared with plasma as the reference standard. In all undiluted samples, negative and positive percentage agreement and overall rate of agreement were 100 % between all sample types (Cohen's kappa coefficient of 1). In serially diluted samples, agreement was high (>95 %) between fDBS and vDBS, and as expected, positive percentage agreement between both DBS sample types and plasma was lower (>66 %). CONCLUSIONS: Performance of the INNOTEST® HCV Ab IV assay in DBS was acceptable, thus whole blood collected on DBS may represent an alternative sample type for this assay in settings where venous blood collection is not possible.

Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: A multicentre prospective study.

BACKGROUND: This study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings. METHODS: Testing was conducted at three facilities in two countries (Georgia, Cambodia) using matched fingerstick whole blood, plasma and serum samples. Investigational RDTs were compared with a composite reference standard (CRS) comprised of three laboratory tests, and a reference RDT. RESULTS: In matched samples from 489 HCV positive and 967 HCV negative participants, specificity with both investigational RDTs was high using either reference method (≥98.4% in all sample types). Sensitivity was lower in whole blood versus plasma and serum for both RDTs compared with the CRS (86.5-91.4% vs 97.5-98.0% and 97.3-97.1%) and reference RDT (93.6-97.8% vs 100% and 99.4%). Sensitivity improved when considering only samples with detectable HCV viral load. CONCLUSION: Sensitivity was highest in serum and plasma versus whole blood. The World Health Organization prequalification criterion (≥98%) was narrowly missed by both RDTs in serum, and one in plasma, possibly due to the intended user factor. Performance in whole blood was considered adequate, given potential roles of HCV infection history, improved sensitivity with detectable viral load and performance similarities to the reference RDT.

Diagnostic accuracy of 3 urine lipoarabinomannan tuberculosis assays in HIV-negative outpatients.

BACKGROUNDInadequate tuberculosis (TB) diagnostics are a major hurdle in the reduction of disease burden, and accurate point-of-care tests (POCTs) are urgently needed. We assessed the diagnostic accuracy of Fujifilm SILVAMP TB lipoarabinomannan (FujiLAM) POCT for TB diagnosis in HIV-negative outpatients and compared it with Alere Determine TB LAM Ag (AlereLAM) POCT and a laboratory-based ultrasensitive electrochemiluminescence LAM research assay (EclLAM).METHODSIn this multicenter diagnostic test accuracy study, we recruited HIV-negative adults with symptoms suggestive of pulmonary TB presenting to outpatient health care centers in Peru and South Africa. Urine samples were tested using FujiLAM, AlereLAM, and EclLAM, and the diagnostic accuracy was assessed against a microbiological reference standard (MRS) and a composite reference standard.RESULTSThree hundred seventy-two HIV-negative participants were included and the prevalence of microbiologically confirmed TB was 30%. Compared with the MRS, the sensitivities of AlereLAM, FujiLAM, and EclLAM were 10.8% (95% confidence interval [CI] 6.3%-18.0%), 53.2% (95% CI 43.9%-62.1%), and 66.7% (95% CI 57.5%-74.7%), respectively. The specificities of AlereLAM, FujiLAM, and EclLAM were 92.3% (95% CI 88.5%-95.0%), 98.9% (95% CI 96.7%-99.6%), and 98.1% (95% CI 95.6%-99.2%), respectively. Positive likelihood ratios of AlereLAM, FujiLAM, and EclLAM were 1.4, 46.2, and 34.8, respectively, and positive predictive values were 37.5%, 95.2%, and 93.7%, respectively.CONCLUSIONCompared with AlereLAM, FujiLAM detected 5 times more patients with TB in HIV-negative participants, had a high positive predictive value, and has the potential to improve rapid diagnosis of TB at the point-of-care. EclLAM demonstrated that additional sensitivity gains are possible, which highlights LAM's potential as a biomarker. Additional research is required to assess FujiLAM's performance in prospective cohorts, its cost-effectiveness, and its impact in real-world clinical settings.FUNDINGGlobal Health Innovative Technology Fund, the UK Department for International Development, the Dutch Ministry of Foreign Affairs, the Bill and Melinda Gates Foundation, the Australian Department of Foreign Affairs and Trade, the German Federal Ministry of Education and Research through Kreditanstalt für Wiederaufbau, and the NIH and National Institute of Allergy and Infectious Diseases.

Values, preferences and current hepatitis B and C testing practices in low- and middle-income countries: results of a survey of end users and implementers.

BACKGROUND: Access to hepatitis B virus (HBV) and hepatitis C virus (HCV) diagnostics remains a key bottleneck in scale-up of access to HBV and HCV treatment, particularly in low- and middle-income countries (LMICs) that lack laboratory resources and skilled personnel. To inform the development of World Health Organization (WHO) testing guidelines on who to test and how to test, we performed a "values and preferences" survey of end users and implementers of hepatitis testing in LMICs on current hepatitis B and C testing practices and acceptability of diagnostic approaches, as well as preferences for the future. METHODS: The survey consisted of a four-part, 28 question online survey tool using SurveyMonkey software. The invitation to participate was sent via email to a network of contacts in hepatitis clinical care, research, advocacy and industry. RESULTS: The survey collected responses on current testing practices from 48 respondents in 23 LMICs. Only a small proportion of hepatitis testing is currently funded through government-supported programmes. Most limit their testing programmes to blood donor screening and although testing is recommended in several populations, this is not well implemented. Also, there is still very limited access to virological testing. CONCLUSIONS: The survey showed that HBV and HCV testing programmes in LMICs are inadequate and/or scarce. Lack of affordable diagnostic tests; lack of funding, public education and awareness; absence of national policies and guidelines; and a dearth of skilled health professionals are the most important barriers to scaling up HBV and HCV diagnosis and treatment.