Usability and acceptability of oral fluid- and blood-based hepatitis C virus self-testing among the general population and men who have sex with men in Malaysia.

Hepatitis C self-testing (HCVST) is emerging as an additional strategy that could help to expand access to HCV testing. We conducted a study to assess the usability and acceptability of two types of HCVST, oral fluid- and blood-based, among the general population and men who have sex with men (MSM) in Malaysia. An observational study was conducted in three primary care centres in Malaysia. Participants who were layman users performed the oral fluid- and blood-based HCVST sequentially. Usability was assessed by calculating the rate of errors observed, the rate of difficulties faced by participants as well as inter-reader (self-test interpreted by self-tester vs interpreted by trained user) and inter-operator concordances (self-test vs test performed by trained user). The acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. Participants were also required to read contrived test results which included "positive", "negative", and "invalid". There was a total of 200 participants (100 general population, 100 MSM; mean age 33.6 ± 14.0 years). We found a high acceptability of oral fluid- and blood-based HCVST across both general population and MSM. User errors, related to timekeeping and reading within stipulated time, were common. However, the majority of the participants were still able to obtain and interpret results correctly, including that of contrived results, although there was substantial difficulty interpreting weak positive results. The high acceptability of HCVST among the participants did not appreciably change after they had experienced both tests, with 97.0% of all participants indicating they would be willing to use HCVST again and 98.5% of them indicating they would recommend it to people they knew. There was no significant difference between the general population and MSM in these aspects. Our study demonstrates that both oral fluid- and blood-based HCVST are highly acceptable among both the general population and MSM. Both populations also showed comparable ability to conduct the tests and interpret the results. Overall, this study suggests that HCVST could be introduced as an addition to existing HCV testing services in Malaysia. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in the country.

Molecular point of care testing for hepatitis C: available technologies, pipeline and promising future directions.

Hepatitis C (HCV) remains a major public health problem, despite the availability of effective treatments. In many areas, the ability to diagnose HCV infection at the point of care is key to scaling up access to care and treatment. To achieve this, an accurate, easy-to-use and affordable diagnostic tool is required - this would enable decentralized testing and the creation of one-stop centers to eliminate gaps in the care cascade, which would help reach the millions of people with undiagnosed HCV in low- and middle-income countries and high-risk populations in high income countries. In this review, we examine the current state of point-of-care molecular technologies, the advantages and limitations of currently available devices (both near- and true-point-of-care), the potential of molecular testing to transform diagnostic medicine in the future, and the challenges that need to be addressed for broader adoption of this technology in routine clinical practice.

SARS-CoV-2 self-testing in Peru: a cross-sectional survey of values and attitudes of the general population.

OBJECTIVES: To assess the values of and attitudes towards the use of rapid SARS-CoV-2 antigen-detection tests for self-testing in a rural and an urban area in Peru. DESIGN: Cross-sectional, street-based population survey. SETTING: A series of over 400 randomly selected street points in Valle del Mantaro and in Lima. PARTICIPANTS: 438 respondents (203 female) participated. They were all older than 17 years and provided informed consent for participation. INTERVENTION: All respondents answered on the spot, a 35-item questionnaire developed in KoboToolbox. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes of interest were: likelihood to use a SARS-CoV-2 self-test; willingness to pay for a SARS-CoV-2 self-test and likelihood to comply with recommended actions following a positive SARS-CoV-2 self-test result. Bivariate analyses and Poisson regression (PR) analyses were performed to identify significant associations between dependent variables and independent variables pertaining to respondents' characteristics, risk perception and previous experiences with conventional COVID-19 testing. RESULTS: Of the 438 respondents, 51.49% had previous experience with conventional COVID-19 testing; 20.37% had COVID-19 disease; 86.96% accepted the idea of SARS-CoV-2 self-testing; and, 78.95% would be likely to use it if needed. Almost all (94.75%) would pay for a self-testing device (mean acceptable payment: US$10.4) if it was not provided free of charge by health authorities. Overall, 93.12%, 86.93% and 85.32% would self-isolate, report the results and warn their contacts, respectively. Being a female (adjusted PR 1.05, 95% CI 1.00 to 1.09, p<0.018), having completed secondary education (adjusted PR 1.18, 95% CI 1.02 to 1.37, p<0.024) and expressing likelihood to use self-testing (adjusted PR 1.08, 95% CI 1.01 to 1.16, p<0.0.24) could be predictors of willingness to pay for a self-test. CONCLUSIONS: Self-testing is perceived as an acceptable approach. Health authorities in Peru should facilitate access to this approach to complement healthcare facilities-led testing efforts for COVID-19. Future research is necessary to understand the impact of self-testing in case detection and pandemic control.

People's willingness to use COVID-19 self-testing in Nigeria: a cross-sectional survey.

OBJECTIVES: Nigeria has been badly affected by the COVID-19 pandemic, and the poor testing coverage in the country may make controlling the spread of COVID-19 challenging. The aim of this study was to assess the general public's acceptability of SARS-CoV-2 self-testing as an approach which could help to address this gap. SETTING: A household-based survey was conducted in five urban and five rural local government areas in the states of Akwa Ibom, Anambra, Benue, Kaduna and Lagos, in mid-2021. PARTICIPANTS: 2126 respondents (969 were female) participated. A five-pronged, probabilistic sampling approach was used to recruit individuals older than 17 years and available to participate when randomly approached in their households by the surveyors. A 35-item questionnaire was used to collect data on their values towards SARS-CoV-2 self-testing. Primary outcomes were: likelihood to use a self-test; willingness to pay for a self-test; and likely actions following a reactive self-test result. RESULTS: Of the total 2126 respondents, 14 (0.66%) were aware of COVID-19 self-testing, 1738 (81.80%) agreed with the idea of people being able to self-test for COVID-19, 1786 (84.05%) were likely/very likely to use self-tests if available, 1931 (90.87%) would report a positive result and 1875 (88.28%) would isolate if they self-tested positive. Factors significantly associated with the use of a self-test were having a college education or higher (adjusted Odds Ratio (AOR): 1.55; 95% CI: 1.03 to 2.33), full-time employment (AOR: 1.67; 95% CI: 1.06 to 2.63), feeling at moderate/high risk of COVID-19 (AOR: 2.43; 95% CI: 1.70 to 3.47) and presence of individuals at risk of COVID-19 within the household (AOR: 1.38; 95% CI: 1.06 to 1.78). CONCLUSION: A majority of Nigerians agree with the concept of COVID-19 self-testing and would act to protect public health on self-testing positive. Self-test implementation research is necessary to frame how acceptability impacts uptake of preventive behaviours following a positive and a negative self-test result.

Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study.

BACKGROUND: People who inject drugs (PWID) are disproportionally affected by hepatitis C virus (HCV) infection and many remain undiagnosed. HCV self-testing (HCVST) may be an effective approach to increase testing uptake, but has rarely been used among PWID. We assessed the usability and acceptability of HCVST among PWID in Kenya. METHODS: We conducted a cross-sectional study nested within a cohort study between August and December 2020 on Kenya's North Coast region. Participants were handed a prototype oral fluid HCVST kit and asked to conduct the test relying on the instructions for use. Usability was assessed by documenting errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Among 150 participants, 19% were female and 65.3% had primary level education or lower. 71.3% made at least one error, 56.7% experienced some difficulty during at least one step, and the majority of participants (78%) required assistance during at least one step of the procedure. Most common errors occurred when placing the tube into the stand (18%), collecting the oral fluid sample (24%) and timing of reading results (53%). There was a strong association between presence of symptoms of opiate withdrawals and observed errors (94% vs 62%; p = 0.016) in a sub-group of 74 participants assessed. Inter-reader and inter-operator concordance were 97.7% (kappa: 0.92) and 99.2% (kappa: 0.95), respectively. Acceptability assessed by asking whether participants would choose to use HCVST prior to and after conducting HCVST was 98% and 95%, respectively. CONCLUSIONS: We found a high acceptability of oral fluid HCVST among PWID. User errors were common and were associated with the presence of withdrawal symptoms among users. Despite errors, most participants were able to obtain and interpret results correctly. These findings suggest that this group of users may benefit from greater messaging and education including options to receive direct assistance when self-testing for HCV.

Are Kenyans Likely to Use COVID-19 Self-Testing Kits? Results From a Cross-Sectional Survey.

Objectives: To understand the public's perceptions around rapid SARS-CoV-2 antigen self-testing in Kenya, including the drivers of acceptability, willingness to pay, and adherence to hygiene and prevention recommendations following a positive self-test. Methods: A household-based, cross-sectional survey, using a 35-item questionnaire, was conducted in Mombasa and Taita-Taveta counties, Kenya, during August 2021. Individuals aged ≥18 years were enrolled using a stratified sampling approach. Results: There were 419 participants (mean age 35.7 years). A minority (10.5%) had ever tested for SARS-CoV-2. If SARS-CoV-2 self-testing were available, 39.9% and 41.5% would be likely and very likely, respectively, to use it. If unavailable free-of-charge, 63.01% would pay for it. Multivariate analyses suggested that people in rural areas (Coefficient 0.30, 95%CI: 0.11-0.48, p = 0.002), aged 36-55 (Coefficient 0.21, 95%CI: 0.03-0.40, p = 0.023), and employed full time (Coefficient 0.32, 95%CI: 0.06-0.58, p = 0.016) would have more odds to adhere to recommended hygiene and prevention actions. Conclusion: SARS-CoV-2 self-testing was considered acceptable. Availability of self-testing could expand access to COVID-19 testing in Kenya, particularly among rural communities who have limited access to testing, and among mildly symptomatic individuals.

Usability and acceptability of oral-based HCV self-testing among key populations: a mixed-methods evaluation in Tbilisi, Georgia.

BACKGROUND: Hepatitis C virus self-testing (HCVST) is an additional approach that may expand access to HCV testing. We conducted a mixed-methods cross-sectional observational study to assess the usability and acceptability of HCVST among people who inject drugs (PWID), men who have sex with men (MSM) and transgender (TG) people in Tbilisi, Georgia. METHODS: The study was conducted from December 2019 to June 2020 among PWID at one harm reduction site and among MSM/TG at one community-based organization. We used a convergent parallel mixed-methods design. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. A subset of participants participated in cognitive and in-depth interviews. RESULTS: A total of 90 PWID, 84 MSM and 6 TG were observed performing HCVST. PWID were older (median age 35 vs 24) and had a lower level of education compared to MSM/TG (27% vs 59%). The proportion of participants who completed all steps successfully without assistance was 60% among PWID and 80% among MSM/TG. The most common error was in sample collection and this was observed more often among PWID than MSM/TG (21% vs 6%; p = 0.002). More PWID requested assistance during HCVST compared to MSM/TG (22% vs 8%; p = 0.011). Acceptability was high in both groups (98% vs 96%; p = 0.407). Inter-reader agreement was 97% among PWID and 99% among MSM/TG. Qualitative data from cognitive (n = 20) and in-depth interviews (n = 20) was consistent with the quantitative data confirming a high usability and acceptability. CONCLUSIONS: HCVST was highly acceptable among key populations in Georgia of relatively high educational level, and most participants performed HCVST correctly. A significant difference in usability was observed among PWID compared to MSM/TG, indicating that PWID may benefit from improved messaging and education as well as options to receive direct assistance when self-testing for HCV.

Assessing Values and Preferences Toward SARS-CoV-2 Self-testing Among the General Population and Their Representatives, Health Care Personnel, and Decision-Makers: Protocol for a Multicountry Mixed Methods Study.

BACKGROUND: Accessible, safe, and client-centered SARS-CoV-2 testing services are an effective way to halt its transmission. Testing enables infected individuals to isolate or quarantine to prevent further transmission. In countries with limited health systems and laboratory capacity, it can be challenging to provide accessible and safe screening for COVID-19. Self-testing provides a convenient, private, and safe testing option; however, it also raises important concerns about lack of counseling and ensuring timely reporting of self-test results to national surveillance systems. Investigating community members' views and perceptions regarding SARS-CoV-2 self-testing is crucial to inform the most effective and safe strategies for implementing said testing. OBJECTIVE: We aimed to determine whether SARS-CoV-2 self-testing was useful to diagnose and prevent the spread of SARS-CoV-2 for populations in low-resource settings and under which circumstances it would be acceptable. METHODS: This multisite, mixed methods, observational study will be conducted in 9 countries-Brazil, India, Indonesia, Kenya, Malawi, Nigeria, Peru, the Philippines, and South Africa-and will consists of 2 components: cross-sectional surveys and interviews (semistructured and group) among 4 respondent groupings: the general population, general population representatives, health care workers, and decision-makers. General population and health care worker survey responses will be analyzed separately from each other, using bivariate and multivariate inferential analysis and descriptive statistics. Semistructured interviews and group interviews will be audiorecorded, transcribed, and coded for thematic comparative analysis. RESULTS: As of November 19, 2021, participant enrollment is ongoing; 4364 participants have been enrolled in the general population survey, and 2233 participants have been enrolled in the health care workers survey. In the qualitative inquiry, 298 participants have been enrolled. We plan to complete data collection by December 31, 2021 and publish results in 2022 via publications, presentations at conferences, and dissemination events specifically targeted at local decision-makers, civil society, and patient groups. CONCLUSIONS: The views and perceptions of local populations are crucial in the discussion of the safest strategies for implementing SARS-CoV-2 self-testing. We intend to identify sociocultural specificities that may hinder or accelerate the widespread utilization of SARS-CoV-2 self-testing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33088.

Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia.

Point-of-care diagnostics have the potential to increase diagnosis and linkage to care and help reach the WHO targets to eliminate hepatitis C virus (HCV) by 2030. Here, we evaluated the diagnostic accuracy of Genedrive HCV ID assay for the qualitative detection of HCV RNA in decentralized settings in two low- and middle-income countries using fresh plasma specimens from 426 participants. The Abbott RealTime HCV assay was used as the gold standard. Genedrive HCV ID assay was conducted by different users. Users also completed questionnaires to assess the usability of Genedrive. At detection thresholds of 12 IU/mL or 30 IU/mL, 1000 IU/mL, and 2362 IU/mL, the sensitivity was 96.2% (95% CI: 92.7-98.4), 100% (98.2-100), and 100% (98.2-100), respectively; the specificity was 99.5% (95% CI: 97.4-100), 99.5% (97.5-100), and 98.7% (96.1-100), respectively. All genotypes detected using the gold-standard assay were also detected with Genedrive. Users found Genedrive easy to use. Genedrive is a simple and accurate test to confirm chronic HCV infection in decentralized, real-life, resource-limited settings. This novel diagnostic tool could contribute to closing the current gap in HCV diagnosis.

A Lay-User Assessment of Hepatitis C Virus Self-Testing Device Usability and Interpretation in Johannesburg, South Africa.

Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore lay-user usability of three prototype kits was assessed. This was a cross-sectional observational study conducted with 171 (CareStart n = 60, Bioline n = 52, First Response n = 59) participants. Participants were given one of the three HCVST kits with only instructions for use (IFU) and asked to perform the test in front of a professional trained in rapid diagnostic tests (RDT). Usability indices were calculated based on the correctness of performing each step of the product-specific process followed by contrived results interpretation and a post-test interview. The usability index was 93.9% for CareStart, 90.7% for Bioline and 94.9% for First Response. Most errors were on incorrect handwashing, sample collection and transfer to the test device. An average of 93.1% of contrived results were correctly interpreted, with most errors related to interpreting invalid results. Most participants (n = 167) stated they would visit a clinic after a positive result. With negative results, nearly half (28/60 (46.7%)) stated they should condomize, while just over two-thirds of participants that used Bioline (35/52 (67.3%)) and First Response (38/59 (64.4%)) said they should re-test. Most participants (n = 162) found the devices easy to use. Participants liked that self-testing was fast, private and convenient, however there were some confusion with IFU steps and pictures, finger-pricking with the lancet, collecting blood after the finger-prick, and transferring the sample/buffer. Prototype HCVST kits exhibit high usability and result interpretation by lay-users, and should be considered for SRA approval.

Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study.

BACKGROUND: Most tuberculosis-related deaths in people with HIV could be prevented with earlier diagnosis and treatment. The only commercially available tuberculosis point-of-care test (Alere Determine TB LAM Ag [AlereLAM]) has suboptimal sensitivity, which restricts its use in clinical practice. The novel Fujifilm SILVAMP TB LAM (FujiLAM) assay has been developed to improve the sensitivity of AlereLAM. We assessed the diagnostic accuracy of the FujiLAM assay for the detection of tuberculosis in hospital inpatients with HIV compared with the AlereLAM assay. METHODS: For this diagnostic accuracy study, we assessed biobanked urine samples obtained from the FIND Specimen Bank and the University of Cape Town Biobank, which had been collected from hospital inpatients (aged ≥18 years) with HIV during three independent prospective cohort studies done at two South African hospitals. Urine samples were tested using FujiLAM and AlereLAM assays. The conduct and reporting of each test was done blind to other test results. The primary objective was to assess the diagnostic accuracy of FujiLAM compared with AlereLAM, against microbiological and composite reference standards (including clinical diagnoses). FINDINGS: Between April 18, 2018, and May 3, 2018, urine samples from 968 hospital inpatients with HIV were evaluated. The prevalence of microbiologically-confirmed tuberculosis was 62% and the median CD4 count was 86 cells per µL. Using the microbiological reference standard, the estimated sensitivity of FujiLAM was 70·4% (95% CI 53·0 to 83·1) compared with 42·3% (31·7 to 51·8) for AlereLAM (difference 28·1%) and the estimated specificity of FujiLAM was 90·8% (86·0 to 94·4) and 95·0% (87·7-98·8) for AlereLAM (difference -4·2%). Against the composite reference standard, the specificity of both assays was higher (95·7% [92·0 to 98·0] for FujiLAM vs 98·2% [95·7 to 99·6] for AlereLAM; difference -2·5%), but the sensitivity of both assays was lower (64·9% [50·1 to 76·7] for FujiLAM vs 38·2% [28·1 to 47·3] for AlereLAM; difference 26·7%). INTERPRETATION: In comparison to AlereLAM, FujiLAM offers superior diagnostic sensitivity, while maintaining specificity, and could transform rapid point-of-care tuberculosis diagnosis for hospital inpatients with HIV. The applicability of FujiLAM for settings of intended use requires prospective assessment. FUNDING: Global Health Innovative Technology Fund, UK Department for International Development, Dutch Ministry of Foreign Affairs, Bill & Melinda Gates Foundation, German Federal Ministry of Education and Research, Australian Department of Foreign Affairs and Trade, Wellcome Trust, Department of Science and Technology and National Research Foundation of South Africa, and South African Medical Research Council.

Optimising diagnosis of viraemic hepatitis C infection: the development of a target product profile.

BACKGROUND: The current low access to virological testing to confirm chronic viraemic HCV infection in low- and middle-income countries (LMIC) is limiting the rollout of hepatitis C (HCV) care. Existing tests are complex, costly and require sophisticated laboratory infrastructure. Diagnostic manufacturers need guidance on the optimal characteristics a virological test needs to have to ensure the greatest impact on HCV diagnosis and treatment in LMIC. Our objective was to develop a target product profile (TPP) for diagnosis of HCV viraemia using a global stakeholder consensus-based approach. METHODS: Based on the standardised process established to develop consensus-based TPPs, we followed five key steps. (i) Identifying key potential global stakeholders for consultation and input into the TPP development process. (ii) Informal priority-setting exercise with key experts to identify the needs that should be the highest priority for the TPP development; (iii) Defining the key TPP domains (scope, performance and operational characteristics and price). (iv) Delphi-like process with larger group of key stakeholder to facilitate feedback on the key TPP criteria and consensus building based on pre-defined consensus criteria. (v) A final consensus-gathering meeting for discussions around disputed criteria. A complementary values and preferences survey helped to assess trade-offs between different key characteristics. RESULTS: The following key attributes for the TPP for a test to confirm HCV viraemic infection were identified: The scope defined is for both HCV detection as well as confirmation of cure. The timeline of development for tests envisioned in the TPP is 5 years. The test should be developed for use by health-care workers or laboratory technicians with limited training in countries with a medium to high prevalence of HCV (1.5-3.5% and >3.5%) and in high-risk populations in low prevalence settings (<1.5%). A clinical sensitivity at a minimum of 90% is considered sufficient (analytical sensitivity of the equivalent of 3000 IU/ml), particularly if the test increases access to testing through an affordable price, increase ease-of-use and feasibility on capillary blood. Polyvalency would be optimal (i.e. ability to test for HIV and others). The only characteristic that full agreement could not be achieved on was the price for a virological test. Discussants felt that to reach the optimal target price substantial trade-offs had to be made (e.g. in regards to sensitivity and integration). CONCLUSION: The TPP and V&P survey results define the need for an easy-to-use, low cost test to increase access to diagnosis and linkage to care in LMIC.