METHODS: We established a multi-country cross-sectional dataset of first available quantitative HCV RNA linked to demographic and clinical data. We excluded individuals on HCV treatment. We analyzed the distribution of HCV RNA and determined critical thresholds for detection of HCV viraemia. We then performed logistic regression to evaluate factors associated with LLV, and derived relative sensitivities for significant covariates.
RESULTS: The dataset included 66,640 individuals with HCV viraemia from Georgia (44.4%), Canada (40.9%), India (8.1%), Cambodia (2.6%), Egypt (1.6%), Pakistan (1.3%), Cameroon (0.4%), Indonesia (0.2%), Thailand (0.2%), Vietnam (0.1%), Malaysia (0.05%), and Mozambique (0.02%). The 97% LOD was 1,318 IU/mL (95% CI 1298.4, 1322.3). Factors associated with LLV were younger age 18-30 vs. 51-64 years (OR 2.56 95% CI 2.19, 2.99), female vs. male sex (OR 1.32, 95% CI 1.18, 1.49), and advanced fibrosis stage F4 vs. F0-1 (OR 1.44, 95%CI 1.21, 1.69). Only the younger age group had a decreased relative sensitivity below 95% at 93.3%.
CONCLUSIONS: In this global dataset, a test with an LOD of 1,318 IU/mL would identify 97% of viraemic HCV infections among almost all populations. This LOD will help guide manufacturers in the development of affordable POC diagnostics to expand HCV testing and linkage to care in LMICs.
LAY SUMMARY: We created and analyzed a dataset from 12 countries with 66,640 participants with chronic hepatitis C virus infection. We determined that about 97% of those with viraemic infection had 1300 International Units/mL or more of circulating virus at the time of diagnosis. While current diagnostic tests can detect as little as 12 International Units/mL of virus, our findings suggest that increasing the level of detection closer to 1300 would maintain good test accuracy and will likely allow for more affordable portable tests to be developed for use in low and middle income countries.
METHODS: Adults were selected through a stratified, two-stage cluster community sample in Selangor, Malaysia. The reliability, convergent validity, and discriminant validity of the measurement model were assessed before implementing a partial least squares structural equation model (PLS-SEM) to evaluate the significance of the structural paths.
RESULTS: A total of 728 participants were enrolled. The five constructs all showed adequate internal reliability, convergent validity, and discriminant validity. There was a significant, positive relationship to WTP from constructs (perceived barriers [Path coefficient (β) = 0.082, P = 0.036], perceived susceptibility [β = 0.214, P<0.001], and cues to action [β = 0.166, P<0.001]), and the model all together accounted for 8.8% of the variation in WTP. There was a significant, negative relationship between perceived barriers and perceived benefit [β = -0.261, P<0.001], which accounted for 6.8% of variation in perceived benefit.
CONCLUSIONS: Policy and programs should be targeted that can modify individuals' thoughts about disease risk, their obstacles in obtaining the preventive action, and their readiness to obtain a vaccine. Such programs include educational materials about disease risk and clinic visits that can pair HepB screening and vaccination.