METHODS: This cross-sectional study was based on the data collected from the Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) study in 25 primary healthcare clinics across three regions of Malaysia. The findings of biochemical tests were used to calculate the APRI for each study participant. Transient elastography was used as a standard reference for the diagnosis of cirrhosis. The area under the receiver operating curve (AUROC) was used to determine the discriminative ability of APRI in both HCV mono-infected and HCV/HIV co-infected patients. The diagnostic performance of APRI at three different cutoffs (>1.0, ≥1.5 and >2.0) were also evaluated.
RESULTS: This study included 867 HCV-RNA-positive patients, 158 (16.1%) were co-infected with HIV. For the HCV mono-infected patients, the sensitivity, specificity, positive predictive value (PPV) and negative predictive values (NPV) for the cut-off of >1.0 were 61.8%, 88.7%, 73.8% and 81.9%, and for the cut-off of ≥1.5, 45.6%, 97.0%, 88.7% and 77.6%, respectively. A much lower sensitivity (29.9%) was observed for the cut-off of >2.0. The diagnostic accuracy of APRI at the cut-off of ≥1.5 in the HCV/HIV co-infected patients was relatively suboptimal.
CONCLUSION: APRI, with a cut-off of ≥1.5, can more accurately predict LC among hepatitis C patients in Malaysia. However, additional physical examination and laboratory assessment are likely to be required to support the diagnosis, especially in those with HCV/HIV co-infection.
DESIGN: We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).
SETTING: We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings-namely, workplace and healthcare facilities.
RESULTS: Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04-3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58-87% for countries with off-site self-testing (outside the workplace, for example, home) and 15-50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29-35%) versus off-site self-testing (7-27%).
CONCLUSIONS: Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.