Rapid Point-of-Care Testing for Genital Tract Inflammatory Cytokine Biomarkers to Diagnose Asymptomatic Sexually Transmitted Infections and Bacterial Vaginosis in Women: Cost Estimation and Budget Impact Analysis.

Abstract

Screening for genital inflammation can reveal asymptomatic cases of sexually transmitted infections (STIs) and bacterial vaginosis (BV), useful in settings where only syndromic management is available. This study aimed to estimate the incremental cost of screening using a new cytokine biomarker rapid test and determine the budget impact of providing this service in primary health facilities in South Africa. Costs of adding genital inflammation screening to existing family planning services were estimated for women (15-49 years) attending 3 different family planning clinics in US $2016. The predicted unit cost per patient screened from a provider's perspective was calculated using bottom-up and top-down approaches and was used to analyze the budget impact of scaling up and providing this service in primary health facilities countrywide. Univariate sensitivity analyses tested the robustness of the findings. The incremental cost per woman screened for genital inflammation ranged between US $3.19 and US $4.79. The scaled-up costs ranged between US $7,245,775 and US $22,212,636 countrywide, annually. This was based on the number of women of reproductive age currently seeking contraceptive care at all primary health care facilities, as a proxy for those most susceptible to asymptomatic STIs/BV. The cost estimates were sensitive to changes in personnel costs, utilization rate, and population coverage rates. This screening tool is likely to increase case detection, contributing to better STI/BV management and control, in addition to reducing women's risk of HIV acquisition. The incremental cost estimates could make implementation affordable.