Recommendations on qPCR/ddPCR assay validation by GCC.

Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited regulatory guidance for the use of qPCR and a complete lack of any regulatory guidelines for the use of the newer ddPCR to support regulated bioanalysis.

Recommendations on ELISpot assay validation by the GCC.

Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays.

Brief Motivational Intervention to Improve Adolescent Sexual Health Service Uptake: A Pilot Randomized Controlled Trial in the Emergency Department.

Objective: To test the hypothesis that our motivational sexual health intervention (SexHealth) would increase health service uptake when compared with control.

Study Design: In a randomized controlled trial at a pediatric emergency department, sexually active adolescents received either the SexHealth intervention or printed materials (control). SexHealth, delivered by a health educator, was a tablet-based, interactive intervention that included motivational techniques to promote sexual health, condom skills training, and tailored service recommendations.

Recommendations for Delivering COVID-19 Vaccine in Jails: Evidence from Kansas, Iowa, Nebraska, and Missouri.

We report on data we collected from a 2018 survey examining jails' human papillomavirus virus vaccine delivery capacity and on a secondary analysis we conducted to describe factors similarly associated with delivery planning for the COVID-19 vaccine. We provide recommendations for delivering the COVID-19 vaccine in jails, based on evidence from Kansas, Iowa, Nebraska, and Missouri. Our key finding is that jails have limited staff to implement vaccination and will require collaboration between jail administrators, jail medical staff, and local health departments.