Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End User Setting.

Although U.S. Food and Drug Administration-approved and CLIA-waived point-of-care (POC) molecular systems are being implemented in routine clinical practice, instrument reliability, test performance in the hands of end users, and the potential for environmental contamination resulting from use of POC molecular systems have not been extensively evaluated. We performed a prospective evaluation of the Roche cobas Liat group A streptococcus (GAS) assay compared to routine real-time PCR. We evaluated test accuracy, instrument failure rate, and monitored for environmental contamination when testing was performed by minimally trained end users in an Express Care Clinic environment. The overall concordance of the Liat GAS assay with routine testing was 97.2% (455/468). The average Liat failure rate across three analyzers was 6.6% (33/501) (range, 3.7 to 11.6%), and no environmental contamination was detected during the course of the study. The cobas Liat platform and GAS assay demonstrated reliable performance in the end user setting and may serve as a rapid, POC option for routine diagnostic testing for certain infectious diseases, including GAS.

Impact of Electronic Point-of-Care Prompts on Human Papillomavirus Vaccine Uptake in Retail Clinics.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates nationally are low. This study determined if an electronic point-of-care prompt in the retail clinic setting increases HPV vaccination rates among an eligible population. STUDY DESIGN: An interrupted time series assessed change in weekly HPV vaccination rates with the introduction of an electronic point-of-care prompt and rate change in post-intervention period. SETTING/PARTICIPANTS: The study sites were two similar retail care clinics in Rochester, Minnesota. Participants were patients who presented to the retail clinics setting between the ages of 9 and 26 years from September 12, 2016, to September 30, 2017. INTERVENTION: HPV vaccine (nonavalent) was made available at both retail clinics. Staff completed a 2-hour lecture on HPV vaccine and one-on-one training for use of the prompt. Pre- and post-intervention rates of HPV vaccination after initiation of electronic point-of-care prompt were measured. A satisfaction survey was given to all patients or parents/guardians between the ages of 9 and 26 years regardless of HPV vaccine status. MAIN OUTCOME MEASURES: HPV vaccination rates per week before and after the introduction of the electronic point-of-care prompt along with satisfaction with HPV vaccine availability and the point-of-care prompt in the retail clinic setting. Data analysis was completed January 2018. RESULTS: The point-of-care prompt increased the median weekly HPV vaccination rate by 8.6 per 100 patient visits (95% CI=5.8, 11.5, p<0.001). Patients thought it was convenient having HPV vaccine available and helpful to be reminded of the need for HPV vaccine. CONCLUSIONS: This study demonstrates a significant increase of HPV vaccine rates in the retail clinic setting with use of a point-of-care prompt.