Perceptions of an Ideal Point-of-Care Test for Sexually Transmitted Infections – A Qualitative Study of Focus Group Discussions with Medical Providers

Yu-Hsiang Hsieh,Patricia Kissinger,Mary Jett-Goheen,Charlotte A. Gaydos,Mathilda Barnes,Anne M. Rompalo,Jill Huppert,M. Terry Hogan

doi:10.1371/journal.pone.0014144

Abstract

BackgroundA point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World Health Organization Sexually Transmitted Diseases Diagnostics Initiative was formed over 15 years ago. Therefore, our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings.Methodology/Principal FindingsA qualitative study, encompassing eight focus groups, was conducted from March 2008 through April 2009. Participants included 6 STD clinic directors, 63 clinicians, and 7 public health/laboratory/epidemiology professionals in the STI field. Discussion topics included currently available POCT, perceived barriers to using POCT in clinics, priority STI for the development of new POCT, and characteristics of the ideal POCT. All discussions were recorded and transcribed verbatim. Themes raised as barriers for current POCT included complexity, long time frames of the so-called “rapid” test, multiple time-driven steps, requiring laboratory technician, difficulty in reading result, interruption of workflow, unreliability, and invasiveness. Chlamydia trachomatis was identified as the priority organism for development of a new STI POCT. Themes indicated for the ideal POCT included rapid turnaround (up to 20 minutes), ease of use, non-invasive, accurate (preferred sensitivity and specificity in the range of high 90s), Clinical Laboratory Improvement Amendments (CLIA)-waived, user-friendly (for both patients and staff), compact, durable, and sturdy.Conclusions/SignificanceFocus group discussions with STI experts and professionals highlighted chlamydia as the top priority pathogen for POCT development, and identified the qualities of new POCT for STIs. Participants endorsed ease of use, rapid turnaround and high accuracy as essential characteristics of an ideal POCT.

Highlights

Transmitted infections (STIs), caused by more than 30 different sexually transmissible microorganisms, comprise the leading group of reportable diseases in the United States each year with an annual estimate of more than 19 million new cases [1] and 9.3–15.5 billion dollars in costs [2,3]
Our goal was to explore the perceptions of the ideal types and characteristics for STI point-of-care test (POCT) for use in clinics and other care settings through focus group discussions conducted with clinicians, opinion leaders, and public health professionals
Used and reported POCTs for STIs The most common currently used POCT for STIs reported from participants was the wet mount test, i.e. saline and potassium hydroxide (KOH) slide preparation of vaginal fluid for Trichomonas vaginalis, candidiasis and bacterial vaginosis detection

Summary

Introduction

Transmitted infections (STIs), caused by more than 30 different sexually transmissible microorganisms, comprise the leading group of reportable diseases in the United States each year with an annual estimate of more than 19 million new cases [1] and 9.3–15.5 billion dollars in costs [2,3]. Current diagnostic testing algorithms result in a turn-around time of 2–14 days before laboratory test results are available to clinical providers and patients This has contributed to low rates of patient return for test results [4,5], reinfection of the presenting patient, and ongoing transmission of infection in the patient’s partner(s). An accurate STI diagnostic with rapid turnaround time can provide clinicians with specific test result and may allow directed STI treatment within a single visit. Such a rapid test could effectively curtail STI transmission especially in those vulnerable populations mentioned above. A point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. Our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings

Objectives

Methods

Results

Conclusion