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

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. 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.A 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.Focus 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

What Qualities Are Most Important to Making a Point of Care Test Desirable for Clinicians and Others Offering Sexually Transmitted Infection Testing?

To investigate the possible effects of different levels of attributes of a point-of-care test (POCT) on sexually transmitted infection (STI) professionals' decisions regarding an ideal POCT for STI(s).An online survey was designed based on a large-scale in-depth focus discussion study among STI experts and professionals. The last section of the survey "build your own POCT" was designed by employing the discrete choice experiment approach. Practicing clinicians from two venues, STI-related international conference attendees and U.S. STD clinic clinicians were invited to participate in the survey. Conditional logistical regression modeling was used for data analysis.Overall, 256 subjects took the online survey with 218 (85%) completing it. Most of the participants were STD clinic clinicians who already used some POCTs in their practice. "The time frame required" was identified as a major barrier that currently made it difficult to use STI POCTs. Chlamydia trachomatis was the organism chosen as the top priority for a new POCT, followed by a test that would diagnose early seroconversion for HIV, and a syphilis POCT. Without regard to organism type selected, sensitivity of 90-99% was always the most important attribute to be considered, followed by a cost of $20. However, when the test platform was prioritized for early HIV seroconversion or syphilis, sensitivity was still ranked as most important, but specificity was rated second most important.STI professionals preferred C. trachomatis as the top priority for a new POCT with sensitivity over 90%, low cost, and a very short completion time

Cost-effectiveness Analysis of Chlamydia trachomatis Screening Via Internet-based Self-collected Swabs Compared With Clinic-based Sample Collection

BACKGROUND: : Although the Centers for Disease Control and Prevention have recommended population-wide Chlamydia trachomatis screening of sexually active women less than 26 years of age, more than half of sexually active young women are not routinely screened. A Website (IWTK, www.iwantthekit.org), was developed in 2004 to promote home-based sample collection. METHODS: : A decision tree was designed to model a hypothetical cohort of 10,000 women per year who order an internet-based C. trachomatis screening kit. We compared the incremental cost-effectiveness of 2 screening strategies: self-sampling via the IWTK website, and traditional, clinic-based screening by the same cohort of women who used IWTK. Probabilities and costs were estimated for each node in the decision tree. Estimates were derived from primary data, published data, and unpublished health data. RESULTS: : The internet-based screening strategy prevented 35.5 more cases of pelvic inflammatory disease and saved an additional $41,000 in direct medical costs as compared with the clinic-based screening strategy. CONCLUSION: : Our model estimates demonstrated that an internet-based, self-swab screening strategy was cost-effective compared with the traditional, clinic-based screening strategy. Assuming that the popularity of the use of the internet as a resource for information about healthcare and sexually transmitted infections leads to an increased use of IWTK, the public health benefit of this cost-effective strategy will be even greater

Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting

OBJECTIVES: To compare the effectiveness and cost-effectiveness of a promising new point-of-care (POC) chlamydia test with traditional nucleic acid amplification testing (NAAT), and to determine the characteristics that would make a POC test most cost-effective. METHODS: A decision tree was constructed to model chlamydia screening visits to a sexually transmitted disease clinic by a hypothetical cohort of 10 000 women. The model incorporated programmatic screening costs, treatment costs and medical costs averted through prevention of pelvic inflammatory disease (PID) and its sequelae. Parameter values and costs were estimated for each node in the decision tree based on primary data, published data and unpublished health data. RESULTS: For the base-case scenario (POC sensitivity 92.9%; 47.5% of women willing to wait 40 min for test results; test cost $33.48), POC was estimated to save US$5050 for each case of PID averted compared with NAAT. One-way sensitivity analyses indicated that POC would dominate NAAT if the POC test cost is CONCLUSIONS: A promising new chlamydia POC test is likely to be cost-effective compared with traditional NAAT. The POC test sensitivity, cost and proportion of women willing to wait for the POC test result are key elements to determining the cost-effectiveness of any new POC test strategy

Clinical Evaluation of 2 Point-of-Care Lateral Flow Tests for the Diagnosis of Syphilis.

A diagnostic performance study comparing the only Food and Drug Administration-approved, point-of-care (POC) treponemal test (Syphilis Health Check) and the World Health Organization pre-qualified SD Bioline POC treponemal test against a treponemal hemagglutination test (TPHA) and a sequential algorithm of nontreponemal rapid plasma reagin and TPHA found both POC tests had >85% sensitivity compared with the TPHA and >85% sensitivity and >95% specificity compared with the rapid plasma reagin and TPHA standards

Some quotes on point-of-care tests (POCTs) for sexually transmitted infections (STIs) from the participants of structured discussion sessions.

<p>Some quotes on point-of-care tests (POCTs) for sexually transmitted infections (STIs) from the participants of structured discussion sessions.</p