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

Abstract

BackgroundTo 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).MethodsAn 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.ResultsOverall, 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.ConclusionsSTI professionals preferred C. trachomatis as the top priority for a new POCT with sensitivity over 90%, low cost, and a very short completion time.

Blind Evaluation of the Microwave-Accelerated Metal-Enhanced Fluorescence Ultrarapid and Sensitive Chlamydia trachomatis Test by Use of Clinical Samples

“…The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative has developed the ASSURED (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to those in need) criteria as benchmarks to determine whether a diagnostic test addresses certain disease control needs (46). According to a qualitative study of focus group discussions with medical care providers, C. trachomatis was identified as the priority organism for the development of a new POC test and the ideal POC test for C. trachomatis detection should be accurate and rapid (Ͻ20 min) (47). A recent review of available POC tests for detection of STIs reported disappointing sensitivity for tests for Chlamydia (3).…”

Point of care diagnostics for sexually transmitted infections: perspectives and advances

“…Methodologies to measure these metrics, estimate and weigh these variable parameters are drastically needed [20]. Another important issue in the adoption of POC tests is to determine the needs of clinicians who use POC tests [21,22]. …”

STI management and control in North America IUSTI region

“…1314 Surveys have demonstrated that clinicians desire POCTs with specific qualities. 1516 Sadly, we have few good Federal Drug Administration-approved POC tests, 17 other than for HIV and trichomonas in the USA, 18 but several promising ones are in development. 1920 …”