A profile of the binx health io® molecular point-of-care test for chlamydia and gonorrhea in women and men

ABSTRACT

Introduction: Point-of-care (POC) tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are urgently needed to control the STI epidemic in order to offer patients an immediate diagnoses and accurate treatment before they leave a clinical encounter and thus reduce transmission and sequelae. Nucleic acid amplification tests (NAATs) have increased sensitivity and specificity, but very few POC assays can provide results of such tests within the usual time of the patient visit.

Areas covered: This review describes the technology and performance characteristics of the binx health io® [Boston, MA] (binx io) CT/NG assay, a new rapid molecular POC assay. The assay is compared to other available molecular POC tests. We also describe the importance of time to results and assay performance for this POC assay.

Expert opinion: The binx io CT/NG assay offers the ability to incorporate the use of POC tests to identify and immediately treat chlamydia and gonococcal infections into the clinical visit, which will provide improved outcomes for patients. Additional implementation studies are needed to optimize the adoption of this new test.

KEYWORDS:

• Chlamydia trachomatis
• Molecular Diagnostics
• Neisseria gonorrhoeae
• Point of Care testing
• Sexually Transmitted Diseases
• binx health

Article Highlights

• The binx health io CT/NG assay is a highly accurate molecular assay that compares well to laboratory-based molecular diagnostics.

• The assay can be performed using male urine or female vaginal swabs.

• The testing steps (transfer to the cartridge, and inserting the cartridge and running the assay) can be performed by health-care providers who have no laboratory training.

• The results are available within 30 min, and the adoption of a sample-first clinic flow facilitates the availability of results before the conclusion of the clinic visit.

• The assay supports test and treat in a single visit that is important for accurate treatment.

• The future promises more tests on the market with options to detect a greater number of pathogens and/or antimicrobial resistance genetic marker

Declaration of interest

B. Van Der Pol receives grant funding from: Abbott Molecular, BD Diagnostics, binx health, BioFire Molecular, Cepheid, Hologic, Rheonix, Roche Molecular, and SpeeDx. CA Gaydos receives grant funding from: Hologic, Cepheid, Becton Dickenson, SpeeDx, and Abbott. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.