Point-by-Point Progress: Gonorrhea Point of Care Tests

ABSTRACT

Introduction

Point-of-care (POC) tests for Neisseria gonorrhoeae (Ng) are urgently needed to control the gonorrhea epidemic, so patients can receive immediate diagnoses and treatment. While the advent of nucleic acid amplification tests (NAATs) has improved the accuracy of Ng identification, very few POC assays are able to provide results of such tests at the clinical visit. Additionally, antimicrobial resistance (AMR) presents a unique treatment challenge for Ng.

Areas covered

This review notes that older POC tests have lower sensitivity for Ng, compared to the currently-available NAATs, and are not adequate for the current demand for high sensitivity. Promising newer assays, which can be used at the POC are covered. This review also includes data about clinicians’ and patients’ acceptability and expectations of POC tests for Ng, testing of extragenital specimens, pooling studies, as well as their impact clinically, and use in low-resource settings.

Expert opinion

The ability to use POC tests to identify and immediately treat Ng infections at the patient encounter offers many benefits and opportunities. POC tests for Ng are currently available, but not widely used especially in low-resource settings. Further development of POC tests with AMR testing capacity is needed to help guide antimicrobial stewardship.

KEYWORDS:

• Neisseria gonorrhoeae
• point-of-care tests
• antimicrobial resistance
• sexually transmitted infections
• diagnostics

Article highlights

• Sensitivity, specificity, and positive and negative predictive values are important parameters of the ideal POC test for gonorrhea and very important in screening situations, especially in low prevalence settings.

• Using POC tests to identify and immediately treat Ng infections at the patient encounter may result in opportunities to prevent forward transmission.

• POC tests for diagnosis of gonorrhea are acceptable to both clinicians and patients.

• There are optimistic newer POC assays, which can be used at the clinical encounter that are FDA cleared and others that are showing promising results.

• Currently, there are two FDA-cleared assays that have been recognized for use at the point of the clinical encounter, which can provide results in either 30 or 90 minutes. Other promising assays are in the pipeline.

• Genotypic antimicrobial testing for gonorrhea for ciprofloxacin by PCR is possible by research assays, but there is not yet a test that is available as a commercial POC assay.

• POC assays for other antibiotics could help antimicrobial stewardship.

• Quality control issues concerning the use of proper controls and user’s training will require careful adherence for widespread adoption of POC assays outside of the laboratory.

Declaration of interest

C Gaydos has received research grant support from NIH as noted above and from Hologic, Cepheid, Becton Dickenson, SpeeDX, Abbott, Roche. 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 funded by the NIH (U54EB007958, NIBIB, NIH; U-01 068613, NIAID, NIH; R01AI138978, NIAID, NIH)