Lateral flow assay for detection and recovery of live cell Neisseria gonorrhoeae

Abstract

Gonorrhea, caused by Neisseria gonorrhoeae, is a global disease that disproportionately impacts low- and middle-income countries. Current testing methods have failed to significantly reduce disease burden, thereby allowing untreated gonorrhea infections to cause infertility and contribute to the spread of antibiotic resistance. Therefore, low-cost testing is desperately needed to combat this obligate human pathogen. Here, we developed a lateral flow assay (LFA) that identifies N. gonorrhoeae infection at the point of care (POC). The LFA utilizes whole cell bacteria without pretreatment, thus allowing for viable cell recovery after testing. While other LFAs require preheating or multiple lysing steps, our assay displays high accuracy with a single sample application step, thus making it easier for an untrained user and enabling true at-home diagnosis of gonorrhea. Furthermore, we were able to recover viable N. gonorrhoeae cells from the positive test line, thus enabling downstream antibiotic susceptibility testing. This colorimetric, paper-based, reader-free system costs $0.38 USD per test and can improve upon syndromic management currently employed in low-resource and POC settings.

Keywords

• Diagnostics
• Point of care
• Lateral flow
• Lateral flow assay
• Gonorrhea
• Low cost