ReportInfectious Disease

A portable magnetofluidic platform for detecting sexually transmitted infections and antimicrobial susceptibility

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Science Translational Medicine  12 May 2021:
Vol. 13, Issue 593, eabf6356
DOI: 10.1126/scitranslmed.abf6356

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A rapid point-of-care test for gonorrhea

Rapid diagnosis of sexually transmitted infections in the clinic ensures treatment with the appropriate antibiotic. Trick et al. developed a cartridge-based magnetofluidic polymerase chain reaction platform that detects Neisseria gonorrhoeae, the pathogen causing gonorrhea, in urethral swabs from patients within 15 min. This test simultaneously reported whether the strains detected are resistant to the antimicrobial drug ciprofloxacin. Testing of urethral swab samples was performed at sexual health clinics in Baltimore and in Kampala, Uganda. This study demonstrates that this rapid assay can detect gonorrhea at the point of care and determine ciprofloxacin resistance of the pathogen.

Abstract

Effective treatment of sexually transmitted infections (STIs) is limited by diagnostics that cannot deliver results rapidly while the patient is still in the clinic. The gold standard methods for identification of STIs are nucleic acid amplification tests (NAATs), which are too expensive for widespread use and have lengthy turnaround times. To address the need for fast and affordable diagnostics, we have developed a portable, rapid, on-cartridge magnetofluidic purification and testing (PROMPT) polymerase chain reaction (PCR) test. We show that it can detect Neisseria gonorrhoeae, the pathogen causing gonorrhea, with simultaneous genotyping of the pathogen for resistance to the antimicrobial drug ciprofloxacin in <15 min. The duplex test was integrated into a low-cost thermoplastic cartridge with automated processing of penile swab samples from patients using magnetic beads. A compact instrument conducted DNA extraction, PCR, and analysis of results while relaying data to the user via a smartphone app. This platform was tested on penile swab samples from sexual health clinics in Baltimore, MD, USA (n = 66) and Kampala, Uganda (n = 151) with an overall sensitivity and specificity of 97.7% (95% CI, 94.7 to 100%) and 97.6% (95% CI, 94.1 to 100%), respectively, for N. gonorrhoeae detection and 100% concordance with culture results for ciprofloxacin resistance. This study paves the way for delivering accessible PCR diagnostics for rapidly detecting STIs at the point of care, helping to guide treatment decisions and combat the rise of antimicrobial resistant pathogens.

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