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New rapid test identifies N. gonorrhoeae in less than 15 minutes

A new portable, rapid test can detect Neisseria gonorrhoeae in less than 15 minutes — faster than standard-of-care tests that can take hours or days.

Jeff Wang, PhD, a professor at the Johns Hopkins Whiting School of Engineering, said the development of easy-to-use, rapid, accurate and low-cost STI tests are “a critical component” for combating the STI “crisis.”

Source: Trick AY, et al. Sci Transl Med. 2021;doi:10.1126/scitranslmed.abf6356.

“The ability to rapidly identify N. gonorrhoeae and characterize the antimicrobial susceptibility profile has promising implications for promoting antimicrobial stewardship to reduce antimicrobial resistance selection pressure,” Wang told Healio.

Gonorrhea is the second most common STI in the United States and has become increasingly resistant to drugs recommended to treat it.

Jeff Wang

“Although ciprofloxacin is no longer recommended for the treatment of gonorrhea in the United States, up to 80% of gonorrhea infections are still ciprofloxacin susceptible,” Wang said. “Point-of-care test use of our platform to rapidly identify susceptible infections opens opportunities for providing access to less expensive oral ciprofloxacin treatments compared to the current first-line recommended dual therapy of injectable ceftriaxone and oral azithromycin.”

Wang and colleagues developed an on-cartridge magnetofluidic purification and testing PCR test that detects N. gonorrhoeae and analyzes its resistance to ciprofloxacin. The test was used on penile swab samples from 66 patients in Baltimore and 151 patients in Kampala, Uganda. A compact tool performed DNA extraction, PCR, analyzed results and relayed data to patients via a phone application.

The test’s overall sensitivity was 97.7% (95% CI, 94.7%-100%), and its specificity was 97.6% (95% CI, 94.1%-100%) for N. gonorrhoeae. Test results were also in 100% concordance with culture results for ciprofloxacin resistance.

“The advances demonstrated so far in magnetofluidic cartridge technology show great promise for delivering rapid gold-standard infectious disease diagnostics in a scalable and accessible format which could revolutionize STI treatment and rationalize antimicrobial use and stewardship,” Wang said.

Wang also said that the material cost of a test cartridge is approximately $2.

“The delivery of our devices to clinics in low rescues will require regulatory approval and collaboration with industrial partners for manufacturing and distribution,” Wang said. “We are working toward this goal through forming a university spinoff and expect to deliver the products within 2 to 3 years.”

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Sources/Disclosures

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Source:

Trick AY, et al. Sci Transl Med. 2021;doi:10.1126/scitranslmed.abf6356.

Disclosures: Wang reports being a coinventor on patent PCT/US2019/029937, a disposable reagent scaffold for biochemical process integration, that is associated with the study. Please see the study for all other authors’ relevant financial disclosures.