Novel lateral flow assay rapid and cost-effective point-of-care test for diagnosis of Neisseria gonorrhoeae: Lancet

The key findings of the study were as follows:

• Between March 7 and September 19, 2022, 200 male patients and 200 female patients were enrolled, with median ages of 24 years and 25 years, respectively.

• Additionally, 23 male patients and 12 female patients with partner notification slips were enrolled.

• The NG-LFA demonstrated a sensitivity of 96.1% in urine specimens and 91.7% in vaginal swabs, with specificities of 97.2% and 96.3%, respectively.

• NG-MAST analysis revealed 93 different sequence types among LFA-positive specimens.

The study implicated that novel NG-LFA exhibited excellent clinical sensitivity and specificity in symptomatic male and female patients, meeting the criteria set forth in the target product profile. This assay could serve as a valuable tool for optimizing clinical management and reducing unnecessary antibiotic use, particularly in settings with limited access to laboratory testing.

The NG-LFA presents a promising advancement in the diagnosis of N. gonorrhoeae infections, offering high sensitivity and specificity in symptomatic patients. Its implementation could lead to more effective management strategies and contribute to the global efforts to combat gonorrhea.

Reference:

Peters, R. P. H., Klausner, J. D., Mazzola, L., Mdingi, M. M., Jung, H., Gigi, R. M. S., Piton, J., Daniels, J., de Vos, L., Adamson, P. C., Gleeson, B., & Ferreyra, C. (2024). Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation. Lancet, 403(10427), 657–664. https://doi.org/10.1016/s0140-6736(23)02240-7