Novel lateral flow assay rapid and cost-effective point-of-care test for diagnosis of Neisseria gonorrhoeae: Lancet
Effective control of Neisseria gonorrhoeae (N. gonorrhoeae) relies on rapid and accurate diagnostic tests. The World Health Organization (WHO) and Foundation for Innovative New Diagnostics (FIND) have established criteria for a non-molecular rapid point-of-care test, emphasizing the need for high sensitivity and specificity, quick turnaround time, and affordability. A novel lateral flow assay (NG-LFA) has been developed to meet these requirements.
In a recent cross-sectional study conducted in South Africa, researchers evaluated the performance of the NG-LFA at primary health-care facilities. This study was published in The Lancet journal. The study was conducted by Prof. Remco and colleagues.
Male patients with urethral discharge syndrome and female patients with vaginal discharge syndrome were recruited from five health facilities. First-void urine specimens and nurse-collected vaginal swabs were tested in-facility with the NG-LFA and Xpert CT/NG PCR assay. N. gonorrhoeae multi-antigen sequence typing (NG-MAST) was performed on all LFA-positive specimens.
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
