{
  "abstract": "Objectives Neisseria gonorrhoeae infection is a global health concern. An affordable and rapid point-of-care test is essential to optimise clinical care and could be used to detect and treat asymptomatic infection. Previously, a novel lateral flow assay for N. gonorrhoeae infection (NG LFA) met WHO test performance requirements in a symptomatic population. This study aimed to determine the performance of the NG LFA for detection of N. gonorrhoeae in people without symptoms.Methods In this cross-sectional study, we evaluated a novel N. gonorrhoeae lateral flow assay in urine from 500 asymptomatic men and vaginal swabs from 400 asymptomatic women in South Africa. Individuals visiting four primary healthcare facilities in the Buffalo City district, South Africa were enrolled if they were adults (18–49 years) and did not report any genitourinary symptoms, regardless of the reason for visiting the facility. First-void urine specimens and nurse-collected vaginal swabs were tested onsite with the NG-LFA and compared with the Xpert CT/NG assay. Discordant specimens were further investigated.Results Between March and July 2023, we enrolled 500 male and 400 female participants. The median age of male participants was 21 years (range: 18–49 years), and female participants, 32 years (range: 18–49 years). In urine specimens, NG-LFA sensitivity was 80.6% (Wilson 95% CI 63.7 to 90.8) and 81.8% in vaginal swab specimens (65·6–91.4). The specificity was 94.2% in urine specimens (91.8 to 96.0) and 98.1% in vaginal specimens (96.1 to 99.1). All NG-LFA positive/Xpert negative cases were negative for N. gonorrhoeae or other Neisseria species in additional molecular testing.Conclusions The NG LFA in vaginal swab specimens met WHO criteria for a screening test in low-resource settings. The NG LFA in male urine specimens met sensitivity criteria but did not meet the criteria for specificity.",
  "authors": [
    {
      "affiliations": [
        "Research Unit, Foundation for Professional Development, East London, South Africa",
        "Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa",
        "Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa"
      ],
      "name": "Remco P H Peters"
    },
    {
      "affiliations": [
        "University of Southern California, Keck School of Medicine, Los Angeles, California, USA"
      ],
      "name": "Jeffrey D Klausner"
    },
    {
      "affiliations": [
        "Foundation for Innovative New Diagnostics, Geneva, Switzerland"
      ],
      "name": "Laura T Mazzola"
    },
    {
      "affiliations": [
        "Research Unit, Foundation for Professional Development, East London, South Africa",
        "Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa"
      ],
      "name": "Mildred Mandisa Mdingi"
    },
    {
      "affiliations": [
        "Foundation for Innovative New Diagnostics, Geneva, Switzerland"
      ],
      "name": "Benjamin Blumel"
    },
    {
      "affiliations": [
        "Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa"
      ],
      "name": "Hyunsul Jung"
    },
    {
      "affiliations": [
        "Research Unit, Foundation for Professional Development, East London, South Africa",
        "Department of Social and Preventive Medicine, University of Bern, Bern, Switzerland"
      ],
      "name": "Ranjana M S Gigi"
    },
    {
      "affiliations": [
        "Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona, USA"
      ],
      "name": "Joseph Daniels"
    },
    {
      "affiliations": [
        "Research Unit, Foundation for Professional Development, East London, South Africa"
      ],
      "name": "Lindsey De Vos"
    },
    {
      "affiliations": [
        "Division of Infectious Diseases, University of California Los Angeles, Los Angeles, California, USA"
      ],
      "name": "Paul C Adamson"
    },
    {
      "affiliations": [
        "Foundation for Innovative New Diagnostics, Geneva, Switzerland"
      ],
      "name": "Birgitta Gleeson"
    },
    {
      "affiliations": [
        "Foundation for Innovative New Diagnostics, Geneva, Switzerland"
      ],
      "name": "Cecilia Ferreyra"
    }
  ],
  "title": "Cross-sectional evaluation of a lateral flow assay for point-of-care detection of Neisseria gonorrhoeae in asymptomatic individuals at primary healthcare facilities in South Africa",
  "uid": "caa2b0e6-8658-5550-95d4-94f13c7c36a3"
}