Poster Presentation 14th Lorne Infection and Immunity 2024

Genital InFlammation Test (GIFT) for sexual and reproductive health: point-of-care screening tool for sexually transmitted infections and bacterial vaginosis (#106)

Lindi Masson 1 2 3 4 , Monalisa T Manhanzva 1 , Fezile Khumalo 1 , Micaela Lurie 1 , Eneyi Kpokiri 5 , Ramla Fatime Tanko 1 , Tanya Pidwell 1 , Bahiah Meyer 1 , Phumla Radebe 1 , Conita Lombard 1 , Celia Mehou-Loko 1 , Yacoeb Ganief 1 , Tania Crucitti 6 , Theodora Mayouya Gamana 6 , Katherine Gill 7 , Nicola Thomas 7 , Anda Madikida 7 , Karabo Mahlangu 7 , Janneke van de Wijgert 8 , Bich-Tram Huynh 9 , Camille Fortas 9 , Chido Dziva Chikwari 5 10 11 , Katharina Kranzer 5 , Tinashe Mwaturu 5 , Lyndon Mungur 12 , Ashley Uys 12 , Darryl Uys 12 , Ayako Honda 13 , Sarah Bernays 5 14 , Linda-Gail Bekker 7 , Edina Sinanovic 15 , Elise Smith 15 , Suzanna Francis 5 16 , Saberi Marais 17 , Constance Mackworth-Young 5 , Emma Harding-Esch 5 , David Anderson 4 , Jo-Ann S Passmore 1 2 18
  1. Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
  2. Centre for the AIDS Programme of Research in South Africa, Durban, South Africa
  3. Central Clinical School, Monash University, Melbourne, Australia
  4. Burnet Institute, Melbourne, VIC, Australia
  5. London School of Hygiene & Tropical Medicine, London, UK
  6. Institut Pasteur de Madagascar, Antananarivo, Madagascar
  7. Desmond Tutu HIV Centre, Cape Town, South Africa
  8. University Medical Center Utrecht, Utrecht, Netherlands
  9. Institut Pasteur, Paris, France
  10. Organization for Public Health Interventions and Development, Harare, Zimbabwe
  11. Biomedical Research and Training Institute, Harare, Zimbabwe
  12. Medical Diagnostech, Cape Town, South Africa
  13. Hitotsubashi University, Kunitachi, Japan
  14. School of Public Health, University of Sydney, Sydney, Australia
  15. Health Economics Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
  16. International AIDS Vaccine Initiative, Amsterdam, Netherlands
  17. Research Contracts and Innovation, University of Cape Town, Cape Town, South Africa
  18. National Health Laboratory Service, Cape Town, South Africa

Background: Female genital tract inflammation increases risk of adverse sexual and reproductive outcomes, including HIV acquisition and preterm birth. This inflammation is primarily caused by sexually transmitted infections (STIs) and bacterial vaginosis (BV), which are asymptomatic in most women. Although gold standard nucleic acid amplification diagnostic tests (NAATs) have been developed to detect these infections, their cost and required resources limit their use for routine screening. We have validated biomarkers of vaginal inflammation (IL-1α, IL-1β, IP-10) caused by STIs/BV in five African cohorts. We aim to develop and implement a low-cost rapid point-of-care test, called the Genital InFlammation Test (GIFT), to measure these biomarkers and increase STI/BV case-finding.

 

Methods: We developed two lateral flow immunochromatographic prototypes measuring both IL-1α and β in a multiplexed assay and IP-10. The devices were evaluated using recombinant cytokines and vaginal swabs collected from South African women and the results were compared to ELISA. Optimal vaginal swab type and equipment-free processing methods were determined. A two-round modified Delphi survey was administered globally to evaluate stakeholder recommendations for implementation.

 

Results: The prototype devices had analytical sensitivities <50pg/ml for IL-1α and β and <70pg/ml for IP-10. The test line intensities observed by the naked eye correlated with ELISA concentrations (r=0.78, p=0.02; r=0.90, p=0.001; r=0.97, p<0.0001 for IL-1α and β and IP-10, respectively). Flocked swabs were identified as the best swab type and swab compression by hand in phosphate buffered saline preloaded into soft nozzle-cap tubes increased cytokine recovery from vaginal swab secretions compared to vortexing. Sixty-four stakeholders, mainly healthcare professionals, responded to the Delphi survey. The majority (84%) would offer screening with GIFT to sexually active asymptomatic women in low and middle-income regions.

 

Conclusion: If offered to women attending healthcare clinics or used for self-testing, GIFT could increase STI/BV case-finding. The GIFT device, user experience and cost-effectiveness are currently being evaluated in three settings in Africa. The next step will be to identify use cases for GIFT in other world regions, including the Asia-Pacific.