New in vitro Point-of-Care Diagnostic Tests for Gonorrhea and Syphilis using the Doctor Vida® Pocket

• Autor(a) principal: Calheta, Ana Catarina Sousa
• Data de Publicação: 2023
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10362/159732
• topic: Point-of-Care; LAMP; Diagnosis; Doctor Vida®; in vitro Diagnosis; STDs; Domínio/Área Científica::Engenharia e Tecnologia::Outras Engenharias e Tecnologias

Sexually transmitted diseases (STDs) are spreading around the world, due to the difficulty in treating and controlling infections. Two of the most common STDs are Gonorrhea and Syphilis, which are responsible for millions of infections. The rapid transmission and high antibiotic resistance of the bacteria responsible for Gonorrhea makes it difficult to follow up, which requires new forms of diagnosis that are fast to prevent the transmission. In addition, Syphilis has reappeared, and even though there is treatment and a cure, as well as several accessible forms of diagnosis, new ways of control that can diagnose the first stages of infection are necessary. Thus, new point-of-care tests (POCTs) that enable rapid diagnosis in a single clinic visit are needed, reducing the transmission and late treatment, essential for low resource settings where follow-up is practically impossible. Doctor Vida® pocket is a POCT device, developed by STAB VIDA, which relies on LAMP (Loop-mediated Isothermal Amplification) technique, with results visible in real time using an app. Two tests for the diagnosis of these STDs were developed for this device, in which various samples were tested, including vaginal, anal, oral and lesion swabs, as well as urine. The Gonorrhea diagnostic test, that targets the porA pseudogene of Neisseria gonorrhoeae, showed relative sensitivity of 96% and specificity of 75% for LAB1 samples (n=58) and relative sensitivity of 92% and specificity of 95% for LAB2 samples (n=39). For the Syphilis test developed, designed to target the polA gene of Treponema pallidum subsp. pallidum, a 94% sensitivity and a 100% specificity was achieved for LAB2 samples (n=39). These results show the molecular detection of both bacteria using Doctor Vida® pocket in less than 1-hour.