Peris María Paz, Alonso Henar, Escolar Cristina, Tristancho-Baró Alexander, Abad María Pilar, Rezusta Antonio, Milagro Ana
Institute for Health Research Aragon, 50009 Zaragoza, Spain.
Department of Animal Pathology, Faculty of Veterinary Sciences, Universidad de Zaragoza, 50013 Zaragoza, Spain.
Antibiotics (Basel). 2024 Oct 28;13(11):1011. doi: 10.3390/antibiotics13111011.
and can cause similar clinical syndromes and may coexist in infections. In emergency medicine, empirical treatment targeting both pathogens is often employed, potentially contributing to antibiotic resistance. Gonococcal resistance has emerged against first-line antimicrobials, necessitating prior testing for fluoroquinolone susceptibility. Certest Biotec developed two molecular diagnostic products for simultaneous detection: VIASURE & Real-Time PCR Detection Kit and VIASURE Ciprofloxacin-Resistant Real-Time PCR Detection Kit. To evaluate these products, clinical performance assessments were conducted at the Clinical Microbiology Laboratory of Miguel Servet University Hospital in Zaragoza, Spain. : Both VIASURE assays under study demonstrated high clinical sensitivity and specificity compared to reference molecular assays and Sanger sequencing. These kits offer an accurate diagnosis, facilitating appropriate treatment choices while addressing concerns about emerging antibiotic resistance. : A total of 540 clinical samples from 540 patients already characterized as positive or negative for CT and NG by a molecular assay and by antibiotic susceptibility testing for ciprofloxacin using a concentration gradient diffusion method were used for the clinical evaluation. In cases where sensitivity results were unavailable, conventional PCR and Sanger sequencing were employed.
并且可引起相似的临床综合征，且可能在感染中同时存在。在急诊医学中，针对两种病原体的经验性治疗经常被采用，这可能会导致抗生素耐药性。淋球菌已对一线抗菌药物产生耐药性，因此需要事先检测氟喹诺酮敏感性。Certest Biotec公司开发了两种用于同时检测的分子诊断产品：VIASURE淋球菌和沙眼衣原体实时荧光定量PCR检测试剂盒以及VIASURE耐环丙沙星淋球菌实时荧光定量PCR检测试剂盒。为评估这些产品，在西班牙萨拉戈萨的米格尔·塞尔维特大学医院临床微生物实验室进行了临床性能评估。：与参考分子检测方法和桑格测序相比，所研究的两种VIASURE检测方法均显示出高临床敏感性和特异性。这些试剂盒提供了准确的诊断，有助于做出合适的治疗选择，同时解决了对新出现的抗生素耐药性的担忧。：总共540份来自540名患者的临床样本被用于临床评估，这些样本已通过分子检测确定为沙眼衣原体（CT）和淋病奈瑟菌（NG）阳性或阴性，并通过浓度梯度扩散法进行了环丙沙星抗生素敏感性检测。在无法获得敏感性结果的情况下，采用了常规PCR和桑格测序。
