性传播感染(STIs)是全球最常见的传染病之一,经常导致合并感染。在高危人群中及时检测生殖道病原体对于预防性传播感染至关重要。我们评估了NAP-Fluo循环系统,创新的微流控核酸检测平台,具有同时识别沙眼衣原体(CT)的能力,淋病奈瑟菌(NG),解脲脲原体(UU),生殖支原体(MG),尿道或宫颈分泌物中的人型支原体(MH)。
■检测限(LODs),重复性,特异性,使用标准菌株评估系统的抗干扰性,由24种病原体组成的小组,和七个干扰物。我们使用该系统分析了302个临床样本,并将结果与五个已批准的商业参考试剂盒的结果进行了比较。
■系统达到500IFU/mL的LOD,500CFU/mL,和500CCU/mL的CT,NG,和UU/MG/MH,分别,表现出高稳定性(变异系数<1.1%),特异性,和抗干扰。在302个临床样本中,237单检测呈阳性,双重,三联感染率为35.6%,16.2%,和3.0%,分别。参考试剂盒检测到138个阳性样品。UU与商业参考试剂盒的一致率为100%,NG,MH;CT为94.85%;MG为80.00%。
■该系统提供了一个简化的,快速,和多路检测方法,减少了测试时间和复杂性。尽管它在纯菌株中表现良好,当使用CT和MG的临床样本时,它有局限性,建议在临床广泛使用之前需要进一步改进。
UNASSIGNED: Sexually transmitted infections (STIs) are among the most common infectious diseases worldwide, often leading to coinfections. Timely detection of genital tract pathogens in at-risk populations is crucial for preventing STIs. We evaluated the NAP-Fluo Cycler System, an innovative microfluidic nucleic acid detection platform, for its ability to simultaneously identify Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Ureaplasma urealyticum (UU), Mycoplasma genitalium (MG), and Mycoplasma hominis (MH) in urethral or cervical secretions.
UNASSIGNED: The limits of detection (LODs), repeatability, specificity, and interference resistance of the system were evaluated using standard strains, a panel of 24 pathogens, and seven interferents. We used the system to analyze 302 clinical samples and compared the results with those of five approved commercial reference kits.
UNASSIGNED: The system achieved LODs of 500 IFU/mL, 500 CFU/mL, and 500 CCU/mL for CT, NG, and UU/MG/MH, respectively, demonstrating high stability (coefficient of variation <1.1 %), specificity, and resistance to interference. Among 302 clinical samples, 237 tested positive with single, dual, and triple infection rates of 35.6 %, 16.2 %, and 3.0 %, respectively. The reference kits detected 138 positive samples. The concordance rates with commercial reference kits were 100 % for UU, NG, and MH; 94.85 % for CT; and 80.00 % for MG.
UNASSIGNED: This system offers a streamlined, rapid, and multiplex detection method that reduces testing time and complexity. Although it performs well with pure strains, it has limitations when using clinical samples of CT and MG, suggesting the need for further refinement before its widespread use in the clinic.