The group B Streptococcus (GBS) is a type of pathogen that seriously threatens the health of mothers and infants. Prompt and timely diagnosis is crucial for good patient outcomes. However, the traditional bacterial culture and polymerase chain reaction methods are limited by their speed and involve complex operating procedures. Herein, we successfully established an integrated microfluidic sample-to-answer system for nucleic acid-based detection of GBS directly in vaginal/anal swab samples. Meanwhile, we demonstrated a dynamical reaction mechanism of Bst/FEN1-based nucleic acid amplification, which differs from traditional Bst-based isothermal amplification strategies. The system integrates cell lysis and nucleic acid purification, separation, amplification, and detection, enabling rapid (about 45 min to the entire analysis) and highly accurate (98% accuracy) analysis in a clinical setting. Experimental results show that the system offers a good detection limit (500 CFU/mL), perfect specificity (no cross-reactivity with 25 other common pathogens), excellent stability (coefficient of variation less than 3%), and good anti-interference performance. This novel system holds great potential as a nucleic acid-based diagnostic tool in clinical applications for detecting not only GBS but also other types of pathogens.

中文翻译：

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集成的微流控样品至应答系统，用于直接基于核酸检测临床阴道/肛门拭子样品中的B组链球菌。

B族链球菌（GBS）是一种严重威胁母亲和婴儿健康的病原体。及时和及时的诊断对于患者的良好结局至关重要。然而，传统的细菌培养和聚合酶链反应方法受到其速度的限制，并且涉及复杂的操作程序。在这里，我们成功地建立了一个集成的微流体样品-应答系统，用于直接在阴道/肛门拭子样品中基于核酸的GBS检测。同时，我们证明了基于Bst / FEN1的核酸扩增的动态反应机理，与传统的基于Bst /等温扩增策略不同。该系统集成了细胞裂解和核酸纯化，分离，扩增和检测，在临床环境中可以进行快速（整个分析大约需要45分钟）和高精度（98％准确度）分析。实验结果表明，该系统具有良好的检测限（500 CFU / mL），完美的特异性（与其他25种常见病原体无交叉反应），出色的稳定性（变异系数小于3％）和良好的抗干扰性能。在临床应用中，这种新颖的系统作为基于核酸的诊断工具具有巨大的潜力，不仅可以检测GBS，还可以检测其他类型的病原体。