clinical evaluation

临床评价
  • 文章类型: Journal Article
    精确的放射治疗计划对于确保用于放射治疗的成胶质细胞瘤(GBM)的准确分割至关重要。然而,传统的人工分割过程是劳动密集型的,严重依赖放射肿瘤学家的经验。在这项回顾性研究中,提出了一种新的自动分割方法来解决这些问题。为了评估该方法在不同场景中的适用性,我们使用从四个多中心数据集和包括非对比CT在内的回顾性数据收集中抽取的148名合格患者进行了其开发和评估。多序列MRI扫描,和相应的医疗记录.所有患者均经组织学证实为高级别胶质瘤(HGG)。通过利用多模态成像的先验知识,提出了一种基于深度学习的方法(PKMI-Net),用于自动分割GBM的大体肿瘤体积(GTV)和临床目标体积(CTV1和CTV2)。所提出的PKMI-Net在分段方面表现出很高的准确性,分别,GTV,CTV1和CTV2在11名患者的测试集中,Dice相似系数(DSC)为0.94、0.95和0.92;95%Hausdorff距离(HD95)为2.07、1.18和3.95mm;平均表面距离(ASD)为0.69、0.39和1.17mm;相对体积差异(RVD)为5.50%,9.68%,3.97%。此外,绝大多数的GTV,PKMI-Net产生的CTV1和CTV2是临床上可接受的,并且不需要对临床实践进行修订。在我们的多中心评估中,PKMI-Net在各种数据集中表现出一致和强大的泛化能力,证明其在自动分割GBM中的有效性。所提出的多模态成像中使用先验知识的方法可以提高GBM的轮廓精度,这具有提高GBM放射治疗质量和效率的潜力。
    A precise radiotherapy plan is crucial to ensure accurate segmentation of glioblastomas (GBMs) for radiation therapy. However, the traditional manual segmentation process is labor-intensive and heavily reliant on the experience of radiation oncologists. In this retrospective study, a novel auto-segmentation method is proposed to address these problems. To assess the method\'s applicability across diverse scenarios, we conducted its development and evaluation using a cohort of 148 eligible patients drawn from four multicenter datasets and retrospective data collection including noncontrast CT, multisequence MRI scans, and corresponding medical records. All patients were diagnosed with histologically confirmed high-grade glioma (HGG). A deep learning-based method (PKMI-Net) for automatically segmenting gross tumor volume (GTV) and clinical target volumes (CTV1 and CTV2) of GBMs was proposed by leveraging prior knowledge from multimodal imaging. The proposed PKMI-Net demonstrated high accuracy in segmenting, respectively, GTV, CTV1, and CTV2 in an 11-patient test set, achieving Dice similarity coefficients (DSC) of 0.94, 0.95, and 0.92; 95% Hausdorff distances (HD95) of 2.07, 1.18, and 3.95 mm; average surface distances (ASD) of 0.69, 0.39, and 1.17 mm; and relative volume differences (RVD) of 5.50%, 9.68%, and 3.97%. Moreover, the vast majority of GTV, CTV1, and CTV2 produced by PKMI-Net are clinically acceptable and require no revision for clinical practice. In our multicenter evaluation, the PKMI-Net exhibited consistent and robust generalizability across the various datasets, demonstrating its effectiveness in automatically segmenting GBMs. The proposed method using prior knowledge in multimodal imaging can improve the contouring accuracy of GBMs, which holds the potential to improve the quality and efficiency of GBMs\' radiotherapy.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    目的:使用多机构数据,探讨虚拟对比增强MRI(VCE-MRI)在鼻咽癌(NPC)大体肿瘤体积(GTV)勾画中的潜力。
    方法:本研究回顾性检索T1加权(T1w),T2加权(T2w)MRI,来自三个肿瘤中心的348例经活检证实的NPC患者的钆对比增强MRI(CE-MRI)和计划CT。使用288名患者训练了多模态引导协同神经网络(MmgSN-Net),以利用T1w和T2wMRI中的互补特征进行VCE-MRI合成,对60例患者进行了独立评估。三名获得委员会认证的放射肿瘤学家和两名医学物理学家参与了三个方面的临床评估:合成VCE-MRI的图像质量评估,VCE-MRI辅助靶区勾画,以及基于VCE-MRI的轮廓在治疗计划中的有效性。图像质量评估包括VCE-MRI和CE-MRI的可区分性。肿瘤与正常组织界面的清晰度和肿瘤侵袭风险区域对比增强的准确性。原发性肿瘤的描绘和治疗计划由放射肿瘤学家和医学物理学家手动进行,分别。
    结果:区分VCE-MRI和CE-MRI的平均准确率为31.67%;VCE-MRI和CE-MRI在肿瘤与正常组织界面的清晰度方面没有观察到显着差异;对于肿瘤侵袭风险区域的对比增强的准确性,准确率为85.8%。图像质量评估结果表明,VCE-MRI的图像质量与真实的CE-MRI高度相似。计划目标体积的平均剂量学差异小于1Gy。
    结论:VCE-MRI在NPC患者的肿瘤勾画中非常有希望取代基于钆的CE-MRI。
    OBJECTIVE: To investigate the potential of virtual contrast-enhanced MRI (VCE-MRI) for gross-tumor-volume (GTV) delineation of nasopharyngeal carcinoma (NPC) using multi-institutional data.
    METHODS: This study retrospectively retrieved T1-weighted (T1w), T2-weighted (T2w) MRI, gadolinium-based contrast-enhanced MRI (CE-MRI) and planning CT of 348 biopsy-proven NPC patients from three oncology centers. A multimodality-guided synergistic neural network (MMgSN-Net) was trained using 288 patients to leverage complementary features in T1w and T2w MRI for VCE-MRI synthesis, which was independently evaluated using 60 patients. Three board-certified radiation oncologists and two medical physicists participated in clinical evaluations in three aspects: image quality assessment of the synthetic VCE-MRI, VCE-MRI in assisting target volume delineation, and effectiveness of VCE-MRI-based contours in treatment planning. The image quality assessment includes distinguishability between VCE-MRI and CE-MRI, clarity of tumor-to-normal tissue interface and veracity of contrast enhancement in tumor invasion risk areas. Primary tumor delineation and treatment planning were manually performed by radiation oncologists and medical physicists, respectively.
    RESULTS: The mean accuracy to distinguish VCE-MRI from CE-MRI was 31.67%; no significant difference was observed in the clarity of tumor-to-normal tissue interface between VCE-MRI and CE-MRI; for the veracity of contrast enhancement in tumor invasion risk areas, an accuracy of 85.8% was obtained. The image quality assessment results suggest that the image quality of VCE-MRI is highly similar to real CE-MRI. The mean dosimetric difference of planning target volumes were less than 1Gy.
    CONCLUSIONS: The VCE-MRI is highly promising to replace the use of gadolinium-based CE-MRI in tumor delineation of NPC patients.
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  • 文章类型: Journal Article
    在冠状病毒大流行之后,引起粘膜和全身免疫反应的呼吸道粘膜疫苗引起了越来越多的关注.然而,人体生理特征对粘膜免疫的评估提出了重大挑战,这直接阻碍了呼吸道粘膜疫苗的开发和应用。
    本研究总结了呼吸道粘膜中免疫反应的特征,并回顾了评估对呼吸道粘膜疫苗的免疫反应的现状和挑战。
    分泌性免疫球蛋白A(S-IgA)是粘膜部位的主要效应分子,是评估呼吸道粘膜疫苗的常用指标。然而,呼吸道独特的生理结构对S-IgA的临床采集和检测提出了重大挑战。因此,必须开发一种具有高收集效率和接受度的采样方法,一种灵敏的检测方法,粘膜抗体的参考材料,并建立与临床保护相关的S-IgA阈值。在评估粘膜细胞免疫时,样品收集甚至更具挑战性。因此,应建立具有高可操作性和高耐受性的粘膜细胞取样方法。还应探索能够反映粘膜细胞免疫的循环系统的靶标。
    UNASSIGNED: Following the coronavirus disease pandemic, respiratory mucosal vaccines that elicit both mucosal and systemic immune responses have garnered increasing attention. However, human physiological characteristics pose significant challenges in the evaluation of mucosal immunity, which directly impedes the development and application of respiratory mucosal vaccines.
    UNASSIGNED: This study summarizes the characteristics of immune responses in the respiratory mucosa and reviews the current status and challenges in evaluating immune response to respiratory mucosal vaccines.
    UNASSIGNED: Secretory Immunoglobulin A (S-IgA) is a major effector molecule at mucosal sites and a commonly used indicator for evaluating respiratory mucosal vaccines. However, the unique physiological structure of the respiratory tract pose significant challenges for the clinical collection and detection of S-IgA. Therefore, it is imperative to develop a sampling method with high collection efficiency and acceptance, a sensitive detection method, reference materials for mucosal antibodies, and to establish a threshold for S-IgA that correlates with clinical protection. Sample collection is even more challenging when evaluating mucosal cell immunity. Therefore, a mucosal cell sampling method with high operability and high tolerance should be established. Targets of the circulatory system capable of reflecting mucosal cellular immunity should also be explored.
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  • 文章类型: Journal Article
    脂联素(ADPN),血清/血浆脂联素水平与胰岛素抵抗和2型糖尿病密切相关,较低的脂联素水平预测糖尿病风险增加,是不同种族糖尿病高危人群糖尿病风险的有力指标。利用化学发光免疫分析(CLIA)的独特原理和性能优势,一种高灵敏度的ADPN-CLIA方法,基于夹心式两步法的原理,建立了高特异性和宽检测范围,以磁性颗粒(MPs)为固相载体,吖啶酯(AE)为化学发光反应体系。所需主要原材料的选择,MPs包被抗体的制备条件,AE标记抗体的方法,样品要求和反应模式进行了优化和评估。成功进行了AE标记实验,标记效率为8.366,抗体利用率为96.8%。ADPN的化学发光免疫分析在0ng/mL到250ng/mL之间具有良好的线性关系(R2=0.9993),检出限为0.05ng/mL。测定内和测定间精密度的变异系数(CV)均小于5%。准确度的回收率为91.26%至107.46%。开发的ADPN-CLIA与免疫比浊法之间的80份临床血清样品的比较实验表明,相关系数为0.956,Bland-Altman分析表明,一致的极限为-0.364和0.433。
    Adiponectin (ADPN), which serum/plasma adiponectin levels are closely associated with insulin resistance and type 2 diabetes, and lower adiponectin levels predict an increased risk of diabetes, is a strong indicator of diabetes risk in people at high risk of diabetes in different races. Using the unique principle and performance advantages of chemiluminescence immunoassay (CLIA), an ADPN-CLIA method with high sensitivity, high specificity and wide detection range was established based on the principle of two-steps method of sandwich-type, with the magnetic particles (MPs) as the solid phase carrier and acridinium ester (AE) as the chemiluminescence reaction system. The selection of the main raw materials required, the preparation conditions of MPs-coated antibodies, the methods of AE-labeled antibodies, sample requirements and reaction modes were optimized and evaluated. AE labeling experiment was successfully performed with the labeling efficiency of 8.366 and the antibody utilization rate of 96.8%. The chemiluminescent immunoassay for ADPN had a good linear relationship from 0 ng/mL to 250 ng/mL (R2 =0.9993), with the detection limit of 0.05 ng/mL. The coefficient of variation (CV) of intra-assay and inter-assay precision were both less than 5% respectively. The recovery rates for accuracy were from 91.26% to 107.46%. The comparison experiment of 80 clinical serum samples between the developed ADPN-CLIA with the immunoturbidimetry showed that the correlation coefficient was 0.956, and the Bland-Altman analysis showed that the limits of agreement were - 0.364 and 0.433.
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  • 文章类型: Journal Article
    背景:没有评估皮肤光老化的标准。皮肤镜检查是一种非侵入性检测方法,可用于评估光老化。
    目的:评估皮肤光老化评估与临床和病理评估之间的相关性。
    方法:年龄,临床评估(Fitzpatrick分类法,Glogau光老化分类,和Chung的标准化图像标尺),组织病理学(Masson染色和MMP-1免疫组织化学),和皮肤镜检查(Hu's和Isik's)对40个供体皮肤样本进行统计学分析,进行Spearman秩相关分析。
    结果:Hu总分与Isik皮肤镜检查之间存在强相关性。皮肤镜检查与组织病理学的相关性高于临床评估方法。毛细血管扩张酶与扁桃体之间有很强的相关性。干燥症,浅层皱纹,弥漫性红斑,毛细血管扩张酶,网状色素沉着与三种临床评价方法显著相关。浅表皱纹与Masson相关,MMP-1,各种临床指标,和其他皮肤镜件。
    结论:皮肤镜检查与临床和组织病理学检查有良好的相关性。皮肤镜检查可能有助于评估皮肤光老化。
    BACKGROUND: There are no standards for evaluating skin photoaging. Dermoscopy is a non-invasive detection method that might be useful for evaluating photoaging.
    OBJECTIVE: To assess the correlation between the dermoscopic evaluation of photoaging and clinical and pathological evaluations.
    METHODS: The age, clinical evaluation (Fitzpatrick classification, Glogau Photoaging Classification, and Chung\'s standardized image ruler), histopathology (Masson staining and MMP-1 immunohistochemistry), and dermoscopy (Hu\'s and Isik\'s) of 40 donor skin samples were analyzed statistically, and Spearman rank correlation analysis was performed.
    RESULTS: There was a robust correlation between the total Hu scores and Isik dermoscopy. The correlation of dermoscopy with histopathology was higher than that of clinical evaluation methods. There is a strong correlation between telangiectases and lentigo. Xerosis, superficial wrinkle, diffuse erythema, telangiectases, and reticular pigmentation were significantly correlated with the three clinical evaluation methods. Superficial wrinkles were correlated with Masson, MMP-1, various clinical indicators, and other dermoscopic items.
    CONCLUSIONS: There is a good correlation between dermoscopy and clinical and histopathological examination. Dermoscopy might help evaluate skin photoaging.
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  • 文章类型: Journal Article
    抗原快速诊断检测(Ag-RDT)是一种检测SARS-COV-2核衣壳蛋白的检测试剂盒,基于胶体金法。准确的诊断对限制SARS-COV-2的传播具有重要作用,也有助于患者尽早接受治疗。这项研究的目的是使用从两种不同的拭子收集的样品对新型Ag-RDT进行临床评估。DEEPBLUE®COVID-19抗原检测试剂盒用于检查实验中的受试者。对于用鼻拭子收集的样本进行抗原测试,敏感性为91.7%(95%CI83.6-96.6%),特异性为100%(95%CI98.1-100%).对于鼻咽拭子,敏感性为96.8%(95%CI93.6~98.7%),特异性为100%(95%CI98.2~100%).FisherPrecision检验显示鼻咽拭子Ag-RDTs和鼻拭子Ag-RDTs与RT-qPCR检验之间存在显着相关性(p值<0.001)。结果表明,患者使用该试剂盒进行的检测与RT-qPCR相当。
    The antigen rapid diagnostic test (Ag-RDT) is an assay kit for detecting the SARS-COV-2 nucleocapsid proteins, based on the colloidal gold method.Accurate diagnosis has an important role in limiting the transmission of SARS-COV-2, and also helps patients to receive earlier treatment .The object of this study was to perform the clinical evaluation of a novel Ag-RDTs with samples collected from two different swabs.DEEPBLUE®COVID-19 antigen detection kit used for the examination of the subjects in the experiment.For antigen testing on samples collected with nasal swabs, sensitivity was 91.7 % (95 % CI 83.6-96.6 %) and specificity was 100 %(95 %CI 98.1-100 %).For nasopharyngeal swabs, the sensitivity was 96.8 % (95 % CI 93.6-98.7 %) and the specificity was 100 % (95 % CI 98.2-100 %).Fisher Precision test showed a significant correlation between nasopharyngeal swab Ag-RDTs and nasal swab Ag-RDTs and RT-qPCR test (p-value <0.001).The results showed that the patients use the kit for testing were comparable to the RT-qPCR.
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  • 文章类型: Journal Article
    目的:这项研究的目的是确定低狼疮疾病活动度(LLDAS)和临床缓解(CR)的belimumab联合标准治疗(SoC)治疗是否是儿童期发病的SLE(cSLE)可实现的目标。
    方法:这个多中心,一项干预前后研究在中国15个中心进行.主要终点是描述使用贝利木单抗加SoC治疗后3、6和12个月达到LLDAS和CR的患者比例。使用多元回归模型来估算缺失数据。使用泊松回归模型来计算贝利木单抗治疗对降低严重疾病风险和新损伤发生率的影响。
    结果:来自15个中心的193例(92.2%为女性)患有活动性cSLE。在3、6和12个月时,LLDAS(CR)的比例为12.4%(1.0%),25.6%(4.5%)和70.3%(29.7%),分别。平均SELENA-SLEDAI评分从基线时的11.0下降到第3、6和12个月时的3.7、2.9和1.7。在基线,所有患者均接受类固醇治疗,平均(SD)泼尼松等效剂量为31.0(18.2)mg/天,在第3个月降至19.4(10.8)mg/天,在第6个月降至12.6(7.2)mg/天,在第12个月降至6.7(5.3)mg/天。症状和免疫学指标也明显改善。
    结论:这是中国第一个也是最大样本量的对接受贝利木单抗治疗的cSLE患者的前瞻性临床干预研究。LLDAS和CR是cSLE中belimumab加SoC治疗的目标。
    OBJECTIVE: The aim of this study is to identify whether low lupus disease activity status (LLDAS) and clinical remission (CR) of belimumab plus standard of care (SoC) therapy are achievable goals in childhood-onset SLE (cSLE).
    METHODS: This multicentre, one arm pre-post intervention study was conducted at 15 centres in China. The primary end point was to describe the proportion of patients who achieved LLDAS and CR after 3, 6 and 12 months after treatment with belimumab plus SoC therapy. A multiple regression model was used to impute missing data. A Poisson regression model was used to calculate the effect of belimumab treatment on the reduced risk of serious diseases and the incidence of new damage.
    RESULTS: A total of 193 (92.2% female) with active cSLE from 15 centres were included. At 3, 6 and 12 months, the proportion of LLDAS (CR) was 12.4% (1.0%), 25.6% (4.5%) and 70.3% (29.7%), respectively. The mean SELENA-SLEDAI score decreased from 11.0 at baseline to 3.7, 2.9 and 1.7 at 3, 6 and 12 months. At baseline, all patients received steroids at a mean (s.d.) prednisone equivalent dose of 31.0 (18.2) mg/day, which decreased to 19.4 (10.8) mg/day at month 3, 12.6 (7.2) mg/day at month 6 and 6.7 (5.3) mg/day at month 12. The symptoms and immunological indicators were also significantly improved.
    CONCLUSIONS: This is the first and largest sample size prospective clinical intervention study of cSLE patients treated with belimumab in China. LLDAS and CR were attainable treat-to-target of belimumab plus SoC therapy in cSLE.
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  • 文章类型: Journal Article
    目的:评估头皮脂溢性皮炎(SSD)的三个症状指标,即头皮剥落,最大红斑面积,瘙痒,开发一个“16点量表”,“为了探讨其与SSD严重程度的关系,并验证了16分量表的可靠性。
    方法:一位皮肤科医生使用16点量表评估患有SSD的患者,并借助SPSS26.0软件对收集到的数据进行统计分析。测量数据表示为(平均值±SD),组间比较采用非参数检验.我们使用双变量相关分析方法进行相关分析,利用Spearman相关系数分析非正态分布数据变量之间的关系。p<0.05表示差异具有统计学意义。
    结果:“16分量表”的总分与疾病的严重程度密切相关,头皮剥落的相关性最强。与单一得分相比,总分与疾病严重程度的相关性较高。轻度患者的评分范围为(0,5],对于中度患者是(5,9],对于重症患者是(9,16]。
    结论:A\“16点量表”,由粘附性头皮剥落的项目组成(0-10),最大红斑面积(0-3),瘙痒(0-3),用于对SSD患者进行评分,总分与SSD的严重程度密切相关并加以区分。推荐评价标准:总分0-5分表示轻度SSD,6-9点表示中等SSD,10-16点表示严重的SSD。这些标准有助于规范疾病诊断和治疗,和疗效评估。
    OBJECTIVE: To evaluate the three symptom indicators of scalp seborrheic dermatitis (SSD), namely scalp flaking, maximum erythema area, and pruritus, to develop a \"16-point scale,\" to explore its relationship with the severity of SSD, and verify the reliability of the 16-point scale.
    METHODS: A dermatologist evaluated patients with SSD using a 16-point scale, and statistically analyzed the collected data with the help of SPSS 26.0 software. The measurement data are expressed as (mean ± SD), and the intergroup comparison was done using a non-parametric test. We performed the correlation analysis using the bivariate correlation analysis method, and the relationship among non-normal distribution data variables were analyzed using Spearman\'s correlation coefficient. p < 0.05 indicated that the difference was statistically significant.
    RESULTS: The total score of the \"16-point scale\" strongly correlated with the severity of disease, where scalp flaking had the strongest correlation. As compared with a single score, the correlation of the total score with the severity of disease was higher. The scoring range for mild patients was (0, 5], that for moderate patients was (5, 9], and that for severe patients was (9, 16].
    CONCLUSIONS: A \"16-point scale\", consisting of items for adherent scalp flaking (0-10), maximum erythema area (0-3), and pruritus (0-3), was used to score the patients with SSD, and the total score was strongly correlated with and differentiated the severity of SSD. Recommended evaluation criteria: a total score of 0-5 points indicates mild SSD, 6-9 points indicates moderate SSD, 10-16 points indicates severe SSD. These criteria can help to standardize disease diagnosis and treatment, and efficacy assessment.
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  • 文章类型: Multicenter Study
    目的:淋病奈瑟菌的耐药性(AMR)是对公众健康的紧迫威胁,随着FC428克隆等高水平抗性菌株的出现。本研究旨在评估淋病奈瑟菌AMR(HRM-NG-AMR)的高分辨率熔解试验,以诊断淋病奈瑟菌感染并检测超广谱头孢菌素和阿奇霉素耐药性。
    方法:为了评估HRM-NG-AMR测定的性能,我们采用了1488个样本的多中心采集,包括770个分离株和718个泌尿生殖器拭子.淋病奈瑟菌的存在通过培养证实。使用琼脂稀释法确定抗生素对测试分离物的最小抑制浓度。
    结果:关于淋病奈瑟菌的鉴定,HRM-NG-AMR的灵敏度为95.15%(95%置信区间[CI],91.65-97.28)和使用培养作为标准的96.44%(95%CI,94.17-97.89)的特异性。关于AMR检测,头孢克肟的特异性为96.29%(95%CI,94.57~97.50),阿奇霉素的特异性为99.52%(95%CI,98.68~99.85).此外,阿奇霉素的敏感性为31.34%(95%CI,20.87-43.97),头孢曲松的敏感性为79.10%(95%CI,63.52-89.42).我们确定98.81%(664/672)和91.52%(615/672)的淋病奈瑟菌分离株对头孢曲松和头孢克肟敏感,分别,通过检测非马赛克penA。最后,准确鉴定了40株具有penA-60.001等位基因的基因型FC428相关菌株。
    结论:HRM-NG-AMR检测在检测淋病奈瑟菌感染和预测AMR方面显示出良好的诊断性能。研究旨在评估该测定在临床环境中的应用,以增强AMR监测和治疗干预。
    OBJECTIVE: Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (N. gonorrhoeae) is an urgent threat to public health, with the emergence of highly resistant strains such as the FC428 clone. This study aimed to evaluate the high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) for diagnosing N. gonorrhoeae infection and detecting extended-spectrum cephalosporins and azithromycin resistance.
    METHODS: A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
    RESULTS: Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65-97.28) and a specificity of 96.44% (95% CI 94.17-97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57-97.50) for cefixime to 99.52% (95% CI 98.68-99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87-43.97) for azithromycin to 79.10% (95% CI 63.52-89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
    CONCLUSIONS: The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
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