diagnostic performance

诊断性能
  • 文章类型: Journal Article
    背景:前列腺癌是中老年男性最常见的恶性肿瘤之一,具有重要的预后意义,最近的研究表明,利用新的虚拟单能量图像的双能量计算机断层扫描(DECT)可以提高癌症的检出率。这项研究旨在评估从DECT动脉期扫描重建的虚拟单能量图像对前列腺病变的图像质量及其对前列腺癌的诊断性能的影响。
    方法:回顾性分析2019年7月至2023年12月在梅州市人民医院行DECT扫描的83例前列腺癌或前列腺增生患者。分析的变量包括年龄,肿瘤直径和血清前列腺特异性抗原(PSA)水平,在其他人中。我们还比较了CT值,信噪比(SNR),主观图像质量评级,虚拟单能量图像(40-100keV)和常规线性混合图像之间的对比度噪声比(CNR)。进行接收器工作特征(ROC)曲线分析,以评估虚拟单能量图像(40keV和50keV)与常规图像相比的诊断功效。
    结果:40keV的虚拟单能量图像显示,与常规线性混合图像(66.66±15.5)相比,前列腺癌的CT值(168.19±57.14)明显更高(P<0.001)。与常规图像相比,50keV图像还显示出升高的CT值(121.73±39.21)(P<0.001)。40keV(3.81±2.13)和50keV(2.95±1.50)组的CNR值明显高于常规混合组(P<0.001)。主观评价表明,与常规图像相比,40keV(中值评分5)和50keV(中值评分5)图像的图像质量评分明显更好(P<0.05)。ROC曲线分析显示,与常规图像(AUC:0.849)相比,基于CT值的40keV(AUC:0.910)和50keV(AUC:0.910)图像的诊断准确性更高。
    结论:从DECT动脉期扫描在40keV和50keV重建的虚拟单能量图像显著提高了前列腺病变的图像质量,提高了前列腺癌的诊断效能。
    BACKGROUND: Prostate cancer is one of the most common malignant tumors in middle-aged and elderly men and carries significant prognostic implications, and recent studies suggest that dual-energy computed tomography (DECT) utilizing new virtual monoenergetic images can enhance cancer detection rates. This study aimed to assess the impact of virtual monoenergetic images reconstructed from DECT arterial phase scans on the image quality of prostate lesions and their diagnostic performance for prostate cancer.
    METHODS: We conducted a retrospective analysis of 83 patients with prostate cancer or prostatic hyperplasia who underwent DECT scans at Meizhou People\'s Hospital between July 2019 and December 2023. The variables analyzed included age, tumor diameter and serum prostate-specific antigen (PSA) levels, among others. We also compared CT values, signal-to-noise ratio (SNR), subjective image quality ratings, and contrast-to-noise ratio (CNR) between virtual monoenergetic images (40-100 keV) and conventional linear blending images. Receiver operating characteristic (ROC) curve analyses were performed to evaluate the diagnostic efficacy of virtual monoenergetic images (40 keV and 50 keV) compared to conventional images.
    RESULTS: Virtual monoenergetic images at 40 keV showed significantly higher CT values (168.19 ± 57.14) compared to conventional linear blending images (66.66 ± 15.5) for prostate cancer (P < 0.001). The 50 keV images also demonstrated elevated CT values (121.73 ± 39.21) compared to conventional images (P < 0.001). CNR values for the 40 keV (3.81 ± 2.13) and 50 keV (2.95 ± 1.50) groups were significantly higher than the conventional blending group (P < 0.001). Subjective evaluations indicated markedly better image quality scores for 40 keV (median score of 5) and 50 keV (median score of 5) images compared to conventional images (P < 0.05). ROC curve analysis revealed superior diagnostic accuracy for 40 keV (AUC: 0.910) and 50 keV (AUC: 0.910) images based on CT values compared to conventional images (AUC: 0.849).
    CONCLUSIONS: Virtual monoenergetic images reconstructed at 40 keV and 50 keV from DECT arterial phase scans substantially enhance the image quality of prostate lesions and improve diagnostic efficacy for prostate cancer.
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  • 文章类型: Journal Article
    血清学检测在乙型肝炎病毒标志物的诊断中起着至关重要的作用,治疗,预后,为了比较AutolumoA2000Plus和雅培建筑师i2000系统在检测乙型肝炎感染标志物方面的诊断性能。共有6个HBV血清转换小组和743名参与者参加了这项研究,包括383例HBV感染患者和360例健康成人。临床诊断信息,实验室结果,收集和HBV基因分型以评估A2000Plus和i2000系统在检测HBV感染标志物方面的诊断性能。结果表明,在六个血清转换面板和743个来自人群的血清样品中,两个检测系统中HBV标志物的总一致性百分比均>90%。两种分析仪中乙型肝炎病毒血清学标志物之间的卡方检验的χ2值在550.7和743.0之间,p<0.0001。HBV标志物一致性测试结果显示两个分析仪之间的完美一致性,Kappa值范围为0.854至1.000。对于特定的样品,包括C型乙型肝炎患者,慢性乙型肝炎,乙型肝炎相关肝硬化,和肝细胞癌,spearman相关分析显示HBsAg相关系数范围为0.8532至0.9745,p<0.001。总之,AutolumoA2000Plus在一致性和相关性方面的诊断性能与检测乙型肝炎感染标志物时的雅培建筑师i2000相当。AutolumoA2000Plus系统可用作HBV标志物检测的可靠仪器。
    Serological detection of hepatitis B virus markers plays a vital role in the diagnosis, treatment, prognosis, and therapeutic surveillance of hepatitis B. To compare the diagnostic performance of Autolumo A2000Plus and Abbott Architect i2000 systems in the detection of hepatitis B infection markers. A total of 6 HBV seroconversion panels and 743 participants were enrolled in this study, including 383 HBV-infected patients and 360 healthy adults. Clinical diagnostic information, laboratory results, and HBV genotyping were collected to evaluate the diagnostic performance of the A2000Plus and i2000 systems in detecting HBV infection markers. The results showed that the total percent agreement of HBV markers was all >90 % in both detection systems among the six seroconversion panels and 743 serum samples from the population. The χ2 values of the Chi-square test among hepatitis B virus serological markers in both analyzers were between 550.7 and 743.0, p < 0.0001. HBV marker consistency test results show perfect consistency between the two analyzers, with Kappa values ranging from 0.854 to 1.000. For specific samples, including Hepatitis B patients with Genotype C, chronic hepatitis B, hepatitis B-related cirrhosis, and hepatocellular carcinoma, spearman correlation analysis showed HBsAg correlation coefficients ranging from 0.8532 to 0.9745, p < 0.001 in both analyzers. In conclusion, Autolumo A2000Plus diagnostic performance in consistency and correlation is comparable to Abbott Architect i2000 when detecting markers of hepatitis B infection. The Autolumo A2000Plus system can be used as a reliable instrument for HBV marker detection.
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  • 文章类型: Journal Article
    背景:传统膝关节磁共振成像诊断前交叉韧带撕裂的准确性,尤其是局部的眼泪,相对较低,可能导致误诊和漏诊。本研究旨在评估一种新型成像方法的诊断性能,最佳屈膝角度的高分辨率斜冠状MRI,ACL的眼泪。
    方法:用扫描辅助装置扫描50名健康志愿者,以获得最佳的ACL屈曲角度。对于严格按照纳入和排除标准选择的92例膝关节外伤患者,进行常规膝关节扩展扫描(对照组)和基于最佳屈膝角度的高分辨率斜冠状扫描(实验组).两名观察者以5分制对ACL可见性进行了盲目评估。关节镜定义的结果确定了每种方法的诊断指标和灵敏度,特异性,正预测值,计算阴性预测值和准确性.
    结果:健康志愿者的平均最佳屈曲角度约为30°(30.3°±5.0°)。成像显示实验组96.7%的图像完全可视化ACL,对照组为12.0%。实验组的诊断指标超过对照组:灵敏度(94.9%vs.76.3%),特异性(97.0%vs.81.8%),阳性预测值(98.2%vs.88.2%),阴性预测值(91.4%与65.9%),和准确性(95.7%与78.3%)。ROC分析显示实验组的诊断性能优越,AUC为0.945,对照组为0.776(p<0.0001)。
    结论:与常规技术相比,在最佳30°屈膝角度下的高分辨率斜冠状成像改善了ACL的可视化和诊断性能。
    BACKGROUND: The accuracy of traditional knee MR imaging in diagnosing anterior cruciate ligament tears, especially partial tears, is relatively low, which may lead to misdiagnosis and missed diagnosis. This study aimed to assess the diagnostic performance of a novel imaging method, high-resolution oblique coronal MRI at an optimal flexed-knee Angle, for ACL tears.
    METHODS: 50 healthy volunteers were scanned with a scan-assisted device for the optimal flexion angle of ACL. For 92 knee trauma patients selected strictly according to inclusion and exclusion criteria, conventional extended-knee scans (control group) and high-resolution oblique coronal scans based on the optimal flexed-knee angle (experimental group) were conducted. Two observers rated ACL visibility blindly on a 5-point scale. Arthroscopy-defined outcomes determined diagnostic metrics for each method and sensitivity, specificity, positive predictive value, negative predictive value and accuracy were calculated.
    RESULTS: The average optimal flexion angle for healthy volunteers was approximately 30° (30.3° ± 5.0°). Imaging demonstrated complete visualization of the ACL in 96.7% of images in the experimental group versus 12.0% in the control group. The diagnostic indicators of the experimental group surpassed those of the control group: sensitivity (94.9% vs. 76.3%), specificity (97.0% vs. 81.8%), positive predictive value (98.2% vs. 88.2%), negative predictive value(91.4% vs. 65.9%), and accuracy (95.7% vs. 78.3%). ROC analysis indicated superior diagnostic performance in the experimental group, with an AUC of 0.945 compared with 0.776 for the control group (p < 0.0001).
    CONCLUSIONS: High-resolution oblique coronal imaging at the optimal 30° flexed-knee angle improved ACL visualization and diagnostic performance compared with conventional techniques.
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  • 文章类型: Journal Article
    背景:查加斯病(CD),一种被忽视的由克氏锥虫引起的寄生虫病,在拉丁美洲构成了重大的健康威胁,并且由于人类迁移而在全球范围内出现。克氏锥虫感染人类和其他100多种哺乳动物,包括狗,这是评估人类感染风险的重要哨兵。尽管如此,由于缺乏商业测试,犬中克氏杆菌的血清诊断仍然受到损害。在这项研究中,我们调查了四种嵌合重组克氏T.cruziIBMP抗原(IBMP-8.1,IBMP-8.2,IBMP-8.3和IBMP-8.4)用于检测抗T.狗的克鲁氏抗体,使用潜在类分析(LCA)。
    方法:我们检测了663份犬血清样本,采用间接ELISA与嵌合抗原。LCA被用来建立一个潜在变量作为克氏虫感染的黄金标准,揭示每种抗原的不同反应模式。
    结果:IBMP(巴拉那州分子生物学研究所的葡萄牙语缩写)抗原的ROC曲线下面积(AUC)值为90.9%至97.3%。最高的灵敏度归因于IBMP-8.2(89.8%),而IBMP-8.1、IBMP-8.3和IBMP-8.4达到73.5%,79.6%,和85.7%,分别。观察到最高的特异性为IBMP-8.4(98.6%),其次是IBMP-8.2、IBMP-8.3和IBMP-8.1,特异性为98.3%,94.4%,92.7%,分别。预测值根据患病率的不同而不同,表明在地方性环境中的有效性更高。
    结论:我们的发现强调了IBMP-8.2和IBMP-8.4在犬中对克氏锥虫的血清诊断的显着诊断性能,代表了狗CD诊断的一个有前途的工具。这些嵌合重组抗原不仅可以增强CD监测策略,而且对公共卫生具有更广泛的影响。为全球抗击这种被忽视的热带病做出贡献。
    BACKGROUND: Chagas disease (CD), a neglected parasitic disease caused by Trypanosoma cruzi, poses a significant health threat in Latin America and has emerged globally because of human migration. Trypanosoma cruzi infects humans and over 100 other mammalian species, including dogs, which are important sentinels for assessing the risk of human infection. Nonetheless, the serodiagnosis of T. cruzi in dogs is still impaired by the absence of commercial tests. In this study, we investigated the diagnostic accuracy of four chimeric recombinant T. cruzi IBMP antigens (IBMP-8.1, IBMP-8.2, IBMP-8.3, and IBMP-8.4) for detecting anti-T. cruzi antibodies in dogs, using latent class analysis (LCA).
    METHODS: We examined 663 canine serum samples, employing indirect ELISA with the chimeric antigens. LCA was utilized to establish a latent variable as a gold standard for T. cruzi infection, revealing distinct response patterns for each antigen.
    RESULTS: The IBMP (Portuguese acronym for the Molecular Biology Institute of Paraná) antigens achieved area under the ROC curve (AUC) values ranging from 90.9% to 97.3%. The highest sensitivity was attributed to IBMP-8.2 (89.8%), while IBMP-8.1, IBMP-8.3, and IBMP-8.4 achieved 73.5%, 79.6%, and 85.7%, respectively. The highest specificity was observed for IBMP-8.4 (98.6%), followed by IBMP-8.2, IBMP-8.3, and IBMP-8.1 with specificities of 98.3%, 94.4%, and 92.7%, respectively. Predictive values varied according to prevalence, indicating higher effectiveness in endemic settings.
    CONCLUSIONS: Our findings underscore the remarkable diagnostic performance of IBMP-8.2 and IBMP-8.4 for the serodiagnosis of Trypanosoma cruzi in dogs, representing a promising tool for the diagnosis of CD in dogs. These chimeric recombinant antigens may not only enhance CD surveillance strategies but also hold broader implications for public health, contributing to the global fight against this neglected tropical disease.
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  • 文章类型: Journal Article
    这项研究的目的是半定量评估PET/CT代谢参数在区分良性或恶性心脏或心包肿块中的诊断性能。招募了41例接受18F-FDGPET/CT检查的新诊断的心脏/心包肿块患者。PET/CT代谢参数包括最大标准化摄取值(SUVmax),平均标准化摄取值(SUVmean),总病变糖酵解(TLG),肿瘤代谢体积(MTV),测量或计算最大肿瘤-纵隔背景比(TMR)和最大肿瘤-肝脏背景比(TLR),以评估心脏/心包肿块的良性或恶性.与良性心脏/心包病变相比,心脏/心包恶性肿瘤有更高的SUVmax,Suvmean,TLG,MTV,TMR,和TLR。所有这些PET/CT代谢参数在良性或恶性心脏或心包肿块的半定量评估中显示出较高的诊断性能。SUVmean和MTV的诊断准确率最高。因此,PET/CT代谢参数可半定量评价良性或恶性心脏/心包肿块。
    The objective of this study was to evaluate semi-quantitatively the diagnostic performance of PET/CT metabolic parameters in differentiating benign or malignant cardiac or pericardial masses. A total of forty-one patients with newly diagnosed cardiac/pericardial masses who underwent 18F-FDG PET/CT were recruited. PET/CT metabolic parameters including the maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), total lesion glycolysis (TLG), tumor metabolic volume (MTV), the maximum tumor-to-mediastinal background ratio (TMR) and the maximum tumor-to-liver background ratio (TLR) is measured or calculated to evaluate the benign or malignant nature of cardiac/pericardial masses. Compared with benign cardiac/pericardial lesions, cardiac/pericardial malignancies had higher SUVmax, SUVmean, TLG, MTV, TMR, and TLR. All these PET/CT metabolic parameters showed high diagnostic performance in semi-quantitative evaluation of benign or malignant cardiac or pericardial masses, and SUVmean and MTV had the highest diagnostic accuracy. Therefore, PET/CT metabolic parameters can semi-quantitatively evaluate the benign or malignant cardiac/pericardial masses.
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  • 文章类型: Journal Article
    本研究的目的是评估在线参考系统(ORS,STATdxElsevier,阿姆斯特丹,荷兰)影响在影像学检查中发现经组织学证实的罕见或非典型腹部肿瘤和病变。总的来说,回顾性纳入101例罕见肿瘤实体或病变和常见肿瘤的不典型表现的患者。盲目的读数是由四名具有不同经验水平的放射科医生进行的,谁报告:(a)正确的诊断(CD),(b)发现诊断所需的时间,和(C)诊断信心,最初没有ORS的帮助。有经验的读者(居住后3年的经验,CD49.5%),以及具有1年居住经验的高级读者(CD43.6%),与经验不足的读者(CD25.7%)相比,具有5年经验的居民(CD46.5%)的正确诊断频率更高。只有先进的读者才能实现正确诊断的显着改进,具有5年经验的居民(CD,ORS为58.4%;p<0.001)。具有1年居住后经验的高级读者略有改善(CDORS47.5%)。有经验的读者(CDORS50.5%)和经验不足的读者(CDORS27.7%)没有显着改善。使用ORS时,总体主观置信度显着增加(3.2±0.9vs.3.8±0.9;p<0.001)。虽然ORS对所有读者做出正确的诊断产生了积极的影响,它更青睐具有更多临床经验的放射科医生,而不是没有经验的住院医生。此外,ORS显著提高了所有放射科医师的诊断信心.总之,除一名读者外,ORS对罕见或非典型腹部肿瘤和病变的诊断无显著影响.最大的好处是诊断信心的提高。
    The purpose of the present study is to evaluate whether an online reference system (ORS, STATdx Elsevier, Amsterdam, Netherlands) impacts finding the histologically confirmed diagnosis of rare or atypical abdominal tumors and lesions in radiologic imaging. In total, 101 patients with rare tumor entities or lesions and atypical manifestations of common tumors were enrolled retrospectively. Blinded readings were performed by four radiologists with varying levels of experience, who reported on: (a) correct diagnosis (CD), (b) time needed to find the diagnosis, and (c) diagnostic confidence, initially without followed by the assistance of the ORS. The experienced reader (3 years of experience post-residency, CD 49.5%), as well as the advanced reader with 1 year of experience post-residency (CD 43.6%), and a resident with 5 years of experience (CD 46.5%) made the correct diagnosis more frequently compared to the less experienced reader (CD 25.7%). A significant improvement in making the correct diagnosis was only achieved by the advanced reader, the resident with 5 years of experience (CD with ORS 58.4%; p < 0.001). The advanced reader with 1 year of experience post-residency improved slightly (CD ORS 47.5%). The experienced reader (CD ORS 50.5%) and the less experienced reader (CD ORS 27.7%) did not improve significantly. The overall subjective confidence increased significantly when ORS was used (3.2 ± 0.9 vs. 3.8 ± 0.9; p < 0.001). While the ORS had a positive impact on making the correct diagnosis throughout all readers, it favored radiologists with more clinical experience rather than inexperienced residents. Moreover, the ORS increased the diagnostic confidence of all radiologists significantly. In conclusion, the ORS had no significant impact on the diagnosis of rare or atypical abdominal tumors and lesions except for one reader. The greatest benefit is the increase in diagnostic confidence.
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  • 文章类型: Journal Article
    背景:肝移植(LT)后肝动脉闭塞(HAO)是一种毁灭性的并发症,导致早期移植物丢失并降低总体生存率。超声是LT术后患者HAO的既定评估方法,尤其是那些复杂的肝动脉重建。
    目的:探讨肝移植术后患者发生HAO的超声特征及相关危险因素。
    方法:回顾性分析2016年11月至2022年7月深圳市第三人民医院收治的400例成人LT患者的超声特征及与HAO相关的临床危险因素。包括14例经手术诊断为急性HAO(A-HAO)的患者和15例诊断为慢性HAO(C-HAO)的患者。采用随机数字表法随机选择同期无HAO并发症患者33例作为对照组。所有患者均接受超声检查。参数包括阻力指数(RI),收缩期峰值速度(PSV),比较各组的门静脉流速(PVV)。此外,收集所有患者的基本临床资料,包括性别,年龄,初步诊断,D-二聚体浓度,总操作时间,冷缺血时间,热缺血时间,术中失血和输血,术中尿量,输液,终末期肝病模型(MELD)评分,以及是否进行了复杂的肝动脉重建。此外,分析了LT术后影响HAO形成的危险因素。
    结果:与非HAO组相比,A-HAO组PVV和RI较高,PSV较低。相反,C-HAO组的PSV和RI均低于非HAO组.与非HAO组相比,A-HAO组进行复杂肝动脉重建的患者比例和闭塞前的γ-谷氨酰转移酶(GGT)水平明显更高。然而,两组D-二聚体无明显差异,MELD得分,闭塞前丙氨酸转氨酶和天冬氨酸转氨酶水平,或术中条件。
    结论:闭塞前肝动脉的超声特征与术后HAO的发展显著相关。此外,复杂的肝动脉重建,定义为需要在供体肝动脉之间进行额外吻合的移植物血运重建,构成A-HAO的风险因素。此外,异常闭塞前GGT升高是重要的生化指标。因此,超声检查是筛查HAO的重要工具,特别是在具有确定的危险因素的患者中。
    BACKGROUND: Hepatic artery occlusion (HAO) after liver transplantation (LT) is a devastating complication, resulting in early graft loss and reduced overall survival. Ultrasound is an established assessment method for HAO in patients following LT, especially those with complex hepatic artery reconstruction.
    OBJECTIVE: To investigate the ultrasound characteristics and analyze the risk factors associated with HAO in patients after LT.
    METHODS: We retrospectively analyzed the ultrasound characteristics and the clinic risk factors associated with HAO in 400 adult LT patients who were enrolled and treated at the Third People\'s Hospital of Shenzhen between November 2016 and July 2022. Fourteen patients diagnosed with acute HAO (A-HAO) by surgery and fifteen diagnosed with chronic HAO (C-HAO) were included. A control group of 33 patients without HAO complications during the same period were randomly selected using a random number table. All patients underwent an ultrasonography examination. Parameters including resistance index (RI), peak systolic velocity (PSV), and portal vein velocity (PVV) were compared across the groups. Additionally, basic clinical data were collected for all patients, including gender, age, primary diagnosis, D-dimer concentration, total operation time, cold ischemia time, hot ischemia time, intraoperative blood loss and transfusion, intraoperative urine volume, infusion, model for end-stage liver disease (MELD) score, and whether complex hepatic artery reconstructions were performed. Furthermore, risk factors influencing HAO formation after LT were analyzed.
    RESULTS: Compared to the non-HAO group, PVV and RI were higher in the A-HAO group, while PSV was lower. Conversely, both PSV and RI were lower in the C-HAO group compared to the non-HAO group. The proportion of patients undergoing complex hepatic artery reconstructions and the gamma-glutamyltransferase (GGT) level before occlusion were significantly higher in the A-HAO group compared to the non-HAO group. However, there were no distinct differences between the two groups in D-dimer, MELD score, pre-occlusion alanine transaminase and aspartate transaminase levels, or intraoperative conditions.
    CONCLUSIONS: Ultrasound features of the hepatic artery before occlusion are significantly associated with postoperative HAO development. Additionally, complex hepatic artery reconstructions, defined as revascularization of the graft requiring additional anastomosis between donor hepatic arteries, constitute a risk factor for A-HAO. Besides, abnormal pre-occlusion GGT elevation is an important biochemical indicator. Therefore, ultrasound examination serves as an important tool for screening HAO, especially in patients with the identified risk factors.
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  • 文章类型: Journal Article
    SARS-CoV-2的出现引发了全球大流行,对公共卫生产生了深远的影响。大流行格局的快速变化和体外诊断的局限性导致引入了许多具有可变性能的诊断设备。在这项研究中,我们评估了巴西三种商业血清学检测方法,用于检测抗SARS-CoV-2抗体。
    我们从SARS-CoV-2阴性献血者中收集了90份血清样本,从SARS-CoV-2阳性献血者中收集了352份血清样本,未接种疫苗的患者,按症状发作分类。随后,我们评估了三种商业酶免疫测定的诊断性能:GOLDELISA(酶联免疫吸附测定)COVID-19Ig(免疫球蛋白)GIgM,抗SARS-CoV-2NCPIgMELISA,和抗SARS-CoV-2NCPIgGELISA。
    我们的研究结果表明,GOLDELISACOVID-19IgGIgM表现出最高的敏感性(57.7%)和诊断优势比,在大多数分析时间范围内超过制造商报告的灵敏度,同时保持异常特异性(98.9%)。相反,抗SARS-CoV-2NCPIgGELISA显示灵敏度较低,但与独立评估一致,具有100%的特异性。然而,抗SARS-CoV-2NCPIgMELISA显示出比声称更低的灵敏度,特别是在逆转录聚合酶链反应阳性结果后不久收集的样品中。症状出现后15-21天和超过22天,性能改善,但在第一周,抗SARS-CoV-2NCPIgMELISA和抗SARS-CoV-2NCPIgGELISA难以区分阳性和阴性样品。
    我们的研究强调需要标准化的验证方案,以解决制造商声称和实际性能之间的差异。这些见解为医疗保健从业人员和决策者提供了有关这些测定在各种临床情况下的诊断能力的基本信息。
    UNASSIGNED: The emergence of SARS-CoV-2 has triggered a global pandemic with profound implications for public health. Rapid changes in the pandemic landscape and limitations in in vitro diagnostics led to the introduction of numerous diagnostic devices with variable performance. In this study, we evaluated three commercial serological assays in Brazil for detecting anti-SARS-CoV-2 antibodies.
    UNASSIGNED: We collected 90 serum samples from SARS-CoV-2-negative blood donors and 352 from SARS-CoV-2-positive, unvaccinated patients, categorized by symptom onset. Subsequently, we assessed the diagnostic performance of three commercial enzyme immunoassays: GOLD ELISA (enzyme-linked immunosorbent assay) COVID-19 Ig (immunoglobulin) G + IgM, Anti-SARS-CoV-2 NCP IgM ELISA, and Anti-SARS-CoV-2 NCP IgG ELISA.
    UNASSIGNED: Our findings revealed that the GOLD ELISA COVID-19 IgG + IgM exhibited the highest sensitivity (57.7%) and diagnostic odds ratio, surpassing the manufacturer\'s reported sensitivity in most analyzed time frames while maintaining exceptional specificity (98.9%). Conversely, the Anti-SARS-CoV-2 NCP IgG ELISA demonstrated lower sensitivity but aligned with independent evaluations, boasting a specificity of 100%. However, the Anti-SARS-CoV-2 NCP IgM ELISA exhibited lower sensitivity than claimed, particularly in samples collected shortly after positive reverse transcription polymerase chain reaction results. Performance improved 15-21 days after symptom onset and beyond 22 days, but in the first week, both Anti-SARS-CoV-2 NCP IgM ELISA and Anti-SARS-CoV-2 NCP IgG ELISA struggled to differentiate positive and negative samples.
    UNASSIGNED: Our study emphasizes the need for standardized validation protocols to address discrepancies between manufacturer-claimed and actual performance. These insights provide essential information for health care practitioners and policymakers regarding the diagnostic capabilities of these assays in various clinical scenarios.
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  • 文章类型: Journal Article
    背景:评估基于MRI的形态学特征,以改进美国放射学学会甲状腺成像报告和数据系统(ACR-TIRADS)对甲状腺结节进行分类。
    方法:对术后病理证实的728个甲状腺结节(良性453个,恶性275个)进行回顾性分析。采用单因素和多因素logistic回归分析发现甲状腺良恶性结节MRI形态学特征的独立预测因子。当存在基于MRI的形态学特征的独立预测因子时,改进的方法涉及将ACR-TIRADS水平提高一个,无论是单独还是组合,反过来减少一个。该研究比较了传统ACR-TIRADS和不同改进版本的性能。
    结果:在分析的各种MRI形态学特征中,限制性弥散和逆转晕征被确定为甲状腺恶性结节的显著独立危险因素(OR=45.1,95%CI=23.2-87.5,P<0.001;OR=38.0,95%CI=20.4-70.7,P<0.001),随后被纳入最终表现评估.常规和四种改进的ACR-TIRADS的接收器工作特征曲线下面积(AUC)为0.887(95%CI:0.861-0.909),0.945(95%CI:0.926-0.961),0.947(95%CI:0.928-0.962),0.945(95%CI:0.926-0.961)和0.951(95%CI:0.932-0.965),分别。常规和四种改良ACR-TIRADS的不必要活检率为62.8%,30.0%,27.1%,26.8%和29.1%,分别,恶性漏诊率为1.1%,2.8%,3.7%,5.4%和1.2%。
    结论:ACR-TIRADS的MRI形态学特征改善了诊断性能,降低了不必要的活检率,同时保持了较低的恶性漏诊率。
    BACKGROUND: To assess MRI-based morphological features in improving the American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS) for categorizing thyroid nodules.
    METHODS: A retrospective analysis was performed on 728 thyroid nodules (453 benign and 275 malignant) that postoperative pathology confirmed. Univariate and multivariate logistic regression analyses were used to find independent predictors of MRI morphological features in benign and malignant thyroid nodules. The improved method involved increasing the ACR-TIRADS level by one when there are independent predictors of MRI-based morphological features, whether individually or in combination, and conversely decreasing it by one. The study compared the performance of conventional ACR-TIRADS and different improved versions.
    RESULTS: Among the various MRI morphological features analyzed, restricted diffusion and reversed halo sign were determined to be significant independent risk factors for malignant thyroid nodules (OR = 45.1, 95% CI = 23.2-87.5, P < 0.001; OR = 38.0, 95% CI = 20.4-70.7, P < 0.001) and were subsequently included in the final assessment of performance. The areas under the receiver operating characteristic curves (AUCs) for both the conventional and four improved ACR-TIRADSs were 0.887 (95% CI: 0.861-0.909), 0.945 (95% CI: 0.926-0.961), 0.947 (95% CI: 0.928-0.962), 0.945 (95% CI: 0.926-0.961) and 0.951 (95% CI: 0.932-0.965), respectively. The unnecessary biopsy rates for the conventional and four improved ACR-TIRADSs were 62.8%, 30.0%, 27.1%, 26.8% and 29.1%, respectively, while the malignant missed diagnosis rates were 1.1%, 2.8%, 3.7%, 5.4% and 1.2%.
    CONCLUSIONS: MRI morphological features with ACR-TIRADS has improved diagnostic performance and reduce unnecessary biopsy rate while maintaining a low malignant missed diagnosis rate.
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  • 文章类型: Journal Article
    使用均质样品评估不同品牌的免疫层析测试(ICT)试剂对沙眼衣原体的诊断性能,为试剂质量控制提供参考。
    评估了八种市售ICT试剂,其中3个采用乳胶法,5个采用胶体金法。使用沙眼衣原体的纯培养液进行分析性能评估,以及使用从研究对象获得的宫颈上皮细胞样本进行临床应用验证,进行了。使用核酸扩增试验定量沙眼衣原体的浓度。
    分析性能评估中不同ICT试剂的检测限(LOD)从9.5×103到1×105IFU/mL不等,只有一种试剂符合制造商说明书中规定的LOD。同样,临床应用验证中只有一种试剂达到分析LOD,四种试剂是分析LOD的2.1-4.2倍,三种试剂未能在临床样本中检测到阳性结果。
    不同方法和不同品牌的ICT试剂在临床实践中的诊断性能与制造商的说明和实验室评估的结果不同。在实际用于临床实践之前,应评估试剂的诊断性能。
    UNASSIGNED: To evaluate the diagnostic performance of different brands of immunochromatographic test (ICT) reagents for Chlamydia trachomatis using homogenized samples to provide a reference for reagent quality control.
    UNASSIGNED: Eight commercially available ICT reagents were evaluated, of which three used the latex method and five used the colloidal gold method. Analytical performance evaluation using a pure culture broth of C. trachomatis, as well as clinical application validation using cervical epithelial cell samples acquired from the research subjects, were conducted. The concentration of C. trachomatis was quantified using a nucleic acid amplification test.
    UNASSIGNED: The limit of detection (LOD) of different ICT reagents in the analytical performance evaluation varied from 9.5 × 103 to 1 × 105 IFU/mL, and only one reagent met the LOD specified in the manufacturer\'s instructions. Likewise, only one reagent in the clinical application validation achieved the analytical LOD, four reagents were 2.1-4.2-fold of the analytical LODs, and three reagents failed to detect positive results in clinical samples.
    UNASSIGNED: The diagnostic performance of different methods and different brands of ICT reagents in clinical practice was different from the manufacturer\'s instructions and the results of laboratory evaluation. The diagnostic performance of reagents should be evaluated before they are actually used in clinical practice.
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