test validation

测试验证
  • 文章类型: Journal Article
    临床验证的人乳头瘤病毒(HPV)检测在宫颈癌筛查中至关重要。在这项研究中,我们评估了AllplexHPVHR检测试验(Seegene,韩国)根据国际标准的临床准确性和可重复性,使用实时高风险HPVm2000检测(雅培,美国)作为标准比较器。AllplexHPVHR测定对检测宫颈上皮内瘤变分级(CIN)2级或更差(CIN2)具有显着的非劣性敏感性,比率为1.00(95%CI:0.97-1.03,P=0.006),对检测CIN3+的敏感性不显著,比率为1.00(95%CI:0.88-1.13,P=0.098),和非劣等特异性排除CIN2+,与标准比较相比,比率为0.99(95%CI:0.99-1.00,P<0.001)。此外,该分析在同一实验室内[96.5%(95%CI:94.6~97.9),kappa值为0.91(95%CI:0.87~0.95)]和实验室间[96.7%(95%CI:94.8~98.0),kappa值为0.91(95%CI:0.87~0.95)]以及每个HPV类型的整体高危型HPV阳性具有优异的重现性.将我们的研究数据与另一项独立研究的数据进行汇总支持我们的发现的一致性。我们得出的结论是,检测宫颈癌前病变的临床准确性和AllplexHPVHR检测测定的可重复性均符合宫颈癌筛查中使用的国际验证标准。重要意义根据完善的国际指南对人乳头瘤病毒(HPV)测定进行临床验证对于确保仅在筛选的情况下使用经过验证的测定至关重要(Meijer等人。,IntJ癌症,2009).准则,由国际财团开发,对于宫颈上皮内瘤变(CIN)2级或更差(CIN2+)的检测,要求新的HPV检测与标准比较试验相比具有非低劣的准确性。此外,新的HPV检测应满足实验室内和实验室间可重复性的特定标准,以确保检测始终具有技术精确性和稳健性能.将我们的研究数据与另一项独立研究的数据进行汇总支持我们的发现的一致性。总之,宫颈癌前病变的临床准确性和AllplexHPVHR检测试验的可重复性均符合宫颈癌筛查的国际验证标准.
    Clinically validated human papillomavirus (HPV) assays are crucial in cervical cancer screening. In this study, we evaluated the Allplex HPV HR Detection assay (Seegene, SouthKorea) for its clinical accuracy and reproducibility according to the international criteria, using the RealTime High Risk HPV m2000 assay (Abbott, USA) as standard comparator. The Allplex HPV HR assay exhibits significant non-inferior sensitivity to detect cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+) with a ratio of 1.00 (95% CI: 0.97-1.03, P = 0.006), insignificant non-inferior sensitivity to detect CIN3+ with a ratio of 1.00 (95% CI: 0.88-1.13, P = 0.098), and non-inferior specificity to exclude CIN2+ with a ratio of 0.99 (95% CI: 0.99-1.00, P < 0.001) compared to the standard comparator. In addition, the assay shows an excellent reproducibility within the same laboratory [96.5% (95% CI: 94.6-97.9) with a kappa value of 0.91 (95% CI: 0.87-0.95)] and between laboratories [96.7% (95% CI: 94.8-98.0) with a kappa value of 0.91 (95% CI: 0.87-0.95)] for overall high-risk HPV positivity as well as for each individual HPV type. Pooling our study data with those of another independent study supports the consistency of our findings. We conclude that both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.IMPORTANCEThe clinical validation of human papillomavirus (HPV) assays in accordance with well-established international guidelines is crucial to ensure that only validated assays are used in the context of screening (Meijer et al., Int J Cancer, 2009). The guidelines, developed by an international consortium, require that a novel HPV assay has non-inferior accuracy against a standard comparator test for the detection of cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+). Additionally, a new HPV assay should meet specific criteria for both intra- and inter-laboratory reproducibility to ensure the assay consistently exhibits technical precision and robust performance. Pooling our study data with those of another independent study supports the consistency of our findings. In conclusion, both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.
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  • 文章类型: Journal Article
    尽管了解印尼组织的道德气候很重要,缺乏衡量这一点的标准化量表。因此,这项研究旨在适应,验证,并确保印度尼西亚文化背景下道德气候问卷(ECQ)的一致性。
    数据来自565名18岁或以上的印度尼西亚人,使用在线调查和便利抽样。为了确保准确的测量,Beaton的指导方针得到了遵守。可靠性是用克朗巴赫的阿尔法和麦当劳的欧米茄来评估的,而效度是通过各种分析来检验的,包括内容效度指数和验证性因子分析。
    印尼版的ECQ措施利己主义者,仁慈的,和有原则的伦理气候可靠(克朗巴赫的α:利己主义=0.809,原则=0.920,仁慈=0.910)。有效性分析确认问卷的有效性。人口统计学分析显示年龄影响主要维度,而组织类型会影响所有维度。
    印尼版的ECQ表现出强大的心理测量特性和跨文化适应能力,使其成为评估18岁或以上印度尼西亚人道德气候的有价值的工具。
    UNASSIGNED: Despite the importance of understanding ethical climates in Indonesian organizations, a standardized scale for measuring this is lacking. Therefore, this study aims to adapt, validate, and ensure the consistency of the Ethical Climate Questionnaire (ECQ) within Indonesia\'s cultural context.
    UNASSIGNED: Data were collected from 565 Indonesian individuals aged 18 or older, using an online survey and convenience sampling. To ensure accurate measurements, Beaton\'s guidelines were followed. Reliability was assessed using Cronbach\'s alpha and McDonald\'s omega, while validity was examined through various analyses including content validity index and confirmatory factor analysis.
    UNASSIGNED: The Indonesian version of the ECQ measures egoist, benevolent, and principled ethical climates reliably (Cronbach\'s alpha: egoism=0.809, principle=0.920, benevolence=0.910). Validity analyses confirm the questionnaire\'s validity. Demographic analysis shows age impacts the principle dimension, while organizational type affects all dimensions.
    UNASSIGNED: The Indonesian version of the ECQ demonstrates strong psychometric properties and cross-cultural adaptability, making it a valuable tool for assessing ethical climates among Indonesian individuals aged 18 or older.
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  • 文章类型: Journal Article
    目标:2019年冠状病毒病大流行对全球公共卫生产生重大影响,经济,和社会。正如大流行的第一阶段所示,准确及时的诊断对疾病控制至关重要,预防,和监测。尽管严重急性呼吸道综合症冠状病毒2(SARS-CoV-2)的大流行阶段已经结束,诊断试验仍然需要在个体患者水平上监测SARS-CoV-2,区域性,在全国范围内,以及保持传染病准备工具,以使用人口和废水监测来监测任何新的SARS-CoV-2跨境传播。世卫组织和疾病控制中心等中央卫生保健政策实体的预期,EMA,多个国家卫生当局认为,SARS-CoV-2将在未来几年内作为地方性呼吸道疾病存在。因此,关键的战略考虑是从应对大量患者的大流行情况转变为允许对可疑患者进行精确诊断,并在低患病率环境中进行正确管理。
    The coronavirus disease 2019 (COVID-19) pandemic demonstrated the need for accurate diagnostic testing for the early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the pandemic has ended, accurate assays are still needed to monitor viral spread at national levels and beyond through population and wastewater surveillance. To enhance early detection, SARS-CoV-2 assays should have high diagnostic accuracy and should be validated to assure accurate results. Three distinct SARS-CoV-2 assays were evaluated with clinical samples using the VALCOR (VALidation of SARS-CORona Virus-2 assays) framework, with the TaqPath COVID-19 assay (ThermoFisher Scientific, USA) as a comparator. We evaluated clinical sensitivity, specificity, limit of detection (LOD), and overall concordance between comparator and three index Allplex SARS-CoV-2 assays (Seegene, South Korea): Allplex-SC2, Allplex-SC2Fast (Fast PCR), and Allplex-SC2FabR (SARS-CoV-2/FluA/FluB/respiratory syncytial virus). Analytical performance and LOD of index assays were assessed using a dilution series of three synthetic SARS-CoV-2 sequence reference materials (RMs). Ninety SARS-CoV-2 positives and 90 SARS-CoV-2 negatives were tested. All Allplex assays had 100.0% sensitivity (95%CI = 95.9%-100.0%). Allplex-SC2 and Allplex-SC2Fast assays had 97.8% specificity (95%CI = 92.3%-99.7%) and 98.9% overall concordance [κ = 0.978 (95%CI = 0.947-1.000)]. Allplex-SC2FabR assay showed 100.0% specificity (95%CI = 95.9%-100.0%) and 100.0% overall concordance [κ = 1.000 (95%CI = 1.000-1.000)]. LOD assessment of index assays revealed detection down to 2.61 × 102 copies/mL in clinical samples, while the analytical LOD was 9.00 × 102 copies/mL. In conclusion, the evaluation of the three Seegene Allplex SARS-CoV-2 assays showed high sensitivity and specificity and an overall good assay concordance with the comparator. The assays showed low analytical LOD using RM and even a slightly lower LOD in clinical samples. Non-overlapping target gene sequences between SARS-CoV-2 assays and RMs emphasize the need for aligning targeted sequences of diagnostic assays and RMs.IMPORTANCEThe coronavirus disease 2019 pandemic has a significant impact on global public health, economies, and societies. As shown through the first phases of the pandemic, accurate and timely diagnosis is crucial for disease control, prevention, and monitoring. Though the pandemic phase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has concluded, diagnostic assays remain in demand to monitor SARS-CoV-2 at the individual patient level, regionally, and nationally, as well as to remain an infectious disease preparedness instrument to monitor any new SARS-CoV-2 dissemination across borders using population and wastewater surveillance. The anticipation by WHO and central health care policy entities such as the Center for Disease Control, EMA, and multiple national health authorities is that SARS-CoV-2 will reside as an endemic respiratory disease for years to come. The key strategic consideration is hence shifting from combating a pandemic situation with a high number of patients to instead allowing precise diagnostics of suspected patients with the intention of correct management in a low-prevalence setting.
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  • 文章类型: Journal Article
    基于人乳头瘤病毒(HPV)的宫颈筛查的实施在各国继续迅速发展。证据表明,检测高风险人乳头瘤病毒(hrHPV)脱氧核糖核酸(DNA)的检测比基于细胞学的筛查更有效。与宫颈癌前病变的标准比较物相比,新的hrHPVDNA检测方法的验证需要临床准确性和良好的可重复性。本研究建立在先前对RIATOLHPV基因分型qPCR测定的诊断准确性评估的基础上,旨在评估可重复性的国际验证标准。使用来自比利时国家HPV参考中心细胞学档案的550个残余宫颈细胞材料评估了RIATOL-qPCR测定的内部和相互再现性。在宫颈癌筛查的背景下收集样本,并在两个不同的实验室进行测试。国际再现性标准包括关于kappa≥0.50的hrHPVDNA检测超过87%的实验室内和实验室间协议的95%置信区间的下限。RIATOL-qPCR分析显示出优异的实验室内可重复性,总体一致性为98.2(95%CI96.6-99.1%),κ为0.96。实验室间检测显示总体一致性为98.5(95%CI97.1-99.4%),κ为0.97。RIATOL-qPCR测定满足用于宫颈癌筛查的HPV测试再现性要求的第三个标准。
    The implementation of cervical screening based on human papillomavirus (HPV) continues to progress rapidly across countries. Evidence has shown that assays detecting high-risk human papillomavirus (hrHPV) deoxyribonucleic acid (DNA) are more effective than cytology-based screening. Validation of new hrHPV DNA assays requires both noninferior clinical accuracy compared to a standard comparator for cervical precancer and good reproducibility. This study builds upon previous diagnostic accuracy assessments of the RIATOL HPV genotyping qPCR assay and aims to evaluate the international validation criteria for reproducibility. The intra- and interreproducibility of the RIATOL-qPCR assay were assessed using 550 remnant cervical cell material from the cytology archive of the National Reference Center for HPV in Belgium. Specimens were collected in the context of cervical cancer screening and tested in two different laboratories. The international reproducibility criteria include the lower bound of 95% confidence interval of the intra- and interlaboratory agreement regarding the detection of hrHPV DNA exceeding 87% with kappa ≥0.50. The RIATOL-qPCR assay demonstrated excellent intralaboratory reproducibility, achieving an overall agreement of 98.2 (95% CI 96.6-99.1%) and a kappa of 0.96. Interlaboratory testing showed an overall agreement of 98.5 (95% CI 97.1-99.4%) with a kappa of 0.97. The RIATOL-qPCR assay fulfills the third criterion for HPV test reproducibility requirement for use in cervical cancer screening.
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  • 文章类型: Journal Article
    Leonhard博士对现有的恶意研究文献及其对神经心理学实践的影响进行了全面而有见地的批评。他们的统计批评主要集中在涉及多个测试时诊断推断的关键问题上。虽然莱昂哈德有效地解决了某些误解,文献中存在一些被忽视的误解,并引入了一些新的困惑。为了提供平衡的评论,这一评价既考虑了莱昂哈德的批评,也考虑了恶意的研究文献。此外,贝叶斯诊断推理的简要介绍,利用多个测试的结果,提供。澄清了关于贝叶斯推理的误解,并阐明了贝叶斯推理的有效方法。彻底讨论了简单贝叶斯模型的假设,并且证明了链式似然比方法是该模型的不适当应用,这是由于Leonhard确定的一个原因和以前尚未认识到的另一个原因。Leonhard关于增量有效性对无条件相关性的主要依赖性以及所谓的简单贝叶斯模型的数学不正确性的结论被驳斥。最后,探索和讨论了该领域未来研究和实践的潜在方向。
    Dr. Leonhard presents a comprehensive and insightful critique of the existing malingering research literature and its implications for neuropsychological practice. Their statistical critique primarily focuses on the crucial issue of diagnostic inference when multiple tests are involved. While Leonhard effectively addresses certain misunderstandings, there are some overlooked misconceptions within the literature and a few new confusions were introduced. In order to provide a balanced commentary, this evaluation considers both Leonhard\'s critiques and the malingering research literature. Furthermore, a concise introduction to Bayesian diagnostic inference, utilizing the results of multiple tests, is provided. Misunderstandings regarding Bayesian inference are clarified, and a valid approach to Bayesian inference is elucidated. The assumptions underlying the simple Bayes model are thoroughly discussed, and it is demonstrated that the chained likelihood ratios method is an inappropriate application of this model due to one reason identified by Leonhard and another reason that has not been previously recognized. Leonhard\'s conclusions regarding the primary dependence of incremental validity on unconditional correlations and the alleged mathematical incorrectness of the simple Bayes model are refuted. Finally, potential directions for future research and practice in this field are explored and discussed.
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  • 文章类型: Journal Article
    背景:产后特定焦虑量表(PSAS)是一项国际措施,旨在评估母亲在产后一天至六个月内经历的焦虑;该量表被翻译成阿拉伯语,并在巴勒斯坦背景下进行验证,以测试巴勒斯坦妇女的产后焦虑。
    目的:当前的研究旨在使用验证性因子分析(CFA)测试巴勒斯坦背景下阿拉伯语语言中的心理测量特性和阶乘结构。这项研究的样本包括使用便利样本从巴勒斯坦西岸卫生中心招募的475名巴勒斯坦妇女。61%的年龄在20-30岁之间,39%的年龄在31-40岁之间。
    结果:PSAS在评估巴勒斯坦背景下的产后焦虑方面表现出良好的有效性和可靠性指标。CFA的结果表明,在评估巴勒斯坦母亲的产后焦虑时,四因素结构的稳定结构:(1)能力和依恋焦虑,(2)婴儿安全和福利焦虑,(3)实际的婴儿护理焦虑和(4)对母亲的心理社会适应,由原始的四因素结构组成的量表。
    结论:PSAS在巴勒斯坦背景下显示出良好的有效性指标。因此,建议对巴勒斯坦社会的临床和非临床群体进行类似的研究.PSAS可以是评估产后几个月妇女焦虑水平的有用措施;这将使心理健康提供者能够为焦虑水平高的母亲提供心理干预。
    结论:产后期间,母亲特别容易受到许多明显变化的影响,这些变化通常被认为是痛苦和压力。尽管这种压力源很常见,由于这些压力源,一些母亲可能会经历严重的焦虑。验证评估巴勒斯坦妇女产后焦虑的国际工具至关重要,由于政治冲突,生活在这种背景下的妇女经历了一些压力和生活挑战。PSAS可以是评估产后几个月母亲焦虑水平的有用措施;这使心理健康提供者能够为焦虑水平高的母亲提供心理干预。
    BACKGROUND: The Postpartum-Specific Anxiety Scale (PSAS) is an international measure designed to evaluate anxiety experienced by mothers in the postpartum period from one day to six months; the scale was translated into Arabic and validated within Palestinian context to test postpartum anxiety among Palestinian women.
    OBJECTIVE: The current study aimed to test the psychometric properties and the factorial structure within the Arabic language in a Palestinian context using confirmatory factor analysis (CFA). The sample of this study consisted of 475 Palestinian women recruited from health centers in the West Banks of Palestine using a convenience sample. 61% were of ages 20-30 years and 39% percent ages 31-40 years.
    RESULTS: The PSAS showed good validity and reliability indicators in assessing postpartum anxiety within Palestinian context. Results of CFA showed a stable construct of a four-factor structure in assessing postpartum anxiety among Palestinian mothers: (1) competence and attachment anxieties, (2) infant safety and welfare anxieties, (3) practical baby care anxieties and (4) psychosocial adjustment to motherhood, which is consisting with the original four-factor structure of the scale.
    CONCLUSIONS: The PSAS showed good validity indicators within Palestinian context. Therefore, it is recommended to conduct similar studies with clinical and non-clinical groups in the Palestinian society. The PSAS can be a useful measure to assess anxiety levels among women during the postpartum months; which will enable mental health providers to provide psychological interventions for mothers whose anxiety levels are high.
    CONCLUSIONS: During the postpartum period, mothers are particularly vulnerable to a number of distinct changes that are generally perceived as distressing and stressful. Although such stressors are common, some mothers may experience significant anxiety as a result of these stressors. Validating international tools to evaluate postpartum anxiety among Palestinian women is crucial, as women living in this context experience several stressors and life challenges due to the political conflict. The PSAS can be a useful measure to assess anxiety level among mothers during the postpartum months; which enable mental health providers to provide psychological interventions for mothers whose anxiety levels are high.
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  • 文章类型: Introductory Journal Article
    在与标准相关的验证研究中,标准识别和测量通常是事后才想到的。然而,在确定在操作环境中使用什么预测指标时至关重要。因此,本特刊讨论了解决美军入伍人员选拔和分类研究中的“标准问题”的最新进展。在这篇介绍性论文中,回顾了有关军事标准识别和测量的广泛问题以及有关该主题的先前研究,并发表了后续论文,它解决了具体的标准问题,并描述了一个前所未有的联合服务标准项目,被介绍。
    Criterion identification and measurement is often an afterthought in criterion-related validation research. Yet it is essential in determining what predictor measures to use in operational settings. Accordingly, this special issue discusses recent advances in addressing the \"criterion problem\" in U.S. military enlisted personnel selection and classification research. In this introductory paper, broad issues regarding criterion identification and measurement in the military and previous research on this topic are reviewed and subsequent papers, which address specific criterion issues and describe an unprecedented joint-service criterion project, are introduced.
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  • 文章类型: Journal Article
    The COVID-19 pandemic highlighted the importance of diagnostic testing against curbing the spread of SARS-CoV-2. The urgent need and scale for diagnostic tools resulted in manufacturers of SARS-CoV-2 assays receiving emergency authorization that lacked robust analytical or clinical evaluation. As it is highly likely that testing for SARS-CoV-2 will continue to play a central role in public health, the performance characteristics of assays should be evaluated to ensure reliable diagnostic outcomes are achieved.
    VALCOR or \"VALidation of SARS-CORona Virus-2 assays\" is a study protocol designed to set up a framework for test validation of SARS-CoV-2 virus assays. Using clinical samples collated from VALCOR, the performance of Aptima SARS-CoV-2 assay was assessed against a standard comparator assay. Diagnostic test parameters such as sensitivity, specificity and overall per cent agreement were calculated for the clinical performance of Aptima SARS-CoV-2 assay.
    A total of 180 clinical samples were tested with an addition of 40 diluted clinical specimens to determine the limit of detection. When compared to the standard comparator assay Aptima had a sensitivity of 100.0% [95% CI 95.9-100.0] and specificity of 96.7% [95% CI 90.8-99.3]. The overall percent agreement was 98.3% with an excellent Cohen\'s coefficient of κ = 0.967 [95% CI 0.929-1.000]. For the limit of detection, Aptima was able to detect all of the diluted clinical samples.
    In conclusion. validation of Aptima SARS-CoV-2 assay using clinical samples collated through the VALCOR protocol showed excellent test performance. Additionally, Aptima demonstrated high analytical sensitivity by detecting all diluted clinical samples corresponding to a low limit of detection.
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  • 文章类型: Journal Article
    UNASSIGNED:该研究旨在适应和验证最初由Herscovitch和Meyer开发的印尼版本的变更规模承诺。
    UNASSIGNED:数据是通过几所大学的教师在线申请收集的,这些大学经历了印尼政府关于研究相关问题的政策变化。共获得204个响应。使用内容有效性指数(CVI)验证数据,验证性因子分析(CFA),收敛和判别相关性以及Cronbachα。
    未经评估:结果表明,对变化的承诺可以通过三个情感维度来表示,对变革的持续和规范承诺,虽然有一项必须调整。量表内容效度指数(S-CVI)的结果表明,承诺变化量表具有出色的内容效度(S-CVI/Ave=0.97)。CFA结果显示,Cronbach的α与ACTC(α=0.71)获得了良好的结果;CCTC(α=0.83);NCTC(α=0.77)和构造可靠性(CR)值也很好,ACTC=0.85;CCTC=0.86;NCTC=0.86。从收敛性和判别有效性检验的结果来看,研究发现,改变的情感承诺与工作满意度呈正相关,与工作压力呈负相关。然而,对变化规模的连续性和规范性承诺都与这两个变量不相关。
    UNASSIGNED:印尼语版本的承诺变化量表显示出良好的心理测量特性,并且已被证明可以有效地提供对变化的承诺的度量,特别是对印度尼西亚的教职员工来说。
    UNASSIGNED: The study aims to adapt and validate the Indonesian version of the commitment to change scale that was initially developed by Herscovitch and Meyer.
    UNASSIGNED: Data were collected using an online application among faculty members of several universities who have experienced policy changes from the Indonesian government regarding research-related issues. A total of 204 responses were obtained. The data was validated using the Content Validity Index (CVI), the Confirmatory Factor Analysis (CFA), the Convergent and Discriminant correlations as well as the Cronbach\'s alpha.
    UNASSIGNED: The results demonstrated that commitment to change could be represented by three dimensions of affective, continuance and normative commitment to change, although there is one item that must be adjusted. The results of the Scale-Content Validity Index (S-CVI) show that the commitment to change scale has excellent content validity (S-CVI/Ave = 0.97). CFA results show a good fit, Cronbach\'s alpha obtains good results with ACTC (α = 0.71); CCTC (α = 0.83); NCTC (α = 0.77) and Construct Reliability (CR) values obtained are also quite good with ACTC = 0.85; CCTC = 0.86; NCTC = 0.86. From the results of the convergent and discriminant validity tests, it was found that the affective commitment to change positively correlates with job satisfaction and negatively correlates with job stress. However, both continuance and normative commitment to change scale does not correlate with the two variables.
    UNASSIGNED: The Indonesian version of the commitment to change scale shows good psychometric properties and has proven valid to provide the measurement of commitment to change, especially for the faculty members in Indonesia.
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  • 文章类型: Journal Article
    目的:宫颈癌筛查中使用的人乳头瘤病毒(HPV)检测应根据国际标准进行临床验证。OncoPredictHPV®筛选(SCR)是针对13个高风险(hr)HPV的E6/E7基因的部分基因分型多重实时PCR测定。OncoPredictHPV®SCR(指数测定)分别鉴定HPV-16和HPV-18,总共有11个其他hrHPV,包括样品充分性的质量控制,DNA提取效率和PCR抑制。
    方法:1,300份VALGENT-2研究样本(来自参加苏格兰宫颈癌筛查计划的20-60岁女性)用指数测定法和GP5+/6+PCR酶免疫测定(标准比较测定法)进行了测试。与比较指标相比,检测2级或更差(CIN2)的宫颈上皮内瘤变的准确性不低。通过总体一致性和Cohen'skappa评估指标的实验室内和实验室间可重复性,使用亚群体(n=526)。
    结果:该指数对CIN2+的相对灵敏度和特异度与比较为1.01(95CI:0.99-1.03)和1.02(95CI:1.0-1.04),分别。非劣效性p值均≤0.05,但≥30岁患者的CIN3+除外。表现出优异的实验室内和实验室间可重复性,一致性>98%,kappas>0.95。
    结论:OncoPredictHPV®SCR符合宫颈癌筛查中hrHPVDNA检测的三个国际验证标准。本文受版权保护。保留所有权利。
    Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen\'s kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99-1.03) and 1.02 (95% CI: 1.0-1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance >98% and kappas >0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.
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