Sensitivity and specificity

灵敏度和特异性
  • 文章类型: Journal Article
    镰状细胞病(SCD)是全球最常见的遗传性疾病,具有显著的发病率和死亡率。包括在印度。这种疾病在许多地理区域的高患病率要求使用即时快速诊断测试(RDT)进行早期筛查和诊断病例的管理,以降低相关的临床严重程度。鉴于此,本研究旨在验证用于SCD筛查的即时护理RDT试剂盒(SICKLECHECKTM).这项验证和诊断准确性研究是在建议筛查SCD的病例中进行的。对于验证,所有招募的病例均接受了SICKLECHECKTMRDT试剂盒和HPLC(Variant-II)的调查,认为HPLC是金标准.两项测试共筛选了400例。对于样本中是否存在镰状细胞血红蛋白,参考HPLC结果,SICKLECHECKTMRDT试剂盒结果显示灵敏度和特异性分别为99.39%和98.73%。对于\'AS\'模式的检测,SICKLECHECKTMRDT试剂盒的敏感性和特异性分别为99.07%和98.81%。对于\'SS\'模式的检测,SICKLECHECKTMRDT试剂盒的敏感性和特异性分别为97.92%和100.0%。具有β地中海贫血特征的病例,血红蛋白E性状,在SICKLECHECKTMRDT试剂盒中,血红蛋白Lepore性状和在HPLC中诊断出的遗传性持续性胎儿血红蛋白(高HbF%)的性状具有“AA”模式。SICKLECHECKTMRDT试剂盒的高灵敏度和特异性坚持将其用作SCD的即时筛查工具,尤其是在缺乏实验室设施以及需要立即诊断和管理的医院设置中SCD。然而,为了进一步确认,样品应该用其他金标准技术如HPLC进行分析。
    Sickle cell diseases (SCD) are the most common genetic disorders with significant morbidity and mortality worldwide, including in India. The high prevalence of this disorder in many geographical regions calls for the use of a point-of-care rapid diagnostic test (RDT) for early screening and management of the diagnosed cases to reduce the allied clinical severity. In view of this, the present study was undertaken for the validation of a point-of-care RDT kit (SICKLECHECKTM) for the screening of SCD. This validation and diagnostic accuracy study was conducted among the cases advised for screening of SCD. For validation, all the recruited cases were investigated for both the SICKLECHECKTM RDT kit and HPLC (Variant-II) considering HPLC as a gold standard. A total of 400 cases were screened for both tests. For the presence and absence of sickle cell hemoglobin in the samples, SICKLECHECKTM RDT kit results showed a sensitivity and specificity of 99.39% and 98.73% respectively with references to HPLC findings. For the detection of the \'AS\' pattern, the SICKLECHECKTM RDT kit has shown a sensitivity and specificity of 99.07% and 98.81% respectively. For the detection of the \'SS\' pattern, the SICKLECHECKTM RDT kit has shown a sensitivity and specificity of 97.92% and 100.0% respectively. Cases with β thalassemia trait, hemoglobin E trait, hemoglobin Lepore trait and trait for hereditary-persistence-of-fetal-hemoglobin (high HbF %) diagnosed in HPLC were resulted with \'AA\' pattern in SICKLECHECKTM RDT kit. The high sensitivity and specificity of the SICKLECHECKTM RDT kit insist on its use as a point-of-care screening tool for SCD especially where there is a lack of laboratory facilities as well as in hospital-based set-up requiring immediate diagnosis and management of SCD. However, for further confirmation, the samples should be analyzed with other gold standard techniques like HPLC.
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  • 文章类型: Journal Article
    目的:本研究的目的是确定CT扫描在胫骨干骨折中检测关节伸展的实用性,并确定X线参数是否可以预测胫骨远端关节骨折(DTAFs)的存在。
    方法:
    方法:回顾性队列研究。
    方法:单一级创伤中心。
    18岁及以上的患者因发生在胫骨峡部或以下的胫骨干骨折而接受手术治疗。患者被排除在胫骨干骨折延伸到胫骨平台(AO/OTA43B/C),弹道伤害,术前没有CT扫描.
    主要结果是CT效用,定义为在CT上存在DTAF或DTAF位移,而在研究时,高级居民在二次分析的平片上未发现DTAF或DTAF位移。次要结果是影像学参数与手术DTAF之间的关联。单变量检验中P≤0.2的变量包括在多元二元逻辑回归模型中,以确定手术DTAF的独立预测因子。
    结果:纳入了144例患者,平均年龄52岁.76例患者(53%)为男性。CT实用性为41%,用于识别未识别的DTAF。分离的pDTAF的CT效用为79%,57%为中间DTAF,分离的前外侧DTAF为83%,和100%的多个DTAF。DTAF与胫骨干螺旋骨折类型(P<0.001)和腓骨下段骨折(P=0.04)独立相关。在患有螺旋胫骨干骨折和腓骨骨折的患者中,DTAF的手术率为46%(22/48)。
    结论:CT扫描在41%的病例中发现了在平片上无法识别的DTAF。CT扫描在识别非后部DTAF方面最有用。CT扫描可以考虑所有胫骨远端第三骨折,但尤其是那些有螺旋胫骨干模式和腓骨下骨折的人,避免遗漏手术关节损伤。
    方法:预后III级。有关证据级别的完整描述,请参阅作者说明。
    OBJECTIVE: The purpose of this study was to define the utility of CT scans for detecting articular extension in tibial shaft fractures and determine whether radiographic parameters can predict the presence of operative distal tibial articular fractures (DTAFs).
    METHODS:
    METHODS: Retrospective cohort study.
    METHODS: Single level I trauma center.
    UNASSIGNED: Patients age 18 years and older who were treated operatively for tibial shaft fractures occurring at or below the tibial isthmus were included. Patients were excluded for extension of the main tibial shaft fracture into the tibial plafond (AO/OTA 43 B/C), ballistic injuries, and absence of a preoperative CT scan.
    UNASSIGNED: The primary outcome was CT utility, defined as the presence of a DTAF or DTAF displacement on CT that was not recognized on plain radiographs on secondary analysis at the time of the study by a senior-level resident. Secondary outcome was the association between radiographic parameters and operative DTAFs. Variables with P ≤ 0.2 on univariate testing were included in a multiple binary logistic regression model to determine independent predictors of operative DTAFs.
    RESULTS: One hundred forty-four patients were included, with a mean age of 52 years. Seventy-six patients (53%) were men. CT utility was 41% for the identification of unrecognized DTAFs. CT utility was 79% for isolated pDTAF, 57% for medial DTAF, 83% for isolated anterolateral DTAF, and 100% for multiple DTAFs. Operative DTAFs were independently associated with spiral tibial shaft fracture type (P < 0.001) and low fibular fracture (P = 0.04). In patients who had both spiral tibial shaft fracture type and low fibula fracture, the rate of operative DTAF was 46% (22/48).
    CONCLUSIONS: CT scans identified DTAFs that were unrecognized on plain radiographs in 41% of cases. CT scans were most useful in identifying nonposterior DTAFs. CT scans may be considered for all distal third tibial fractures, but especially those with spiral tibial shaft patterns and low fibular fractures, to avoid missing operative articular injury.
    METHODS: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
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  • 文章类型: Journal Article
    布鲁氏菌病代表了全球主要的公共卫生问题。人类传播主要是由于受感染动物食用未经巴氏杀菌的牛奶和乳制品。反刍动物布鲁氏菌属诊断的金标准是细菌分离,但这很耗时。聚合酶链反应(PCR)是一种比细菌培养更快,更敏感的技术。液滴数字PCR(ddPCR)是一种新型的分子测定,在DNA含量低且对扩增抑制剂的敏感性较低的样品中显示出高灵敏度。本研究旨在开发一种用于检测水牛组织样品中流产布鲁氏菌的ddPCR方法。通过实时qPCR使用布鲁氏菌属的能力测试样品验证了该方案。此外,检查了599个组织样品。在参考资料中,qPCR和ddPCR表现出相同的性能并且能够检测到高达225CFU/mL。在现场样本中,ddPCR显示更高的灵敏度(100%),特异性和准确性分别为93.4%和94.15%,分别。ddPCR可以被认为是一种有前途的技术,用于检测兽医标本中的流产芽孢杆菌,通常以细菌数量少为特征,基质和物种多样性高,储存条件差。
    Brucellosis represents a major public health concern worldwide. Human transmission is mainly due to the consumption of unpasteurized milk and dairy products of infected animals. The gold standard for the diagnosis of Brucella spp in ruminants is the bacterial isolation, but it is time-consuming. Polymerase Chain Reaction (PCR) is a quicker and more sensitive technique than bacterial culture. Droplet digital PCR (ddPCR) is a novel molecular assay showing high sensitivity in samples with low amount of DNA and lower susceptibility to amplification inhibitors. Present study aimed to develop a ddPCR protocol for the detection of Brucella abortus in buffalo tissue samples. The protocol was validated using proficiency test samples for Brucella spp by real time qPCR. Furthermore, 599 tissue samples were examined. Among reference materials, qPCR and ddPCR demonstrated same performance and were able to detect up to 225 CFU/mL. Among field samples, ddPCR showed higher sensitivity (100%), specificity and accuracy of 93.4% and 94.15%, respectively. ddPCR could be considered a promising technique to detect B. abortus in veterinary specimens, frequently characterized by low amount of bacteria, high diversity in matrices and species and poor storage conditions.
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  • 文章类型: Journal Article
    背景:有效且可靠的测量情绪发展的工具对于智障人士的正确诊断任务至关重要。这项探索性研究检查了情绪发展量表(SED-S)上项目的心理测量特性。
    方法:样本包括612名智障成年人(Mage=37.35,SDage=13.27;男性占59.8%)。确定了包含敏感性和特异性率以及辨别力的项目有效性分析。
    结果:所有200个项目的“是”答案的相对平均频率为29.5%。平均灵敏度为67.5%,平均特异率为79.3%。大多数项目(85.0%)对相邻阶段表现出良好的鉴别力,尤其是在SED-1、SED-2、SED-3和SED-4之间。特别是在SED-4中,一些项目在这些阶段之间的差异方面表现出弱点。
    结论:本研究增加了以前的验证研究,表明大多数SED-S项目具有心理测量的声音特性。
    BACKGROUND: Valid and reliable instruments for measuring emotional development are critical for a proper diagnostic assignment in individuals with intellectual disabilities. This exploratory study examined the psychometric properties of the items on the Scale of Emotional Development-Short (SED-S).
    METHODS: The sample included 612 adults with intellectual disabilities (Mage = 37.35, SDage = 13.27; 59.8% males). Item validity analysis comprising sensitivity and specificity rates and discriminatory power were determined.
    RESULTS: The relative mean frequency of \'yes\' answers to all 200 items was 29.5%. The mean sensitivity rate was 67.5% and the mean specificity rate was 79.3%. Most items (85.0%) showed good discriminatory power with the adjacent stage(s), especially between SED-1, SED-2, SED-3 and SED-4. Particularly in SED-4 some items showed weaknesses in the differentiation between these stages.
    CONCLUSIONS: This study adds to previous validation studies by showing that most SED-S items have psychometrically sound properties.
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  • 文章类型: Journal Article
    小肠结肠炎耶尔森氏菌(Ye)是一种从人类中分离出的食源性病原体,食物,动物,和环境。耶尔森氏菌病是欧盟第三大最常见的食源性人畜共患病。叶种分为六种生物型1A,1B,2、3、4和5,基于生化反应和约70种血清型。生物型1A是非致病性的,1B是高致病性的,和生物型2-5具有中等或低致病性。由于小肠结肠炎耶尔森氏菌样物种与其他耶尔森氏菌和/或肠杆菌科之间的相似性,用于检测致病性Ye物种的参考分析方法低估了病原体的存在,低浓度的分布病原菌和小肠结肠炎耶尔森氏菌物种的异质性。在这项研究中,验证了ISO/TS18867实时PCR方法在双壳软体动物中鉴定Ye的致病性生物变体。敏感性,使用实验污染的软体动物评估了分子方法的特异性和准确性。结果与ISO10273方法的结果完全一致。最后,我们使用ISO/TS18867评估了在那不勒斯湾收集的70个双壳类软体动物商业样品中是否存在Ye。只有一个样本测试结果是ail基因阳性,根据ISO/TS18867,该基因被认为是检测致病性Ye的目标基因。此外,有了ystB基因,用作Ye生物型1A的靶标,使用实时PCRSYBRGreen平台评估所有样品。结果表明,针对两个样品扩增了ystB基因。
    Yersinia enterocolitica (Ye) is a foodborne pathogen isolated from humans, food, animals, and the environment. Yersiniosis is the third most frequently reported foodborne zoonosis in the European Union. Ye species are divided into six biotypes 1A, 1B, 2, 3, 4, and 5, based on biochemical reactions and about 70 serotypes. Biotype 1A is non-pathogenic, 1B is highly pathogenic, and biotypes 2-5 have moderate or low pathogenicity. The reference analysis method for detecting pathogenic Ye species underestimates the presence of the pathogen due to similarities between Yersinia enterocolitica-like species and other Yersiniaceae and/or Enterobacteriaceae, low concentrations of distribution pathogenic strains and the heterogeneity of Yersinia enterocolitica species. In this study, the real-time PCR method ISO/TS 18867 to identify pathogenic biovars of Ye in bivalve molluscs was validated. The sensitivity, specificity and accuracy of the molecular method were evaluated using molluscs experimentally contaminated. The results fully agree with those obtained with the ISO 10273 method. Finally, we evaluated the presence of Ye in seventy commercial samples of bivalve molluscs collected in the Gulf of Naples using ISO/TS 18867. Only one sample tested resulted positive for the ail gene, which is considered the target gene for detection of pathogenic Ye according to ISO/TS 18867. Additionally, the presence of the ystB gene, used as target for Ye biotype 1A, was assessed in all samples using a real-time PCR SYBR Green platform. The results showed amplification ystB gene aim two samples.
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  • 文章类型: Journal Article
    目的:评估临床评估工具在院外心脏骤停(OHCA)后神经认知筛查中的价值。
    方法:评估的神经认知筛查包括基于表现的蒙特利尔认知评估(MoCA)和符号数字模式测试(SDMT)。患者报告的两个简单问题(TSQ)和观察者报告的关于老年人心脏骤停中认知下降的信息问卷(IQCODE-CA)。在院外心脏骤停(TTM2)后的目标低温与目标常温试验中,在6个月时施用这些仪器。我们使用来自TTM2试验子研究的综合神经心理学测试电池作为金标准来评估神经认知筛查的敏感性和特异性。
    结果:在我们108名OHCA幸存者的队列中(中位年龄=62,88%男性),最有利的截止分数为:MoCA<26;SDMTz≤-1;IQCODE-CA≥3.04。MoCA(敏感性0.64,特异性0.85)和SDMT(敏感性0.59,特异性0.83)的分类准确性高于TSQ(敏感性0.28,特异性0.74)和IQCODE-CA(敏感性0.42,特异性0.60)。当结合使用MoCA或SDMT的切点来识别神经认知障碍时,灵敏度提高(0.74,特异性0.81),曲线下面积=0.77,95%CI[0.69,0.85]。最常见的未识别损伤是在情景记忆和执行功能域内,MoCA或SDMT合并的假阴性病例较少。
    结论:MoCA和SDMT对OHCA人群的神经认知障碍筛查具有可接受的诊断准确性,并且当组合使用时,灵敏度提高。患者和观察者报告与神经认知表现的相关性较差。
    结果:gov标识符:NCT03543371。
    OBJECTIVE: To assess the merit of clinical assessment tools in a neurocognitive screening following out-of-hospital cardiac arrest (OHCA).
    METHODS: The neurocognitive screening that was evaluated included the performance-based Montreal Cognitive Assessment (MoCA) and Symbol Digit Modalities Test (SDMT), the patient-reported Two Simple Questions (TSQ) and the observer-reported Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest (IQCODE-CA). These instruments were administered at 6-months in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest (TTM2) trial. We used a comprehensive neuropsychological test battery from a TTM2 trial sub-study as a gold standard to evaluate the sensitivity and specificity of the neurocognitive screening.
    RESULTS: In our cohort of 108 OHCA survivors (median age = 62, 88% male), the most favourable cut-off scores were: MoCA <26; SDMT z ≤-1; IQCODE-CA ≥3.04. The MoCA (sensitivity 0.64, specificity 0.85) and SDMT (sensitivity 0.59, specificity 0.83) had a higher classification accuracy than the TSQ (sensitivity 0.28, specificity 0.74) and IQCODE-CA (sensitivity 0.42, specificity 0.60). When using the cut-points for MoCA or SDMT in combination to identify neurocognitive impairment, sensitivity improved (0.74, specificity 0.81), area under the curve = 0.77, 95% CI [0.69, 0.85]. The most common unidentified impairments were within the episodic memory and executive functions domains, with fewer false negative cases on the MoCA or SDMT combined.
    CONCLUSIONS: The MoCA and SDMT have acceptable diagnostic accuracy for screening for neurocognitive impairment in an OHCA population, and when used in combination the sensitivity improves. Patient and observer-reports correspond poorly with neurocognitive performance.
    RESULTS: gov Identifier: NCT03543371.
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  • 文章类型: Journal Article
    BACKGROUND:  The early diagnosis of Alzheimer\'s disease (AD) and mild cognitive impairment (MCI) remains a significant challenge in neurology, with conventional methods often limited by subjectivity and variability in interpretation. Integrating deep learning with artificial intelligence (AI) in magnetic resonance imaging (MRI) analysis emerges as a transformative approach, offering the potential for unbiased, highly accurate diagnostic insights.
    OBJECTIVE:  A meta-analysis was designed to analyze the diagnostic accuracy of deep learning of MRI images on AD and MCI models.
    METHODS:  A meta-analysis was performed across PubMed, Embase, and Cochrane library databases following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, focusing on the diagnostic accuracy of deep learning. Subsequently, methodological quality was assessed using the QUADAS-2 checklist. Diagnostic measures, including sensitivity, specificity, likelihood ratios, diagnostic odds ratio, and area under the receiver operating characteristic curve (AUROC) were analyzed, alongside subgroup analyses for T1-weighted and non-T1-weighted MRI.
    RESULTS:  A total of 18 eligible studies were identified. The Spearman correlation coefficient was -0.6506. Meta-analysis showed that the combined sensitivity and specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio were 0.84, 0.86, 6.0, 0.19, and 32, respectively. The AUROC was 0.92. The quiescent point of hierarchical summary of receiver operating characteristic (HSROC) was 3.463. Notably, the images of 12 studies were acquired by T1-weighted MRI alone, and those of the other 6 were gathered by non-T1-weighted MRI alone.
    CONCLUSIONS:  Overall, deep learning of MRI for the diagnosis of AD and MCI showed good sensitivity and specificity and contributed to improving diagnostic accuracy.
    BACKGROUND:  O diagnóstico precoce da doença de Alzheimer (DA) e do comprometimento cognitivo leve (CCL) continua sendo um desafio significativo na neurologia, com métodos convencionais frequentemente limitados pela subjetividade e variabilidade na interpretação. A integração da aprendizagem profunda com a inteligência artificial (IA) na análise de imagens de ressonância magnética surge como uma abordagem transformadora, oferecendo o potencial para insights diagnósticos imparciais e altamente precisos.
    OBJECTIVE:  Uma metanálise foi projetada para analisar a precisão diagnóstica do aprendizado profundo de imagens de ressonância magnética em modelos de DA e CCL. MéTODOS:  Uma metanálise foi realizada nos bancos de dados das bibliotecas PubMed, Embase e Cochrane seguindo as diretrizes Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), com foco na precisão diagnóstica do aprendizado profundo. Posteriormente, a qualidade metodológica foi avaliada por meio do checklist QUADAS-2. Medidas diagnósticas, incluindo sensibilidade, especificidade, razões de verossimilhança, razão de chances diagnósticas e área sob a curva característica de operação do receptor (area under the receiver operating characteristic curve [AUROC]) foram analisadas, juntamente com análises de subgrupo para ressonância magnética ponderada em T1 e não ponderada em T1.
    RESULTS: Um total de 18 estudos elegíveis foram identificados. O coeficiente de correlação de Spearman foi de -0,6506. A metanálise mostrou que a sensibilidade e a especificidade combinadas, a razão de verossimilhança positiva, a razão de verossimilhança negativa e a razão de chances de diagnóstico foram 0,84, 0,86, 6,0, 0,19 e 32, respectivamente. A AUROC foi de 0,92. O ponto quiescente do resumo hierárquico da característica de operação do receptor (hierarchical summary of receiver operating characteristic [HSROC]) foi 3,463. Notavelmente, as imagens de 12 estudos foram adquiridas apenas por ressonância magnética ponderada em T1, e as dos outros 6 foram obtidas apenas por ressonância magnética não ponderada em T1. CONCLUSãO:  Em geral, a aprendizagem profunda da ressonância magnética para o diagnóstico de DA e CCL mostrou boa sensibilidade e especificidade e contribuiu para melhorar a precisão diagnóstica.
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  • 文章类型: Journal Article
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    舌拭子有望作为诊断结核病(TB)的非侵入性样本。然而,与痰相比,它们作为痰液替代品的效用受到PCR检测中不同诊断性能的限制.由于结核分枝杆菌(MTB)细胞的不完全裂解和非靶核酸的共提取,使用基于二氧化硅的DNA提取方法可能会限制灵敏度,这可能会抑制PCR。特异性也可能受损,因为这些方法是劳动密集型的并且易于交叉污染。为了解决这些限制,我们开发了一种样品制备方法,该方法结合了用于MTB裂解的超声处理和使用固定在磁珠上的杂交探针的序列特异性MTBDNA捕获方法.在尖刺的舌头拭子中,我们的杂交捕获方法表明,与基于硅胶的QiagenDNA提取和乙醇沉淀相比,MTBDNA产量增加了100倍.在一项针对南非临床样本的研究中,我们的方案以痰XpertMTB/RIFUltra为参考标准检测活动性肺结核的敏感性为74%(70/94),特异性为98%(41/42).虽然杂交捕获没有显示出比QiagenDNA提取和乙醇沉淀更高的灵敏度,它显示出比以前报道的方法更好的特异性,并且更容易实施.通过集成到护理点平台,这些策略有可能有助于在关键服务不足的患者人群中实现快速的非痰结核诊断.
    Tongue swabs hold promise as a non-invasive sample for diagnosing tuberculosis (TB). However, their utility as replacements for sputum has been limited by their varied diagnostic performance in PCR assays compared to sputum. The use of silica-based DNA extraction methods may limit sensitivity due to incomplete lysis of Mycobacterium tuberculosis (MTB) cells and co-extraction of non-target nucleic acid, which may inhibit PCR. Specificity may also be compromised because these methods are labor-intensive and prone to cross-contamination. To address these limitations, we developed a sample preparation method that combines sonication for MTB lysis and a sequence-specific MTB DNA capture method using hybridization probes immobilized on magnetic beads. In spiked tongue swabs, our hybridization capture method demonstrated a 100-fold increase in MTB DNA yield over silica-based Qiagen DNA extraction and ethanol precipitation. In a study conducted on clinical samples from South Africa, our protocol had 74% (70/94) sensitivity and 98% (41/42) specificity for detecting active pulmonary TB with sputum Xpert MTB/RIF Ultra as the reference standard. While hybridization capture did not show improved sensitivity over Qiagen DNA extraction and ethanol precipitation, it demonstrated better specificity than previously reported methods and was easier to perform. With integration into point-of-care platforms, these strategies have the potential to help enable rapid non-sputum-based TB diagnosis across key underserved patient populations.
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