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Reverse Transcription-PCR-based Sanger Sequencing-confirmed Exon-skipping Effect of a Novel GEN1 Intronic Variant (c.1408+4A>G). 基于逆转录PCR的Sanger测序证实了一种新的GEN1内含子变体的外显子跳跃效应(c.1408+4A>G)。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-16 DOI: 10.3343/alm.2023.0163
Jiyeon Kim, Joonsang Yu, Seunghoo Lee, Sollip Kim, In-Seob Lee, Woochang Lee, Sail Chun
and corresponds to PM2, according to the 2015 American College of Medical Genetics guidelines [9]. Splice-site prediction algorithms, including Netgene2, AdaBoost (score: 0.9), and Random Forest (score: 0.7), predicted a splice-site change. The novel variant was tentatively classified as a variant of uncertain significance (VUS) because its splicing effect and clinical significance were not confirmed. RT-PCR and Sanger sequencing were performed to determine whether the splice donor-site change in the consensus sequence induced aberrant RNA splicing. Total RNA extracted from blood leukocytes of a control subject and the patient using the High Pure RNA Isolation Kit (Roche, India-napolis, IN, USA) was reverse-transcribed into cDNA using the RevertAid First Strand cDNA Synthesis Kit (Thermo Fisher
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引用次数: 0
Head-to-Head Comparison of Nine Assays for the Detection of Anti-Echinococcus Antibodies: A Retrospective Evaluation. 九种抗棘球蚴抗体检测方法的头对头比较:回顾性评价。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-26 DOI: 10.3343/alm.2023.0212
Carolina Mattwich, Kristina Huber, Gisela Bretzel, Sebastian Suerbaum, Andreas Wieser, Karl Dichtl

Background: Echinococcosis is a neglected tropical disease that is severely underdiagnosed in resource-limited settings. In developed countries, diagnosing echinococcosis is challenging, and reliable serological assays are urgently needed. In the Central European Alps, EM is more common than EG; however, data on the diagnostic performance of assays for EM cases are scarce. We evaluated the suitability of nine antibody assays for routine diagnostics.

Methods: Nine commercially available serological assays for detecting anti-Echinococcus antibodies were compared head-to-head using samples collected from 50 patients with echinococcosis and 50 age- and sex-matched control subjects. The assays are Anti-Echinococcus ELISA (IgG) (Euroimmun), Echinococcus IgG ELISA (DRG), Echinococcus IgG ELISA (IBL International), Echinococcus Western Blot IgG (LDBIO Diagnostics), EUROLINE WB (Euroimmun), Hydatidosis ELISA IgG (VirCell), Hydatidosis VIRCLIA IgG Monotest (VirCell), Ridascreen Echinococcus IgG (R-Biopharm), and Virapid Hydatidosis (VirCell). The cases were ranked according to the WHO-Informal Working Group on Echinococcosis (WHO-IWGE) criteria as confirmed, probable, or possible.

Results: The performance of the assays varied greatly, with overall sensitivities ranging between 50% and 88% and specificities between 62% and 100%. We observed a trend toward better performance with cases classified as "confirmed" using the WHO-IWGE criteria. Combined analysis with sequential screening and confirmatory testing resulted in a maximum sensitivity of 84% and specificity of 100%. Differentiation between EG and EM infections is clinically relevant but was found to be unreliable.

Conclusions: Echinococcus serological assays are highly variable in terms of sensitivity and specificity. Knowledge of the pre-test probability in the patient cohort is required to choose a suitable assay. A combined approach with screening and confirmatory assays may be the best diagnostic strategy in many situations.

背景:棘球蚴病是一种被忽视的热带疾病,在资源有限的环境中诊断严重不足。在发达国家,诊断棘球蚴病具有挑战性,迫切需要可靠的血清学检测。在中欧阿尔卑斯山脉,EM比EG更常见;然而,关于EM病例检测的诊断性能的数据很少。我们评估了九种抗体测定法用于常规诊断的适用性。方法:使用从50名棘球蚴病患者和50名年龄和性别匹配的对照受试者中收集的样本,对9种商业上可获得的用于检测抗棘球蚴抗体的血清学检测方法进行头对头比较。检测方法有抗棘球蚴ELISA(IgG)(Euroimmun)、棘球蚴IgG ELISA(DRG)、棘球蚴IgG ELISA、棘球绦虫免疫球蛋白印迹IgG(IBL International)、棘球蚴蛋白质印迹IgG(LDBIO Diagnostics)、EUROLINE WB(Euroimmune)、Hydratidosis ELISA IgG(VirCell)、Hydradidosis VIRCLIA IgG Monottest(VirCell)、Ridascren棘球蚴IgG(R-Biopharm)和Virapid Hydratidois(VirCell)。根据世界卫生组织-棘球蚴病信息工作组(WHO-IWGE)的标准,将病例分为确诊、可能或可能。结果:检测结果差异很大,总体灵敏度在50%至88%之间,特异性在62%至100%之间。我们观察到,使用世界卫生组织-世界卫生组织标准分类为“确诊”的病例有更好表现的趋势。结合序列筛查和验证性测试的分析得出的最大灵敏度为84%,特异性为100%。EG和EM感染之间的区别具有临床相关性,但被发现是不可靠的。结论:棘球蚴血清学检测在敏感性和特异性方面具有高度的可变性。需要了解患者队列中测试前的概率,才能选择合适的检测方法。在许多情况下,筛查和验证性检测相结合的方法可能是最佳的诊断策略。
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引用次数: 0
Concurrent Pleural and Pericardial Involvement in a Patient With De Novo Pure Erythroid Leukemia. De Novo纯红细胞白血病患者并发胸膜和心包受累。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-16 DOI: 10.3343/alm.2023.0252
Yun Zhang, Kechao Li, Xue Li, Hui Wang, Ting Li, Fang Long
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引用次数: 0
A Liquid Chromatography-Tandem Mass Spectrometry Method for Simultaneously Determining Meropenem and Linezolid in Blood and Cerebrospinal Fluid. 液相色谱-串联质谱法同时测定血液和脑脊液中美罗培南和利奈唑胺。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-23 DOI: 10.3343/alm.2023.0250
Joanna Berska, Jolanta Bugajska, Krystyna Sztefko

Antibiotic therapy requires appropriate dosage of drugs for effective treatment. Too low antibiotic concentrations may lead to treatment failure and the development of resistant pathogens, whereas overdosing may cause neurological side effects or hemolytic diseases. Meropenem and linezolid are used only in the treatment of serious infections or when other antibiotics are no longer effective as well as for treating central nervous system infections. It is difficult or sometimes even impossible to predict the relation between dosing of antibiotics and its cerebrospinal fluid (CSF) concentration; thus, a method of determining antibiotics not only in the blood but also in the CSF is needed. Analytical method validation is an integral part of good laboratory practice and ensures high accuracy of the results. We performed complete validation process according to the Food and Drug Administration and European Medicine Agency, covering the aspects precision, specificity, accuracy, recovery, limit of detection, limit of quantification, stability, carry-over, and matrix effects. Our liquid chromatography-tandem mass spectrometry method for the simultaneous measurement of meropenem and linezolid in different matrix meets all the acceptance criteria. The method was successfully applied to determine meropenem and linezolid concentrations in serum and CSF samples obtained from children treated with these antibiotics.

抗生素治疗需要适当剂量的药物才能有效治疗。抗生素浓度过低可能导致治疗失败和耐药性病原体的发展,而过量使用可能导致神经系统副作用或溶血性疾病。美罗培南和利奈唑胺仅用于治疗严重感染或其他抗生素不再有效时,以及用于治疗中枢神经系统感染。很难或有时甚至不可能预测抗生素的给药与其脑脊液(CSF)浓度之间的关系;因此,需要一种不仅在血液中而且在CSF中测定抗生素的方法。分析方法验证是良好实验室实践的组成部分,可确保结果的高准确性。我们根据美国食品药品监督管理局和欧洲药品管理局的要求进行了完整的验证过程,包括精密度、特异性、准确性、回收率、检测限、定量限、稳定性、结转和基质效应。我们的液相色谱-串联质谱法同时测定不同基质中的美罗培南和利奈唑胺,符合所有验收标准。该方法已成功应用于测定接受这些抗生素治疗的儿童血清和脑脊液样本中美罗培南和利奈唑胺的浓度。
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引用次数: 0
Evaluation of a Modified Protocol for the SepsiPrep Kit for Direct Identification and Antimicrobial Susceptibility Testing From Positive Blood Culture Using BACTEC Plus and BacT/Alert Blood Culture Bottles. 使用BACTEC Plus和BacT/Alert血液培养瓶从阳性血液培养物中直接鉴定和抗菌药物敏感性测试的SepsiPrep试剂盒的改进方案的评估。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-30 DOI: 10.3343/alm.2023.0294
In Young Yoo, Sung Il Ha, Hee Jae Huh, Tae Yeul Kim, Hyang Jin Shim, Hyeyoung Lee, Jayoung Kim, Nam Yong Lee, Yeon-Joon Park
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引用次数: 0
The Use of Bone-Turnover Markers in Asia-Pacific Populations. 骨转换标记在亚太地区人群中的应用。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-23 DOI: 10.3343/alm.2023.0214
Samuel Vasikaran, Subashini C Thambiah, Rui Zhen Tan, Tze Ping Loh

Bone-turnover marker (BTM) measurements in the blood or urine reflect the bone-remodeling rate and may be useful for studying and clinically managing metabolic bone diseases. Substantial evidence supporting the diagnostic use of BTMs has accumulated in recent years, together with the publication of several guidelines. Most clinical trials and observational and reference-interval studies have been performed in the Northern Hemisphere and have mainly involved Caucasian populations. This review focuses on the available data for populations from the Asia-Pacific region and offers guidance for using BTMs as diagnostic biomarkers in these populations. The procollagen I N-terminal propeptide and β-isomerized C-terminal telopeptide of type-I collagen (measured in plasma) are reference BTMs used for investigating osteoporosis in clinical settings. Premenopausal reference intervals (established for use with Asia-Pacific populations) and reference change values and treatment targets (used to monitor osteoporosis treatment) help guide the management of osteoporosis. Measuring BTMs that are not affected by renal failure, such as the bone-specific isoenzyme alkaline phosphatase and tartrate-resistant acid phosphatase 5b, may be advantageous for patients with advanced chronic kidney disease. Further studies of the use of BTMs in individuals with metabolic bone disease, coupled with the harmonization of commercial assays to provide equivalent results, will further enhance their clinical applications.

血液或尿液中的骨转换标志物(BTM)测量反映了骨重塑率,可能有助于研究和临床管理代谢性骨病。近年来,随着几项指南的发布,支持BTM诊断使用的大量证据已经积累起来。大多数临床试验、观察和参考区间研究都是在北半球进行的,主要涉及高加索人群。这篇综述的重点是亚太地区人群的可用数据,并为在这些人群中使用BTM作为诊断生物标志物提供了指导。I型胶原的前胶原I N-末端前肽和β-异构C-末端前肽(在血浆中测量)是临床上用于研究骨质疏松症的参考BTM。绝经前参考间隔(为亚太地区人群制定)和参考变化值和治疗目标(用于监测骨质疏松症治疗)有助于指导骨质疏松症的管理。测量不受肾功能衰竭影响的BTM,如骨特异性同工酶碱性磷酸酶和酒石酸盐抗性酸性磷酸酶5b,可能对晚期慢性肾脏疾病患者有利。进一步研究BTM在代谢性骨病患者中的应用,再加上协调商业分析以提供同等结果,将进一步增强其临床应用。
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引用次数: 0
Predictive Performance of Neutrophil Gelatinase Associated Lipocalin, Liver Type Fatty Acid Binding Protein, and Cystatin C for Acute Kidney Injury and Mortality in Severely Ill Patients. 中性粒细胞明胶酶相关脂蛋白、肝型脂肪酸结合蛋白和半胱氨酸蛋白酶抑制剂C对重症患者急性肾损伤和死亡率的预测作用。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-09-26 DOI: 10.3343/alm.2023.0083
Ayu Asakage, Shiro Ishihara, Louis Boutin, François Dépret, Takeshi Sugaya, Naoki Sato, Etienne Gayat, Alexandre Mebazaa, Benjamin Deniau

Background: Acute kidney injury (AKI) is a common condition in severely ill patients associated with poor outcomes. We assessed the associations between urinary neutrophil gelatinase-associated lipocalin (uNGAL), urinary liver-type fatty acid-binding protein (uLFABP), and urinary cystatin C (uCysC) concentrations and patient outcomes.

Methods: We assessed the predictive performances of uNGAL, uLFABP, and uCysC measured in the early phase of intensive care unit (ICU) management and at discharge from the ICU in severely ill patients for short- and long-term outcomes. The primary outcome was the occurrence of AKI during ICU stay; secondary outcomes were 28-day and 1-yr allcause mortality.

Results: In total, 1,759 patients were admitted to the ICU, and 728 (41.4%) developed AKI. Median (interquartile range, IQR) uNGAL, uLFABP, and uCysC concentrations on admission were 147.6 (39.9-827.7) ng/mL, 32.4 (10.5-96.0) ng/mL, and 0.33 (0.12-2.05) mg/L, respectively. Biomarker concentrations on admission were higher in patients who developed AKI and associated with AKI severity. Three hundred fifty-six (20.3%) and 647 (37.9%) patients had died by 28 days and 1-yr, respectively. Urinary biomarker concentrations at ICU discharge were higher in non-survivors than in survivors. The areas under the ROC curve (95% confidence interval) of uLFABP for the prediction of AKI, 28-day mortality, and 1-yr mortality (0.70 [0.67-0.72], 0.63 [0.59-0.66], and 0.57 [0.51-0.63], respectively) were inferior to those of the other biomarkers.

Conclusions: uNGAL, uLFABP, and uCysC concentrations on admission were associated with poor outcomes. However, their predictive performance, individually and in combination, was limited. Further studies are required to confirm our results.

背景:急性肾损伤(AKI)是重症患者的常见疾病,预后不佳。我们评估了尿中性粒细胞明胶酶相关脂质运载蛋白(uNGAL)、尿肝型脂肪酸结合蛋白(uLFABP)和尿胱抑素C(uCysC)浓度与患者预后之间的关系。方法:我们评估了在重症监护室(ICU)管理的早期阶段和重症患者出院时测量的uNGAL、uLFABP和uCysC对短期和长期结果的预测性能。主要结果是ICU期间AKI的发生;次要转归为28天和1年全因死亡率。结果:共有1759名患者入住ICU,728人(41.4%)出现AKI。入院时的中位(四分位间距,IQR)uNGAL、uLFABP和uCysC浓度分别为147.6(39.9-827.7)ng/mL、32.4(10.5-96.0)ng/mL和0.33(0.12-2.05)mg/L。出现AKI并与AKI严重程度相关的患者入院时的生物标志物浓度较高。截至28天和1年,分别有356名(20.3%)和647名(37.9%)患者死亡。ICU出院时,非幸存者的尿液生物标志物浓度高于幸存者。uLFABP预测AKI、28天死亡率和1年死亡率的ROC曲线下面积(95%置信区间)(分别为0.70[0.67-0.72]、0.63[0.59-0.66]和0.57[0.51-0.63])低于其他生物标志物。结论:入院时的uNGAL、uLFABP和uCysC浓度与不良预后相关。然而,它们的预测性能,无论是单独的还是组合的,都是有限的。需要进一步的研究来证实我们的结果。
{"title":"Predictive Performance of Neutrophil Gelatinase Associated Lipocalin, Liver Type Fatty Acid Binding Protein, and Cystatin C for Acute Kidney Injury and Mortality in Severely Ill Patients.","authors":"Ayu Asakage, Shiro Ishihara, Louis Boutin, François Dépret, Takeshi Sugaya, Naoki Sato, Etienne Gayat, Alexandre Mebazaa, Benjamin Deniau","doi":"10.3343/alm.2023.0083","DOIUrl":"10.3343/alm.2023.0083","url":null,"abstract":"<p><strong>Background: </strong>Acute kidney injury (AKI) is a common condition in severely ill patients associated with poor outcomes. We assessed the associations between urinary neutrophil gelatinase-associated lipocalin (uNGAL), urinary liver-type fatty acid-binding protein (uLFABP), and urinary cystatin C (uCysC) concentrations and patient outcomes.</p><p><strong>Methods: </strong>We assessed the predictive performances of uNGAL, uLFABP, and uCysC measured in the early phase of intensive care unit (ICU) management and at discharge from the ICU in severely ill patients for short- and long-term outcomes. The primary outcome was the occurrence of AKI during ICU stay; secondary outcomes were 28-day and 1-yr allcause mortality.</p><p><strong>Results: </strong>In total, 1,759 patients were admitted to the ICU, and 728 (41.4%) developed AKI. Median (interquartile range, IQR) uNGAL, uLFABP, and uCysC concentrations on admission were 147.6 (39.9-827.7) ng/mL, 32.4 (10.5-96.0) ng/mL, and 0.33 (0.12-2.05) mg/L, respectively. Biomarker concentrations on admission were higher in patients who developed AKI and associated with AKI severity. Three hundred fifty-six (20.3%) and 647 (37.9%) patients had died by 28 days and 1-yr, respectively. Urinary biomarker concentrations at ICU discharge were higher in non-survivors than in survivors. The areas under the ROC curve (95% confidence interval) of uLFABP for the prediction of AKI, 28-day mortality, and 1-yr mortality (0.70 [0.67-0.72], 0.63 [0.59-0.66], and 0.57 [0.51-0.63], respectively) were inferior to those of the other biomarkers.</p><p><strong>Conclusions: </strong>uNGAL, uLFABP, and uCysC concentrations on admission were associated with poor outcomes. However, their predictive performance, individually and in combination, was limited. Further studies are required to confirm our results.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"144-154"},"PeriodicalIF":4.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41106195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring Renal Function Assessment: Creatinine, Cystatin C, and Estimated Glomerular Filtration Rate Focused on the European Kidney Function Consortium Equation. 探讨肾功能评估:肌酸酐、半胱氨酸蛋白酶抑制剂C和估计肾小球滤过率,重点关注欧洲肾功能联盟方程。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-11-01 DOI: 10.3343/alm.2023.0237
Hans Pottel, Pierre Delanaye, Etienne Cavalier

Serum creatinine and serum cystatin C are the most widely used renal biomarkers for calculating the estimated glomerular filtration rate (eGFR), which is used to estimate the severity of kidney damage. In this review, we present the basic characteristics of these biomarkers, their advantages and disadvantages, some basic history, and current laboratory measurement practices with state-of-the-art methodology. Their clinical utility is described in terms of normal reference intervals, graphically presented with age-dependent reference intervals, and their use in eGFR equations.

血清肌酐和血清胱抑素C是用于计算估计肾小球滤过率(eGFR)的最广泛使用的肾脏生物标志物,用于估计肾损伤的严重程度。在这篇综述中,我们介绍了这些生物标志物的基本特征、它们的优缺点、一些基本历史以及目前最先进的实验室测量方法。它们的临床实用性以正常参考区间描述,以年龄相关参考区间图示,并在eGFR方程中使用。
{"title":"Exploring Renal Function Assessment: Creatinine, Cystatin C, and Estimated Glomerular Filtration Rate Focused on the European Kidney Function Consortium Equation.","authors":"Hans Pottel, Pierre Delanaye, Etienne Cavalier","doi":"10.3343/alm.2023.0237","DOIUrl":"10.3343/alm.2023.0237","url":null,"abstract":"<p><p>Serum creatinine and serum cystatin C are the most widely used renal biomarkers for calculating the estimated glomerular filtration rate (eGFR), which is used to estimate the severity of kidney damage. In this review, we present the basic characteristics of these biomarkers, their advantages and disadvantages, some basic history, and current laboratory measurement practices with state-of-the-art methodology. Their clinical utility is described in terms of normal reference intervals, graphically presented with age-dependent reference intervals, and their use in eGFR equations.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"135-143"},"PeriodicalIF":4.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628758/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71420161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Next-Generation Sequencing-Based Molecular Profiling Using Cell-Free DNA: A Valuable Tool for the Diagnostic and Prognostic Evaluation of Patients With Gastric Cancer. 使用无细胞DNA进行基于下一代序列的分子谱分析:癌症患者诊断和预后评估的有价值工具。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-26 DOI: 10.3343/alm.2023.0391
Mi-Ae Jang
{"title":"Next-Generation Sequencing-Based Molecular Profiling Using Cell-Free DNA: A Valuable Tool for the Diagnostic and Prognostic Evaluation of Patients With Gastric Cancer.","authors":"Mi-Ae Jang","doi":"10.3343/alm.2023.0391","DOIUrl":"10.3343/alm.2023.0391","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"119-121"},"PeriodicalIF":4.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50160515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identification of Potential Genomic Alterations Using Pan-Cancer Cell-Free DNA Next-Generation Sequencing in Patients With Gastric Cancer. 用泛癌细胞游离DNA下一代测序法鉴定癌症患者潜在的基因组改变。
IF 4.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-30 DOI: 10.3343/alm.2023.0187
Boyeon Kim, Yoonjung Kim, Jae Yong Cho, Kyung-A Lee

Background: Molecular cancer profiling may lead to appropriate trials for molecularly targeted therapies. Cell-free DNA (cfDNA) is a promising diagnostic and/or prognostic biomarker in gastric cancer (GC). We characterized somatic genomic alterations in cfDNA of patients with GC.

Methods: Medical records and cfDNA data of 81 patients diagnosed as having GC were reviewed. Forty-nine and 32 patients were tested using the Oncomine Pan-Cancer Cell-Free Assay on the Ion Torrent platform and AlphaLiquid 100 kit on the Illumina platform, respectively.

Results: Tier I or II alterations were detected in 64.2% (52/81) of patients. Biomarkers for potential targeted therapy were detected in 55.6% of patients (45/81), and clinical trials are underway. ERBB2 amplification is actionable and was detected in 4.9% of patients (4/81). Among biomarkers showing potential for possible targeted therapy, TP53 mutation (38.3%, 35 variants in 31 patients, 31/81) and FGFR2 amplification (6.2%, 5/81) were detected the most.

Conclusions: Next-generation sequencing of cfDNA is a promising technique for the molecular profiling of GC. Evidence suggests that cfDNA analysis can provide accurate and reliable information on somatic genomic alterations in patients with GC, potentially replacing tissue biopsy as a diagnostic and prognostic tool. Through cfDNA analysis for molecular profiling, it may be possible to translate the molecular classification into therapeutic targets and predictive biomarkers, leading to personalized treatment options for patients with GC in the future.

背景:分子癌症图谱可能导致分子靶向治疗的适当试验。无细胞DNA(cfDNA)是癌症(GC)的一种很有前途的诊断和/或预后生物标志物。我们对GC患者cfDNA的体细胞基因组变化进行了表征。方法:对81例胃癌患者的病历资料和cfDNA资料进行回顾性分析。分别使用Ion Torrent平台上的Oncomine Pan-Cancer Cell-Free Assay和Illumina平台上的AlphaLiquid 100试剂盒对49名和32名患者进行了测试。结果:64.2%(52/81)的患者检测到I或II级改变。55.6%的患者(45/81)检测到潜在靶向治疗的生物标志物,临床试验正在进行中。ERBB2扩增是可行的,在4.9%的患者中检测到(4/81)。在显示可能靶向治疗潜力的生物标志物中,检测到的TP53突变(38.3%,31名患者中有35种变体,31/81)和FGFR2扩增(6.2%,5/81)最多。结论:cfDNA的下一代测序是一种很有前途的GC分子图谱分析技术。有证据表明,cfDNA分析可以为GC患者的体细胞基因组改变提供准确可靠的信息,有可能取代组织活检作为诊断和预后工具。通过cfDNA分析进行分子图谱分析,可能将分子分类转化为治疗靶点和预测性生物标志物,从而为GC患者提供未来的个性化治疗选择。
{"title":"Identification of Potential Genomic Alterations Using Pan-Cancer Cell-Free DNA Next-Generation Sequencing in Patients With Gastric Cancer.","authors":"Boyeon Kim, Yoonjung Kim, Jae Yong Cho, Kyung-A Lee","doi":"10.3343/alm.2023.0187","DOIUrl":"10.3343/alm.2023.0187","url":null,"abstract":"<p><strong>Background: </strong>Molecular cancer profiling may lead to appropriate trials for molecularly targeted therapies. Cell-free DNA (cfDNA) is a promising diagnostic and/or prognostic biomarker in gastric cancer (GC). We characterized somatic genomic alterations in cfDNA of patients with GC.</p><p><strong>Methods: </strong>Medical records and cfDNA data of 81 patients diagnosed as having GC were reviewed. Forty-nine and 32 patients were tested using the Oncomine Pan-Cancer Cell-Free Assay on the Ion Torrent platform and AlphaLiquid 100 kit on the Illumina platform, respectively.</p><p><strong>Results: </strong>Tier I or II alterations were detected in 64.2% (52/81) of patients. Biomarkers for potential targeted therapy were detected in 55.6% of patients (45/81), and clinical trials are underway. <i>ERBB2</i> amplification is actionable and was detected in 4.9% of patients (4/81). Among biomarkers showing potential for possible targeted therapy, <i>TP53</i> mutation (38.3%, 35 variants in 31 patients, 31/81) and <i>FGFR2</i> amplification (6.2%, 5/81) were detected the most.</p><p><strong>Conclusions: </strong>Next-generation sequencing of cfDNA is a promising technique for the molecular profiling of GC. Evidence suggests that cfDNA analysis can provide accurate and reliable information on somatic genomic alterations in patients with GC, potentially replacing tissue biopsy as a diagnostic and prognostic tool. Through cfDNA analysis for molecular profiling, it may be possible to translate the molecular classification into therapeutic targets and predictive biomarkers, leading to personalized treatment options for patients with GC in the future.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"164-173"},"PeriodicalIF":4.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71410373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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Annals of Laboratory Medicine
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