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Transient presence of stomatocytes: A clue to the diagnosis of overhydrated hereditary stomatocytosis in a child with beta-thalassemia 一过性出现的口腔细胞:诊断β地中海贫血患儿遗传性口腔细胞过多症的线索
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-13 DOI: 10.1002/jcla.24991
Yanhui Chen, Qile Lin, Wenpeng Ni, Kunyi Deng, Lilian Li
Overhydrated hereditary stomatocytosis (OHSt) is a rare disorder characterized by abnormalities in erythrocytic volume homeostasis. Early and accurate diagnosis is essential for appropriate management and genetic counseling.
遗传性口细胞增生症(OHSt)是一种罕见的疾病,其特征是红细胞体积内平衡异常。早期和准确的诊断对于适当的管理和遗传咨询至关重要。
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引用次数: 0
Age-specific reference intervals for liver function tests in healthy neonates, infants, and young children in Iran 伊朗健康新生儿、婴幼儿肝功能检测的特定年龄参考区间
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-12 DOI: 10.1002/jcla.24995
Seyede Negin Badakhshan, Hamideh Ghazizadeh, Maryam Mohammadi-Bajgiran, Habibollah Esmaily, Mahdiyeh Yaghooti Khorasani, Mary Kathryn Bohn, Mehran Pashirzad, Atieh Kamel Khodabandeh, Sara Ghazi Zadeh, Iman Alami-Arani, Hamidreza Rahimi, Gordon A. Ferns, Hassan Boskabadi, Reza Assaran-Darban, Khosrow Adeli, Majid Ghayour-Mobarhan
The reference intervals (RIs) for liver function tests (LFTs) were determined in Iranian children for the first time.
首次在伊朗儿童中确定肝功能检查的参考区间(RIs)。
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引用次数: 0
The platelet storage lesion, what are we working for? 血小板贮存病变,我们在做什么?
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-09 DOI: 10.1002/jcla.24994
Cheng Liu, Yang Su, Wanwan Guo, Xiaolong Ma, Rui Qiao

Background

Platelet concentrate (PC) transfusions are crucial in prevention and treatment of bleeding in infection, surgery, leukemia, and thrombocytopenia patients. Although the technology for platelet preparation and storage has evolved over the decades, there are still challenges in the demand for platelets in blood banks because the platelet shelf life is limited to 5 days due to bacterial contamination and platelet storage lesions (PSLs) at 20–24°C under constant horizontal agitation. In addition, the relations between some adverse effects of platelet transfusions and PSLs have also been considered. Therefore, understanding the mechanisms of PSLs is conducive to obtaining high quality platelets and facilitating safe and effective platelet transfusions.

Objective

This review summarizes developments in mechanistic research of PSLs and their relationship with clinical practice, providing insights for future research.

Methods

Authors conducted a search on PubMed and Web of Science using the professional terms “PSL” and “platelet transfusion.” The obtained literature was then roughly categorized based on their research content. Similar studies were grouped into the same sections, and further searches were conducted based on the keywords of each section.

Results

Different studies have explored PSLs from various perspectives, including changes in platelet morphology, surface molecules, biological response modifiers (BMRs), metabolism, and proteins and RNA, in an attempt to monitor PSLs and identify intervention targets that could alleviate PSLs. Moreover, novel platelet storage conditions, including platelet additive solutions (PAS) and reconsidered cold storage methods, are explored. There are two approaches to obtaining high-quality platelets. One approach simulates the in vivo environment to maintain platelet activity, while the other keeps platelets at a low activity level in vitro under low temperatures.

Conclusion

Understanding PSLs helps us identify good intervention targets and assess the therapeutic effects of different PSLs stages for different patients.

输注浓缩血小板(PC)对预防和治疗感染、手术、白血病和血小板减少症患者的出血至关重要。尽管几十年来血小板制备和储存技术不断发展,但血库对血小板的需求仍面临挑战,因为细菌污染和血小板储存病变(PSLs)导致血小板在 20-24°C 温度下持续水平搅拌,使血小板保质期限制在 5 天。此外,血小板输注的一些不良反应与 PSLs 之间的关系也被考虑在内。因此,了解 PSLs 的机理有利于获得高质量的血小板,促进安全有效的血小板输注。
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引用次数: 0
Chinese expert consensus statement on the clinical application of AFP/AFP-L3%/DCP using GALAD and GALAD-like algorithm in HCC 使用 GALAD 和类 GALAD 算法对 AFP/AFP-L3%/DCP 在 HCC 中的临床应用的中国专家共识声明
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-08 DOI: 10.1002/jcla.24990
Chenjun Huang, Xiao Xiao, Lin Zhou, Fuxiang Chen, Jianyi Wang, Xiaobo Hu, Chunfang Gao
Primary hepatocellular carcinoma (HCC) is one of the most prevalent world-wide malignancies. Half of the newly developed HCC occurs in China. Optimizing the strategies for high-risk surveillance and early diagnosis are pivotal for improving 5-year survival. Constructing the scientific non-invasive detection technologies feasible for medical and healthcare institutions is among the key routes for elevating the efficacies of HCC identification and follow-up.
原发性肝细胞癌(HCC)是全球最常见的恶性肿瘤之一。新发的 HCC 有一半发生在中国。优化高危监测和早期诊断策略是提高 5 年生存率的关键。为医疗卫生机构构建科学可行的无创检测技术,是提高 HCC 识别和随访效率的关键途径之一。
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引用次数: 0
High-throughput RNA sequencing of the T cell receptor alpha and beta chains for simultaneous clonality and biological analyses in Sezary syndrome. 对T细胞受体α和β链进行高通量RNA测序,同时对塞扎里综合征进行克隆性和生物学分析。
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-12-19 DOI: 10.1002/jcla.24982
Gonzalo Blanco, Daniel López-Aventín, Ramon M Pujol, Andrea Gómez-Llonín, Anna Puiggros, Manuela López-Sánchez, Teresa Estrach, Mª Pilar García-Muret, Ingrid López-Lerma, Octavio Servitje, Beatriz Bellosillo, Manuel Muro, Blanca Espinet, Raquel Rabionet, Fernando Gallardo

Background: Previous investigations pointed out a role for antigen stimulation in Sezary syndrome (SS). High-throughput sequencing of the T cell receptor (TR) offers several applications beyond diagnostic purposes, including the study of T cell pathogenesis.

Methods: We performed high-throughput RNA sequencing of the TR alpha (TRA) and beta (TRB) genes focusing on the complementarity-determining region 3 (CDR3) in 11 SS and one erythrodermic mycosis fungoides (MF) patients. Five psoriasis patients were employed as controls. Peripheral blood CD4+ cells were isolated and RNA sequenced (HiSeq2500). High-resolution HLA typing was performed in neoplastic patients.

Results: Highly expanded predominant TRA and TRB CDR3 were only found in SS patients (median frequency: 94.4% and 93.7%). No remarkable CDR3 expansions were observed in psoriasis patients (median frequency of predominant TRA and TRB CDR3: 0.87% and 0.69%, p < 0.001 compared to SS). CDR3 almost identical to the predominant were identified within each SS patient and were exponentially correlated with frequencies of the predominant CDR3 (R2  = 0.918, p < 0.001). Forty-six different CDR3 were shared between SS patients displaying HLA similarities, including predominant TRA and TRB CDR3 in one patient that were found in other three patients. Additionally, 351 antigen matches were detected (Cytomegalovirus, Epstein-Barr, Influenza virus, and self-antigens), and the predominant CDR3 of two different SS patients matched CDR3 with specificity for Influenza and Epstein-Barr viruses.

Conclusions: Besides detecting clonality, these findings shed light on the nature of SS-related antigens, pointing to RNA sequencing as a useful tool for simultaneous clonality and biological analysis in SS.

背景:以前的研究指出了抗原刺激在塞扎里综合征(SS)中的作用。T细胞受体(TR)的高通量测序提供了一些诊断以外的应用,包括对T细胞发病机制的研究:我们对 11 名 SS 患者和一名红皮病型放线菌病(MF)患者的 TR alpha (TRA) 和 beta (TRB) 基因进行了高通量 RNA 测序,重点是互补性决定区 3 (CDR3)。五名银屑病患者作为对照。分离外周血 CD4+ 细胞并进行 RNA 测序(HiSeq2500)。对肿瘤患者进行了高分辨率 HLA 分型:结果:仅在 SS 患者中发现 TRA 和 TRB CDR3 高度扩增(中位频率:94.4% 和 93.7%)。在银屑病患者中未观察到明显的 CDR3 扩增(TRA 和 TRB CDR3 优势频率的中位数:0.87% 和 0.69%,P 2 = 0.918,P 结论:除了检测克隆性外,这些研究还发现,在银屑病患者中,TRA 和 TRB CDR3 的扩增频率分别为 0.87%和 0.69%,P 2 = 0.918:除了检测克隆性,这些发现还揭示了 SS 相关抗原的性质,表明 RNA 测序是同时进行 SS 克隆性和生物学分析的有用工具。
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引用次数: 0
Evaluation of the fully automated urine particle analyzer UF-1500. 全自动尿液颗粒分析仪UF-1500的评估。
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-12-02 DOI: 10.1002/jcla.24993
Yoshifumi Morita, Rin Yokoyama, Masami Tanaka, Naru Nakatsuka, Takashi Hisasue, Yoshikazu Ono, Makoto Kurano

Background and aims: This study primarily assessed the performance of the UF-1500, the novel and compact model of the fully automated urine particle analyzer and evaluated its performance against the existing UF-5000 instrument.

Materials and methods: A total of 648 residual urine specimens were randomly collected and examined using both the UF-1500 and UF-5000 instruments as well as manual microscopy. For each parameter, the concordance rates and detection accuracy of the UF-1500 against manual microscopy were compared with the UF-5000.

Results: The concordance rates between the UF-1500 and manual microscopy were 75.3%-98.5%. The UF-1500 concordance rates within one group agreement were observed to be >90%, for all parameters except for YLCs. The differences within one group agreement between the UF-1500 and manual microscopy were insignificant, in comparison to the UF-5000, with exceptions noted for ECs and YLCs. The sensitivity and specificity of the UF-1500 for RBCs, WBCs, Squa.ECs, and BACT exceeded 80%, while the positive predictive values of ECs and CASTs were below 70%.

Conclusion: The UF-1500 exhibited a performance that was comparable to the existing instrument, the UF-5000, and was suitable to be introduced in clinical practice. For the samples with suspected false-positive or false-negative results, a manual microscopic examination is required for accurate testing.

背景和目的:本研究主要评估了新型紧凑型全自动尿液颗粒分析仪UF-1500的性能,并将其与现有的UF-5000仪器进行了比较。材料与方法:随机收集648份残尿标本,采用UF-1500、UF-5000仪器及人工显微镜检查。对于每个参数,将UF-1500与UF-5000对手工显微镜的一致性率和检测精度进行比较。结果:UF-1500与人工镜检的符合率为75.3% ~ 98.5%。在一组协议中,除YLCs外,所有参数的UF-1500一致性率均>90%。与UF-5000相比,UF-1500和手动显微镜在一组协议内的差异微不足道,除了ec和ylc例外。UF-1500检测红细胞、白细胞、白细胞的敏感性和特异性。ECs、BACT阳性预测值均超过80%,ECs、cast阳性预测值均低于70%。结论:UF-1500具有与现有仪器UF-5000相当的性能,适合在临床推广使用。对于疑似假阳性或假阴性结果的样品,需要进行人工显微镜检查以进行准确检测。
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引用次数: 0
Performance evaluation of sperm concentration, motility, and morphological analysis for GSA-810 series of sperm quality analysis system. GSA-810系列精子质量分析系统的精子浓度、活力及形态分析性能评价。
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-11-27 DOI: 10.1002/jcla.24986
Yan-Mei Ge, Jin-Chun Lu, Shan-Shan Tang, Yuan-Hua Xu, Yuan-Jiao Liang

Background: The performance evaluation of each computer-assisted sperm analysis (CASA) system may provide a basis for the interpretation of clinical results and further improvement of the CASA system.

Methods: The accuracy of the GSA-810 CASA system was evaluated by detecting latex bead quality control products. The precision of sperm concentration, morphology, and percentages of progressively motile sperm (PR) were evaluated by coefficient of variation (CV). Three samples with sperm concentration of about 100 × 106 /mL were diluted to evaluate the linear range.

Results: The detection values of latex beads were within the range of target values. The CVs of sperm concentration and PR were significantly and negatively correlated with sperm concentration (r = -0.561, p = 0.001) and PR value (r = -0.621, p < 0.001), respectively. The R2 values of the linear range of sperm concentration were ≥0.99. There was no significant difference in sperm motility and PR within 1-10 min at 36.5°C ± 0.5°C. The coincidence rates of sperm morphology and sperm head morphology for 36 semen samples analyzed by the GSA-810 system and manual method were 99.40% and 99.67%, respectively. The CVs of the percentage of sperm with abnormal morphology and percentage of sperm with abnormal head morphology were less than 5%.

Conclusion: The GSA-810 system can accurately analyze normal semen samples, but the repeatability of the results is poor for oligozoospermia and asthenozoospermia samples. The future CASA system for analyzing sperm morphology should focus on recognizing the middle and tail segments of a spermatozoon.

背景:对各计算机辅助精子分析(CASA)系统的性能进行评价,可为临床结果的解释和进一步完善CASA系统提供依据。方法:通过检测乳胶珠质控品,对GSA-810 CASA系统的准确性进行评价。通过变异系数(CV)评估精子浓度、形态和渐进式活动精子(PR)百分比的精度。对精子浓度约为100 × 106 /mL的3份样品进行稀释,评价其线性范围。结果:乳珠的检出值在目标值范围内。精子浓度、PR的cv与精子浓度呈显著负相关(r = -0.561, p = 0.001), PR值呈显著负相关(r = -0.621, p 2值在精子浓度线性范围≥0.99)。在36.5℃±0.5℃条件下,1 ~ 10 min内精子活力和PR无显著差异。GSA-810系统与手工方法分析的36份精液样本精子形态与精子头形态符合率分别为99.40%和99.67%。精子形态异常百分率和头部形态异常百分率的cv值均小于5%。结论:GSA-810系统能准确分析正常精液样本,但对少精症和弱精症样本结果重复性较差。未来用于精子形态分析的CASA系统应侧重于识别精子的中间和尾部。
{"title":"Performance evaluation of sperm concentration, motility, and morphological analysis for GSA-810 series of sperm quality analysis system.","authors":"Yan-Mei Ge, Jin-Chun Lu, Shan-Shan Tang, Yuan-Hua Xu, Yuan-Jiao Liang","doi":"10.1002/jcla.24986","DOIUrl":"10.1002/jcla.24986","url":null,"abstract":"<p><strong>Background: </strong>The performance evaluation of each computer-assisted sperm analysis (CASA) system may provide a basis for the interpretation of clinical results and further improvement of the CASA system.</p><p><strong>Methods: </strong>The accuracy of the GSA-810 CASA system was evaluated by detecting latex bead quality control products. The precision of sperm concentration, morphology, and percentages of progressively motile sperm (PR) were evaluated by coefficient of variation (CV). Three samples with sperm concentration of about 100 × 10<sup>6</sup> /mL were diluted to evaluate the linear range.</p><p><strong>Results: </strong>The detection values of latex beads were within the range of target values. The CVs of sperm concentration and PR were significantly and negatively correlated with sperm concentration (r = -0.561, p = 0.001) and PR value (r = -0.621, p < 0.001), respectively. The R<sup>2</sup> values of the linear range of sperm concentration were ≥0.99. There was no significant difference in sperm motility and PR within 1-10 min at 36.5°C ± 0.5°C. The coincidence rates of sperm morphology and sperm head morphology for 36 semen samples analyzed by the GSA-810 system and manual method were 99.40% and 99.67%, respectively. The CVs of the percentage of sperm with abnormal morphology and percentage of sperm with abnormal head morphology were less than 5%.</p><p><strong>Conclusion: </strong>The GSA-810 system can accurately analyze normal semen samples, but the repeatability of the results is poor for oligozoospermia and asthenozoospermia samples. The future CASA system for analyzing sperm morphology should focus on recognizing the middle and tail segments of a spermatozoon.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e24986"},"PeriodicalIF":2.7,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10756940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138444858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Expanded molecular detection of MPL codon p.W515 and p.S505N mutations in myeloproliferative neoplasms. MPL密码子p.W515和p.S505N突变在骨髓增长性肿瘤中的扩展分子检测。
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-12-07 DOI: 10.1002/jcla.24992
Eric W Miller, Celeste M Lamberson, Ratilal R Akabari, Michel R Nasr, Steven M Sperber

Background: Patients negative for the JAK2 p.V617F somatic variant are frequently reflexed to testing for MPL exon 10 variants. Detection of these variants via multiplexed allele-specific PCR followed by fragment analysis has been previously published. The present study builds on this concept by improving the detection of the p.W515A variant, adding a second allele-specific primer to detect the p.W515R variant, and incorporating an improved primer for p.S505N detection.

Methods: The W515 amplification employs 5'-labeled allele-specific forward primers to detect p.W515K, p.W515L, p.W515R, and p.W515A. The p.S505N amplification includes an allele-specific reverse primer with a tail extension. Fragments were subject to capillary electrophoresis on an ABI 3500 Genetic Analyzer and analyzed using GeneMapper 6.0 (Thermo Fisher Scientific).

Results: Thirty MPL-negative and 13 MPL-positive samples previously tested by a reference laboratory were tested with the MPL LDT. Results were 100% concordant. The MPL LDT has a limit of detection of at least 5% VAF for the p.W515 variants and 10% VAF for the p.S505N variant.

Conclusion: Current MPL assays are predominantly focused on p.W515L/K and p.S505N mutations. We have engineered an MPL test for detecting p.W515A/L/K/R and p.S505N variants, thereby increasing the diagnostic yield with little additional expense or technician time.

背景:JAK2 p.V617F体细胞变异体阴性的患者经常对MPL外显子10变异体进行检测。通过多重等位基因特异性PCR检测这些变异,然后进行片段分析已经发表。本研究在此基础上改进了p.W515A变异的检测,增加了第二个等位基因特异性引物来检测p.W515R变异,并结合了一个改进的引物来检测p.S505N。方法:W515扩增采用5′标记等位基因特异性正向引物检测p.W515K、p.W515L、p.W515R和p.W515A。p.S505N扩增包括一个带有尾部延伸的等位基因特异性反向引物。片段在ABI 3500遗传分析仪上进行毛细管电泳,使用GeneMapper 6.0 (Thermo Fisher Scientific)进行分析。结果:30个MPL阴性和13个MPL阳性样本先前在参考实验室检测,用MPL LDT检测。结果100%一致。MPL LDT对p.W515型和p.S505N型具有至少5% VAF和10% VAF的检测极限。结论:目前的MPL检测主要集中在p.W515L/K和p.S505N突变。我们设计了一种MPL测试,用于检测p.W515A/L/K/R和p.S505N变体,从而在几乎没有额外费用或技术人员时间的情况下提高了诊断率。
{"title":"Expanded molecular detection of MPL codon p.W515 and p.S505N mutations in myeloproliferative neoplasms.","authors":"Eric W Miller, Celeste M Lamberson, Ratilal R Akabari, Michel R Nasr, Steven M Sperber","doi":"10.1002/jcla.24992","DOIUrl":"10.1002/jcla.24992","url":null,"abstract":"<p><strong>Background: </strong>Patients negative for the JAK2 p.V617F somatic variant are frequently reflexed to testing for MPL exon 10 variants. Detection of these variants via multiplexed allele-specific PCR followed by fragment analysis has been previously published. The present study builds on this concept by improving the detection of the p.W515A variant, adding a second allele-specific primer to detect the p.W515R variant, and incorporating an improved primer for p.S505N detection.</p><p><strong>Methods: </strong>The W515 amplification employs 5'-labeled allele-specific forward primers to detect p.W515K, p.W515L, p.W515R, and p.W515A. The p.S505N amplification includes an allele-specific reverse primer with a tail extension. Fragments were subject to capillary electrophoresis on an ABI 3500 Genetic Analyzer and analyzed using GeneMapper 6.0 (Thermo Fisher Scientific).</p><p><strong>Results: </strong>Thirty MPL-negative and 13 MPL-positive samples previously tested by a reference laboratory were tested with the MPL LDT. Results were 100% concordant. The MPL LDT has a limit of detection of at least 5% VAF for the p.W515 variants and 10% VAF for the p.S505N variant.</p><p><strong>Conclusion: </strong>Current MPL assays are predominantly focused on p.W515L/K and p.S505N mutations. We have engineered an MPL test for detecting p.W515A/L/K/R and p.S505N variants, thereby increasing the diagnostic yield with little additional expense or technician time.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e24992"},"PeriodicalIF":2.7,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10756946/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138498548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Application of the cell-based RT-qPCR assay (C-QPA) for potency detection of the novel trivalent rotavirus vaccine in China. 基于细胞的RT-qPCR法(C-QPA)在新型三价轮状病毒疫苗效力检测中的应用
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-11-17 DOI: 10.1002/jcla.24989
Yunjin Wang, YueYue Liu, Hong Bao, Yueru Chen, Guiying Kou, Mingqiang Wang, Shengfang Fu, Wen Huo, Wenzhu Guan, Yahui Cheng, Xu Zhou, Xiongxiong Li

Background: Because of the deficiencies of traditional methods in multivalent rotavirus vaccine potency detection, a cell-based quantitative RT-qPCR assay (C-QPA) was established and validated for specificity, precision, and accuracy.

Methods: In order to further validate the robustness of this method in actual titer detection, the linear range and the practical application under different conditions were tested using monovalent and trivalent rotavirus samples and standards.

Results: Results showed that the linear range was 2.0-6.5, 3.9-8.3, and 3.5-8.1 UI (unit of infectivity) for G2, G3, and G4, respectively. Besides, unknown sample with high titer exceeding the linear range can be calculated by dilution. The UIs of serotypes G2, G3, and G4 in monovalent and trivalent rotavirus samples showed a relative deviation ≤4.10%, and the monovalent samples of the same serotype with or without protective agents showed a relative deviation ≤4.28%; the coefficient of variation (CV) of at least 176 tests (548 individual runs) of 3 in vitro-transcribed RNA standards with certain concentrations was not higher than 6.50%; the results of the trivalent samples tested by more than 149 times in 5 years (467 individual runs) showed the CVs lower than 12.66%; 15 samples detected by one laboratory showed a CV lower than 9.83%, while other three samples tested by two independent laboratories showed a CV lower than 6.90%.

Conclusion: In summary, the C-QPA has good linearity, durability, repeatability, and reproducibility in practical application and has been proved by the authority to be widely used in the production, quality control and release of the recently licensed trivalent vaccine in China.

背景:针对传统多价轮状病毒疫苗效价检测方法的不足,建立了一种基于细胞的定量RT-qPCR检测方法(C-QPA),并对其特异性、精密度和准确性进行了验证。方法:为进一步验证该方法在实际滴度检测中的稳健性,分别采用单价和三价轮状病毒样品和标准品对其线性范围和不同条件下的实际应用情况进行检验。结果:结果显示,G2、G3和G4的线性范围分别为2.0 ~ 6.5、3.9 ~ 8.3和3.5 ~ 8.1 UI(传染性单位)。此外,通过稀释可以计算出超出线性范围的高效价的未知样品。单价和三价轮状病毒样品中血清型G2、G3和G4的相对偏差≤4.10%,同一血清型的单价样品在使用或不使用保护剂时相对偏差≤4.28%;3种特定浓度的体外转录RNA标准物至少176次(548组)的变异系数(CV)不大于6.50%;5年内检测次数大于149次(467次)的三价样品,cv < 12.66%;一个实验室检测的15个样品CV值低于9.83%,另外两个独立实验室检测的3个样品CV值低于6.90%。结论:综上所述,C-QPA在实际应用中具有良好的线性、耐用性、可重复性和再现性,已被权威机构证明可广泛应用于中国新近获批的三价疫苗的生产、质量控制和放行。
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引用次数: 0
A novel cuproptosis-related prognostic gene signature in adrenocortical carcinoma 肾上腺皮质癌中一种新的与铜裂相关的预后基因特征。
IF 2.7 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-23 DOI: 10.1002/jcla.24981
Wenjun Gao, Xiaoyan He, Qi Huangfu, Yanqi Xie, Keliang Chen, Chengfang Sun, Jingchao Wei, Bohan Wang

Background

Adrenocortical carcinoma (ACC) is an aggressive and rare malignant tumor associated with poor outcomes. Cuproptosis, a new pattern of cell death, relies on mitochondrial respiration and is associated with protein lipoylation. Increasing evidence has demonstrated the potential roles of cuproptosis in several tumor entities. However, the relationship between cuproptosis and ACC remains unclear.

Methods

In total, 10 cuproptosis-related genes (CRGs) of patients with ACC were obtained from the Gene Expression Omnibus (GEO) and The Cancer Genome Atlas (TCGA) databases and differential expression analysis of CRGs was analyzed. Functional enrichment of the CRGs was performed and protein–protein interaction analysis was utilized to explore the association between the CRGs. Cuproptosis-related risk score (CRRS) was constructed by Lasso Cox regression and validated.

Results

In the current study, the alteration and expression patterns of 10 CRGs in TCGA–ACC datasets were analyzed. We identified different expression patterns of CRGs in ACCs, discovered strong associations between CRGs and ACCs, and found that the CRGs were associated with immune infiltration in ACCs. A CRRS was created thereafter to predict overall survival (OS). CRRS = (0.083103718) *FDX1 + (−0.278423862) *LIAS+(0.090985682) *DLAT+(−0.018784047) *PDHA1 + (0.297218951) *MTF1 + (0.310197964) *CDKN2A. Patients were divided into high- and low-risk groups based on their CRRS, and independent prognostic factors were investigated. Finally, CDKN2A and FDX1 were found to be independent prognostic predictors of patients with ACC.

Conclusions

CDKN2A and FDX1 are independent prognostic predictors of patients with ACC. Cuproptosis may play a role in the development of ACC, providing a new perspective on therapeutic strategies related to CRGs for cancer prevention and treatment.

背景:肾上腺皮质癌(ACC)是一种侵袭性的罕见恶性肿瘤,预后较差。铜胞坏死是一种新的细胞死亡模式,依赖于线粒体呼吸,并与蛋白质脂酰化有关。越来越多的证据表明,铜增生在几种肿瘤实体中的潜在作用。然而,畸形与ACC之间的关系尚不清楚。方法:从基因表达图谱(Gene Expression Omnibus, GEO)和癌症基因组图谱(the Cancer Genome Atlas, TCGA)数据库中获取10个ACC患者铜裂相关基因(cuprotosis - correlation genes, CRGs),对CRGs进行差异表达分析。对CRGs进行功能富集,并利用蛋白-蛋白相互作用分析来探索CRGs之间的关联。采用Lasso Cox回归构建铜中毒相关风险评分(CRRS)并进行验证。结果:本研究分析了TCGA-ACC数据集中10个CRGs的变化和表达模式。我们鉴定了CRGs在ACCs中的不同表达模式,发现了CRGs与ACCs之间的强相关性,并发现CRGs与ACCs的免疫浸润有关。随后建立CRRS来预测总生存期(OS)。Crrs = (0.083103718) * fdx1 +(-0.278423862) * lias +(0.090985682) * dlat +(-0.018784047) * pdha1 +(0.297218951) * mtf1 +(0.310197964) * cdkn2a。根据患者的CRRS分为高危组和低危组,并调查独立预后因素。最后,CDKN2A和FDX1被发现是ACC患者的独立预后预测因子。结论:CDKN2A和FDX1是ACC患者预后的独立预测因子。cuprotosis可能在ACC的发生发展中发挥作用,为研究与CRGs相关的癌症防治治疗策略提供了新的视角。
{"title":"A novel cuproptosis-related prognostic gene signature in adrenocortical carcinoma","authors":"Wenjun Gao,&nbsp;Xiaoyan He,&nbsp;Qi Huangfu,&nbsp;Yanqi Xie,&nbsp;Keliang Chen,&nbsp;Chengfang Sun,&nbsp;Jingchao Wei,&nbsp;Bohan Wang","doi":"10.1002/jcla.24981","DOIUrl":"10.1002/jcla.24981","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Adrenocortical carcinoma (ACC) is an aggressive and rare malignant tumor associated with poor outcomes. Cuproptosis, a new pattern of cell death, relies on mitochondrial respiration and is associated with protein lipoylation. Increasing evidence has demonstrated the potential roles of cuproptosis in several tumor entities. However, the relationship between cuproptosis and ACC remains unclear.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In total, 10 cuproptosis-related genes (CRGs) of patients with ACC were obtained from the Gene Expression Omnibus (GEO) and The Cancer Genome Atlas (TCGA) databases and differential expression analysis of CRGs was analyzed. Functional enrichment of the CRGs was performed and protein–protein interaction analysis was utilized to explore the association between the CRGs. Cuproptosis-related risk score (CRRS) was constructed by Lasso Cox regression and validated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the current study, the alteration and expression patterns of 10 CRGs in TCGA–ACC datasets were analyzed. We identified different expression patterns of CRGs in ACCs, discovered strong associations between CRGs and ACCs, and found that the CRGs were associated with immune infiltration in ACCs. A CRRS was created thereafter to predict overall survival (OS). CRRS = (0.083103718) *FDX1 + (−0.278423862) *LIAS+(0.090985682) *DLAT+(−0.018784047) *PDHA1 + (0.297218951) *MTF1 + (0.310197964) *CDKN2A. Patients were divided into high- and low-risk groups based on their CRRS, and independent prognostic factors were investigated. Finally, CDKN2A and FDX1 were found to be independent prognostic predictors of patients with ACC.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>CDKN2A and FDX1 are independent prognostic predictors of patients with ACC. Cuproptosis may play a role in the development of ACC, providing a new perspective on therapeutic strategies related to CRGs for cancer prevention and treatment.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"37 21-22","pages":""},"PeriodicalIF":2.7,"publicationDate":"2023-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10749488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138299195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
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