日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and

2025 年生物分析最新问题白皮书:生物标志物校准品和稳定性;核素标记免疫球蛋白结合免疫球蛋白 (NULISA) 的评估;神经丝和自身抗体生物标志物检测;消除 IgM 干扰;酶联免疫斑点 (ELISpot) 和荧光斑点 (FluoroSpot) 最佳实践;模块化高清流式细胞术;单细胞分析成像流式细胞术(第二部分 A - 关于生物标志物发现、开发、验证和监管审批、配体结合分析 (LBA) 和基于细胞的分析 (CBA) 的建议;第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断 (IVD/CDx) 的意见)

Hersey, Sarah; McGuire, Kristina; Kholmanskikh, Olga; Bivi, Nicoletta; Bandukwala, Abbas; Gong, Binsheng; Irwin, Chad; Ray, Soma; Gunsior, Michele; Avanesov, Andrei; Baker, Brian; Bond, Sarah; Braun, Alexander; Buoninfante, Alessandra; Dessy, Francis; Fang, Xiaodong; Garofolo, Fabio; Gomme, Emily; Hays, Amanda; King, Lindsay; Mayer, Christian; McGregor, Jessica; McHenry, Melis; Nowocin, Anna; Rubel, Carrie; Sanderink, Gerard; Scott, Bradley; Scully, Ingrid; Seyda, Agnes; Stoop, Jeroen; Tang, Huaping; Neto, Joao Tavares; Walravens, Karl; Wang, Kai; Wassmer, Sarah; Xiao, Wenming; Zhu, Liang; Zoghbi, Jad; Brockus, Catherine; Petit-Frere, Corinne; Coble, Kelly; Fischer, Sally; Yearwood, Graham; Cao, Liching; Dysinger, Mark; Grimaldi, Christine; Jiang, Yong; Joyce, Alison; Kerridge, Claire; Lu, Kun; McCush, Fred; Nolan, Katrina; Connor, Ellen O'; Palmer, Rachel; Reese, Kimberly; Stubenrauch, Kay-Gunnar; Verch, Thorsten; Beaver, Christopher; Mendez, Luis; Decman, Vilma; Bhavaraju, Kamala; Huleatt, James; Trampont, Paul C; Eck, Steven; Goihberg, Polina; Alcaide, Enrique Gomez; Hedrick, Michael Nathan; Jalah, Rashmi; McGrath, Shannon; Ogorman, William; Prior, Sandra; Sehra, Sarita; Shaik, Saleem; Standifer, Nathan; Stevens, Chad; Stevens, Erin; Sun, Yongliang Steve

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)

2024 年生物分析最新议题白皮书:美国实验室自建检测 (LDT) 和欧盟体外诊断医疗器械法规 (IVDR) 的影响;高参数流式细胞术的 AI/ML;Olink 技术的崛起;腺相关病毒 (AAV) 基因疗法的伴随诊断 (CDx);多平台整合生物分析;超灵敏 ADA/NAb 配体结合分析 (LBA)(第二部分 A - 生物标志物、体外诊断/伴随诊断检测 (BAV)、细胞检测 (CBA) 和配体结合分析 (LBA) 的高级策略建议;第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断和生物标志物检测验证的意见)

Bivi, Nicoletta; Graham, Danielle; Joglekar, Laura; McGuire, Kristina; Stoop, Jeroen; Zoghbi, Jad; Baker, Brian; Bandukwala, Abbas; Bond, Sarah; Buoninfante, Alessandra; Chen, Jeff; Dysinger, Mark; Engelbergs, Jörg; Fiscella, Michele; Garofolo, Fabio; Hopper, Shirley; Jones, Barry; King, Lindsay; Murphy, Rocio; Palmer, Rachel; Sanderink, Gerard; Seyda, Agnes; Tang, Huaping; Van Tuyl, Andrea; Wagner, Leslie; Walravens, Karl; Wang, Kai; Zander, Hilke; Zhu, Liang; Li, Ming; Lin, Yi-Dong; Natalia, Mahwish; Standifer, Nathan; Eck, Steven; Goihberg, Polina; Grugan, Katharine; Hedrick, Michael Nathan; Hopkins, Greg; Kar, Sumit; Keller, Steve; McGrath, Shannon; O'Gorman, Bill; Stevens, Chad; Stevens, Erin; Terszowski, Grzegorz; Trampont, Paul C; Yao, Shuyu; Joyce, Alison; Kumar, Seema; Owen, Carolina; Pine, Samuel; Yearwood, Graham; Cao, Liching; Clausen, Valerie; Coble, Kelly; Culbert, Andria; Gupta, Shalini; Hughes, Richard; Liu, Susana; Lu, Kun; Martello, Rita; Reese, Kimberly J; Stubenrauch, Kay-Gunnar; Wen, Yi

Mothers prefer a hybrid model of postpartum care: a pilot mixed method study

母亲们更倾向于混合式产后护理模式:一项混合方法试点研究

Moosa, Aminath Shiwaza; Poon, Zhimin; Koh, Lindy Ai Keng; Kagradaimdoo, Dhana Letchimy; Park, Yaesol; Yang, Yuhan; Bivi, Suliha; Ng, Ding Xuan; Ling, Eileen Koh Yi; Tan, Ngiap Chuan

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)

2023 年生物分析最新问题白皮书:ADA 检测的 ISR、dPCR 与 qPCR 的兴起、疫苗检测的国际参考标准、抗 AAV TAb 给药后评估、NanoString 验证、ELISpot 作为金标准(第三部分 - 关于基因治疗、细胞治疗、疫苗免疫原性和技术的建议;生物治疗免疫原性和风险评估;ADA/NAb 检测/报告协调)

Mora, Johanna; Palmer, Rachel; Wagner, Leslie; Wu, Bonnie; Partridge, Michael; Meena; Sonderegger, Ivo; Smeraglia, John; Bivi, Nicoletta; Dakappagari, Naveen; Diebold, Sandra; Garofolo, Fabio; Grimaldi, Christine; Kalina, Warren; Kamerud, John; Kar, Sumit; Marshall, Jean-Claude; Mayer, Christian; Melton, Andrew; Merdek, Keith; Nolan, Katrina; Picard, Serge; Shao, Weiping; Seitzer, Jessica; Tanaka, Yoichi; Tounekti, Omar; Vigil, Adam; Walravens, Karl; Xu, Joshua; Xu, Weifeng; Xu, Yuanxin; Yang, Lin; Zhu, Liang; Verthelyi, Daniela; Kubiak, Robert J; Coble, Kelly; Gupta, Swati; Abhari, Mohsen Rajabi; Richards, Susan; Song, Yuan; Ullmann, Martin; Calderon, Boris; Cludts, Isabelle; Gunn, George R; Gupta, Shalini; Ishii-Watabe, Akiko; Manangeeswaran, Mohanraj; Maxfield, Kimberly; McCush, Fred; O'Day, Christine; Peng, Kate; Poetzl, Johann; Rasamoelisolo, Michele; Saad, Ola M; Scheibner, Kara; Shubow, Sophie; Song, Sam; Thacker, Seth

Characterization of the cytokine storm reflects hyperinflammatory endothelial dysfunction in COVID-19

细胞因子风暴的特征反映了COVID-19中的过度炎症性内皮功能障碍

Sims, Jonathan T; Krishnan, Venkatesh; Chang, Ching-Yun; Engle, Sarah M; Casalini, Giacomo; Rodgers, George H; Bivi, Nicoletta; Nickoloff, Brian J; Konrad, Robert J; de Bono, Stephanie; Higgs, Richard E; Benschop, Robert J; Ottaviani, Silvia; Cardoso, Anabela; Nirula, Ajay; Corbellino, Mario; Stebbing, Justin

Efficacy of Facial Exercises in Facial Expression Categorization in Schizophrenia

面部练习对精神分裂症患者面部表情分类的疗效

Pancotti, Francesco; Mele, Sonia; Callegari, Vincenzo; Bivi, Raffaella; Saracino, Francesca; Craighero, Laila

Investigation of pre-existing reactivity to biotherapeutics can uncover potential immunogenic epitopes and predict immunogenicity risk

研究对生物治疗药物的预先反应可以发现潜在的免疫原性表位并预测免疫原性风险

Nicoletta Bivi, Terry Moore, George Rodgers, Heather Denning, Travis Shockley, Craig A Swearingen, Valentina Gelfanova, Boris Calderon, Daniel A Peterson, Michael E Hodsdon, Robert W Siegel, Richard E Higgs, Robert J Konrad

Assessment and Clinical Relevance of Serum IL-19 Levels in Psoriasis and Atopic Dermatitis Using a Sensitive and Specific Novel Immunoassay

利用一种灵敏且特异的新型免疫测定法评估银屑病和特应性皮炎患者血清IL-19水平及其临床意义

Konrad, Robert J; Higgs, Richard E; Rodgers, George H; Ming, Wenyu; Qian, Yue-Wei; Bivi, Nicoletta; Mack, Justin K; Siegel, Robert W; Nickoloff, Brian J

Stat3 in osteocytes mediates osteogenic response to loading

骨细胞中的Stat3介导负重引起的成骨反应。

Corry, Kylie A; Zhou, Hongkang; Brustovetsky, Tatiana; Himes, Evan R; Bivi, Nicoletta; Horn, M Ryne; Kitase, Yukiko; Wallace, Joseph M; Bellido, Teresita; Brustovetsky, Nickolay; Li, Jiliang

Control of Basal Stem Rot Disease in Oil Palm by Supplementation of Calcium, Copper, and Salicylic Acid

通过补充钙、铜和水杨酸来控制油棕基腐病

Bivi, M Shahul Hamid Rahamah; Paiko, Adamu Saidu; Khairulmazmi, Ahmad; Akhtar, M S; Idris, Abu Seman