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Bio-Design and Manufacturing  2025 Vol.8 No.6 P.962-975

http://doi.org/10.1631/bdm.2500274


Pathological quality control chips for tuberculosis


Author(s):  Enru Ye (???), Jing He (??), Lingna Zhang (???), Chaofan He (???), Qiuju Zhou (???), Juan Xu (??), Meifu Gan (???) & Yong He (??)

Affiliation(s):  1 Department of Pathology, Taizhou Hospital, Zhejiang University, Linhai 317000, China 2 State Key Laboratory of Fluid Power and Mechatronic Systems & Liangzhu Laboratory, School of Mechanical Engineering, Zhejiang University, Hangzhou 310027, China 3 Key Laboratory of 3D Printing Process and Equipment of Zhejiang Province, School of Mechanical Engineering, Zhejiang University, Hangzhou 310027, China 4 Laboratory Department, Taizhou Hospital, Zhejiang University, Linhai 317000, China

Corresponding email(s):   xuj4806@enzemed.com, ganmf@enzemed.com

Key Words:  Mycobacterium tuberculosis (MTB) Pathological model Quality control (QC) chip


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Enru Ye (???), Jing He (??), Lingna Zhang (???), Chaofan He (???), Qiuju Zhou (???), Juan Xu (??), Meifu Gan (???) & Yong He (??) . Pathological quality control chips for tuberculosis[J]. Journal of Zhejiang University Science D, 2025, 8(6): 962-975.

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Abstract: 
Globally, approximately 10 million new tuberculosis (TB) cases are reported annually. Delayed diagnosis due to low detec tion rates is the primary cause of mortality. Although pathological examination is commonly used for diagnosing TB, 5% 30% of cases remain undiagnosed, emphasizing the urgent need to establish quality control (QC) standards to reduce rates of misdiagnosis and missed diagnoses. To address this, we introduced a novel QC chip for detecting Mycobacterium tuberculo sis (MTB). A quantitative pathological QC model was constructed by precisely and uniformly integrating MTB and HeLa cells into a photocurable hydrogel. This model was then sliced into uniform sections to create QC chips. It demonstrated that the QC chips exhibited no significant differences in intra-batch or inter-batch variation (coefficient of variation <5%), and re mained stable at ?80 C for one year. Furthermore, these chips were found to be 100% effective when tested with 240 clini cal samples (200 with special staining and 40 with polymerase chain reaction). In addition to enhancing TB detection rates, this approach offers visualization, quantification, and sustainable production. Overall, this work provides a novel framework for developing QC chips for pathological testing, offering a reliable solution to enhance clinical diagnostic workflows.

结核病病理质控芯片

作者:叶恩如1,何晶2,3,张玲娜1,何超凡2,3,周秋菊4,徐娟1,甘梅富1,贺永2,3 机构:1浙江大学台州医院病理科,中国临海市,317000;2浙江大学机械工程学院流体动力与机电系统国家重点实验室及良渚实验室,中国杭州市,310027;3浙江大学机械工程学院浙江省3D打印工艺与装备重点实验室,中国杭州市,310027;4浙江大学台州医院检验科,中国临海市,317000 目的:全球结核病(TB)新发病例高,低检出率导致的延误治疗仍是主要死因。尽管病理检查是诊断金标准,仍存在5%–30%的漏诊率,凸显了建立质控标准、降低误/漏诊率的紧迫性。本研究旨在研制一种新型的结核分枝杆菌检测质控芯片。 创新点:研制了一种检测结核分枝杆菌的新型质控芯片。该芯片通过将杆菌与 HeLa 细胞精确、均匀地包埋于光固化水凝胶中,构建定量病理质控模型,再切片制成。该方法实现了定量、可视化且可批量生产的质控标准,为结核病病理质控提供了新框架。 方法:研制了新型质控芯片,并进行了批内、批间性能验证和长期储存稳定性测试。使用该芯片对240例临床样本(200例特殊染色 + 40例PCR)进行了有效质控验证。 结论:新型质控芯片的批内、批间性能验证结果显示变异系数<5%,在–80 °C保存一年后仍保持稳定,并对240例临床样本实现了100%有效质控。该芯片为结核病病理质控提供了一个可靠的新框架,并有望优化临床工作流程。
关键词:结核分枝杆菌;病理模型;质控芯片;光固化水凝胶;定量质控;高稳定性

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