| 纯度 | >90%SDS-PAGE. |
| 种属 | Human |
| 靶点 | IVD |
| Uniprot No | P26440 |
| 内毒素 | < 0.01EU/μg |
| 表达宿主 | E.coli |
| 表达区间 | 30-423aa |
| 氨基酸序列 | H SLLPVDDAIN GLSEEQRQLR QTMAKFLQEH LAPKAQEIDR SNEFKNLREF WKQLGNLGVL GITAPVQYGG SGLGYLEHVL VMEEISRASG AVGLSYGAHS NLCINQLVRN GNEAQKEKYL PKLISGEYIG ALAMSEPNAG SDVVSMKLKA EKKGNHYILN GNKFWITNGP DADVLIVYAK TDLAAVPASR GITAFIVEKG MPGFSTSKKL DKLGMRGSNT CELIFEDCKI PAANILGHEN KGVYVLMSGL DLERLVLAGG PLGLMQAVLD HTIPYLHVRE AFGQKIGHFQ LMQGKMADMY TRLMACRQYV YNVAKACDEG HCTAKDCAGV ILYSAECATQ VALDGIQCFG GNGYINDFPM GRFLRDAKLY EIGAGTSEVR RLVIGRAFNA DFH |
| 预测分子量 | kDa |
| 蛋白标签 | His tag N-Terminus |
| 缓冲液 | PBS, pH7.4, containing 0.01% SKL, 1mM DTT, 5% Trehalose and Proclin300. |
| 稳定性 & 储存条件 | Lyophilized protein should be stored at ≤ -20°C, stable for one year after receipt. Reconstituted protein solution can be stored at 2-8°C for 2-7 days. Aliquots of reconstituted samples are stable at ≤ -20°C for 3 months. |
| 复溶 | Always centrifuge tubes before opening.Do not mix by vortex or pipetting. It is not recommended to reconstitute to a concentration less than 100μg/ml. Dissolve the lyophilized protein in distilled water. Please aliquot the reconstituted solution to minimize freeze-thaw cycles. |
以下是3-4篇与IVD(体外诊断)重组蛋白相关的示例参考文献(内容为模拟生成，非真实文献)：
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1. **文献名称**：*Development of Recombinant Antigens for Serodiagnosis of Infectious Diseases*
**作者**：Smith J. et al.
**摘要**：研究利用大肠杆菌表达系统制备重组蛋白抗原，用于HIV和肝炎病毒抗体检测试剂盒，验证其灵敏度和特异性优于传统抗原，为IVD提供低成本、高稳定性解决方案。
2. **文献名称**：*Optimization of Recombinant Protein Expression in Mammalian Cells for IVD Applications*
**作者**：Li X. & Wang H.
**摘要**：通过优化CHO细胞培养条件和载体设计，提高癌症标志物重组蛋白(如CEA、PSA)的产量和稳定性，满足IVD试剂对高纯度蛋白的需求，并验证其在临床检测中的一致性。
3. **文献名称**：*CRISPR-based Engineering of Recombinant Antibodies for Enhanced Diagnostic Performance*
**作者**：Chen R. et al.
**摘要**：利用CRISPR技术改造重组抗体的亲和力和交叉反应性，开发出针对SARS-CoV-2的高灵敏度检测试剂，显著降低假阳性率，推动IVD领域的抗体工程技术革新。
4. **文献名称**：*Comparative Study of Yeast vs. Bacterial Systems for IVD-grade Recombinant Protein Production*
**作者**：Garcia M. et al.
**摘要**：对比毕赤酵母和大肠杆菌表达系统在IVD重组蛋白(如炎症因子IL-6)生产中的优劣，分析糖基化修饰对诊断试剂性能的影响，为IVD企业选择表达平台提供依据。
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以上文献摘要涵盖重组蛋白在传染病、癌症检测、表达系统优化及新技术应用等方向，反映了IVD领域的关键研究热点。
**Background of Recombinant Proteins in IVD**
Recombinant proteins, engineered through genetic modification, play a pivotal role in modern *in vitro diagnostics* (IVD). These proteins are produced by inserting target DNA into host systems (e.g., bacteria, yeast, or mammalian cells), enabling scalable and consistent synthesis of specific proteins. Their application in IVD spans immunoassays, biosensors, and molecular diagnostics, where they serve as critical components like antigens, antibodies, enzymes, or calibrators.
The demand for recombinant proteins surged with advancements in precision medicine and personalized diagnostics. Traditional methods relying on animal-derived proteins faced challenges, including batch variability, ethical concerns, and risk of contamination. Recombinant technology addressed these issues by offering high purity, reproducibility, and customization. For example, recombinant antigens improve specificity in infectious disease tests (e.g., HIV, hepatitis), while engineered antibodies enhance sensitivity in cancer biomarker detection.
The COVID-19 pandemic further highlighted their importance. Rapid development of recombinant spike proteins accelerated SARS-CoV-2 antibody test kits and vaccine research. Additionally, innovations like fusion proteins or tagged variants streamline assay development, enabling multiplex testing and point-of-care solutions.
Despite progress, challenges persist. Complex proteins requiring post-translational modifications (e.g., glycosylation) often necessitate costly mammalian expression systems. Stability during storage and transport also remains a concern. Ongoing research focuses on optimizing expression platforms, improving yield, and enhancing thermal resilience.
Regulatory bodies emphasize stringent quality controls, aligning recombinant protein production with ISO 13485 and GMP standards to ensure diagnostic reliability. As IVD evolves toward automation and AI integration, recombinant proteins will remain foundational, driving innovations in accuracy, accessibility, and global health outcomes.
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