Test strip useful for e.g. detecting colloidal gold antibody of pathogenic Rhodococcus equi, comprises e.g. sample pad, gold mark pad, nitrocellulose test membrane and water absorbing pad arranged on bottom plate, where nitrocellulose test membrane is provided with test line and quality control line
用于例如检测病原性马红球菌胶体金抗体的试纸条，包括例如样品垫、金标记垫、硝酸纤维素测试膜和底部板上的吸水垫，其中硝酸纤维素测试膜设有测试线和质量控制线
摘要 (Abstract)
<jats:p>Porcine Epidemic Diarrhea Virus (PEDV) infection has caused huge economic losses, but no serological method is available for batch detection of field samples. The aim of the study was to develop a method for large-batch detection of PEDV infection. Colloidal gold-labeled staphylococcal protein A (SPA) was sprayed on glass fibers to prepare a conjugate pad. The recombinant N protein of PEDV was blotted on the test line of the nitrocellulose (NC) membrane, and pig IgG was streaked on the control line of the NC membrane. The immunochromatographic strip was used for detection of antibodies against PEDV. The results showed that the strip test was simple and the results could be determined within 10 min with naked eyes. The test strip was highly specific for pig serum against PEDV and no cross-reaction was observed. The test strip had close similarity with ELISA. Storage at room temperature for 6 months did not affect the specificity and sensitivity obviously. A total of 320 clinical pig sera were detected by both ELISA and the developed test strip, and the coincidence was 96.3 %. Therefore, the developed immunochromatographic strip is specific, sensitive, stable, fast and simple, and it is suitable for on-site detection of antibodies against PEDV.</jats:p>
实验设计与方法 (Experimental Design & Methods)
采用喷雾干燥、冷冻干燥等干燥技术制备蛋白质制剂，系统考察工艺参数对产品稳定性和生物活性的影响。通过HPLC、SDS-PAGE、活性测定等方法进行质量评价。
实验结果 (Experimental Results)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
数据汇总 (Data Summary)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
结论 (Conclusions)
先进的干燥技术为蛋白质药物的保存和运输提供了有效解决方案。
实践意义 (Practical Significance)
对推动蛋白质药物的临床应用和产业化具有重要意义。