金标法与微粒子免疫发光法检测血清PSA的比较

目的:探讨金标法快速检测前列腺特异性抗原(PSA)诊断前列腺癌的临床价值。方法:对需检测PSA的39例患者同时运用微粒子免疫发光定量检测法和金标法快速检测PSA,并结合临床诊断进行对比分析。结果:金标法快速检测和微粒子免疫发光定量检测PSA无显著性差别(P>0.05)。结论:金标法定性检测可作为前列腺癌筛选诊断快速有效的检测方法,可作为前列腺癌患者的筛查。     

Phenotype of exogenous microparticle-containing pigment cells of the human Peyer’s patch in inflamed and normal ileum

OBJECTIVES: Pigmented cells, that contain inert, submicron-sized dietary particles, are a consistent feature of the base of human Peyer's patches (PP). We aimed (i) to phenotype these intestinal pigment cells (PC) in archival tissue specimens and (ii) to establish whether PC phenotype is altered in inflammatory conditions, especially Crohn's disease (CD). METHODS: PCs contained within PP were identified by routine haematoxylin and eosin (H&E) staining and dark field microscopy of archival ileal sections for: adenocarcinoma (n = 16), colonic CD (n = 23), non-CD colitis (n = 10). Paraffin-embedded serial sections were graded for microscopic inflammation and then investigated immunohistochemically with antibodies against CD68, MAC387, CD14, CD11b, CD15, CD1a, S100, HLA-DR, CD86 and Cathepsin D. Analyses were by light and confocal microscopies. RESULTS: The majority of PCs were CD68 positive (circa 80%) with a minority (circa 20%) staining for MAC387. Microparticles were mainly identified within cathepsin D negative lysosomal compartments. Histological inflammatory grade and disease type had no influence on cell phenotype. CONCLUSIONS: The microparticle-containing PCs of the PP base are mainly mature macrophages (CD68) of low metabolic and immunological activity. There is no evidence of differential PC phenotype or activation in differing disease states, including CD.     

液相蛋白芯片与酶免疫法检测4种肿瘤标志物的比较

目的：建立液相蛋白芯片测定AFP、CEA、CA19-9、CA125等肿瘤标志物的方法，讨论其应用于临床检验的可行性。方法：分别用液相蛋白芯片法检测微粒子酶免分析法(MEIA)检测的阳性标本AFP60例、CEA 42例、CA19-965例、CA12550例及上述项目阴性样本33例。结果：液相蛋白芯片法检测的样品浓度范围比MEIA法的范围更大，在共同的样品浓度范围内，两检测定性和定量结果基本是一致的。而液相蛋白芯片的方法可以同时进行多指标的检测，体现出高通量的概念，可以节省临床上检测的时间和人力需求。结论：液相蛋白芯片法检测肿瘤标志物，可应用于临床检测。     

血清鳞状细胞癌抗原在鼻腔鼻窦鳞状细胞癌患者中的表达及其临床意义

目的探讨血清鳞状细胞癌抗原（SCCAg）水平与鼻腔鼻窦鳞状细胞癌（Nscc）患者临床分期及治疗预后关系。方法采用微粒子酶免疫分析法（MEIA）检测河北省邢台市眼科医院29例NSCC患者治疗前后血清SCCAg水平。结果29例NSCC患者血清SCCAg阳性率为86．2％（25／29）,SCCAg阳性率与NSCC的TNM分期有关。治疗前后患者血清鳞状细胞癌抗原水平变化差异有统计学意义（P〈0．05）。复发患者SCCAg明显升高。结论血清SCCAg可作为鼻腔鼻窦鳞癌的相关肿瘤标志物,对判断鼻腔鼻窦鳞癌治疗效果、预后有重要的临床意义。     

酶联免疫吸附试验检测乙型肝炎病毒表面抗原临界样本复检范围的探讨

目的探讨酶联免疫吸附试验（ELISA）检测乙型肝炎病毒表面抗原（HBsAg）临界样本的复检范围。方法收集用ELISA初检HBsAg吸光度（A）值在0.07～2.00范围内的样本,用ELISA复检;初、复检结果不符和2次结果均在临界的样本,用微粒子酶免疫法（MEIA）进行复核,并用中和法做确认试验。统计分析结果,选择一个合适的样本复检范围。结果样本初检结果A值在0.070～0.104、0.105～0.300范围内,ELISA复检符合率分别为85.2%、56.9%;MEIA与ELISA复检结果的符合率分别为90.1%、93.9%。A值在0.301～0.500、0.501～1.000、1.001～1.500、1.501～2.000范围内,ELISA复检符合率依次为88.3%、93.8%、99.1%、99.2%,MEIA与ELISA复检结果的符合率为100%。确认试验和MEIA复检结果的符合率样本测定值（S）/阴性对照值（N）在1.50～1.99、2.00～5.00,分别为50.0%和92.7%,其他组均在97.1%以上。结论在操作规范化的实验室内,ELISA初检HBsAg复检范围宜选择样本A值在0.070～0.300范围内;大批量体检时,复检范围应放宽至0.070～0.500;乙肝标志物模式异常的样本也需复检。规定适宜的复检范围既能确保检测结果的准确性,又能避免人力和试剂等物品的浪费。     

RIA法和MEIA法测定血β—HCG结果比较及临床意义

目的 观察ＭＥＩＡ法检测总β－ＨＣＧ和ＲＩＡ法检测β－ＨＣＧ对早孕诊断、人流术后监测等疾病中的应用价值;比较两种方法的灵敏度、特异性;分析它们之间的相关性。方法收集１２１例早孕、人流术后等血清标本,分别用雅陪全自动分析仪（采用ＭＥＩＡ法）和ＲＩＡ法检测总β－ＨＣＧ和β－ＨＣＧ。结果 ＭＥＩＡ法检测早孕的灵敏度为１００％,而ＲＩＡ法为８６．１％;特异性均为１００％,总β－ＨＣＧ和β－ＨＣＧ的相关性为     

t-PSA 、f-PSA和FPSAR对前列腺癌诊断价值的探讨

目的探讨血清总前列腺特异抗原(t-PSA)、游离前列腺特异抗原(f-PSA)和游离与总前列腺特异抗原比值(FPSAR)对前列腺癌(PCa)和良性前列腺增生(BPH)的诊断和鉴别诊断的价值。方法使用雅培AXSYM全自动免疫分析仪,用微粒子酶免疫分析法(MEIA)检测41例正常人群和经临床确诊的49例PCa和124例BPH患者血清中的t-PSA、f-PSA,并计算FPSAR。结果49例PCa患者和124例BPH患者中,PCa组和BPH组的t-PSA、f-PSA、FPSAR差异有显著性(P<0.01)。但有5例PCa和46例BPH患者位于诊断灰区(PSA介于4~10μg/L时)。此PCa组和BPH组的t-PSA、f-PSA差异无显著性(P>0.05),但FPSAR差异有显著性(P<0.05)。结论对于在诊断灰区内的患者,FPSAR因其较高的敏感性和特异性更有助于PCa与BPH的鉴别诊断。若将t-PSA≥20μg/L,f-PSA≥5μg/L,FPSAR<0.1作为PCa的诊断标准,则诊断的特异性高达95%以上。     

检测血清鳞状细胞癌抗原对鼻内翻性乳头状瘤的临床价值

目的探讨血清鳞状细胞癌抗原(squamous cell carcinoma antigen,SCCAg)水平在鼻内翻性乳头状瘤（nasal inverted papilloma,NIP）手术前后的变化及其临床意义。方法采用微粒子酶免疫分析法(microparticle enzyme immunoassay,MEIA)检测34例NIP和12例(nasal squamous cell carcinoma ,NSCC)患者手术前后血清SCCAg水平。结果34例NIP患者血清SCCAg阳性率为67.64%(23/34),12例NSCC患者血清SCCAg阳性率为75%(9/12),手术治疗前后患者血清鳞状细胞癌抗原水平变化差异有统计学意义(P<0.05 )。复发患者SCCAg术后半年明显升高。结论治疗前后血清SCCAg值对估计NIP的生物学行为及评价治疗效果、预后有重要的参考价值。     

Platelet-Derived Procoagulant Microparticles as Blood-based Biomarker of Breast Cancer

Objective: Breast cancer is the main cause of cancer death in women worldwide. Elevated plasma levels of circulating cell-derived microparticles (MPs) have been reported in various types of cancer, including breast cancer, with the ability to mediate inflammation and thrombosis. Microparticles are bioactive agents, and it has been suggested that MPs can be used as a diagnostic, prognostic, or therapeutic biomarker in various diseases. The aim of this study was to investigate the levels of platelet-derived MPs (PMPs) in breast cancer patients. Materials and Methods: In this case-control study, 30 patients with breast cancer and 20 normal subjects were sampled after obtaining written consent. MPs were isolated from blood samples by centrifugation technique. CD42b and annexin V markers were used respectively for counting PMPs and procoagulant MPs with flow cytometry. Results: Flow cytometry results showed that the number of PMPs and procoagulant annexin V positive MPs was significantly higher in the breast cancer patients than normal subjects (p <0.001). The number of the annexin V MPs differed significantly in patients with high tumor size (T2) compared to the patients with low tumor size (T1) and controls (p <0.001). Significant and positive correlations were found between PMP levels and tissue-based biomarkers, tumor grading, and distant metastasis (p <0.05). Tumor histological type did not correlate with the numbers of PMPs (p=0.065). Conclusion: Increased levels of PMPs and activity in terms of hemostasis and having a positive and significant relationship with tumor grading and metastasis may indicate the effective role of PMPs in the pathogenesis and prognosis of breast cancer.     

Applying Pattern Recognition as a Robust Approach for Silicone Oil Droplet Identification in Flow-Microscopy Images of Protein Formulations

Discrimination between potentially immunogenic protein aggregates and harmless pharmaceutical components, like silicone oil, is critical for drug development. Flow imaging techniques allow to measure and, in principle, classify subvisible particles in protein therapeutics. However, automated approaches for silicone oil discrimination are still lacking robustness in terms of accuracy and transferability. In this work, we present an image-based filter that can reliably identify silicone oil particles in protein therapeutics across a wide range of parenteral products. A two-step classification approach is designed for automated silicone oil droplet discrimination, based on particle images generated with a flow imaging instrument. Distinct from previously published methods, our novel image-based filter is trained using silicone oil droplet images only and is, thus, independent of the type of protein samples imaged. Benchmarked against alternative approaches, the proposed filter showed best overall performance in categorizing silicone oil and non-oil particles taken from a variety of protein solutions. Excellent accuracy was observed particularly for higher resolution images. The image-based filter can successfully distinguish silicone oil particles with high accuracy in protein solutions not used for creating the filter, showcasing its high transferability and potential for wide applicability in biopharmaceutical studies.