CN102023211B - Immunochromatographic test strip for full quantitative detection of C-reactive protein and preparation method thereof - Google Patents

Immunochromatographic test strip for full quantitative detection of C-reactive protein and preparation method thereof Download PDF

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CN102023211B
CN102023211B CN 201010550610 CN201010550610A CN102023211B CN 102023211 B CN102023211 B CN 102023211B CN 201010550610 CN201010550610 CN 201010550610 CN 201010550610 A CN201010550610 A CN 201010550610A CN 102023211 B CN102023211 B CN 102023211B
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monoclonal antibody
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CN102023211A (en
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王继华
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广州万孚生物技术股份有限公司
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Abstract

本发明公开了一种全程定量检测C反应蛋白的免疫层析试纸条,所述试纸条由样品垫、标记垫、包被膜、吸水纸顺次搭接粘贴在底板上构成,所述标记垫上包被有荧光胶乳微粒标记的CRP单克隆抗体和荧光胶乳微粒标记的兔IgG;所述包被膜包括检测区和质控区,所述检测区包被有与所述荧光胶乳微粒标记的CRP单克隆抗体处于不同表位的另一种CRP单克隆抗体。 The present invention discloses an immunochromatographic strip on Global quantitative detection of C-reactive protein, the test strip by the sample pad, label pad, the coated film, sequentially overlapping absorbent paper stuck on the bottom plate constituting the marker pad CRP monoclonal antibody-coated latex particles with a fluorescent-labeled rabbit IgG and the fluorescent latex particle-labeled; the packet comprises a film detection zone and the control zone, the detection zone is coated with CRP labeled with the fluorescent latex particles the monoclonal antibody is in another different epitopes of CRP monoclonal antibody. 本发明的C反应蛋白免疫层析试纸条可以达到仅10秒就能对全程CRP进行灵敏的定量测定,更快更精确的诊断疾病和鉴别感染,能检测感染病情和确定抗生素的疗效;全程CRP能同时检测出具hs-CRP和常规CRP两个结果,且有全面的线性范围和良好的检测灵敏度,需要的样品量少,操作非常简便。 C-reactive protein of the present invention can reach the immunochromatographic strip is only 10 seconds to be sensitive to the entire CRP quantitative determination, faster and more accurate differential diagnosis of diseases and infections, disease and infection can be detected to determine the efficacy of antibiotics; full CRP can be issued simultaneously detect and hs-CRP CRP conventional two results, and a comprehensive range of linearity and good detection sensitivity, less sample is needed, operation is very simple.

Description

—种全程定量检测C反应蛋白的免疫层析试纸条及其制备方法 Immunochromatographic strip and method of producing an entire quantitative detection of C-reactive protein -

技术领域 FIELD

[0001] 本发明属于医学检验领域,尤其涉及一种全程定量检测C反应蛋白的免疫层析试纸条及其制备方法。 [0001] The present invention is in the field of medical testing, in particular, it relates to an immunochromatographic strip and a method for preparing full quantitative detection of C-reactive protein.

背景技术 Background technique

[0002] C 反应蛋白(C-reactive protein, CRP), 1930 年Tillet 和Francis 在急性大叶性肺炎患者血清中发现能在钙离子存在时与肺炎球菌C多糖起沉淀反应而得名,是人类重要的急性期反应蛋白,急性期浓度可升高上千倍,循环中的CRP半衰期为19小时。 [0002] C-reactive protein (C-reactive protein, CRP), 1930 and Francis years Tillet discovered in the serum of patients with acute pneumococcal lobar pneumonia in C polysaccharide can be precipitated from the reaction in the presence of calcium ions and named, human important acute phase proteins, acute phase concentration can be increased a thousand times, CRP circulating half-life of 19 hours.

[0003] C反应蛋白可以和肺炎链球菌的荚膜C多糖结合,是机体受到微生物入侵或组织损伤等刺激时肝细胞合成时的急性时相蛋白,当发生炎症疾病或者组织发生溃烂或者坏死时,会在血液中急速升高,但随着组织结构和功能的复原,其含量也恢复正常。 [0003] C-reactive protein and may be capsular polysaccharide of Streptococcus pneumoniae C binding, the body is subjected to acute phase protein synthesis in hepatocytes when invading microorganisms or tissue injury, stimulation, or an inflammatory disease occurs when tissue necrosis or ulceration It will increase rapidly in the blood, but with the recovery of tissue structure and function, its content is also back to normal. 因此,高浓度的CRP测定在诊断细菌感染、癌症等疾病的严重性、进程、愈后以及治疗效果方面具有广泛的临床意义。 Therefore, high concentrations of CRP measurement, prognosis and treatment has a wide range of clinical significance in the diagnosis of bacterial infections, cancer of the seriousness of the process.

[0004] CRP作为心血管疾病最强的危险指标,其水平可以预测将来心肌梗塞及中风的危险性。 [0004] CRP as a risk marker for cardiovascular disease the most, its levels can predict the risk of future heart attack and stroke. 健康人CRP参考范围基本为0.58-1.13mg/L。 Healthy CRP reference range is substantially 0.58-1.13mg / L. CRP含量大于2.lmg/L的人,比较CRP含量小于等于lmg/L者,将来发生心肌梗塞的危险性为后者的2.9倍,发生缺血性中风的危险性为后者的1.9倍,发生外周动脉血管性疾病的危险性为后者的4.1倍。 CRP levels greater than 2.lmg / L person, comparing CRP levels less than or equal lmg / L person, the risk of future myocardial infarction occurs 2.9 times for the latter, ischemic stroke risk is 1.9 times the latter, risk of peripheral arterial vascular diseases is 4.1 times the latter. CRP与血脂的联合测定,较其他危险因子更能预示发生心、脑血管疾病的危险性,是目前进行冠心病危险评估的最佳模型。 Joint determination of CRP and lipids, compared with other risk factors to better predict the risk of cardiovascular and cerebrovascular disease, coronary heart disease is currently the best model for risk assessment. 最近研究表明,低浓度的CRP测定,还可以作为新生儿感染,局部感染等疾病,以及相关疾病的诊断标志物。 Recent studies have shown that low concentrations of CRP measurement, but also as neonatal infection, localized infections and other diseases, as well as diagnostic markers related diseases.

[0005] C反应蛋白是细菌感染和严重组织损伤的一项诊断指标,其升高可见于: [0005] C-reactive protein is a diagnostic indicator of serious bacterial infections and tissue damage, which increase seen in:

[0006] 1.组织损伤、感染、肿瘤、心肌梗塞及一系列急慢性炎症性疾病,如风湿性关节炎、全身性血管炎、多肌痛风湿病等。 [0006] 1. tissue injury, infection, cancer, myocardial infarction, and a series of acute and chronic inflammatory diseases, such as rheumatoid arthritis, systemic vasculitis, polymyalgia rheumatism.

[0007] 2.术后感染及并发症的指标:手术后病人CRP升高,术后7-10天CRP水平应下降,如CRP不降低或再次升高,提示可能并发感染或血栓栓塞。 [0007] 2. indicators of postoperative infections and complications: post-operative patients with elevated CRP, CRP levels after 7-10 days should decrease, such as CRP is not reduced or increased again, suggesting that concurrent infection or thromboembolism.

[0008] 3.可作为细菌性感染和病毒性感染的鉴别诊断:大多数细菌性感染会引起患者血清CRP升高,而病毒性感染则多数不升高。 [0008] 3. The differential diagnosis can be infected as viral and bacterial infections: Most bacterial infections can cause patients with elevated serum CRP, and viral infections of the majority does not rise.

[0009] 4.近年来有研究指出用超敏乳胶增强法测CRP,提高测定的敏感性,可用于冠心病和心梗危险性的预测。 [0009] 4. recent studies indicate that enhanced as measured by CRP latex hypersensitivity, increase the sensitivity of the assay, can be used to predict the risk of coronary heart disease and myocardial infarction.

[0010] 传统的检测CRP的几种方法:在胶乳凝集实验法的灵敏度为1.0mg/L,是半定量的方法,现在已经较少使用;免疫比浊法的灵敏度为5.0mg/L,检测范围为5〜230mg/L,但是需要自动生化分析仪和自动化免疫测定仪等大型仪器,存在操作复杂耗时长,所需要标本量大等问题。 [0010] Several conventional methods Detection of CRP: the sensitivity of latex agglutination test method of 1.0mg / L, is a semi-quantitative method, is now less use; immunoturbidimetric assay sensitivity was 5.0mg / L, detection range 5~230mg / L, but requires an automatic biochemical analyzer and other large automated immunoassay instruments, there is a complex time-consuming operation, it requires large specimen and so on. 化学发光法检测存在时间检测时间长,一般需要耗时90mins左右,需要在实验室专业操作。 Detecting the presence of a long period of time, generally about 90mins require time-consuming, requires specialized in the laboratory chemiluminescence. 放射免疫测定法的灵敏度在3μ g/L,但是存在同位素污染等问题。 The sensitivity of radioimmunoassay in 3μ g / L, but the presence of isotope pollution.

[0011] 全程定量检测C反应蛋白是指其测定方法比传统方法更敏感,测定范围更宽广。 [0011] full quantitative detection of C-reactive protein refers assay method is more sensitive than the conventional method, a broader measuring range. 临床常规测定C反应蛋白的方法为免疫比浊法,测定范围一般为3~200mg/L,但其灵敏度相对较低,无法准确测定3mg/L以下水平的C反应蛋白含量,不能作为心、脑血管疾病的危险指标,预测心、脑血管疾病发生的危险性。 The method of C-reactive protein assay for clinical routine for turbidimetric immunoassay, the measurement range is typically 3 ~ 200mg / L, but relatively low sensitivity, can not be measured accurately 3mg / L or less of C-reactive protein level, can not serve as the heart, brain risk marker of vascular disease, predict heart risk of cerebrovascular disease. 临床高敏C反应蛋白的测定范围又相对较窄,无法准确测定高浓度水平下CRP的含量,不能用于感染性疾病的诊断或者疗效的观察。 Clinical measurement range of the high-sensitivity C-reactive protein and relatively narrow, the content can not be accurately measured at high CRP levels, the diagnostic or therapeutic effect observed infectious diseases can not be used.

发明内容 SUMMARY

[0012] 本发明的目的在于针对现有技术中存在的不足,提供一种既可以测定低水平CRP含量,且灵敏度高、稳定性强、测定准确的全程C反应蛋白检测试纸条。 [0012] The object of the present invention is for the deficiencies in the prior art, there is provided both a low CRP levels can be measured, and high sensitivity, high stability, accurate measurement of C-reactive protein throughout the test strip.

[0013] 为实现上述目的,本发明采取了以下技术方案: [0013] To achieve the above object, the present invention adopts the following technical scheme:

[0014] 一种全程定量检测C反应蛋白的免疫层析试纸条,由样品垫、标记垫、包被膜、吸水纸顺次搭接粘贴在底板上构成,所述标记垫上包含有荧光胶乳微粒标记的CRP单克隆抗体和荧光胶乳微粒标记的兔IgG ;所述包被膜包括检测区和质控区,所述检测区包被有与所述荧光胶乳微粒标记的CRP单克隆抗体处于不同表位的另一种CRP单克隆抗体。 Immunochromatographic strip [0014] A full quantitative detection of C-reactive protein, a sample pad, label pad, the coated film, absorbent paper stuck on the bottom plate sequentially overlapping configuration, the pad comprising a fluorescent labeled latex particles CRP labeled monoclonal antibodies and the fluorescent latex particle-labeled rabbit IgG; the packet comprises a film detection zone and the control zone, the detection zone is coated with the fluorescent labeled latex particles with CRP monoclonal antibody at different epitopes another CRP monoclonal antibody.

[0015] 优选地,所述荧光胶乳微粒标记的CRP单克隆抗体的浓度为0.5~2mg/ml,在试纸条上的用量为0.4~1.0 μ g/cm2。 [0015] Preferably, the concentration of the CRP monoclonal antibody-labeled fluorescent latex particles of 0.5 ~ 2mg / ml, the test strip in an amount of 0.4 ~ 1.0 μ g / cm2. 所述兔IgG的浓度为0.5~2mg/ml,在试纸条上的用量为0.25-0.45 μ g/cm2。 The concentration of rabbit IgG was 0.5 ~ 2mg / ml, the test strip in an amount of 0.25-0.45 μ g / cm2. 所述检测区包被的CRP单克隆抗体的浓度为0.5~2mg/ml,用量按膜包被液量为20 μ l/27-35cm。 The packet detection zone are monoclonal antibody CRP concentration is 0.5 ~ 2mg / ml, according to the amount of film coating solution in an amount of 20 μ l / 27-35cm.

[0016] 优选地,所述荧光胶乳微粒的直径为0.1 μ m~I μ m。 [0016] Preferably, the diameter of the fluorescent latex particles is 0.1 μ m ~ I μ m. 所述荧光胶乳微粒受激发后发射的波长为180nm~800nm。 The fluorescent latex particles emitted upon excitation by wavelengths of 180nm ~ 800nm.

`[0017] 优选地,所述包被膜上的质控区包括包被抗人IgG的Cl线和包被抗兔IgG的C2线。 `[0017] Preferably, the coated film comprising a package quality control area line C2 is anti-human IgG coated Cl lines and anti-rabbit IgG. 所述抗人IgG的浓度为0.5~lmg/ml,抗兔IgG的浓度为0.5~2mg/ml,抗人IgG和抗兔IgG的用量按膜包被液量均为20μ l/27-35cm。 The concentration of anti-human IgG for 0.5 ~ lmg / ml, anti-rabbit IgG at a concentration of 0.5 ~ 2mg / ml, anti-human IgG and anti-rabbit IgG were coated film according to the amount of 20μ l / 27-35cm fluid volume.

[0018] 本发明还提供了一种制备全程定量检测C反应蛋白的免疫层析试纸条的方法,采取了以下技术方案: [0018] The present invention further provides a method of immunization strip for the preparation of a full quantitative detection of C-reactive protein, taking the following technical solution:

[0019] 包括以下步骤: [0019] comprising the steps of:

[0020] A.荧光胶乳的共价活化 [0020] A. covalently fluorescent latex activation

[0021] 超声波处理荧光胶乳微球体30秒后,调节荧光胶乳微球体浓度为1.0XlO12~ After the [0021] fluorescent latex microspheres sonicated for 30 seconds and adjusting the concentration of the fluorescent latex microspheres 1.0XlO12 ~

1.0X 1013/ml,10000~15000xg离心5~15分钟,沉淀物用蒸馏水或50~200mM ρΗ6.0~ 1.0X 1013 / ml, 10000 ~ 15000xg centrifugation for 5 to 15 minutes, the precipitate was washed with distilled water or 50 ~ 200mM ρΗ6.0 ~

7.0磷酸钠溶液溶解,并超声波200W处理30秒;先加入10~100 μ I的20~100mg/ml碳二亚胺,混匀,再加入10~100 μ I的20~100mg/mlN-羟基硫代琥珀酰亚胺,混匀;室温孵育20-40分钟后10000~15000xg、离心5~15分钟,沉淀用20~100mM、pH5.0~6.0的柠檬酸缓冲液溶解,放置于2~8°C条件下备用; 7.0 sodium phosphate solution was dissolved, and 30 seconds of ultrasonic 200W; was added to 20 ~ 100mg / ml carbodiimide of 10 ~ 100 μ I, mix, then add 10 ~ 100 μ I of 20 ~ 100mg / mlN- hydroxy thiol iodosuccinimide, mix; 10000 ~ 15000xg 20-40 minutes incubation room temperature, centrifuged for 5 to 15 minutes, precipitated with 20 ~ 100mM, pH5.0 ~ 6.0 citrate buffer was dissolved, placed in a 2 ~ 8 ° C under a standby condition;

[0022] B.荧光胶乳微粒标记蛋白的制备 B. Preparation of the fluorescent latex particle labeled proteins [0022]

[0023] 将上述活化后的荧光胶乳超声波200W处理30秒后,按照14 8~125^8蛋白/100 μ I荧光胶乳的比例分别加入CRP单克隆抗体和兔IgG,混匀后室温搅拌反应1.5-3小时,离心洗涤2-4次,每次10000~15000xg、离心5~15分钟,沉淀用PBS-TBN溶解并超声波100W处理30秒,用PBS-TBN恢复离心前体积调节至浓度为0.5~2mg/ml,按0.4~ After [0023] The ultrasonic 200W fluorescent latex after the activation treatment for 30 seconds at 14 ^ 8 125 ~ 8 protein / 100 μ I ratio of the fluorescent latex were added CRP monoclonal antibody and rabbit IgG, after mixing the reaction stirred at room temperature 1.5 3 hours, washed by centrifugation 2-4 times 10000 ~ 15000xg, centrifuged for 5 to 15 minutes, the precipitate was dissolved with PBS-TBN and 100W ultrasound for 30 seconds to restore the volume before centrifugation with PBS-TBN adjusted to a concentration of 0.5 to 2mg / ml, 0.4 to press

1.0 μ g/cm2的用量涂覆在标记垫上; The amount of coating 1.0 μ g / cm2 in the tag pad;

[0024] C.包被膜的制备[0025] 分别将另一种CRP单克隆抗体和抗兔IgG用包被缓冲液调节至浓度为0.5〜2mg/ml,将抗人IgG用包被缓冲液调节至浓度为0.5〜lmg/ml,将CRP单克隆抗体喷到包被膜 [0024] C. Preparation of the coated film [0025] Another respectively CRP monoclonal antibody and anti-rabbit IgG was coating buffer adjusted to a concentration of 0.5~2mg / ml, anti-human IgG solution is adjusted with the package buffer to a concentration of 0.5~lmg / ml, the monoclonal antibodies to CRP spraying the coated film

(3)上的检测区,将抗兔IgG和抗人IgG喷到包被膜(3)上的质控区,所述CRP单克隆抗体、抗兔IgG和抗人IgG的用量按膜包被液量均为20μ l/27-35cm,检测区和质控区间隔3-8mm,在湿度< 30%的室温下凉干12-24小时,封袋,备用; The detection zone (3), the anti-rabbit IgG and anti-human IgG to the coated film sprayed on the quality control area (3), the CRP monoclonal antibody, anti-rabbit IgG and anti-human IgG coated film by an amount of liquid amounts are 20μ l / 27-35cm, the detection zone and the control zone spaced 3-8mm, air dried at room temperature under a humidity of 30% <12-24 hours envelope standby;

[0026] D.在底衬上顺次相互搭接地粘贴样品垫、标记垫、包被膜和吸水纸得到试纸板,按照要求切割成适当宽度的试纸条。 [0026] D. sequentially overlap each other in the underlay pasting a sample pad, label pad, absorbent paper and the coated film obtained paper plate, in accordance with the requirements of the cut strip of suitable width.

[0027] 本发明所述的C反应蛋白的免疫层析试纸条的检测原理是双抗体夹心法,将直径范围Ο.ΟΙμπι〜Ιμπι的胶乳微球与一种CRP抗体和各类不同的荧光素共价结合,利用胶乳微球大分子物质具有的羧基、氨基、羟基等基团结合CRP抗原的一种抗体,利用荧光素在激发光作用下可以发射荧光,当此荧光胶乳标记的CRP抗体与检测样本中足够的CRP抗原结合形成复合物,该复合物在层析作用下移动至包被膜的检测区,在包被膜的检测区包被有能与CRP抗原的另一种抗体,该抗体结合在CRP抗原的另一表位上,形成双抗体夹心的复合物。 [0027] The detection principle of an immunochromatographic strip according to the present invention, C-reactive protein is a double antibody sandwich method, the Ο.ΟΙμπι~Ιμπι latex microspheres range in diameter with one-CRP antibody and various types of fluorescence different Su covalent binding latex microspheres using a macromolecular substance having a carboxyl group, an amino group, hydroxyl group CRP binding an antibody to an antigen, using fluorescein excitation under the action of light may emit fluorescence when this CRP antibody-labeled fluorescent latex combined with the test sample sufficient CRP antigen to form a complex, the complex moves to the coated film under the action of chromatographic detection zone, there can be another antibody and CRP antigen, the antibody in the detection zone of the package film package on the other epitopes bound CRP antigen to form a double antibody sandwich complex. 复合物聚积在包被膜的T线处,受到光源激发释放出相应波长的发射光,通过荧光检测系统将捕捉的光信号转化为数字信号,从而可用于准确定量的快速免疫检测中。 T accumulated in the composite film bag line, the light source emitted by the excited release the corresponding wavelength, by a fluorescence detection system is captured optical signal into a digital signal so as to be fast for accurate quantitative immunoassay.

[0028] 荧光胶乳标记CRP抗体是将直径范围在0.01 μ m〜I μ m的胶乳微球与CRP抗体,当此荧光胶乳标记的CRP抗体与检测样本中的相应CRP抗原结合后形成CRP抗原-抗体复合物,该荧光胶乳复合物通过层析作用在包被膜的检测区T线处与预先包被的另一种CRP抗体特异性结合而大量聚积。 [0028] CRP antibody is labeled fluorescent latex having a diameter in the range of 0.01 μ m~I μ m latex microspheres CRP antibody, when bound to this antigen respective CRP CRP antibody-labeled fluorescent latex test sample formed with CRP antigen - antibody complex, the fluorescent latex composite film package by chromatography role in T-line pre-coated with a further detection zone being CRP antibody specifically binding to the large accumulation.

[0029] 利用荧光定量光谱检测系统,由光源激发包被膜上检测区T线处聚积的荧光素,荧光素发射出的荧光被相应的检测系统接收,并通过光电变换、光电转化等过程将光电信号转化成电信号,并由系统中设置的自动控制系统将信号输出,显示出最终的定量结果。 [0029] SYBR Green real spectrum detection system, excitation packets are accumulated in the membrane detection zone T line fluorescein light source, a fluorescent fluorescein emitted is received by a respective detection system, and by a photoelectric conversion, photoelectric conversion and other processes of the photoelectric signals into electrical signals, an automatic control system provided by the system outputs the signal showing the final quantitative results. 由于选择的荧光素的种类的不同,其激发/发射光的波长λ以及自动控制系统也会不同。 Because different types of selection fluorescein excitation / emission light wavelength λ and the automatic control system will be different.

[0030] 本发明的C反应蛋白免疫层析试纸条与放射性免疫、酶联免疫法检测CRP抗体相t匕,具有操作安全(无放射物污染)、简便(简单操作一步完成)、适合单人份检测和快速(3分钟左右即可有结果)等优点;与免疫胶体金标记试纸条相比,本发明具有灵敏度更高、准确定量、多指标检测(不同波段的荧光胶乳标记应用于多指标同步定量检测)、标记稳定性更好等优点。 [0030] C-reactive protein of the present invention and the immunochromatographic strip radioimmunoassay, enzyme-linked immunosorbent assay with antibodies CRP t dagger, with safe operation (no radiation contamination), simple (simple one step), for single parts of people detection and rapid (about 3 minutes with a result), etc; immunogold labeling compared with the test strip, the present invention has higher sensitivity, accurate quantification, multiple index detection (fluorescence in different wavelength bands labeled latex applied multi-sync indicators quantitative detection), better stability etc. marker.

[0031] 本发明的C反应蛋白免疫层析试纸条可以达到仅10秒就能对全程CRP进行灵敏的定量测定,更快更精确的诊断疾病和鉴别感染,能检测感染病情和确定抗生素的疗效;全程CRP能同时检测出具hs-CRP和常规CRP两个结果,且有全面的线性范围(0.5-200mg/L)和良好的检测灵敏度(Pg/ML级),需要的样品量少,操作非常简便。 [0031] C-reactive protein of the present invention, the immunochromatographic strip is only 10 seconds to reach the whole of the quantitative determination of CRP for sensitive, faster and more accurate differential diagnosis of disease and infection, detection of infectious disease can be determined and antibiotics effect; full issued CRP can simultaneously detect and hs-CRP CRP conventional two results, and there is full linear range (0.5-200mg / L), and good detection sensitivity (Pg / ML level), less sample required, the operation very simple.

附图说明 BRIEF DESCRIPTION

[0032] 图1为本发明的全程定量检测CRP免疫层析试纸条的结构示意图; [0032] FIG 1 full quantitative structural diagram of the present invention the detection of CRP immunochromatographic strip;

[0033] 附图标记:1、样品塾;2、标记塾;3、包被I旲;4、吸水纸;5、检测区;6、质控区;7、底板。 [0033] The reference numerals: 1, Sample Sook; 2, numerals Sook; 3, coated Dae I; 4, absorbent paper; 5, detection zone; 6, quality control area; 7, the bottom plate.

具体实施方式[0034] 以下结合附图和具体实施例来详细说明本发明。 DETAILED DESCRIPTION [0034] The following specific embodiments of the present invention and will be described in detail in conjunction with the accompanying drawings.

[0035] 实施例1 [0035] Example 1

[0036] 在本发明实施例中,所采用的CRP抗体为常规单克隆抗体技术制备的单抗,利用双抗体夹心法检测CRP抗原的原理检测标本。 [0036] In an embodiment of the present invention, CRP monoclonal antibody used was prepared by conventional monoclonal antibody technology, antigen detection principle for detecting CRP antibody sandwich method using two samples.

[0037] 如图1所示,在该实施例中,全程定量检测CRP免疫层析试纸条,包括远端和近端,样品垫I位于试纸条的近端,它含有一个亲水性的孔状隔膜,样品垫I是加样区,用于吸取待检测CRP检测样本。 [0037] As shown in FIG. 1, in this embodiment, full quantitative immunochromatographic strip CRP, comprising a distal end and a proximal end, the proximal end of the sample pad positioned test strip I, which contains a hydrophilic the porous membrane, a sample pad application zone I, for drawing sample to be detected detecting CRP. 样品垫I与远端之间,依次搭接有玻璃纤维素膜材质的标记垫2、硝酸纤维素膜材质的包被膜3和吸水纸4。 Between the distal end of the sample pad and I, sequentially overlapping glass cellulose membrane material marking pad 2, a nitrocellulose membrane material film 3 and the absorbent paper bag 4. 样品垫1、标记垫2、包被膜3和吸水纸4都设置在底板7上。 A sample pad, label pad 2, 3 and absorbent paper bag film 4 are provided on the bottom plate 7.

[0038] 在该实施例中,标记垫2上是使用特定的激发光(470nm)/发射光(525nm)波长的荧光胶乳(直径约300nm)标记I株CRP单克隆抗体和兔IgG ;包被膜3的检测区T线处采用CRP的另一株单克隆抗体(0.5〜2mg/ml)来包被。 [0038] In this embodiment, the pad 2 is labeled using specific excitation light (470nm) / emitted light (525nm) fluorescent latex wavelength (about 300 nm in diameter) strain I labeled monoclonal antibodies and rabbit CRP IgG; the coated film T line detection zone 3 using other strains CRP monoclonal antibody (0.5~2mg / ml) to coat. 在包被膜3的质控区Cl线处使用浓度为0.5〜lmg/ml的抗人IgG进行包被,用于中和血清中的非特异性人IgG,起到过滤的作用,防止血清中的非特异性人IgG对质控C1、C2线、T线处反应的影响,C2线包被有抗兔IgG,浓度为0.5〜2mg/ml,用于结合荧光胶乳标记的兔IgG,用于检测试纸条的有效性,CRP单克隆抗体、抗兔IgG和抗人IgG的用量按膜包被液量均为20 μ l/27-35cm。 Cl concentration in the quality control area line package film 3 is 0.5~lmg / ml of anti-human IgG were coated, and used in the non-specific human serum IgG, the filter acts to prevent non-specific serum heterosexual human IgG to quality control C1, C2 line, the influence of the reaction line T, C2 wire coated with anti-rabbit IgG, concentration 0.5~2mg / ml, rabbit IgG for binding fluorescent labeled latex, a test strip Article effectiveness, CRP monoclonal antibody, anti-rabbit IgG and anti-human IgG coated films are used in an amount by 20 μ l / 27-35cm fluid volume.

[0039] 在该实施例中,全程定量检测C反应蛋白的免疫层析试纸条的制备包括以下步骤: [0039] In this embodiment, the entire C-reactive protein was prepared in quantitative immunochromatographic strip detecting comprises the steps of:

[0040] 1.荧光胶乳的共价活化 [0040] 1. The fluorescent latex covalent activation

[0041] 超声波处理胶乳微球体30秒后,调节胶乳微球体浓度为1.0X IO12〜1.0X IO13/ml, 10000〜15000xg离心10分钟,离心后收集沉淀物用蒸懼水或者IOOmM pH6.0磷酸钠溶液溶解,并超声波200W处理30秒;先加入50 μ I的lOOmg/mlEDC,震荡混匀,再加入50 μ I的50mg/ml N-羟基硫代琥珀酰亚胺(S μ If0-NHS),震荡混匀;室温孵育30分钟后10000〜15000xg、离心5〜15分钟,沉淀用lOOmM、pH5.0〜6.0的柠檬酸缓冲液溶解,放置在2〜8 °C条件下备用; After [0041] The latex microspheres sonicated for 30 seconds to adjust the concentration of the latex microspheres 1.0X IO12~1.0X IO13 / ml, 10000~15000xg centrifugation for 10 min, the precipitate was collected after centrifugation with distilled water or fear IOOmM pH6.0 phosphate solution of sodium was dissolved, and 30 seconds of ultrasonic 200W; was added to 50 μ I of lOOmg / mlEDC, vortexed, then added 50mg / ml N- hydroxysulfosuccinimide 50 μ I of (S μ If0-NHS) , vortexed; 10000~15000xg after 30 minutes incubation at room temperature, centrifuged 5~15 minutes, precipitated with lOOmM, pH5.0~6.0 citrate buffer solution, is placed in a standby condition at 2~8 ° C;

[0042] 2.荧光胶乳微粒标记蛋白的制备 [0042] 2. Preparation of the fluorescent latex particle-labeled protein

[0043] 将上述活化后的荧光胶乳超声波200W处理30秒后,按照50 μ g蛋白/100 μ I荧光胶乳的比例加入CRP抗体和兔IgG,Votex混匀后室温搅拌反应2小时,离心洗涤3次,每次10000〜15000xg、离心10分钟,沉淀用PBS-TBN溶解并超声波100W处理30秒,用PBS-TBN恢复离心前体积调节至浓度为1.0mg/ml,按0.8 μ g/cm2的用量涂覆在标记垫上; After [0043] The ultrasonic 200W fluorescent latex after the activation treatment for 30 seconds in accordance with 50 μ g protein / 100 μ I ratio of the added fluorescent latex and rabbit CRP antibody IgG, after mixing Votex stirred at room temperature for 2 hours, centrifuged and washed 3 times 10000~15000xg, centrifuged for 10 minutes, the precipitate was dissolved with PBS-TBN and 100W ultrasound for 30 seconds, and restored before centrifugation with PBS-TBN volume was adjusted to a concentration of 1.0mg / ml, 0.8 μ g amounts press / cm2, coated mat marker;

[0044] 3.CRP抗体包被到包被膜 [0044] 3.CRP antibody coated onto the coated film

[0045] 将另一种CRP单克隆抗体和抗兔IgG用包被缓冲液调节至浓度为1.0mg/ml,将抗人IgG用包被缓冲液调节至浓度为0.8mg/ml,按膜包被液量为20 μ l/30cm的用量将CRP单克隆抗体喷到包被膜3上的检测区,分别按膜包被液量为20 μ l/27cm的用量和膜包被液量为20 μ l/34cm的用量将抗兔IgG和抗人IgG喷到包被膜3上的质控区6,检测区5和质控区6间隔5mm,在湿度< 30%的室温下凉干24小时,封袋,备用; [0045] The CRP monoclonal antibody and another anti-rabbit IgG diluted with coating buffer adjusted to a concentration of 1.0mg / ml, anti-human IgG diluted with coating buffer adjusted to a concentration of 0.8mg / ml, by the membrane package the liquid volume was 20 μ l / 30cm amounts of sprayed film packet CRP monoclonal antibody to the detection zone 3, respectively, according to the film coating solution in an amount of 20 μ l / 27cm and the amount of liquid film coating amount of 20 μ the amount of l / 34cm would be anti-rabbit IgG and anti-human IgG to the discharge region 6 on the package quality control coating 3, and the control detection zone 5 zone 6 spaced 5mm, air dried at room temperature under a humidity of 30% <24 hours, seal bags, standby;

[0046] 4.在底板上依次相互搭接地粘贴样品垫1、标记垫2、包被膜3和吸水纸4得到试纸板,按照要求切割成适当宽度的试纸条。 [0046] 4. sequentially overlap each other on the base plate attached to a sample pad, label pad 2, the package film 3 and the absorbent paper obtained paper sheet 4, the strip is cut according to the requirements of the appropriate width.

[0047] 在本发明的一个实施例中,全程定量检测CRP免疫层析试纸条,在使用时,组装在由塑料上壳和塑料下壳扣合而成的塑料外壳中,塑料上壳设有两个开孔,加样窗和显示孔,加样窗对应于所述的全程定量检测CRP免疫层析试纸条样品垫1,结果显示窗对应于所述全程定量检测CRP免疫层析试纸条的检测区5和质控区6,该全程定量检测CRP免疫层析试纸条可以从该塑料外壳中取出。 [0047] In one embodiment of the present invention, the quantitative detection of CRP whole immunochromatographic strip, in use, assembled together by a plastic shell housing the buckle made of plastic and the plastic housing, the plastic housing provided there are two openings, and the display window apertures loaded, loaded window corresponding to the full quantitative detection of CRP sample pad of the immunochromatographic strip 1, the results corresponding to the full display window CRP quantitative immunochromatographic the paper detection zone 5 and the control region 6, the quantitative detection of CRP whole immunochromatographic strip can be removed from the plastic housing.

[0048] 本发明的一个实施例中,用来测试免疫层析试纸条的荧光定量光谱检测系统,主要包含荧光光源系统、检测系统及自动软件分析控制系统。 [0048] An embodiment of the present invention, for testing the quantitative fluorescence spectrum detection system immunochromatographic strip, the system mainly comprises a fluorescent light source, the detection system and control system for automatic analysis software.

[0049] 荧光光源系统发出单色激发光,照射在试纸条的检测区,检测区通过反应凝集的荧光胶乳在激发光的作用下,发射出荧光信号,该荧光信号被检测系统捕获,检测系统由光电倍增管和固态检测器组成,检测系统接收入射荧光信号,由光电倍增管实现光信号的放大,然后由固态检测器将光信号转换为电信号,由电信号读出电路将电信号输出,再经过自动软件分析控制系统处理,在显示屏上显示结果。 [0049] The fluorescent light source system emits monochromatic excitation light is irradiated in a detection region of the strip, the detection zone by fluorescent latex agglutination reaction under the action of excitation light, emits fluorescence signal, the fluorescence signal is captured detecting system that detects system by the photomultiplier tubes and solid-state detector composition, the detection system receiving incident fluorescence signal by the photomultiplier tube to achieve an optical signal amplification, and then by the solid state detector converts the optical signal into an electrical signal, the electrical signal from the readout circuit an electrical signal output, and then through an automatic process control system software analysis, the results displayed on the display screen. 实现对样本的精确定量。 Precise quantification of the sample.

[0050] 本发明与德灵DN-100特种蛋白测定仪对417例临床CRP样本(全血/血浆)的测定结果比较表明:在全程范围内测定CRP(0.5〜200mg/L)的准确性高,两种产品检测结果的相关性R2 > 0.98 (y = 1.0035X+0.7457)。 [0050] The present invention relates to dring special DN-100 protein assay measurement result analyzer 417 cases of CRP sample (whole blood / plasma) comparison shows: CRP measured with high accuracy in the whole range (0.5~200mg / L) of both product test results, the correlation R2> 0.98 (y = 1.0035X + 0.7457). 与英国朗道(RANDOX) CRP校准系列质控品的线性相关性R2 > 0.9。 Landau and UK (RANDOX) linear calibration series of control materials CRP correlation R2> 0.9.

Claims (2)

1.一种全程定量检测C反应蛋白的免疫层析试纸条,所述试纸条由样品垫(I)、标记垫(2)、包被膜(3)、吸水纸(4)顺次搭接粘贴在底板上构成,其特征在于,所述标记垫(2)上包被有荧光胶乳微粒标记的CRP单克隆抗体和荧光胶乳微粒标记的兔IgG ;所述包被膜(3)包括检测区(5)和质控区(6),所述检测区(5)包被有与所述荧光胶乳微粒标记的CRP单克隆抗体处于不同表位的另一种CRP单克隆抗体;所述包被膜上的质控区包括包被抗人IgG的Cl线和包被抗兔IgG的C2线;所述抗人IgG的浓度为0.8mg/ml,抗兔IgG的浓度为.1.0mg/ml,抗人IgG和抗兔IgG的用量按膜包被液量分别为20μ l/34cm和20 μ l/27cm ;所述荧光胶乳微粒标记的CRP单克隆抗体的浓度为1.0mg/ml,在试纸条上的用量为0.8 μ g/cm2 ;所述突光胶乳微粒标记的兔IgG的浓度为1.0mg/ml,在试纸条上的用量为0.8 μ g/cm2 ;所述检测区包被的CRP单克隆抗 An immunochromatographic strip full quantitative detection of C-reactive protein, a sample pad of the test strip (the I), marking pad (2), the coated film (3), absorbent paper (4) sequentially take then stuck on the bottom plate configuration, wherein said marking pad (2) coated with a rabbit IgG CRP monoclonal antibody and the fluorescent latex particle-labeled fluorescent latex particles labeled; said package film (3) comprises a detection zone (5) and the control area (6), said detection zone (5) coated with the fluorescent latex particle-labeled monoclonal antibody CRP CRP monoclonal antibody is in another different epitopes; the packet envelope quality control area includes a packet on the line C2 is anti-human IgG coated Cl lines and anti-rabbit IgG; and the anti-human IgG concentration was 0.8mg / ml, concentration of anti-rabbit IgG was .1.0mg / ml, anti- anti-rabbit IgG and human IgG by an amount of the film coating solution in amounts of 20μ l / 34cm and 20 μ l / 27cm; monoclonal antibody CRP concentration of the fluorescent labeled latex microparticles was 1.0mg / ml, the test strip on an amount of 0.8 μ g / cm2; the concentration of the rabbit IgG labeled latex particles projecting light of 1.0mg / ml, the test strip in an amount of 0.8 μ g / cm2; the detection zone coated CRP monoclonal anti 的浓度为1.0mg/ml,用量按膜包被液量为20 μ l/30cm ;所述荧光胶乳微粒的直径为300nm ;所述荧光胶乳微粒的激发光波长为470nm,所述荧光胶乳微粒受激发后发射的波长为525nm。 A concentration of 1.0mg / ml, the amount of film coating solution by an amount of 20 μ l / 30cm; the fluorescent latex particles having a diameter of 300 nm; excitation wavelength of the fluorescent latex particles of 470nm, the fluorescent latex particles by emission wavelength after excitation of 525nm.
2.—种权利要求1所述的全程定量检测C反应蛋白的免疫层析试纸条的制备方法,其特征在于,包括以下步骤: A.荧光胶乳的共价活化超声波处理荧光胶乳微球体30秒后,调节荧光胶乳微球体浓度为1.0X IO12~.1.0XlO1Vml, 10000~15000xg离心10分钟,沉淀物用蒸馏水或100mMpH6.0磷酸钠溶液溶解,并超声波200W处理30秒;先加入50 μ I的100mg/ml碳二亚胺,混匀,再加入50 μ I的.50mg/ml N-羟基硫代琥珀酰亚胺,混匀;室温孵育30分钟后10000~15000xg、离心5~15分钟,沉淀用100mM、pH5.0~6.0的柠檬酸缓冲液溶解,放置于2~8°C条件下备用; B.灭光13父乳微粒标记蛋白的制备将上述活化后的荧光胶乳超声波200W处理30秒后,按照50 μ g蛋白/100 μ I荧光胶乳的比例分别加入CRP单克隆抗体和兔IgG,混匀后室温搅拌反应2小时,离心洗涤3次,每次.10000~15000xg、离心10分钟,沉淀用PBS-TBN溶解并超声波IOOW处理3 Preparation of immunochromatographic strip C throughout the quantitative detection of the kind of claim 1 2.- reactive protein, characterized by comprising the steps of: A. covalently fluorescent latex activation sonication fluorescent latex microspheres 30 after the second, adjusting the concentration of the fluorescent latex microspheres 1.0X IO12 ~ .1.0XlO1Vml, 10000 ~ 15000xg centrifuged for 10 minutes, precipitate was dissolved in distilled water or 100mMpH6.0 sodium phosphate solution, and 200W ultrasound for 30 seconds; the first was added 50 μ I the 100mg / ml carbodiimide, mix, then add 50 μ I of .50mg / ml N- hydroxysulfosuccinimide, mix; incubating 10000 ~ 15000xg 30 minutes at room temperature, centrifuged for 5 to 15 minutes, precipitated with 10OmM, citrate buffer pH5.0 ~ 6.0 was dissolved, placed in the standby condition 2 ~ 8 ° C; B. preparation of light 13 off the parent milk proteins fluorescent labeled microparticles latex 200W ultrasonic activation treatment after the 30 after the second, in accordance with 50 μ g protein / 100 μ I ratio of the fluorescent latex were added CRP monoclonal antibody and rabbit IgG, after mixing was stirred at room temperature for 2 hours, centrifuged and washed 3 times .10000 ~ 15000xg, centrifuged for 10 minutes , the precipitate was dissolved with PBS-TBN and ultrasonic treatment for 3 IOOW 0秒,用PBS-TBN恢复离心前体积调节至浓度为lmg/ml,按0.8 μ g/cm2的用量涂覆在标记垫上; C.包被膜的制备分别将另一种CRP单克隆抗体和抗兔IgG用包被缓冲液调节至浓度为1.0mg/ml,将抗人IgG用包被缓冲液调节至浓度为0.8mg/ml,将CRP单克隆抗体喷到包被膜(3)上的检测区,将抗兔IgG和抗人IgG喷到包被膜(3)上的质控区,所述CRP单克隆抗体、抗兔IgG和抗人IgG的用量按膜包被液量分别为20μ l/30cm、20l.! l/27cm、20l.! l/34cm,检测区和质控区间隔5mm,在湿度< 30%的室温下凉干24小时,封袋,备用; D.在底衬上顺次相互搭接地粘贴样品垫(I)、标记垫(2)、包被膜(3)和吸水纸(4)得到试纸板,按照要求切割成适当宽度的试纸条。 0 seconds, the volume was adjusted to recover before centrifugation with PBS-TBN to a concentration lmg / ml, according to the amount of coating 0.8 μ g / cm2 in the tag pad; C. Preparation of the coated film, respectively, and another anti-CRP monoclonal antibody rabbit IgG diluted with coating buffer adjusted to a concentration of 1.0mg / ml, anti-human IgG diluted with coating buffer adjusted to a concentration of 0.8mg / ml, the monoclonal antibodies to CRP spray package film (3) a detection zone , the anti-rabbit IgG and anti-human IgG to the coated film sprayed on the quality control area (3), the CRP monoclonal antibody, anti-rabbit IgG and anti-human IgG according to the amount of film coating solution in amounts of 20μ l / 30cm , 20l l / 27cm, 20l l / 34cm, detection zone and the control zone spaced 5mm, air dried at room temperature under a humidity of 30% <24 hours, envelope, standby;.!.! D. sequentially on the underlay paste sample pad to overlap each other (the I), marking pad (2), the coated film (3) and the absorbent paper (4) to give the paper sheet, according to the requirements of the cut strip of suitable width.
CN 201010550610 2010-11-19 2010-11-19 Immunochromatographic test strip for full quantitative detection of C-reactive protein and preparation method thereof CN102023211B (en)

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