WO2018068459A1 - Combined diagnosis test strip assembly - Google Patents

Combined diagnosis test strip assembly Download PDF

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WO2018068459A1
WO2018068459A1 PCT/CN2017/074730 CN2017074730W WO2018068459A1 WO 2018068459 A1 WO2018068459 A1 WO 2018068459A1 CN 2017074730 W CN2017074730 W CN 2017074730W WO 2018068459 A1 WO2018068459 A1 WO 2018068459A1
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detection line
antibody
test strip
line
detection
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PCT/CN2017/074730
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French (fr)
Chinese (zh)
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张二盈
齐芳
李镇雄
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深圳市金准生物医学工程有限公司
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Publication of WO2018068459A1 publication Critical patent/WO2018068459A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids

Definitions

  • D-dimer has a molecular weight of about 190 kDa and is one of the specific degradation products of cross-linked fibrin.
  • the activity of fibrinolytic enzyme and inhibitory enzyme in the body maintains a dynamic balance, and the blood circulation in the body is in an orderly and normal operation, and no coagulation occurs, and no D-Dimer is produced.
  • thrombin catalyzes fibrinogen alpha in the body when thrombosis occurs.
  • the chain cleaves FPA to form fibrin I; and FPB is cleaved from the beta strand to form fibrin II.
  • cTnI, D-Dimer, CK-MB, H-FABP, BNP and NT-proBNP have their clinical diagnostic significance, combined with better use in the diagnosis of cardiovascular and cerebrovascular, respiratory system, etc. disease.
  • a joint diagnostic test strip assembly comprising a ferrule and at least one test strip fixed in the ferrule, each test strip comprising a bottom plate and a sample sequentially disposed on a surface layer of the bottom plate along a length direction of the bottom plate a pad, a bonding pad, a signal detecting pad and an absorbent pad, each signal detecting pad is provided with a quality control line at one side of the near absorbent pad, and a cTnI is provided on the signal detecting pad of all the test strips.
  • the number of test strips set is three, wherein the cTnI
  • the test line, CK-MB test line, D-Dimer test line, H-FABP test line, and BNP test/NT-proBNP test line are set on the three test strips.
  • FIG. 1 is a schematic plan view showing the structure of a test strip according to Embodiment 1 of the present invention.
  • the joint diagnostic test strip assembly includes a ferrule 10 and a test strip 11 fixed in the ferrule 10, the test strip 11 including a bottom plate And a sample pad 111, a bonding pad 112, a signal detecting pad 113 and an absorbent pad 114 disposed in the longitudinal direction of the bottom plate 110.
  • the signal detecting pad 113 is provided with a quality at one side of the near absorbent pad 114.
  • Control line 1130, and a cTnI is disposed between the quality control line 1130 and the bonding pad 114.
  • FIG. 6 shows another embodiment of the present invention.
  • the joint diagnostic test strip assembly includes a ferrule 40 and three test strips 41 fixed in the ferrule, each test strip 41
  • the invention includes a bottom plate 410 and a sample pad 411, a bonding pad 412, a signal detecting pad 413 and an absorbent pad 414 disposed in the longitudinal direction of the bottom plate 410.
  • the signal detecting pad 413 is at a side of the near absorbent pad 414.
  • a quality control line 4130 is provided, wherein a cTnI is disposed on the signal detecting pad 413 of a test strip 41.
  • the joint diagnostic test strip assembly includes a ferrule 60 in which four test strips 61 are fixed, which will be cTnI.
  • the detection line 6131, the CK-MB detection line 6132, the D-Dimer detection line 6133, the H-FABP detection line 6134, and the BNP/NT-proBNP detection line 6135 are disposed on the four test strips 61, thus passing a joint diagnostic test strip.
  • the components can simultaneously realize the detection of five items such as cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.

Abstract

Disclosed is a combined diagnosis test strip assembly, comprising a card cover (10, 20, 30, 40, 50, 60, 70) and at least one test strip (11, 21, 31, 41, 51, 61, 71) fixed in the card cover (10, 20, 30, 40, 50, 60, 70). Each test strip (11, 21, 31, 41, 51, 61, 71) comprises a bottom board (110, 210, 310, 410, 510, 610, 710), and a sample pad (111, 211, 311, 411, 511, 611, 711), a conjugate pad (112, 212, 312, 412, 512, 612, 712), a signal detection pad (113, 213, 313, 413, 513, 613, 713) and an absorbent pad (114, 214, 314, 414, 514, 614, 714) sequentially provided on a surface layer of the bottom board (110, 210, 310, 410, 510, 610, 710) in the lengthwise direction of the bottom board (110, 210, 310, 410, 510, 610, 710). Each signal detection pad (113, 213, 313, 413, 513, 613, 713) is provided with a quality control line (1130, 2130, 3130, 4130, 5130, 6130, 7130) on a side thereof close to the absorbent pad (114, 214, 314, 414, 514, 614, 714). The signal detection pads (113, 213, 313, 413, 513, 613, 713) of all the test strips (11, 21, 31, 41, 51, 61, 71) are totally provided with a cTnI test line (1131, 2131, 3131, 4131, 5131, 6131, 7131), a CK-MB test line (1132, 2132, 3132, 4132, 5132, 6132, 7132), a D-Dimer test line (1133, 2133, 3133, 4133, 5133, 6133, 7133), an H-FABP test line (1134, 2134, 3134, 4134, 5134, 6134, 7134) and a BNP/NT-proBNP test line (1135, 2135, 3135, 4135, 5135, 6135, 7135). The card cover (10, 20, 30, 40, 50, 60, 70) is provided with a sample adding hole (100, 200, 300, 400, 500, 600, 700) corresponding to the sample pad (111, 211, 311, 411, 511, 611, 711), and is provided with a display window (101, 201, 301, 401, 501, 601, 701) corresponding to the signal detection pad (113, 213, 313, 413, 513, 613, 713). The combined diagnosis test strip assembly can be used to test the five items simultaneously, with accurate and sensitive test results, a time-saving and labour-saving test procedure, and reduced cost.

Description

一种联合诊断试纸组件  Joint diagnostic test paper assembly
技术领域Technical field
本实用新型涉及生物医学检测工具，尤其涉及一种联合诊断试纸组件。The utility model relates to a biomedical testing tool, in particular to a joint diagnostic test paper component.
背景技术Background technique
心肌肌钙蛋白I（cardiac troponin I, cTnI）是组成心肌肌钙蛋白复合物的亚单位之一，分子量为22.5kD。在心肌细胞受损后，随肌原纤维崩解破坏而不断释放进入血液。cTnI在心肌与骨骼肌中具有独特的氨基酸排列，所以心肌中cTnI具有心肌特异性，能检出酶学方法检查不出的微小的心肌坏死。从上世纪九十年代起，cTnI已成为诊断心肌损伤的首选生化指标之一。1999年和2000年世界生化检测标准化协会、欧洲心脏病协会和美国心脏病学会提出了新的AMI（急性心肌梗塞）定义和诊断标准，把血清标志物检测，特别是肌钙蛋白，放在了特别重要的位置。2001年11月美国心脏病学会和心脏病协会提出测定cTnI作为诊断AMI和急性冠状动脉综合症危险分层的第一位标准。在人类心肌损伤的诊断中，cTnI已经成为“金标准”之一。对AMI病人最初诊断，预后评价，ACS（acute coronary syndrome,急性冠状动脉综合征）危险分层，ACS病人是否需要立即进行冠状动脉搭桥术，以及发生心脏重要事件的预后判断等具有重要意义。 Cardiac troponin I (cardiac troponin I, cTnI) is one of the subunits that make up the cardiac troponin complex with a molecular weight of 22.5 kD. After the myocardial cells are damaged, they are released into the blood as the myofibrils disintegrate. cTnI has a unique amino acid arrangement in the myocardium and skeletal muscle, so cTnI in the myocardium has myocardial specificity and can detect tiny myocardial necrosis that cannot be detected by enzymology. Since the 1990s, cTnI has become one of the preferred biochemical indicators for the diagnosis of myocardial injury. In 1999 and 2000, the World Biochemical Testing Standards Association, the European Heart Association and the American College of Cardiology introduced new definitions and diagnostic criteria for AMI (acute myocardial infarction), placing serum markers, especially troponin, A particularly important location. In November 2001, the American College of Cardiology and Heart Association proposed the determination of cTnI as the first criterion for diagnosing the risk stratification of AMI and acute coronary syndrome. In the diagnosis of human myocardial damage, cTnI has become one of the "gold standard". Initial diagnosis of AMI patients, prognosis evaluation, ACS (acute Coron Syndrome, acute coronary syndrome) risk stratification, whether ACS patients need immediate coronary artery bypass surgery, and the prognosis of cardiac events are important.
肌酸激酶（Creztinekinase，CK）的分子量为81kD的二聚体，有四种不同的形式：线粒体同工酶CK-MiMi（线粒体型）、胞浆同工酶CK-MM（肌型）、CK-BB（脑型）和心型同工酶CK-MB（杂化型）。其中98%-99%的CK-MB存在于心肌细胞内，故称其为心型同工酶。CK-MB在AMI发病4-6小时开始升高，12-24小时达高峰，可为正常的20倍，约2天降至正常，对AMI诊断具有较高的敏感性，其阳性率在90%以上。但CK-MB并非心脏所特有的酶，正常人骨骼肌中也有少量CK-MB，且CK-MB诊断时间窗口短，其敏感性和特异性都不尽如人意。尽管如此，CK-MB却仍是目前用来诊断AMI的最理想的酶指标。 The molecular weight of creztinekinase (CK) is 81kD dimer, which has four different forms: mitochondrial isoenzyme CK-MiMi (mitochondrial type), cytoplasmic isoenzyme CK-MM (muscle type), CK - BB (brain type) and cardioid isoenzyme CK-MB (hybrid type). Among them, 98%-99% of CK-MB is present in cardiomyocytes, so it is called cardotype isoenzyme. CK-MB begins to rise in 4-6 hours after AMI, peaks at 12-24 hours, can be 20 times normal, and falls to normal in about 2 days. It has high sensitivity to AMI diagnosis, and its positive rate is 90. %the above. However, CK-MB is not a unique enzyme in the heart. There is also a small amount of CK-MB in normal human skeletal muscle, and the CK-MB diagnosis time window is short, and its sensitivity and specificity are not satisfactory. Despite this, CK-MB is still the most ideal enzyme indicator for diagnosing AMI.
D-二聚体（D-Dimer，DD）分子量大小约为190kDa，是交联纤维蛋白的特异降解产物之一。生理状态下，体内纤维蛋白溶酶和抑制酶活性保持动态平衡，机体内的血液循环有序、正常的运行，没有凝血发生，也就没有D-Dimer生成。在病理状态下，发生凝血有血栓形成时，机体内的凝血酶催化纤维蛋白原α 链裂解出FPA，生成纤维蛋白Ⅰ；从β链上裂解出FPB，生成纤维蛋白Ⅱ。纤维蛋白在血管壁上被Ⅻ作用，经过活化后的纤溶酶裂解产生各种的FDP碎片，随后在r 链的作用下产生包含r链相连的两个D片段，即D-Dimer。机体凝血、抗凝和纤溶系统平衡失调，凝血功能会随之增强，产生一系列的特异性降解产物，D-Dimer的含量也会增高。D-二聚体是凝血过程激活的一个极为敏感的标记物，当获得的D-二聚体值低于临界值时，便可排除下肢的深静脉血栓（DVT）和肺栓塞（PE），具有很高的灵敏度。 D-dimer (DD) has a molecular weight of about 190 kDa and is one of the specific degradation products of cross-linked fibrin. Under physiological conditions, the activity of fibrinolytic enzyme and inhibitory enzyme in the body maintains a dynamic balance, and the blood circulation in the body is in an orderly and normal operation, and no coagulation occurs, and no D-Dimer is produced. In the pathological state, thrombin catalyzes fibrinogen alpha in the body when thrombosis occurs. The chain cleaves FPA to form fibrin I; and FPB is cleaved from the beta strand to form fibrin II. Fibrin is acted upon by XII on the vessel wall and is lysed by activated plasmin to produce various FDP fragments, followed by r Under the action of the chain, two D fragments containing the r chain are joined, namely D-Dimer. The body's coagulation, anticoagulation and fibrinolysis system balance imbalance, coagulation function will be enhanced, resulting in a series of specific degradation products, D-Dimer content will also increase. D-dimer is an extremely sensitive marker for the activation of the coagulation process. When the D-dimer value obtained is below the critical value, the deep vein thrombosis (DVT) and pulmonary embolism (PE) of the lower extremity can be excluded. Has a high sensitivity.
心肌型脂肪酸结合蛋白(H-FABP)是一种新的AMI的血清标志物，是心肌细胞中富含的一种小分子(14k-15kD)细胞质蛋白。H-FABP含量在骨骼肌中比心肌中低10倍,在肾脏、肝脏和小肠中含量也很低，心肌损伤后，H-FABP释放至细胞外，出现于血液中，在AMI早期(0-3小时)即可检测到血清H-FABP。H-FABP自上世纪90年代起开始作为诊断AMI的早期诊断指标，它对诊断AMI的敏感性、特异性和准确率均较高，故在临床上有广泛应用前景。 Myocardial fatty acid binding protein (H-FABP) is a novel serum marker of AMI, a small molecule (14k-15kD) cytoplasmic protein enriched in cardiomyocytes. The content of H-FABP is 10 times lower in skeletal muscle than in myocardium, and is also low in kidney, liver and small intestine. After myocardial injury, H-FABP is released to the outside of the cell and appears in the blood, in the early stage of AMI (0- Serum H-FABP was detected in 3 hours). Since the 1990s, H-FABP has been used as an early diagnostic indicator for the diagnosis of AMI. It has high sensitivity, specificity and accuracy for diagnosing AMI, so it has broad application prospects in clinical practice.
1988年，日本学者Tetsuji Sudoh等首次从猪脑分离纯化出一种具有强力的利纳、利尿、扩血管和降压作用环状多肽物质，因此命名为脑钠肽（btain natriuretiv peptide，BNP)。BNP主要在心室合成与分泌，反映心室压力与容量负荷的变化，同时也受机械和神经刺激的调节。人类BNP基因片段位于1号染色体短臂的远端，其cDNA由1900个核苷酸组成，mRNA由900-1000个核苷酸组成，它可表达生成由134个氨基酸构成的前脑钠肽原（preProBNP)，随后被蛋白酶在N端切掉1条26个氨基酸的片断，形成具有108个氨基酸的脑钠肽前体(ProBNP)。脑钠肽前体并不储存于分泌颗粒，主要从心室分泌，在其分泌或进入血液循环的过程中，被蛋白水解酶裂解成没有生物活性含76个氨基酸的N端片段NT-proBNP（N-terminal pro-B-typenatriuretic peptide，NT-proBNP）和有生物活性的含32个氨基酸的C端片段BNP。In 1988, Japanese scholar Tetsuji For the first time, Sudoh et al. isolated and purified a cyclic peptide substance with strong Liner, diuretic, vasodilator and antihypertensive effects from pig brain, hence the name brain natriuretic peptide (btain natriuretiv). Peptide, BNP). BNP is mainly synthesized and secreted in the ventricle, reflecting changes in ventricular pressure and volume load, as well as mechanical and neurostimulation. The human BNP gene fragment is located at the distal end of the short arm of chromosome 1 and its cDNA consists of 1900 nucleotides. The mRNA consists of 900-1000 nucleotides, which can express the pro-brain natriuretic peptide composed of 134 amino acids. (preProBNP), followed by a protease to cleave a 26 amino acid fragment at the N-terminus to form a brain natriuretic peptide precursor (ProBNP) having 108 amino acids. The brain natriuretic peptide precursor is not stored in the secretory granules and is mainly secreted from the ventricle. During its secretion or into the blood circulation, it is cleaved by proteolytic enzymes into an N-terminal fragment NT-proBNP (N-free biologically active) containing 76 amino acids. -terminal pro-B-type natriuretic peptide, NT-proBNP) and biologically active C-terminal fragment BNP containing 32 amino acids.
脑钠肽是心脏细胞产生的结构相关的肽类激素家族钠尿肽中的一种。当心功能不全时，由于心脏容量负荷或压力负荷增加，心肌受到牵张或室壁压力增大，会使血中BNP的指标浓度增高，而这恰恰是诊断心衰较为敏感的指标。可以独立预测左心室舒张末期压力升高状况。因此，BNP可以作为一个更好的预示心衰状况的指标。在2001年修订的欧洲心脏病学会心衰诊疗指南中，已经把脑钠肽作为心衰诊断的工具。2005年欧洲和美国的指南，均进一步肯定了脑钠肽在心衰诊断中的作用。 Brain natriuretic peptide is one of the structurally related peptide hormone family natriuretic peptides produced by cardiac cells. When the heart function is incomplete, the heart muscle is stretched or the wall pressure is increased due to the increase of cardiac volume load or pressure load, which will increase the concentration of BNP in the blood, which is precisely the sensitive index for diagnosing heart failure. Left ventricular end-diastolic pressure rise can be independently predicted. Therefore, BNP can be used as a better indicator of heart failure. Brain natriuretic peptide has been used as a tool for the diagnosis of heart failure in the revised European Society of Cardiology Heart Failure Guidelines in 2001. The 2005 European and American guidelines further affirmed the role of brain natriuretic peptide in the diagnosis of heart failure.
NT-proBNP是BNP激素原分裂后没有活性的N-末端片段，与BNP相比，半衰期更长，更稳定，其浓度可反映短暂时间内新合成的而不是贮存的BNP释放，因此更能反映BNP通路的激活。是公认的反映心室功能的敏感指标，其在心力衰竭的诊断、预后评估和个体化治疗监测方面具有重要的临床价值。近年的研究发现，NT-proBNP与心、脑血管疾病，呼吸系统疾病及肾脏疾病等均有密切联系。NT-proBNP is an N-terminal fragment that is inactive after BNP prohormone splitting. Compared with BNP, it has a longer half-life and is more stable. Its concentration reflects the release of newly synthesized but not stored BNP in a short period of time, so it is more reflective. Activation of the BNP pathway. It is a recognized sensitive index reflecting ventricular function, and it has important clinical value in the diagnosis, prognosis assessment and individualized treatment monitoring of heart failure. Recent studies have found that NT-proBNP is closely related to heart and cerebrovascular diseases, respiratory diseases and kidney diseases.
综上所述，cTnI、D-Dimer、CK-MB、H-FABP、BNP和NT-proBNP几种标志物的各有其临床诊断意义，联合使用更好的辅助诊断心脑血管、呼吸系统等疾病。In summary, cTnI, D-Dimer, CK-MB, H-FABP, BNP and NT-proBNP have their clinical diagnostic significance, combined with better use in the diagnosis of cardiovascular and cerebrovascular, respiratory system, etc. disease.
实用新型内容Utility model content
本实用新型要解决的技术问题在于提供一种可同时进行多项目联合检测的联合诊断试纸组件。The technical problem to be solved by the utility model is to provide a joint diagnostic test paper assembly capable of simultaneous multi-item joint detection.
为解决上述技术问题，本实用新型采用如下技术方案。一种联合诊断试纸组件，包括有一卡套和至少一固定于所述卡套中的试纸条，每一试纸条包括一底板及沿所述底板长度方向在底板的表层依次设置的一样品垫、一结合垫、一信号检测垫及一吸水垫，每一信号检测垫在其近吸水垫的一侧处设有一质控线，在所有试纸条的信号检测垫上，共设有一cTnI 检测线、一CK-MB检测线、一D-Dimer检测线、一H-FABP检测线和一BNP/NT-proBNP检测线，所述卡套上对应于所述样品垫处开设有加样孔，而对应于所述信号检测垫处开设有显示窗口。In order to solve the above technical problems, the present invention adopts the following technical solutions. A joint diagnostic test strip assembly comprising a ferrule and at least one test strip fixed in the ferrule, each test strip comprising a bottom plate and a sample sequentially disposed on a surface layer of the bottom plate along a length direction of the bottom plate a pad, a bonding pad, a signal detecting pad and an absorbent pad, each signal detecting pad is provided with a quality control line at one side of the near absorbent pad, and a cTnI is provided on the signal detecting pad of all the test strips. a detection line, a CK-MB detection line, a D-Dimer detection line, an H-FABP detection line, and a BNP/NT-proBNP detection line, wherein the ferrule is provided with a sample hole corresponding to the sample pad And a display window is opened corresponding to the signal detecting pad.
上述联合诊断试纸组件中，所设置的试纸条的数目为一，其中，于所述试纸条的信号检测垫上间隔设置有所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线。In the above joint diagnostic test strip assembly, the number of test strips is one, wherein the cTnI is interposed on the signal detecting mat of the test strip. Detection line, CK-MB detection line, D-Dimer detection line, H-FABP detection line and BNP/NT-proBNP detection line.
上述联合诊断试纸组件中，所设置的试纸条的数目为二，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线分设于二试纸条上。。In the above joint diagnostic test strip assembly, the number of test strips set is two, wherein the cTnI The detection line, CK-MB detection line, D-Dimer detection line, H-FABP detection line and BNP/NT-proBNP detection line are set on the two test strips. .
上述联合诊断试纸组件中，所设置的试纸条的数目为三，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP检/NT-proBNP检测线分设于三试纸条上。In the above joint diagnostic test strip assembly, the number of test strips set is three, wherein the cTnI The test line, CK-MB test line, D-Dimer test line, H-FABP test line, and BNP test/NT-proBNP test line are set on the three test strips.
上述联合诊断试纸组件中，所设置的试纸条的数目为四，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线分设于四试纸条上。In the above joint diagnostic test strip assembly, the number of test strips set is four, wherein the cTnI The detection line, CK-MB detection line, D-Dimer detection line, H-FABP detection line and BNP/NT-proBNP detection line are set on the four test strips.
上述联合诊断试纸组件中，所设置的试纸条的数目为五，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线分别设置于每一试纸条上。In the above joint diagnostic test strip assembly, the number of test strips set is five, wherein the cTnI The detection line, the CK-MB detection line, the D-Dimer detection line, the H-FABP detection line, and the BNP/NT-proBNP detection line are respectively disposed on each test strip.
上述联合诊断试纸组件中，所述试纸条的结合垫表面喷涂有标记物标记的对应五个检测项目的单克隆抗体Ⅰ，所述标记物为荧光物质、彩色微球或者胶体金，所述五个检测项目的单克隆抗体分别为cTnI抗体Ⅰ、CK-MB抗体Ⅰ、D-Dimer抗体Ⅰ、H-FABP抗体Ⅰ与BNP/NT-proBNP抗体Ⅰ。In the above joint diagnostic test strip assembly, the surface of the binding pad of the test strip is sprayed with a monoclonal antibody I corresponding to five detection items labeled with a label, the label being a fluorescent substance, a colored microsphere or a colloidal gold. The monoclonal antibodies of the five test items were cTnI antibody I, CK-MB antibody I, D-Dimer antibody I, H-FABP antibody I and BNP/NT-proBNP antibody I, respectively.
上述联合诊断试纸组件中，所述试纸条的检测线上分别设有与标记各自检测项目抗体Ⅰ具有不同抗原决定簇的对应的单克隆抗体Ⅱ：cTnI检测线上设有与标记cTnI抗体Ⅰ具有不同抗原决定簇的cTnI抗体Ⅱ，CK-MB检测线上设有与标记CK-MB抗体Ⅰ具有不同抗原决定簇的CK-MB抗体Ⅱ，D-Dimer检测线上设有与标记D-Dimer抗体Ⅰ具有不同抗原决定簇的D-Dimer抗体Ⅱ，H-FABP检测线上设有与标记H-FABP抗体Ⅰ具有不同抗原决定簇的H-FABP抗体Ⅱ，BNP检测线上设有与标记BNP抗体Ⅰ具有不同抗原决定簇的BNP抗体Ⅱ，NT-proBNP检测线上设有与NT-proBNP抗体Ⅰ具有不同抗原决定簇的NT-proBNP抗体Ⅱ。In the joint diagnostic test strip assembly, the detection line of the test strip is provided with a corresponding monoclonal antibody II having a different antigenic determinant from the respective detection item antibody I: cTnI detection line is provided with the labeled cTnI antibody I cTnI antibody II with different antigenic determinants, CK-MB antibody II with different antigenic determinants from labeled CK-MB antibody I on the CK-MB detection line, and D-Dimer on the D-Dimer detection line Antibody I has D-Dimer antibody II with different antigenic determinants, H-FABP antibody II with different antigenic determinants from labeled H-FABP antibody I is provided on the H-FABP detection line, and BNP is provided on the BNP detection line. Antibody I has BNP antibody II with different antigenic determinants, and NT-proBNP antibody II having a different antigenic determinant from NT-proBNP antibody I is provided on the NT-proBNP detection line.
上述联合诊断试纸组件中，所述试纸条的质控线上设有对应标记五个检测项目的单克隆抗体Ⅰ的二抗，分别为：cTnI抗体Ⅰ的二抗、CK-MB抗体Ⅰ的二抗、D-Dimer抗体Ⅰ的二抗、H-FABP抗体Ⅰ的二抗、BNP/NT-proBNP抗体Ⅰ的二抗。In the above joint diagnostic test strip assembly, the secondary control antibody of the monoclonal antibody I corresponding to the five detection items is provided on the quality control line of the test strip, respectively: secondary antibody of cTnI antibody I, CK-MB antibody I Secondary antibody, secondary antibody of D-Dimer antibody I, secondary antibody of H-FABP antibody I, secondary antibody of BNP/NT-proBNP antibody I.
本实用新型的有益技术效果是：该联合诊断试纸组件中包括有一卡套及至少一设置于该卡套中的试纸条，在所有试纸条的信号检测垫上共设有一cTnI 检测线、一CK-MB检测线、一D-Dimer检测线、一H-FABP检测线、一BNP/NT-proBNP检测线，如此，可以同时检测cTnI、CK-MB、D-Dimer、H-FABP与BNP或NT-proBNP的浓度，不仅便于使用者进行检测操作，并使得检测结果更加全面准确，提高了心脑血管、呼吸系统等疾病的检测效率。The beneficial technical effect of the present invention is that the joint diagnostic test paper assembly includes a ferrule and at least one test strip disposed in the ferrule, and a cTnI is disposed on the signal detecting pads of all the test strips. Detection line, a CK-MB detection line, a D-Dimer detection line, an H-FABP detection line, and a BNP/NT-proBNP detection line, so that cTnI, CK-MB, D-Dimer, H- can be simultaneously detected. The concentration of FABP and BNP or NT-proBNP not only facilitates the user to perform the detection operation, but also makes the detection result more comprehensive and accurate, and improves the detection efficiency of diseases such as cardiovascular and respiratory diseases.
附图说明DRAWINGS
图1为本实用新型实施例1的试纸条的平面结构示意图。 1 is a schematic plan view showing the structure of a test strip according to Embodiment 1 of the present invention.
图2为本实用新型实施例1的试纸条装入卡套后的结构示意图。2 is a schematic structural view of the test strip of the first embodiment of the present invention after being loaded into the ferrule.
图3为本实用新型实施例1的试纸条的侧面结构示意图。3 is a schematic side view showing the structure of a test strip according to Embodiment 1 of the present invention.
图4为本实用新型实施例2的试纸条的平面结构示意图。4 is a schematic plan view showing the structure of a test strip according to Embodiment 2 of the present invention.
图5为本实用新型实施例3的试纸条的平面结构示意图。Figure 5 is a plan view showing the structure of a test strip according to Embodiment 3 of the present invention.
图6为本实用新型实施例3的试纸条的平面结构示意图。Figure 6 is a plan view showing the structure of a test strip according to Embodiment 3 of the present invention.
图7为本实用新型实施例4的试纸条的平面结构示意图。Figure 7 is a plan view showing the structure of a test strip according to Embodiment 4 of the present invention.
图8为本实用新型实施例5的试纸条的平面结构示意图。Figure 8 is a plan view showing the structure of a test strip according to Embodiment 5 of the present invention.
图9为本实用新型实施例6的试纸条的平面结构示意图。Figure 9 is a plan view showing the structure of a test strip according to Embodiment 6 of the present invention.
具体实施方式detailed description
为使本领域技术人员更加清楚地理解本实用新型的目的、技术方案和优点，一下结合附图和实施例对本实用新型做进一步阐释。The present invention will be further explained in conjunction with the accompanying drawings and embodiments in order to provide a further understanding of the present invention.
实施列1：Implementation column 1:
请参阅图1至图3所示，在一种优选实施例中，联合诊断试纸组件包括有一卡套10和一固定于该卡套10中的试纸条11，该试纸条11包括有一底板110及沿该底板110长度方向依次设置的一样品垫111、一结合垫112、一信号检测垫113和一吸水垫114，该信号检测垫113在其近吸水垫114的一侧处设有一质控线1130，而在其位于该质控线1130和结合垫114之间间隔设置有一cTnI 检测线1131、一CK-MB检测线1132、一D-Dimer检测线1133、一H-FABP检测线1134和一BNP/NT-proBNP检测线1135，该卡套10上对应于该样品垫111处开设有一加样孔100，而对应于该信号检测垫113处开设有一显示窗口101。Referring to FIG. 1 to FIG. 3, in a preferred embodiment, the joint diagnostic test strip assembly includes a ferrule 10 and a test strip 11 fixed in the ferrule 10, the test strip 11 including a bottom plate And a sample pad 111, a bonding pad 112, a signal detecting pad 113 and an absorbent pad 114 disposed in the longitudinal direction of the bottom plate 110. The signal detecting pad 113 is provided with a quality at one side of the near absorbent pad 114. Control line 1130, and a cTnI is disposed between the quality control line 1130 and the bonding pad 114. a detection line 1131, a CK-MB detection line 1132, a D-Dimer detection line 1133, an H-FABP detection line 1134, and a BNP/NT-proBNP detection line 1135, the ferrule 10 corresponding to the sample pad 111 A sample hole 100 is opened, and a display window 101 is defined corresponding to the signal detecting pad 113.
在一些实施例中，可在卡套10内形成插槽（图中没有示出），将底板110插设于该插槽中，从而实现该试纸条11固定于该卡套10之内。In some embodiments, a slot (not shown) may be formed in the ferrule 10, and the bottom plate 110 is inserted into the slot, so that the test strip 11 is fixed within the ferrule 10.
该结合垫113表面喷涂有标记物标记的对应五个检测项目的单克隆抗体Ⅰ，所述标记物为荧光物质、彩色微球或者胶体金，所述五个检测项目的单克隆抗体分别为cTnI抗体Ⅰ、CK-MB抗体Ⅰ、D-Dimer抗体Ⅰ、H-FABP抗体Ⅰ与BNP/NT-proBNP抗体Ⅰ。The surface of the binding pad 113 is sprayed with a label-labeled monoclonal antibody I corresponding to five detection items, the label is a fluorescent substance, a colored microsphere or a colloidal gold, and the monoclonal antibodies of the five detection items are respectively cTnI. Antibody I, CK-MB Antibody I, D-Dimer Antibody I, H-FABP Antibody I and BNP/NT-proBNP Antibody I.
所述五条检测线上分别设有与标记各自检测项目抗体Ⅰ具有不同抗原决定簇的对应的单克隆抗体Ⅱ：cTnI检测线1131上设有与标记cTnI抗体Ⅰ具有不同抗原决定簇的cTnI抗体Ⅱ，CK-MB检测线1132上设有与标记CK-MB抗体Ⅰ具有不同抗原决定簇的CK-MB抗体Ⅱ，D-Dimer检测线1133上设有与标记D-Dimer抗体Ⅰ具有不同抗原决定簇的D-Dimer抗体Ⅱ，H-FABP检测线1134上设有与标记H-FABP抗体Ⅰ具有不同抗原决定簇的H-FABP抗体Ⅱ，BNP/NT-proBNP检测线1135上设有与标记BNP抗体Ⅰ/NT-proBNP抗体Ⅰ具有不同抗原决定簇的BNP抗体Ⅱ/NT-proBNP抗体Ⅱ。Each of the five detection lines is provided with a corresponding monoclonal antibody II having a different antigenic determinant from the respective detection item antibody I: cTnI detection line 1131 is provided with a cTnI antibody II having a different antigenic determinant from the labeled cTnI antibody I. The CK-MB detection line 1132 is provided with a CK-MB antibody II having a different antigenic determinant than the labeled CK-MB antibody I, and the D-Dimer detection line 1133 is provided with a different antigenic determinant from the labeled D-Dimer antibody I. D-Dimer antibody II, H-FABP detection line 1134 is provided with H-FABP antibody II having a different antigenic determinant than labeled H-FABP antibody I, and BNP/NT-proBNP detection line 1135 is provided with labeled BNP antibody I/NT-proBNP Antibody I has a different antigenic determinant of BNP antibody II/NT-proBNP antibody II.
该质控线1130上设有标记对应五个检测项目的单克隆抗体Ⅰ的二抗，分别为：cTnI抗体Ⅰ的二抗、CK-MB抗体Ⅰ的二抗、D-Dimer抗体Ⅰ的二抗、H-FABP抗体Ⅰ的二抗、BNP/NT-proBNP抗体Ⅰ的二抗。The control line 1130 is provided with a secondary antibody labeled with monoclonal antibody I corresponding to five detection items, namely: secondary antibody of cTnI antibody I, secondary antibody of CK-MB antibody I, secondary antibody of D-Dimer antibody I , secondary antibody of H-FABP antibody I, secondary antibody of BNP/NT-proBNP antibody I.
优选地，所述底板110是PVC底板。Preferably, the bottom plate 110 is a PVC bottom plate.
在上述实施例中，该联合诊断试纸组件包括有一卡套10，于该卡套10内固定有一试纸条11，该试纸条11的信号检测垫113设有一cTnI 检测线、一CK-MB检测线、一D-Dimer检测线、一H-FABP检测线和BNP/NT-proBNP检测线，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP等五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 10, and a test strip 11 is fixed in the ferrule 10, and the signal detecting pad 113 of the test strip 11 is provided with a cTnI. Detection line, a CK-MB detection line, a D-Dimer detection line, an H-FABP detection line, and a BNP/NT-proBNP detection line. Thus, cTnI, CK-MB can be simultaneously realized by a combined diagnostic test strip component. The detection of five items such as D-Dimer, H-FABP, and BNP/NT-proBNP makes the test results accurate and sensitive, and the detection process saves time and labor and saves costs.
实施列2：Implementation column 2:
图4示出了本实用新型的另一实施例，在此实施例中，该联合诊断试纸组件包括有一卡套20及二固定于该卡套中的试纸条21，每试纸条21包括有一底板210及沿该底板210长度方向依次设置的一样品垫211、一结合垫212、一信号检测垫213和一吸水垫214，该信号检测垫213在其近吸水垫214的一侧处设有一质控线2130，其中，于一试纸条21的信号检测垫213上设有一cTnI 检测线2131、一CK-MB检测线2132、一D-Dimer检测线2133和一H-FABP检测线2134，而于另一试纸条21的信号检测垫213上设有一BNP/NT-proBNP检测线2135，该卡套20上对应于该样品垫211处开设有加样孔200，而对应于该信号检测垫213处开设有显示窗口201。FIG. 4 shows another embodiment of the present invention. In this embodiment, the joint diagnostic test strip assembly includes a ferrule 20 and two test strips 21 fixed in the ferrule, each test strip 21 including There is a bottom plate 210 and a sample pad 211, a bonding pad 212, a signal detecting pad 213 and an absorbent pad 214 disposed in the longitudinal direction of the bottom plate 210. The signal detecting pad 213 is disposed at one side of the near absorbent pad 214. There is a quality control line 2130, wherein a cTnI is disposed on the signal detecting pad 213 of a test strip 21. The detection line 2131, a CK-MB detection line 2132, a D-Dimer detection line 2133 and an H-FABP detection line 2134, and a BNP/NT-proBNP detection on the signal detection pad 213 of the other test strip 21 A wire 2135 is disposed on the ferrule 20 corresponding to the sample pad 211, and a display window 201 is defined corresponding to the signal detecting pad 213.
当然，在其他的实施例中，也可将cTnI 检测线2131、CK-MB检测线2132、D-Dimer检测线2133、H-FABP检测线2134和BNP/NT-proBNP检测线2135中的任意其他四条检测线设置于一试纸条21上，而将剩余的一检测线设置于另一试纸条21上。Of course, in other embodiments, cTnI can also be used. The detection line 2131, the CK-MB detection line 2132, the D-Dimer detection line 2133, the H-FABP detection line 2134, and any other four detection lines of the BNP/NT-proBNP detection line 2135 are disposed on a test strip 21, and The remaining one detection line is placed on the other test strip 21.
在此实施例中，卡套20、试纸条21、底板210、样品垫211、结合垫212、信号检测垫213、吸水垫214、质控线2130、cTnI 检测线2131、CK-MB检测线2132、D-Dimer检测线2133、H-FABP检测线2134、NP/NT-proBNP检测线2135、加样孔200、显示窗口201等部件的结构和制成材料与实施例1的相同。In this embodiment, the ferrule 20, the test strip 21, the bottom plate 210, the sample pad 211, the bonding pad 212, the signal detecting pad 213, the water absorbing pad 214, the quality control line 2130, the cTnI Structure and material of components such as detection line 2131, CK-MB detection line 2132, D-Dimer detection line 2133, H-FABP detection line 2134, NP/NT-proBNP detection line 2135, sample application hole 200, display window 201, and the like The same as in the first embodiment.
在上述实施例中，该联合诊断试纸组件包括有一卡套20，于该卡套内固定有二试纸条21，将cTnI 检测线2131、CK-MB检测线2132、D-Dimer检测线2133、H-FABP检测线2134和BNP/NT-proBNP检测线2135分设于两个试纸条21上，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP等五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 20, and two test strips 21 are fixed in the ferrule, and cTnI is The detection line 2131, the CK-MB detection line 2132, the D-Dimer detection line 2133, the H-FABP detection line 2134, and the BNP/NT-proBNP detection line 2135 are disposed on the two test strips 21, thus passing a joint diagnostic test strip. The components can simultaneously realize the detection of five items such as cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.
实施列3：Implementation column 3:
图5示出了本实用新型的另一实施例，在此实施例中，该联合诊断试纸组件包括有一卡套30及二固定于该卡套中的试纸条31，每试纸条31包括有一底板310及沿该底板310长度方向依次设置的一样品垫311、一结合垫312、一信号检测垫313和一吸水垫314，该信号检测垫313在其近吸水垫314的一侧处设有一质控线3130，其中，于一试纸条31的信号检测垫313上设有一cTnI 检测线3131、一CK-MB检测线3132及一D-Dimer检测线3133，而于另一试纸条31的信号检测垫313上设有一H-FABP检测线3134和一BNP/NT-proBNP检测线3135，该卡套30上对应于该样品垫311处开设有加样孔300，而对应于该信号检测垫313处开设有显示窗口301。FIG. 5 shows another embodiment of the present invention. In this embodiment, the joint diagnostic test strip assembly includes a ferrule 30 and two test strips 31 fixed in the ferrule, each test strip 31 including There is a bottom plate 310 and a sample pad 311, a bonding pad 312, a signal detecting pad 313 and an absorbent pad 314 disposed in the longitudinal direction of the bottom plate 310. The signal detecting pad 313 is disposed at one side of the near absorbent pad 314. There is a quality control line 3130, wherein a cTnI is disposed on the signal detecting pad 313 of a test strip 31. The detection line 3131, a CK-MB detection line 3132 and a D-Dimer detection line 3133, and an H-FABP detection line 3134 and a BNP/NT-proBNP detection on the signal detection pad 313 of the other test strip 31 A wire 3135 is disposed on the ferrule 30 corresponding to the sample pad 311, and a display window 301 is defined corresponding to the signal detecting pad 313.
当然，在其他的实施例中，也可将cTnI 检测线3131、CK-MB检测线3132、D-Dimer检测线3133、H-FABP检测线3134和BNP/NT-proBNP检测线3135中的任意其他三条检测线设置于一试纸条31上，而将剩余的两条检测线设置于另一试纸条31上。Of course, in other embodiments, cTnI can also be used. The detection line 3131, the CK-MB detection line 3132, the D-Dimer detection line 3133, the H-FABP detection line 3134, and any other three detection lines of the BNP/NT-proBNP detection line 3135 are disposed on a test strip 31, and The remaining two detection lines are placed on the other test strip 31.
在此实施例中，卡套30、试纸条31、底板310、样品垫311、结合垫312、信号检测垫313、吸水垫314、质控线3130、cTnI 检测线3131、CK-MB检测线3132、D-Dimer检测线3133、H-FABP检测线3134、NP/NT-proBNP检测线3135、加样孔300、显示窗口301等部件的结构和制成材料与实施例1的相同。In this embodiment, the ferrule 30, the test strip 31, the bottom plate 310, the sample pad 311, the bonding pad 312, the signal detecting pad 313, the absorbent pad 314, the quality control line 3130, the cTnI Structure and material of components such as detection line 3131, CK-MB detection line 3132, D-Dimer detection line 3133, H-FABP detection line 3134, NP/NT-proBNP detection line 3135, sample application hole 300, display window 301, and the like The same as in the first embodiment.
在上述实施例中，该联合诊断试纸组件包括有一卡套30，于该卡套内固定有二试纸条31，将cTnI 检测线3131、CK-MB检测线3132、D-Dimer检测线3133、H-FABP检测线3134和BNP/NT-proBNP检测线3135分设于两个试纸条31上，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP等五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 30 in which two test strips 31 are fixed, which will be cTnI The detection line 3131, the CK-MB detection line 3132, the D-Dimer detection line 3133, the H-FABP detection line 3134, and the BNP/NT-proBNP detection line 3135 are disposed on the two test strips 31, thus passing a joint diagnostic test strip The components can simultaneously realize the detection of five items such as cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.
实施列4：Implementation column 4:
图6示出了本实用新型的另一实施例，在此实施例中，该联合诊断试纸组件包括有一卡套40及三个固定于该卡套中的试纸条41，每试纸条41包括有一底板410及沿该底板410长度方向依次设置的一样品垫411、一结合垫412、一信号检测垫413和一吸水垫414，该信号检测垫413在其近吸水垫414的一侧处设有一质控线4130，其中，于一试纸条41的信号检测垫413上设有一cTnI 检测线4131、一CK-MB检测线4132及一D-Dimer检测线4133，于第二试纸条41的信号检测垫413上设有一H-FABP检测线4134，于第三试纸条41的信号检测垫413上设有一BNP/NT-proBNP检测线4135，该卡套40上对应于该样品垫411处开设有加样孔400，而对应于该信号检测垫413处开设有显示窗口401。FIG. 6 shows another embodiment of the present invention. In this embodiment, the joint diagnostic test strip assembly includes a ferrule 40 and three test strips 41 fixed in the ferrule, each test strip 41 The invention includes a bottom plate 410 and a sample pad 411, a bonding pad 412, a signal detecting pad 413 and an absorbent pad 414 disposed in the longitudinal direction of the bottom plate 410. The signal detecting pad 413 is at a side of the near absorbent pad 414. A quality control line 4130 is provided, wherein a cTnI is disposed on the signal detecting pad 413 of a test strip 41. The detection line 4131, the CK-MB detection line 4132 and the D-Dimer detection line 4133 are provided with an H-FABP detection line 4134 on the signal detection pad 413 of the second test strip 41, and the third test strip 41 The signal detecting pad 413 is provided with a BNP/NT-proBNP detecting line 4135. The ferrule 40 is provided with a sampling hole 400 corresponding to the sample pad 411, and a display window 401 is opened corresponding to the signal detecting pad 413.
当然，在其他的实施例中，也可将cTnI 检测线4131、CK-MB检测线4132、D-Dimer检测线4133、H-FABP检测线4134和BNP/NT-proBNP检测线4135中的任意其他三条检测线设置于一试纸条41上，而将剩余的两条检测线分别设置于另两条试纸条41上。Of course, in other embodiments, cTnI can also be used. The detection line 4131, the CK-MB detection line 4132, the D-Dimer detection line 4133, the H-FABP detection line 4134, and any other three detection lines of the BNP/NT-proBNP detection line 4135 are disposed on a test strip 41, and The remaining two detection lines are respectively set on the other two test strips 41.
在此实施例中，卡套40、试纸条41、底板410、样品垫411、结合垫412、信号检测垫413、吸水垫414、质控线4130、cTnI 检测线4131、CK-MB检测线4132、D-Dimer检测线4133、H-FABP检测线4134、NP/NT-proBNP检测线4135、加样孔400、显示窗口401等部件的结构和制成材料与实施例1的相同。In this embodiment, the ferrule 40, the test strip 41, the bottom plate 410, the sample pad 411, the bonding pad 412, the signal detecting pad 413, the absorbent pad 414, the quality control line 4130, the cTnI Structure and material of components such as detection line 4131, CK-MB detection line 4132, D-Dimer detection line 4133, H-FABP detection line 4134, NP/NT-proBNP detection line 4135, sample application hole 400, display window 401, and the like The same as in the first embodiment.
在上述实施例中，该联合诊断试纸组件包括有一卡套40，于该卡套内固定有三试纸条41，将cTnI 检测线4131、CK-MB检测线4132、D-Dimer检测线4133、H-FABP检测线4134和BNP/NT-proBNP检测线4135分设于三个试纸条41上，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP等五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 40 in which three test strips 41 are fixed, which will be cTnI. The detection line 4131, the CK-MB detection line 4132, the D-Dimer detection line 4133, the H-FABP detection line 4134, and the BNP/NT-proBNP detection line 4135 are disposed on the three test strips 41, thus passing a joint diagnostic test strip. The components can simultaneously realize the detection of five items such as cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.
实施列5：Implementation column 5:
图7示出了本实用新型的另一实施例，在此实施例中，该联合诊断试纸组件包括有一卡套50及三个固定于该卡套中的试纸条51，每试纸条51包括有一底板510及沿该底板510长度方向依次设置的一样品垫511、一结合垫512、一信号检测垫513和一吸水垫514，该信号检测垫513在其近吸水垫514的一侧处设有一质控线5130，其中，于第一试纸条51的信号检测垫513上设有一cTnI 检测线5131，于第二试纸条51的信号检测垫513上设有一CK-MB检测线5132及一D-Dimer检测线5133，于第三试纸条51的信号检测垫513上设有一H-FABP检测线5134及一BNP/NT-proBNP检测线5135，该卡套50上对应于该样品垫511处开设有加样孔500，而对应于该信号检测垫513处开设有显示窗口501。FIG. 7 shows another embodiment of the present invention. In this embodiment, the joint diagnostic test strip assembly includes a ferrule 50 and three test strips 51 fixed in the ferrule, each test strip 51 The invention includes a bottom plate 510 and a sample pad 511, a bonding pad 512, a signal detecting pad 513 and an absorbent pad 514 disposed in the longitudinal direction of the bottom plate 510. The signal detecting pad 513 is at a side of the near absorbent pad 514. A quality control line 5130 is provided, wherein a cTnI is disposed on the signal detecting pad 513 of the first test strip 51. The detection line 5131 is provided with a CK-MB detection line 5132 and a D-Dimer detection line 5133 on the signal detection pad 513 of the second test strip 51, and an H is provided on the signal detection pad 513 of the third test strip 51. a FABP detection line 5134 and a BNP/NT-proBNP detection line 5135. The ferrule 50 is provided with a sample insertion hole 500 corresponding to the sample pad 511, and a display window 501 is opened corresponding to the signal detection pad 513.
当然，在其他的实施例中，也可将cTnI 检测线5131、CK-MB检测线5132、D-Dimer检测线5133、H-FABP检测线5134和BNP/NT-proBNP检测线5135中的任意其他一条检测线设置于一试纸条51上，而将剩余的四条检测线分别设置于剩余两条试纸条51上，剩余每条试纸条51的检测线为两条。Of course, in other embodiments, cTnI can also be used. The detection line 5131, the CK-MB detection line 5132, the D-Dimer detection line 5133, the H-FABP detection line 5134, and any other one of the BNP/NT-proBNP detection lines 5135 are disposed on a test strip 51, and The remaining four detection lines are respectively disposed on the remaining two test strips 51, and the remaining detection lines of each of the test strips 51 are two.
在此实施例中，卡套50、试纸条51、底板510、样品垫511、结合垫512、信号检测垫513、吸水垫514、质控线5130、cTnI 检测线5131、CK-MB检测线5132、D-Dimer检测线5133、H-FABP检测线5134、NP/NT-proBNP检测线5135、加样孔500、显示窗口501等部件的结构和制成材料与实施例1的相同。In this embodiment, the ferrule 50, the test strip 51, the bottom plate 510, the sample pad 511, the bonding pad 512, the signal detecting pad 513, the absorbent pad 514, the quality control line 5130, the cTnI Structure and material of components such as detection line 5131, CK-MB detection line 5132, D-Dimer detection line 5133, H-FABP detection line 5134, NP/NT-proBNP detection line 5135, sample insertion hole 500, display window 501, and the like The same as in the first embodiment.
在上述实施例中，该联合诊断试纸组件包括有一卡套50，于该卡套内固定有三试纸条51，将cTnI 检测线5131、CK-MB检测线5132、D-Dimer检测线5133、H-FABP检测线5134和BNP/NT-proBNP检测线5135分设于三个试纸条51上，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP等五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 50 in which three test strips 51 are fixed, which will be cTnI. The detection line 5131, the CK-MB detection line 5132, the D-Dimer detection line 5133, the H-FABP detection line 5134, and the BNP/NT-proBNP detection line 5135 are disposed on the three test strips 51, thus passing a joint diagnostic test strip. The components can simultaneously realize the detection of five items such as cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.
实施列6：Implementation column 6:
图8示出了本实用新型的另一实施例，在此实施例中，该联合诊断试纸组件包括有一卡套60及四个固定于该卡套中的试纸条61，每试纸条61包括有一底板610及沿该底板610长度方向依次设置的一样品垫611、一结合垫612、一信号检测垫613和一吸水垫614，该信号检测垫613在其近吸水垫614的一侧处设有一质控线6130，其中，于一试纸条61的信号检测垫613上设有一cTnI 检测线6131和一CK-MB检测线6132，于剩余三条试纸条61的信号检测垫613上各设有一检测线，分别为一D-Dimer检测线6133，一H-FABP检测线6134及一BNP/NT-proBNP检测线6135，该卡套60上对应于该样品垫611处开设有加样孔600，而对应于该信号检测垫613处开设有显示窗口601。FIG. 8 shows another embodiment of the present invention. In this embodiment, the joint diagnostic test strip assembly includes a ferrule 60 and four test strips 61 fixed in the ferrule, each test strip 61. The invention includes a bottom plate 610 and a sample pad 611, a bonding pad 612, a signal detecting pad 613 and an absorbent pad 614 disposed in the longitudinal direction of the bottom plate 610. The signal detecting pad 613 is at a side of the near absorbent pad 614. A quality control line 6130 is provided, wherein a cTnI is disposed on the signal detecting pad 613 of a test strip 61. The detection line 6131 and the CK-MB detection line 6132 are respectively provided with a detection line on the signal detection pads 613 of the remaining three test strips 61, which are respectively a D-Dimer detection line 6133, an H-FABP detection line 6134 and a The BNP/NT-proBNP detection line 6135 is provided with a sample insertion hole 600 corresponding to the sample pad 611, and a display window 601 is provided corresponding to the signal detection pad 613.
当然，在其他的实施例中，也可将cTnI 检测线6131、CK-MB检测线6132、D-Dimer检测线6133、H-FABP检测线6134和BNP/NT-proBNP检测线6135中的任意其他两条检测线设置于一试纸条61上，而将剩余的三条检测线分别设置于剩余三条试纸条61上，剩余每条试纸条61的检测线为一条。Of course, in other embodiments, cTnI can also be used. The detection line 6131, the CK-MB detection line 6132, the D-Dimer detection line 6133, the H-FABP detection line 6134, and any other two detection lines of the BNP/NT-proBNP detection line 6135 are disposed on a test strip 61. The remaining three detection lines are respectively disposed on the remaining three test strips 61, and the detection line of each of the remaining test strips 61 is one.
在此实施例中，卡套60、试纸条61、底板610、样品垫611、结合垫612、信号检测垫613、吸水垫614、质控线6130、cTnI 检测线6131、CK-MB检测线6132、D-Dimer检测线6133、H-FABP检测线6134、NP/NT-proBNP检测线6135、加样孔600、显示窗口601等部件的结构和制成材料与实施例1的相同。In this embodiment, the ferrule 60, the test strip 61, the bottom plate 610, the sample pad 611, the bonding pad 612, the signal detecting pad 613, the absorbent pad 614, the quality control line 6130, the cTnI Structure and material of components such as detection line 6131, CK-MB detection line 6132, D-Dimer detection line 6133, H-FABP detection line 6134, NP/NT-proBNP detection line 6135, sample insertion hole 600, display window 601, and the like The same as in the first embodiment.
在上述实施例中，该联合诊断试纸组件包括有一卡套60，于该卡套内固定有四试纸条61，将cTnI 检测线6131、CK-MB检测线6132、D-Dimer检测线6133、H-FABP检测线6134和BNP/NT-proBNP检测线6135分设于四个试纸条61上，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP等五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 60 in which four test strips 61 are fixed, which will be cTnI. The detection line 6131, the CK-MB detection line 6132, the D-Dimer detection line 6133, the H-FABP detection line 6134, and the BNP/NT-proBNP detection line 6135 are disposed on the four test strips 61, thus passing a joint diagnostic test strip. The components can simultaneously realize the detection of five items such as cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.
实施列7：Implementation column 7:
图9示出了本实用新型的另一实施例，在此实施例中，该联合诊断试纸组件包括有一卡套70及三个固定于该卡套中的试纸条71，每试纸条71包括有一底板710及沿该底板710长度方向依次设置的一样品垫711、一结合垫712、一信号检测垫713和一吸水垫714，该信号检测垫713在其近吸水垫714的一侧处设有一质控线7130，其中，于第一试纸条71的信号检测垫713上设有一cTnI 检测线7131，于第二试纸条71的信号检测垫713上设有一CK-MB检测线7132，于第三条试纸条71的信号检测垫713上各设有一D-Dimer检测线7133，于第四试纸条71的信号检测垫713上设有一H-FABP检测线7134，于第五试纸条71的信号检测垫713上设有及一BNP/NT-proBNP检测线7135，该卡套70上对应于该样品垫711处开设有加样孔700，而对应于该信号检测垫713处开设有显示窗口701。FIG. 9 shows another embodiment of the present invention. In this embodiment, the joint diagnostic test strip assembly includes a ferrule 70 and three test strips 71 fixed in the ferrule, each test strip 71 The invention includes a bottom plate 710 and a sample pad 711, a bonding pad 712, a signal detecting pad 713 and an absorbent pad 714 disposed in the longitudinal direction of the bottom plate 710. The signal detecting pad 713 is at a side of the near absorbent pad 714. A quality control line 7130 is provided, wherein a cTnI is disposed on the signal detecting pad 713 of the first test strip 71. The detection line 7131 is provided with a CK-MB detection line 7132 on the signal detection pad 713 of the second test strip 71, and a D-Dimer detection line 7133 is provided on the signal detection pad 713 of the third test strip 71. An H-FABP detecting line 7134 is disposed on the signal detecting pad 713 of the fourth test strip 71, and a BNP/NT-proBNP detecting line 7135 is disposed on the signal detecting pad 713 of the fifth test strip 71. A sample insertion hole 700 is formed in the sleeve 70 corresponding to the sample pad 711, and a display window 701 is opened corresponding to the signal detection pad 713.
当然，在其他的实施例中，也可将cTnI 检测线7131、CK-MB检测线7132、D-Dimer检测线7133、H-FABP检测线7134和BNP/NT-proBNP检测线7135中的其他任意一条检测线设置于一试纸条71上，而将剩余的四条检测线分别设置于剩余的四条试纸条71上，剩余每条试纸条71的检测线为一条。Of course, in other embodiments, cTnI can also be used. The detection line 7131, the CK-MB detection line 7132, the D-Dimer detection line 7133, the H-FABP detection line 7134, and any other one of the BNP/NT-proBNP detection lines 7135 are disposed on a test strip 71, and The remaining four detection lines are respectively disposed on the remaining four test strips 71, and the detection line of each of the remaining test strips 71 is one.
在此实施例中，卡套70、试纸条71、底板710、样品垫711、结合垫712、信号检测垫713、吸水垫714、质控线7130、cTnI 检测线7131、CK-MB检测线7132、D-Dimer检测线7133、H-FABP检测线7134、NP/NT-proBNP检测线7135、加样孔700、显示窗口701等部件的结构和制成材料与实施例1的相同。In this embodiment, the ferrule 70, the test strip 71, the bottom plate 710, the sample pad 711, the bonding pad 712, the signal detecting pad 713, the water absorbing pad 714, the quality control line 7130, the cTnI Structure and material of components such as detection line 7131, CK-MB detection line 7132, D-Dimer detection line 7133, H-FABP detection line 7134, NP/NT-proBNP detection line 7135, sample application hole 700, display window 701, and the like The same as in the first embodiment.
在上述实施例中，该联合诊断试纸组件包括有一卡套70，于该卡套内固定有五个试纸条71，将cTnI 检测线7131、CK-MB检测线7132、D-Dimer检测线7133、H-FABP检测线7134和BNP/NT-proBNP检测线7135分设于五个试纸条71上，如此，通过一联合诊断试纸组件即可同时实现cTnI、CK-MB、D-Dimer、H-FABP、及BNP/NT-proBNP五个项目的检测，使得检测结果准确灵敏、检测过程省时省力且节约成本。In the above embodiment, the joint diagnostic test strip assembly includes a ferrule 70 in which five test strips 71 are fixed, which will be cTnI. The detection line 7131, the CK-MB detection line 7132, the D-Dimer detection line 7133, the H-FABP detection line 7134, and the BNP/NT-proBNP detection line 7135 are disposed on the five test strips 71, thus passing a joint diagnostic test strip. The components can simultaneously realize the detection of five items of cTnI, CK-MB, D-Dimer, H-FABP, and BNP/NT-proBNP, which makes the detection result accurate and sensitive, and the detection process saves time and labor and saves cost.
上所述仅为实用新型的优选实施例，而非对本实用新型做任何形势上的限制。本领域的技术人员可在上述实施例的基础上施以各种等同的更改和改进，凡在权力要求范围内所做的等同变化或修饰，均应落入本实用新型的保护范围之内。The above description is only a preferred embodiment of the utility model, and is not intended to limit the scope of the present invention. A person skilled in the art can make various equivalent changes and modifications on the basis of the above embodiments, and all equivalent changes or modifications made within the scope of the claims should fall within the scope of the present invention.

Claims (9)

  1. 一种联合诊断试纸组件，包括有一卡套和至少一固定于所述卡套中的试纸条，每一试纸条包括一底板及沿所述底板长度方向在底板的表层依次设置的一样品垫、一结合垫、一信号检测垫及一吸水垫，每一信号检测垫在其近吸水垫的一侧处设有一质控线，其特征在于，在所有试纸条的信号检测垫上，共设有一cTnI 检测线、一CK-MB检测线、一D-Dimer检测线、一H-FABP检测线和一BNP/NT-proBNP检测线，所述卡套上对应于所述样品垫处开设有加样孔，而对应于所述信号检测垫处开设有显示窗口。 A joint diagnostic test strip assembly comprising a ferrule and at least one test strip fixed in the ferrule, each test strip comprising a bottom plate and a sample sequentially disposed on a surface layer of the bottom plate along a length direction of the bottom plate a pad, a bonding pad, a signal detecting pad and an absorbent pad, each signal detecting pad is provided with a quality control line at one side of the near absorbent pad, which is characterized in that on all the signal detecting pads of the test strip, With a cTnI a detection line, a CK-MB detection line, a D-Dimer detection line, an H-FABP detection line, and a BNP/NT-proBNP detection line, wherein the ferrule is provided with a sample hole corresponding to the sample pad And a display window is opened corresponding to the signal detecting pad.
  2. 如权利要求1所述的联合诊断试纸组件，其特征在于，所设置的试纸条的数目为一，其中，于所述试纸条的信号检测垫上间隔设置有所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线。The joint diagnostic test strip assembly according to claim 1, wherein the number of test strips is one, wherein the cTnI is interposed on the signal detecting mat of the test strip. Detection line, CK-MB detection line, D-Dimer detection line, H-FABP detection line and BNP/NT-proBNP detection line.
  3. 如权利要求1所述的联合诊断试纸组件，其特征在于，所设置的试纸条的数目为二，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线分设于二试纸条上。The joint diagnostic test strip assembly of claim 1 wherein the number of test strips provided is two, wherein said cTnI The detection line, CK-MB detection line, D-Dimer detection line, H-FABP detection line and BNP/NT-proBNP detection line are set on the two test strips.
  4. 如权利要求1所述的联合诊断试纸组件，其特征在于，所设置的试纸条的数目为三，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP检/NT-proBNP检测线分设于三试纸条上。The joint diagnostic test strip assembly of claim 1 wherein the number of test strips provided is three, wherein said cTnI The test line, CK-MB test line, D-Dimer test line, H-FABP test line, and BNP test/NT-proBNP test line are set on the three test strips.
  5. 如权利要求1所述的联合诊断试纸组件，其特征在于，所设置的试纸条的数目为四，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP/NT-proBNP检测线分设于四试纸条上。The joint diagnostic test strip assembly of claim 1 wherein the number of test strips is four, wherein said cTnI The detection line, CK-MB detection line, D-Dimer detection line, H-FABP detection line and BNP/NT-proBNP detection line are set on the four test strips.
  6. 如权利要求1所述的联合诊断试纸组件，其特征在于，所设置的试纸条的数目为五，其中，所述cTnI 检测线、CK-MB检测线、D-Dimer检测线、H-FABP检测线及BNP检测线或NT-proBNP检测线分别设置于每一试纸条上。The joint diagnostic test strip assembly of claim 1 wherein the number of test strips provided is five, wherein said cTnI The detection line, the CK-MB detection line, the D-Dimer detection line, the H-FABP detection line, the BNP detection line or the NT-proBNP detection line are respectively disposed on each test strip.
  7. 如权利要求1所述的联合诊断试纸组件，其特征在于，所述试纸条的结合垫表面喷涂有标记物标记的对应五个检测项目的单克隆抗体Ⅰ，所述标记物为荧光物质、彩色微球或者胶体金，所述五个检测项目的单克隆抗体分别为cTnI抗体Ⅰ、CK-MB抗体Ⅰ、D-Dimer抗体Ⅰ、H-FABP抗体Ⅰ与BNP或NT-proBNP抗体Ⅰ。The joint diagnostic test strip assembly according to claim 1, wherein the surface of the bonding pad of the test strip is sprayed with a label-labeled monoclonal antibody I corresponding to five detection items, the label being a fluorescent substance, For the color microspheres or colloidal gold, the monoclonal antibodies of the five detection items are cTnI antibody I, CK-MB antibody I, D-Dimer antibody I, H-FABP antibody I and BNP or NT-proBNP antibody I, respectively.
  8. 如权利要求1所述的联合诊断试纸组件，其特征在于，所述试纸条的检测线上分别设有与标记各自检测项目抗体Ⅰ具有不同抗原决定簇的对应的单克隆抗体Ⅱ：cTnI检测线上设有与标记cTnI抗体Ⅰ具有不同抗原决定簇的cTnI抗体Ⅱ，CK-MB检测线上设有与标记CK-MB抗体Ⅰ具有不同抗原决定簇的CK-MB抗体Ⅱ，D-Dimer检测线上设有与标记D-Dimer抗体Ⅰ具有不同抗原决定簇的D-Dimer抗体Ⅱ，H-FABP检测线上设有与标记H-FABP抗体Ⅰ具有不同抗原决定簇的H-FABP抗体Ⅱ，BNP检测线上设有与标记BNP抗体Ⅰ具有不同抗原决定簇的BNP抗体Ⅱ，NT-proBNP检测线上设有与NT-proBNP抗体Ⅰ具有不同抗原决定簇的NT-proBNP抗体Ⅱ。The joint diagnostic test strip assembly according to claim 1, wherein the test strips of the test strips are respectively provided with corresponding monoclonal antibody II: cTnI detection having different antigenic determinants from the respective detection item antibody I. cTnI antibody II having a different antigenic determinant from the labeled cTnI antibody I was provided on the line, and CK-MB antibody II having a different antigenic determinant from the labeled CK-MB antibody I was provided on the CK-MB detection line, and D-Dimer detection was performed. A D-Dimer antibody II having a different antigenic determinant from the labeled D-Dimer antibody I is provided on the line, and an H-FABP antibody II having a different antigenic determinant from the labeled H-FABP antibody I is provided on the H-FABP detection line. The BNP detection line is provided with a BNP antibody II having a different antigenic determinant from the labeled BNP antibody I, and the NT-proBNP detection line has an NT-proBNP antibody II having a different antigenic determinant from the NT-proBNP antibody I.
  9. 如权利要求1所述的联合诊断试纸组件，其特征在于，所述试纸条的质控线上设有对应标记五个检测项目的单克隆抗体Ⅰ的二抗，分别为：cTnI抗体Ⅰ的二抗、CK-MB抗体Ⅰ的二抗、D-Dimer抗体Ⅰ的二抗、H-FABP抗体Ⅰ的二抗、BNP/NT-proBNP抗体Ⅰ的二抗。The joint diagnostic test strip assembly according to claim 1, wherein a secondary antibody corresponding to the monoclonal antibody I labeled with five detection items is provided on the quality control line of the test strip, respectively: cTnI antibody I Secondary antibody, secondary antibody of CK-MB antibody I, secondary antibody of D-Dimer antibody I, secondary antibody of H-FABP antibody I, secondary antibody of BNP/NT-proBNP antibody I.
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