CN116500260A - 免疫缺陷病毒抗原和抗体快速定性检测的试纸条、检测卡及检测方法 - Google Patents
免疫缺陷病毒抗原和抗体快速定性检测的试纸条、检测卡及检测方法 Download PDFInfo
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Abstract
本发明公开了一种免疫缺陷病毒抗原和抗体快速定性检测的试纸条、检测卡及检测方法;检测试纸包括单元纳米颗粒A试纸和单元纳米颗粒B试纸;每个所述单元纳米颗粒试纸包括长条状的PVC底板、NC膜、纳米颗粒结合垫、样品垫和吸水纸。本发明的检测卡,其基于纳米颗粒免疫层析平台,使得检测体系可以直接对简单处理后的血液样本进行检测,实现检测操作简单、检测用时短,快速、准确且灵敏度高,特异性又好。
Description
技术领域
本发明涉及生物医学检测技术,尤其涉及一种免疫缺陷病毒抗原和抗体快速定性检测的试纸条、检测卡及检测方法。
背景技术
获得性免疫缺陷综合征简称艾滋病,是一种由人类免疫缺陷病毒(HumanImmunodeficiency Virus,HIV)感染所引起的一种具有严重传染性的免疫缺陷性疾病。该病毒破坏人体的免疫能力,导致免疫系统失去抵抗力,逐渐成为许多伺机性疾病的攻击目标,促成多种临床症状,统称为综合征,而非单纯的一种疾病,而这种综合征可通过直接接触黏膜组织的口腔、生殖器、肛门等或带有病毒的血液、精液、阴道分泌液、乳汁而传染。全球流行的HIV病毒可分为2型:HIV-1型和HIV-2型,在人体内的潜伏期平均为7~10年。HIV感染潜伏期病人没有明显的临床症状,但具有高度的传染性。
由于艾滋病的高传染性,高传播范围及高死亡率,从发现艾滋病起,实际上就建立了相应的实验室诊断方法;由于检测的目的不同,也各自建立起不同的检测方法。对HIV进行检测以发现传染源和切断传播途经是防制AIDS最有效的手段。现阶段,检测方法大致分为三类。如下:
1)病原分离培养方法
病毒分离一般采取培养外周血单个核细胞的方法进行HIV的诊断,经细胞培养通过镜检观察是否存在病毒,该方法检测HIV专一性强,不会出现假阳性,但需要具有一定数量感染细胞存在才能培养分离出病毒,敏感性差、操作时间长、操作复杂,且须在特定P3实验室内进行,成本高,不适用于临床诊断。
2)分子生物学方法
病毒核酸检测主要是通过检测HIV RNA水平来反映病毒载量,灵敏度高,可用于HIV的早期诊断。目前常用测定方法有逆转录PCR(RT-PCR)、核酸序列扩增实验(NASBA)、分支DNA杂交实验(bDNA)、适时荧光PCR技术等。核酸检测方法具有很离的灵敏度,对疾病进展的监测,抗病毒疗效观察和耐药性监测非常重要。但由于HIV基因的多样性,没有一套引物可以覆盖所有的HIV序列使检测的敏感性又受到限制;此外现有的病毒核酸检测方法或是检测仪器、检测试剂昂贵,或是操作复杂,对操作人员要求高既难以在一般实验室推广,又不适用于对大量患者的快速检测,同样不适合广泛应用临床。
3)免疫学方法
(1)酶联免疫方法(ELISA)是实验室检测HIV抗原抗体主要的方法,是通过固相的抗原或者抗体和酶标后的抗原和抗体结合,常见的结合方式有第三代HIV诊断试剂采用双抗原夹心法。酶联免疫法主要原理是采用双抗原夹心的方法进行检测,包被抗原吸附于固相的载体表面,用来和特异抗体结合,当待测物中含有特异抗体时,与其形成抗原-抗体的复合物。但第4代试剂由于同时把抗原和抗体包被在反应板上,存在相互干扰的可能,检测的敏感性和特异性可能都会受到影响。目前,有人对第4代试剂提出了“第二窗口期”的现象,即在HIV急性感染的病例中,存在从血清p24抗原降低到抗体升高的时期,当此期的抗原低于试剂检测限时,检测结果即为阴性,而使用灵敏度高的试剂,则不会出现这种现象。ELISA操作简单,成本低廉,但灵敏度比较低。
(2)免疫胶体金方法(ICA)是将高电子密度的胶体金作为标记物标记在抗体或者抗原上,当其在相应的配体处发生聚集时会产生肉眼可见的颜色,因而可以用以定性或者半定量的检测研究中。随着胶体金研究的发展,在金核的表面可以进行一定的修饰,主要为含硫的配体、含磷化物、磷氧化物、氨基和羧基的配体。该方法灵敏度较低,不能进行定量的检测达不到临床诊断的要求。
(3)放射免疫法(RIA)是利用同位素标记的与未标记的抗原,同抗体发生竞争性抑制反应的方法。该方法会有交叉反应、操作时长较长、仪器价格高、并且有一定的辐射对操作员有一定的损伤。
(4)化学发光免疫分析法(CLIA)是将具有高灵敏度的化学发光测定技术与高特异性的免疫反应相结合,用于各种抗原、半抗原、抗体、激素、酶、脂肪酸、维生素和药物等的检测分析技术。该方法检测精度不高,仪器设备的成本较高。
尽管人类免疫缺陷病毒抗体抗原的检测方法多种多样,随着快速诊断技术的迅速发展,分子检测技术愈趋完善,已经被作为人类免疫缺陷病毒抗原抗体检测的新标准,但因其对实验室条件要求高而无法普及,且商品化的产品较少,未形成系列,多数病原仍不能检测。近年来由于免疫技术的发展及广泛应用,直接检查病毒抗原可达到快速诊断目的,常用方法有直接、间接免疫荧光法、免疫酶法、免疫胶体金法等标记技术,操作方便,快速且成本低廉,适合于临床要求,因此在临床上有重要意义。但人类免疫缺陷病毒窗口期难以检测,应使用不同的诊断方法同时检测,以获得最佳的诊断结果,每种方法都是对其它诊断方法的一种证实和有效的确认,各种方法之间应该是一种互补的关系。
发明内容
基于上述问题,本发明所要解决的问题之一在于提供一种操作简单、检测快速准确、灵敏度高,且免疫缺陷病毒抗原和抗体快速定性检测的试纸条;
本发明所要解决的问题之二在于提供一种检测卡。
本发明所要解决的问题之三在于提供一种免疫缺陷病毒抗原和抗体快速定性检测的检测方法。
本发明的技术方案一如下:
一种免疫缺陷病毒抗原和抗体快速定性检测的试纸条,该试纸条包括单元纳米颗粒A试纸和单元纳米颗粒B试纸;每个所述单元纳米颗粒试纸包括长条状的PVC底板、NC膜、纳米颗粒结合垫、样品垫和吸水纸;所述NC膜粘附在PVC底板中部位置的一表面上,所述纳米颗粒结合垫一端和吸水纸一端分别层叠搭接粘附在NC膜两端;所述样品垫一端层叠搭接粘附在所述纳米颗粒结合垫另一端;所述纳米颗粒结合垫上设置有纳米金标记的抗原,且所述NC膜上设置了相互平行的检测线和质控线。
一实施例,所述试纸条中,所述单元纳米颗粒A试纸中,所述NC膜上设有两条检测线及一条质控线C1;两条检测线分别为检测线T1和检测线T2,所述检测线T1包被HIV gp41抗原,所述检测线T2包被1HIV gp36抗原,质控线包被羊抗鼠IgG。
一实施例,所述试纸条中,所述单元纳米颗粒B试纸中,所述NC膜上设有检测线T3及质控线C2各一条;所述检测线T3包被抗HIV P24抗体,所述质控线C2包被羊抗鼠IgG抗体。
一实施例,所述试纸条中,所述NC膜为CN140膜。
一实施例,所述试纸条中,所述纳米颗粒结合垫为玻璃纤维素膜。
一实施例,所述试纸条中,所述吸水纸优选为滤纸纤维。
一实施例,所述试纸条中,所述吸水垫一端层压搭接NC膜一端的宽度为2mm;所述NC膜另一端被所述纳米颗粒结合垫一端层压搭接宽度为1~2mm;所述样品垫一端层压搭接所述纳米颗粒结合垫另一端的宽度为1~2mm。
本发明还提供一种检测卡,包括上述任一所述试纸条及外壳,所述外壳设有袋状的纳置腔,在所述外壳的一侧面分别设有与所述纳置腔贯通的两个加样孔和两个观察窗;两个观测窗并排设置,两个加样孔并排设置;所述试纸条适配容置到外壳的纳置腔时,所述单元纳米颗粒A试纸和单元纳米颗粒B试纸上各自的NC膜分别与外壳上的两个观察窗对应设置,所述单元纳米颗粒A试纸和单元纳米颗粒B试纸上各自的样品垫则分别与外壳上的两个加样孔对应设置。
一实施例,所述检测卡中,所述检测卡装入一铝箔袋中、放入干燥剂后,密封铝箔袋。
本发明还提供一种免疫缺陷病毒抗原和抗体快速定性检测的检测方法,包括步骤:
取出权利要求8或9任一所述的检测卡,平放在工作台上;
向检测卡中的加样孔滴加人血清或血浆样本;
15~20分钟内,通过检测卡的观察窗观察NC膜上检测线的变化,获得免疫缺陷病毒抗原和抗体含量值。
本发明提出一种免疫缺陷病毒抗原和抗体快速定性检测的试纸条,其基于纳米颗粒免疫层析平台,使得检测体系可以直接对简单处理后的血液样本进行检测,实现检测操作简单、检测用时短,快速、准确且灵敏度高,特异性又好。
附图说明
图1为本发明提供检测卡的单元纳米颗粒A试纸结构示意图;
图2为本发明提供检测卡的单元纳米颗粒B试纸结构示意图
图3为本发明提供检测卡的外壳结构示意图。
具体实施方式
下面结合附图,对本发明的较佳实施例作进一步详细说明。
本发明提供的人类免疫缺陷病毒抗原和抗体快速定性检测的检测卡,包括试纸条和外壳;试纸条和外壳均为长条状构造,且外壳为袋状结构,试纸条适配纳置在所述外壳内。
如图1和2所示,试纸条包括单元纳米颗粒A试纸和单元纳米颗粒B试纸。为区别所见,单元纳米颗粒A试纸和单元纳米颗粒B试纸上,同一组件名称,采用不同的标识号,具体如下:
如图1所示,单元纳米颗粒A试纸包括长条状的PVC底板8、NC膜3、纳米颗粒结合垫2、样品垫1和吸水纸4;NC膜3粘附在PVC底板8中部位置的一表面上,纳米颗粒结合垫2一端和吸水纸4一端分别层叠搭接粘附在NC膜3两端;样品垫1一端层叠搭接粘附在纳米颗粒结合垫2另一端;样品垫1和吸水纸4分别位于PVC底板8的两端;纳米颗粒结合垫2上设置有纳米金标记的抗原,且NC膜3上设置了相互平行的检测线T1 5、检测线T2 6、质控线C1 7;检测线靠近结合垫;其中,检测线T1 5及检测线T2 6统称为检测线(5,6)。
优选地,检测线T1包被HIV gp41抗原,检测线T2包被1HIV gp36抗原,质控线C1包被羊抗鼠IgG;
如图2所示,单元纳米颗粒A试纸包括长条状的PVC底板14、NC膜11、纳米颗粒结合垫10、样品垫9和吸水纸15;NC膜11粘附在PVC底板14中部位置的一表面上,纳米颗粒结合垫10一端和吸水纸14一端分别层叠搭接粘附在NC膜11两端;样品垫9一端层叠搭接粘附在纳米颗粒结合垫10另一端;样品垫9和吸水纸15分别位于PVC底板14的两端;纳米颗粒结合垫10上设置有纳米金标记的抗原,且NC膜11上设置了相互平行的一条检测线T3 12和一条质控线T2 13。
优选地,单元纳米颗粒B试纸中,NC膜11上设有检测线T3及质控线C2各一条;检测线T3包被抗HIV P24抗体,质控线C2包被羊抗鼠IgG抗体。
一实施例中,在单元纳米颗粒A试纸和单元纳米颗粒B试纸上,NC膜为CN140膜、纳米颗粒结合垫为玻璃纤维素膜、吸水纸优选为滤纸纤维。
又一实施例,单元纳米颗粒A试纸和单元纳米颗粒B试纸上,吸水垫一端层压搭接NC膜一端的宽度为2mm;NC膜另一端被纳米颗粒结合垫一端层压搭接宽度为1~2mm;样品垫一端层压搭接所述纳米颗粒结合垫另一端的宽度为1~2mm。
如图3所示,上述外壳设有袋状的纳置腔(图中未示出),在外壳的一侧面分别设有与纳置腔贯通的两个加样孔(16,18)和两个观察窗(17,19);两个观测窗(17,19)并排设置,两个加样孔(16,18)并排设置。且当单元纳米颗粒A试纸适配容置到外壳的A纳置腔时,单元纳米颗粒A试纸上NC膜4与外壳上的观察窗17对应设置,单元纳米颗粒A试纸上样品垫1则与外壳上的加样孔16对应设置。当单元纳米颗粒B试纸适配容置到外壳的B纳置腔时,单元纳米颗粒B试纸上的NC膜11与外壳上的观察窗19对应设置,单元纳米颗粒B试纸上的样品垫9则与外壳上的加样孔18对应设置。
优选地,为了防止检测卡污染或受潮,检测卡被装入一铝箔袋中,放入干燥剂后,密封铝箔袋(图中未示出)。
本发明还提供一种人类免疫缺陷病毒抗原和抗体快速定性检测的检测方法,包括步骤:
1、取出检测卡(如果铝箔袋密封的,则撕去铝箔袋),平放在工作台上;
2、将人血清和/或血浆样本加入稀释液稀释,得到混合样本稀释液;
3、向检测卡中的加样孔16和18滴加100μl人血清或血浆混合样本稀释液;
4、15~20分钟内,通过检测卡的观察窗观察NC膜上检测线的变化,判定人类免疫缺陷病毒抗原和抗体含量值。
如果在20分钟后才显示检测的结果,则表明检测无效。
检测线(T1、T2和/或T3)显色深浅与提取样本中所含的被测物质含量有关,不论颜色强度多少,都应按照检测线(T1、T2和/或T3)是否显色判断结果。
本检测内含质控过程,当质控线出现红色条带,表明操作正确有效,否则测试无效。
以下通过几个实施例来进一步说明
实施例1样品垫预处理
所述处理液为磷酸盐缓冲液,其中还包含1-2%BSA,0.1%Tween-20,2%的海藻糖,pH为7.0-8.0,所述处理液可增加样品垫的吸收能力,控制金标释放,促进层析作用的发生。
实施例2纳米颗粒结合垫制备
(1)一种纳米颗粒标记HIV P24抗体,按以下步骤制备:
a.纳米颗粒的制备:采用柠檬酸钠还原法制备胶体金纳米颗粒。取500ml双蒸水放入2000ml的烧杯内,置于电炉上加热至沸腾,加入60ml质量浓度为1%的氯化金水溶液,继续加热至沸,再向其中快速加入约35ml质量浓度为2%的柠檬酸三钠溶液,继续加热煮沸5min,可看到胶体金溶液颜色由黑色→蓝紫色→酒红色,停止加热,当制备好的胶体金溶液自然冷却至室温时,用纯化水定容至1500ml,于室温环境条件下存放备用。
b.制备HIV P24抗体标记物:取1mL步骤a的纳米颗粒溶液,加入5-10μl质量浓度为0.2M的K2CO3调节纳米颗粒溶液pH,混合均匀,加入10-15μgHIV P24单克隆抗体,混合均匀5min,再加入10μl质量浓度为20%的BSA溶液进行封闭,混合均匀约10分钟后,先以3000-5000r/pm的转速低速离心5-8min,再以10000-12000r/pm的转速高速离心10-15min,去上清,沉淀定容至100μl,沉淀即为和HIV pg41抗原金标物,于4℃保存备用。
(2)一种纳米颗粒标记HIV pg41重组抗原,按以下步骤制备:以本实施例2的步骤(1)同样方法标记HIV pg41重组抗原,得到纳米颗粒标记HIV pg41抗原;
(3)一种纳米颗粒标记HIV pg36重组抗原,按以下步骤制备:以本实施例2的步骤(1)同样方法标记HIV pg36重组抗原,得到纳米颗粒标记HIV pg36抗原;
(4)纳米颗粒稀释液的制备方法:每100毫升纳米颗粒由pH为8.5的0.01M Tris-HCl缓冲液、1%的牛血清白蛋白、10%的蔗糖、0.1%的吐温-20和0.1%的叠氮钠、超纯水制成。
(5)将上述步骤2至步骤3的纳米颗粒-抗原复合物1:1混匀后,用步骤(4)制备的纳米颗粒稀释液进行复溶,后喷涂于玻璃纤维素膜上,为单元A试剂条的金标结合垫;将上述步骤(3)的纳米颗粒-抗体复合物用步骤(4)制备的纳米颗粒稀释液进行复溶,后喷涂于玻璃纤维素膜上,为单元B试剂条的金标结合垫。
实例3 NC膜的包被方法
(1)包被缓冲液的制备方法:所述包被缓冲液由pH为7.4的0.01-0.02M磷酸盐缓冲液、2%的海藻糖和纯化水制成。
(2)将NC140膜粘在PVC底板上,用划膜仪依次在其特定位置上划出质控线和检测线,质控线包被羊抗鼠多抗的包被浓度为1.5mg/ml,包被量1.0μL/cm,检测线的包被浓度为1.0-1.5mg/ml,包被量1.0μL/cm,37℃恒温干燥箱中固定4h后取出备用。
其中,单元纳米颗粒A试纸的NC膜上包被检测线T1的HIV pg41重组抗原和检测线T2的HIV pg36重组抗原,包被浓度为1.0-1.5mg/ml;
单元纳米颗粒B试纸的NC膜上包被HIV P24抗体,包被浓度为1.0-1.5mg/ml。
实例4:检测卡组装
首先,用吸水垫压住NC膜的一端约2mm左右;
其次,NC膜的另一端被纳米颗粒结合垫压住约1~2mm左右;
接着,样品垫压住纳米颗粒结合垫1~2mm左右。用切条机切成3-4mm宽的试纸条,切好的单元纳米颗粒A试纸和单元纳米颗粒B试纸平行装入外壳中,制得检测卡,采用铝箔袋封装并内装干燥剂;
最后,铝箔袋封装的检测卡装入塑料盒,形成HIV抗体和抗原联合快速检测试剂盒。
实例5:检测方法:
将被检血清或血浆平衡至温室,将制备好的检测卡平放,检测时,在单元纳米颗粒A试纸和单元纳米颗粒B试纸上样垫上分别加入100ul被检样品,若样品中含抗HIV抗体、P24抗原,则和样品垫上的标记的纳米颗粒结合,形成复合物,并扩散到NC膜上进一步层析,当遇到包被在NC膜上检测线处的配对抗原、P24抗体时,复合物则又和包被抗原、P24抗体结合,被捕获在包被处,当被捕获的纳米颗粒复合物达到一定数量时,则形成肉眼可见的检测线。若单元纳米颗粒A试纸出现检测线,说明样品中含有抗HIV抗体,若单元纳米颗粒B试纸出现检测线,说明样品中含有HIV p24抗原。若检测线不出现,说明样品为阴性或含量低于试剂盒的最低检测限。质控线作为试剂的质控标准,阳性和阴性样品检测时均会出现。用肉眼直接观察在15-20分钟内质控线、检测线的出现情况,并判定检测结果。
应当理解的是,上述针对本发明较佳实施例的表述较为详细,并不能因此而认为是对本发明专利保护范围的限制,本发明的专利保护范围应以所附权利要求为准。
Claims (10)
1.一种人类免疫缺陷病毒抗原和抗体快速定性检测的试纸条,其特征在于,该试纸条包括单元纳米颗粒A试纸和单元纳米颗粒B试纸;每个所述单元纳米颗粒试纸包括长条状的PVC底板、NC膜、纳米颗粒结合垫、样品垫和吸水纸;所述NC膜粘附在PVC底板中部位置的一表面上,所述纳米颗粒结合垫一端和吸水纸一端分别层叠搭接粘附在NC膜两端;所述样品垫一端层叠搭接粘附在所述纳米颗粒结合垫另一端;所述纳米颗粒结合垫上设置有纳米金标记的抗原,且所述NC膜上设置了相互平行的检测线和质控线。
2.根据权利要求1所述的试纸条,其特征在于,所述单元纳米颗粒A试纸中,所述NC膜上设有两条检测线及一条质控线C1;两条检测线分别为检测线T1和检测线T2,所述检测线T1包被HIV gp41抗原,所述检测线T2包被1HIV gp36抗原,质控线包被羊抗鼠IgG。
3.根据权利要求1所述的试纸条,其特征在于,所述单元纳米颗粒B试纸中,所述NC膜上设有检测线T3及质控线C2各一条;所述检测线T3包被抗HIV P24抗体,所述质控线C2包被羊抗鼠IgG抗体。
4.根据权利要求1所述的试纸条,其特征在于,所述NC膜为CN140膜。
5.根据权利要求1所述的试纸条,其特征在于,所述纳米颗粒结合垫为玻璃纤维素膜。
6.根据权利要求1所述的试纸条,其特征在于,所述吸水纸优选为滤纸纤维。
7.根据权利要求1所述的试纸条,其特征在于,所述吸水垫一端层压搭接NC膜一端的宽度为2mm;所述NC膜另一端被所述纳米颗粒结合垫一端层压搭接宽度为1~2mm;所述样品垫一端层压搭接所述纳米颗粒结合垫另一端的宽度为1~2mm。
8.一种检测卡,其特征在于,包括权利要求1至7任一所述的试纸条及外壳,所述外壳设有袋状的纳置腔,在所述外壳的一侧面分别设有与所述纳置腔贯通的两个加样孔和两个观察窗;两个观测窗并排设置,两个加样孔并排设置;所述试纸条适配容置到外壳的纳置腔时,所述单元纳米颗粒A试纸和单元纳米颗粒B试纸上各自的NC膜分别与外壳上的两个观察窗对应设置,所述单元纳米颗粒A试纸和单元纳米颗粒B试纸上各自的样品垫则分别与外壳上的两个加样孔对应设置。
9.根据权利要求8所述的检测卡,其特征在于,所述检测卡装入一铝箔袋中、放入干燥剂后,密封铝箔袋。
10.一种免疫缺陷病毒抗原和抗体快速定性检测的检测方法,其特征在于,该检测方法包括步骤:
取出权利要求8或9任一所述的检测卡,平放在工作台上;
向检测卡中的加样孔滴加血清或血浆样本;
15~20分钟内,通过检测卡的观察窗观察NC膜上检测线的变化,获得免疫缺陷病毒抗原和抗体含量值。
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