CN102914652B - 一种直接检测乙肝病毒核心抗原的配套便携装置 - Google Patents

一种直接检测乙肝病毒核心抗原的配套便携装置 Download PDF

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CN102914652B
CN102914652B CN201210398153.7A CN201210398153A CN102914652B CN 102914652 B CN102914652 B CN 102914652B CN 201210398153 A CN201210398153 A CN 201210398153A CN 102914652 B CN102914652 B CN 102914652B
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徐连江
李升玲
李翠霞
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Nanjing Genstars Biotech Co ltd
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Abstract

本发明涉及医疗技术领域，尤其是一种直接检测乙肝病毒核心抗原的配套便携装置，包括配套使用的便携检验箱体，所述便携检验箱体内设有加样吸管、微孔板、洗板机、微型震荡器、真空抽气装置、酶标板和加热管；所述便携检验箱体内部中空，间隔设有控温室和震荡室，所述控温室内设有加热管、微孔板支架、微孔板和洗板机，所述震荡室内设有微型震荡器、试剂瓶架、试管架和真空抽气装置，所述便携检验箱体顶部设有震荡器定时开关、酶标板和加样吸管；本发明操作简单、快速，实用性强，便携性高，与PCR探针检测HBV-DNA阳性结果符合率为92.3％，与乙型肝炎两对半检测HBV阳性结果符合率为94.1％，达到实际临床检验要求，适合基层医疗单位使用，有效满足HBV快速检测的临床需要。

Description

一种直接检测乙肝病毒核心抗原的配套便携装置
技术领域
本发明涉及医疗技术领域，尤其是一种直接检测乙肝病毒核心抗原的配套便携装置。
背景技术
临床上，用PCR方法检测HBV DNA能够最准确的反映HBV病毒的复制情况，但因其成本高、操作复杂及实验环境要求高等诸多因素限制，难以作为常规方法来检测HBV的感染。从理论上来说，HBcAg的检出主要差异在HBeAg和HBeAb之间。HBcAg主要出现在HBV感染的早期，它的出现标志着病毒的复制，有较强的传染性；HBeAb的出现则预示着病情趋向好转，这时体内的HBeAg逐渐消失，病毒的复制减弱，传染性减少；HBeAg与HBcAg为病毒复制的中间产物，均为C基因区编码，它们之间的密切基因位置关系决定了它们有较高的表达符合性，所以我们认为一般情况下可以用HBeAg及HBcAg的检测代替PCR HBV DNA的检测来反映HBV的复制情况。
由于血清内游离HBcAg的量极少，常规方法不易检出，通常采用的办法是将乙肝病毒表面抗体和乙肝病毒核心抗体同时包被到微孔板上，乙肝病毒表面抗体与乙肝病毒氏颗粒表面抗原结合，在裂解剂的作用下乙肝病毒氏颗料壳裂解，暴露出乙肝病毒核心抗原后被微孔板上的乙肝病毒核心抗体所吸附，再使过氧化物酶与染色底物反应，最终达到检测乙肝病毒核心抗原的目的。这种方法在包被抗体时，通常采用针对HBsAg和HBcAg的免疫球蛋白多抗多被，多抗作为包被抗体，效价低、特异性差，其检测结果的灵敏度低，操作流程也较长。
随着现代诊断医学的发展，ELISA诊断试剂已经从最初的合成肽抗原，发展到了基因工程抗原。合成肽采用化学方法制备，由于工艺的局限，合成数量有限，只能达到数百个氨基酸，而利用基因工程制备的抗原分子量更大，也具有更强的稳定性，因此用基因工程抗原取代合成肽抗原已成为必然的市场和技术选择。
发明内容
本发明的目的是为了克服上述技术缺点提供一种直接检测乙肝病毒核心抗原的配套便携装置。
本发明解决技术问题采用的技术方案为：一种直接检测乙肝病毒核心抗原的配套便携装置，包括配套使用的便携检验箱体，所述便携检验箱体内设有加样吸管、微孔板、洗板机、微型震荡器、真空抽气装置、酶标板和加热管；所述便携检验箱体内部中空，间隔设有控温室和震荡室，所述控温室内设有加热管、微孔板支架、微孔板和洗板机，所述震荡室内设有微型震荡器、试剂瓶架、试管架和真空抽气装置，所述便携检验箱体顶部设有震荡器定时开关、酶标板和加样吸管。
所述加热管上设有温控板和加热定时开关，所述试管架上设有待检血清试管，所述试剂瓶架上设有促进剂瓶、裂解剂瓶和标记物瓶。
所述洗板机上设有洗板机开关。
所述便携检验箱体背侧面设有电源开关，所述电源开关与加热装置、洗板机、微型震荡器、真空抽气装置分别形成电气通路。
本发明所具有的有益效果是：
本发明操作简单、快速，实用性强，便携性高，与PCR探针检测HBV-DNA阳性结果符合率为92.3％，与乙型肝炎两对半检测HBV阳性结果符合率为94.1％，达到实际临床检验要求，适合基层医疗单位使用，有效满足HBV快速检测的临床需要。
附图说明
附图1为本发明配套便携装置的俯视示意图。
附图2为本发明配套便携装置的纵切面示意图。
具体实施方式
下面结合附图对本发明做以下详细说明。
如图1和2所示，本实用发明包括配套使用的便携检验箱体1，所述便携检验箱体1内设有加样吸管21、微孔板6、洗板机7、微型震荡器10、真空抽气装置19、酶标板18和加热管4；所述便携检验箱体1内部中空，间隔设有控温室2和震荡室3，所述控温室2内设有加热管4、微孔板支架5、微孔板6和洗板机7，所述震荡室3内设有微型震荡器10、试剂瓶架14、试管架12和真空抽气装置19，所述便携检验箱体1顶部设有震荡器定时开关11、酶标板18和加样吸管21；所述加热管4上设有温控板8和加热定时开关9，所述试管架12上设有待检血清试管13，所述试剂瓶架14上设有促进剂瓶15、裂解剂瓶16和标记物瓶17；所述洗板机7上设有洗板机开关22；所述便携检验箱体背侧面设有电源开关20，所述电源开关20与加热装置4、洗板机7、微型震荡器10、真空抽气装置19分别形成电气通路。
实施例：
按常规方法在聚苯乙烯微孔板上同时包被单基因表面抗体MC-抗-HBsAg和单基因核心抗体HBcAg，入洗板机洗7涤三次，拍干；每孔加待检血清100μl，进控温室2内，在37℃环境下孵育60min；每孔加促进剂50μl，进微型震荡器10内振荡1min，进控温室2内，在37℃环境下孵育20min，洗板四次，拍干；每孔加裂解剂100μl，进控温室2内，37℃环境下孵育20min，洗板四次。每孔加酶标记物HRP-抗-HBcAg 100μl，进温控室2内，在37℃环境下孵育60min，进洗板机7，洗板四次，拍干；每孔加100μl底物显色液，进微型震荡器10振荡1min，在室温环境下放置5～20分钟；每孔加2mol/L H2SO450μl终止反应；比色，判定结果。
结果：
本发明与PCR探针检测HBV-DNA阳性结果符合率为92.3％，与乙型肝炎两对半检测HBV阳性结果符合率为94.1％。

Claims (4)

1.一种直接检测乙肝病毒核心抗原的配套便携装置，其特征在于：包括配套使用的便携检验箱体，所述便携检验箱体内设有加样吸管、微孔板、洗板机、微型震荡器、真空抽气装置、酶标板和加热管；所述便携检验箱体内部中空，间隔设有控温室和震荡室，所述控温室内设有加热管、微孔板支架、微孔板和洗板机，所述震荡室内设有微型震荡器、试剂瓶架、试管架和真空抽气装置，所述便携检验箱体顶部设有震荡器定时开关、酶标板和加样吸管。
2.根据权利要求1所述的一种直接检测乙肝病毒核心抗原的配套便携装置，其特征在于：所述加热管上设有温控板和加热定时开关，所述试管架上设有待检血清试管，所述试剂瓶架上设有促进剂瓶、裂解剂瓶和标记物瓶。
3.根据权利要求1所述的一种直接检测乙肝病毒核心抗原的配套便携装置，其特征在于：所述洗板机上设有洗板机开关。
4.根据权利要求1所述的一种直接检测乙肝病毒核心抗原的配套便携装置，其特征在于：所述便携检验箱体背侧面设有电源开关，所述电源开关与加热装置、洗板机、微型震荡器、真空抽气装置分别形成电气通路。
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