CN108303416A - 一种上皮组织染色液试剂盒及其制备方法 - Google Patents

一种上皮组织染色液试剂盒及其制备方法 Download PDF

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CN108303416A
CN108303416A CN201810085306.XA CN201810085306A CN108303416A CN 108303416 A CN108303416 A CN 108303416A CN 201810085306 A CN201810085306 A CN 201810085306A CN 108303416 A CN108303416 A CN 108303416A
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温云飞
黄冬琴
王成林
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Qingdao Hao Platinum Biological Technology Co Ltd
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Abstract

本发明属于宫颈病检测技术领域,公开了一种上皮组织染色液试剂盒及其制备方法,由浓度为10mmol/L的亚甲基蓝、浓度为5mmol/L维生素C(下文简称Vc)、浓度为12mmol/L叶酸和浓度为2mmol/L中性红组成。用Vc还原亚甲基蓝,用叶酸介导;亚甲基蓝浓度为10mmol/L,Vc浓度为5mmol/L,叶酸浓度为12mmol/L;加入中性红调色,中性红浓度为2mmol/L。本发明用棉签蘸取该溶液涂抹宫颈后根据即刻棉签颜色的变化判断是否病变;具有敏感、及时、全面、直观的特点;在妇科窥器检查时30s内完成检测,可以对宫颈病变进行实时评价,以便科学分流患者,提高了患者的依从性,从而减少患者就诊次数。

Description

一种上皮组织染色液试剂盒及其制备方法
技术领域
本发明属于宫颈病检测技术领域,尤其涉及一种上皮组织染色液试剂盒及其制备方法。
背景技术
传统宫颈病检测借助病理检查及PCR技术,尚不能在宫颈检查当时得出结果,做出初步判断,且液基细胞学(TCT)结合HPV检测价格较高,不便于门诊就诊患者及体检患者的常规筛查和及时分流。目前在经济不发达地区或缺少资源的地区仍采用肉眼筛查方法(VIA/VILI)进行初筛,阳性者再行阴道镜检查,但肉眼筛查误差较大。而本检测试剂用拭子蘸取溶液检测样本,通过观察颜色变化来判断病变,此方法操作更简单,检测速度更快,灵敏度更高。
综上所述,现有技术存在的问题是:传统的宫颈病检测方法存在检测成本高,检测速度慢,操作繁琐,不便于门诊就诊患者及体检患者的常规筛查和及时分流,肉眼筛查误差较大。
发明内容
针对现有技术存在的问题,本发明提供了一种上皮组织染色液试剂盒及其制备方法。
本发明是这样实现的,一种上皮组织染色液试剂盒,所述上皮组织染色液试剂盒由浓度为10mmol/L的亚甲基蓝、浓度为5mmol/LVc、浓度为12mmol/L叶酸和浓度为2mmol/L中性红组成。本发明中加入了一种特殊的活化剂使得本发明中亚甲基蓝和叶酸能够很好的结合,从而大大提高了检测的准确性。此活化剂为磷酸乙二胺或磷酸丙二胺或两者的组合使用。
本发明的另一目的在于提供一种所述上皮组织染色液试剂盒的制备方法,所述上皮组织染色液试剂盒的制备方法包括以下步骤:
步骤一,用Vc还原亚甲基蓝,用叶酸介导;亚甲基蓝浓度为10mmol/L,Vc浓度为5mmol/L,叶酸浓度为12mmol/L;
步骤二,加入中性红调色,中性红浓度为2mmol/L。
本发明的另一目的在于提供一种所述上皮组织染色液试剂盒的使用方法,所述上皮组织染色液试剂盒的使用方法包括用拭子蘸取溶液检测样本,黄色为阴性,蓝色为阳性。
本发明的优点及积极效果为:叶酸受体介导的宫颈特殊染色法(FRD)上皮组织染色用棉签蘸取该溶液涂抹宫颈后根据即刻棉签颜色的变化判断是否病变;具有敏感、及时、全面、直观的特点。在妇科窥器检查时30s内完成检测,可以对宫颈病变进行实时评价,以便科学分流患者,提高了患者的依从性,从而减少患者就诊次数。而且本发明中加入了一种特殊的活化剂,磷酸乙二胺或磷酸丙二胺或两者的组合使用,使得本发明中亚甲基蓝和叶酸能够很好的结合,从而大大提高了检测的准确性。
本发明与现有的TCT和HPV技术相比敏感性和特异性好,不需要设备仪器,并且可以对宫颈管病变进行检测,弥补了现有技术的不足。同时成本低,比传统方法成本要低20%~30%,易于患者接受。
检查方法 敏感性 特异性
上皮组织染色法 85.0% 99.0%
FRD特殊染色阳性 75.0% 81.6%
细胞学(≥ASC-H) 56.0% 87.9%
FRD+细胞学(任一为阳性,检查即为阳性) 78.0% 70.7%
FRD+细胞学(同时阳性,检查即为阳性) 50.0% 98.6%
附图说明
图1是本发明实施例提供的上皮组织染色液试剂盒的制备方法流程图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
本发明与现有的TCT和HPV技术相比敏感性好,不需要设备仪器,并且可以对宫颈管病变进行检测,弥补了现有技术的不足。同时价格低,易于患者接受。
下面结合附图对本发明的应用原理作详细的描述。
本发明实施例提供的上皮组织染色液试剂盒由浓度为10mmol/L的亚甲基蓝、浓度为5mmol/LVc、浓度为12mmol/L叶酸和浓度为2mmol/L中性红组成。
如图1所示,本发明实施例提供的上皮组织染色液试剂盒的制备方法包括以下步骤:
S101:用Vc还原亚甲基蓝,用叶酸介导;亚甲基蓝浓度为10mmol/L,Vc浓度为5mmol/L,叶酸浓度为12mmol/L;
S102:加入中性红调色,中性红浓度为2mmol/L。
本发明实施例提供的上皮组织染色液试剂盒的使用方法:用拭子蘸取溶液检测样本,看颜色变化,黄色为阴性,蓝色为阳性。
本发明已经完成来自某三甲医院的1000例样本检测试验,阳性结果检出率≥80.0%。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。

Claims (3)

1.一种上皮组织染色液试剂盒,其特征在于,所述上皮组织染色液试剂盒由浓度为10mmol/L的亚甲基蓝、浓度为5mmol/L Vc、浓度为12mmol/L叶酸和浓度为2mmol/L中性红组成。
2.一种如权利要求1所述上皮组织染色液试剂盒的制备方法,其特征在于,所述上皮组织染色液试剂盒的制备方法包括以下步骤:
步骤一,用Vc还原亚甲基蓝,用叶酸介导;亚甲基蓝浓度为10mmol/L,Vc浓度为5mmol/L,叶酸浓度为12mmol/L;
步骤二,加入中性红调色,中性红浓度为2mmol/L。
3.一种如权利要求1所述上皮组织染色液试剂盒的使用方法,其特征在于,所述上皮组织染色液试剂盒的使用方法包括用拭子蘸取溶液检测样本,黄色为阴性,蓝色为阳性。
CN201810085306.XA 2018-01-29 2018-01-29 一种上皮组织染色液试剂盒及其制备方法 Pending CN108303416A (zh)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109187145A (zh) * 2018-08-23 2019-01-11 杭州元研细胞生物科技有限公司 一种用于宫颈癌早筛的诊断染色液及其制备方法
CN110455602A (zh) * 2019-07-18 2019-11-15 浙江中法制药有限公司 基于脱落细胞染色的特殊染色液及其制备方法和应用
CN113514455A (zh) * 2021-06-29 2021-10-19 广州朗坤生物科技有限公司 检测上皮组织脱落细胞表面叶酸受体表达的方法及试剂盒
CN117804876A (zh) * 2024-03-01 2024-04-02 德州国科医疗科技有限公司 一种叶酸受体介导上皮组织细胞染色液及其制备方法

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CN103185713A (zh) * 2011-12-29 2013-07-03 闫文广 用于上皮组织肿瘤细胞的检测剂组合物及其制备方法
CN103483872A (zh) * 2013-09-30 2014-01-01 青岛农业大学 用于肿瘤组织细胞的染色剂组合物及其制备方法
CN103827654B (zh) * 2011-09-13 2017-06-13 皇家飞利浦有限公司 用于制备进行检查的细胞学样品的系统和试剂盒

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CN103827654B (zh) * 2011-09-13 2017-06-13 皇家飞利浦有限公司 用于制备进行检查的细胞学样品的系统和试剂盒
CN103185713A (zh) * 2011-12-29 2013-07-03 闫文广 用于上皮组织肿瘤细胞的检测剂组合物及其制备方法
CN103483872A (zh) * 2013-09-30 2014-01-01 青岛农业大学 用于肿瘤组织细胞的染色剂组合物及其制备方法

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109187145A (zh) * 2018-08-23 2019-01-11 杭州元研细胞生物科技有限公司 一种用于宫颈癌早筛的诊断染色液及其制备方法
CN110455602A (zh) * 2019-07-18 2019-11-15 浙江中法制药有限公司 基于脱落细胞染色的特殊染色液及其制备方法和应用
CN113514455A (zh) * 2021-06-29 2021-10-19 广州朗坤生物科技有限公司 检测上皮组织脱落细胞表面叶酸受体表达的方法及试剂盒
CN117804876A (zh) * 2024-03-01 2024-04-02 德州国科医疗科技有限公司 一种叶酸受体介导上皮组织细胞染色液及其制备方法
CN117804876B (zh) * 2024-03-01 2024-05-10 德州国科医疗科技有限公司 一种叶酸受体介导上皮组织细胞染色液及其制备方法

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Application publication date: 20180720