立晰宁™阴道微生物荧光试剂临床意义

立晰宁™Clinical significance of vaginal microbiological fluorescence reagent

阴道炎作为妇科常见病、多发病，每年约有500-1000万女性罹患此病，而75%的妇女在一生中至少患病1次。它多由念珠菌（VVC）、滴虫（TV）、细菌（BV）等引起，目前医院常用的湿片镜检等方法，易因标本质量不高、镜检下病原体形态不清晰等原因造成漏检，而培养法虽然检出率高，但检测周期长，不便于临床大范围推广。荧光素标记被测病原体或细胞，一步染色，时间快速，荧光对比度强。背景差异大，特异性染色滴虫，不因滴虫死亡漏检。

Vaginitis, as a common gynecological disease, affects about 5-10 million women every year, and 75% of women get it at least once in their lifetime. It is caused by candida (VVC), trichomonas (TV), bacteria (BV) and so on. It is easy to miss the examination due to poor specimen quality and unclear pathogen morphology under microscopic examination. Although the culture method has a high detection rate, it has a long detection period, which is not easy to popularize widely in clinic. Luciferin tags are used to detect pathogens or cells, One step dyeing, speedy, high fluorescence contrast,

立晰宁^TM阴道微生物荧光试剂是体外诊断试剂，由A液和B液组成，用于对阴道分泌物样本的荧光特殊染色处理。

立晰宁^TM vaginal microbiological fluorescence reagent is in vitro diagnostic reagent, composed of liquid A and Liquid B, used for special fluorescent staining treatment of vaginal secretion samples

A液中的荧光素可以高亲和力地与真菌细胞壁上的β多糖，如几丁质与纤维素等结合，从而标记样品中存在的白色念珠菌等真菌，并在荧光显微镜下可看到特定激发光下产生的蓝白色荧光。

Luciferin in Solution A can bind with polysaccharides on the cell wall of fungi with high affinity, such as chitin and cellulose, so as to label the presence of candida albicans and other fungi in the sample, and the blue and white fluorescence generated by specific excitation light can be seen under the fluorescence microscope.

 B液是经典的极灵敏的荧光染料，它可对细胞和病原微生物中的DNA和RNA有高度的分色能力，可标记样品中病原微生物，并在荧光显微镜下可看到特定激发光下产生的黄绿色荧光，从而突出细胞和病原微生物形态，使得操作人易于辨认。

B liquid is the classic extremely sensitive fluorescent dye, it can have on DNA and RNA in the cell and pathogenic microorganisms highly color separation ability, pathogenic microorganisms can tag samples, and can be seen under the fluorescence microscope under certain excitation light yellow-green fluorescence, so as to highlight the cells and pathogenic microorganisms form, operation of people is easy to recognize.

 本法具有灵敏，快速，简便，结果易观察等优点，具有较高的临床推广意义。

This method is sensitive, rapid, simple and easy to observe the results.

阴道炎检测方法及比较

Detection methods and comparison of vaginitis

立晰宁™检测内容及适用范围

立晰宁™ testing content and scope of application

本品由AB液组成，A液可标识标本中存在的真菌（如念珠菌孢子、真菌菌丝等），B液可标识标本中存在的滴虫、细菌（加德纳菌、厌氧菌、动弯杆菌、球菌/链球菌等），更可标识标本中的白细胞、上皮细胞、乳酸杆菌、杂菌等直观数量分布，并能据此做出阴道清洁度的评价，涵盖了阴道炎检测的大部分项目。

This product is composed of AB fluid, A fluid can identify specimens of fungi such as candida spores, the fungal hyphae, etc.), fluid B can identify specimens of trichomonad, bacteria (Gardner bacteria, anaerobic bacteria, curved bacillus, streptococcus aureus/etc.), can identify more specimens of white blood cells, epithelial cells, lactic acid bacteria and bacterial number distribution intuitively, and correspondingly make vaginal cleanness, covers most of vaginitis detection project.

适用标本：阴道分泌物

Suitable specimen: vaginal secretions

适用科室：妇科、产科、病理科、生殖中心、皮肤科等科室

Applicable departments: gynecology, obstetrics, pathology, reproductive center, dermatology and other departments

使用范围：妇科门诊常规检查，妇科术前，孕前检查，产科常规检查，不孕不育男女筛                             查，皮肤性病检查等。

Scope of use: gynecological outpatient routine examination, gynecological surgery, pre-pregnancy examination, routine obstetric examination, infertility screening for men and women, skin STD examination, etc.

立晰宁™操作步骤

立晰宁™operating steps

将阴道分泌物标本采集后，在载玻片上左右各均匀涂抹一份样本，并在样本上分别滴加A、B液；混匀后加上盖玻片；用显微镜的UV波段（紫色光源）观察经A染液染色的标本，用B波段（蓝色光源）观察经B染液染色的标本即可，1-2分钟即可完成检验。

After sampling the vaginal secretions, smear one sample evenly on the left and right sides of the slide, and add liquid A and liquid B to the sample. Mix well and add cover glass. The specimen stained by A is observed at UV band (purple light source) and at B band (blue light source). The test can be completed in 1-2 minutes.

立晰宁™产品优势

立晰宁™product advantages

操作简单：标本无需特殊处理，直接滴加

Simple operation: the specimen does not need special treatment, add directly

检测快速：染色时间仅需30秒即可辨读

Fast detection: the dyeing time is only 30 seconds and readable

识别度高：镜下荧光显色清晰，易于判别

High recognition: the fluorescence under the mirror is clear and easy to distinguish

准确区分：能准确区分BV、VVC、TV

Accurate differentiation: Can accurately distinguish BV, VVC, TV

符合率高：临床检出率和符合率高

High coincidence rate: high clinical detection rate and coincidence rate          

镜检（白细胞、杂菌）  

镜检（念珠菌）

立晰宁™染色后背景细胞大致都呈绿色，被检微生物（包括阴道杆菌）大都呈橙色或亮橙色，极易将相关病原物从大量上皮细胞，脓细胞之中查找出来，从而完成高质量的检测。

立晰宁™After staining, the background cells were generally green, and most of the microorganisms tested (including vaginobacteria) were orange or bright orange, which made it easy to find out the related pathogens from a large number of epithelial cells and pus cells, so as to complete high-quality detection.

收费项目参考

Reference of charge items

品名：立晰宁™免疫显色试剂

Name: 立晰宁™Immune chromogenic reagent

型号及规格：Ⅱ型；20测试/盒，50测试/盒，100测试/盒

Types and specifications: Ⅱ type; 20 test/box, 50 test/box, 100 test/box

产品组成：由染色液（A液）和显色液（B液）组成

Product composition: it consists of dyeing solution (Liquid A) and developing solution (liquid B)

预期用途：在免疫组化反应或原位杂交反应中与首要抗原抗体结合，通过染色，将靶点进行标记。

Intended use: Binding to primary antigens and antibodies in immunohistochemical reactions or in situ hybridization, and marking of targets by staining.

医疗器械备案凭证号：粤穗械备20201095号

Medical device record certificate No. : Yuesui Zhuangbei 20201095

生产备案凭证编号：粤穗食药监械生产备20190157号

Production record certificate No. : Guangdong Food and Drug Regulatory Production preparation no. 20190157

生产企业：广州翰德泽信医药科技有限公司

Manufacturer: Guangzhou Handezexin Pharmaceutical Technology Co., LTD

储存及有效期：常温避光储存，有效期24个月。

Storage and expiry date: stored at room temperature and away from light, valid for 24 months.