Тест на беременность (ХГЧ) в виде ручки, тестовая палочка, одиночная упаковка 3.0

One Step HCG Urine Pregnancy Test Kit（Cassette）

For OTC Use Only

INTENDED USE

One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

SUMMARY AND EXPLANATION

One Step HCG Urine Pregnancy Test measures the presence of the hormone, Human Chorionic Gonadotrophin (HCG), in human urine for the early detection of pregnancy. During pregnancy, the placenta produces HCG after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, urine contains higher levels of HCG at concentrations of 25mIU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mIU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mIU/ml with peak levels of 100,000 to 200,000mIU/ml.

PRINCIPLE

The HCG assay is a rapid one-step test based on immunochromatographic technology. A membrane with an absorbent pad over a strip of fiber glass paper is impregnated with a colloidal conjugate of gold particles and monoclonal antibodies to HCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-HCG monoclonal antibodies affixed on the test zone (“T”) will bind the HCG-gold conjugate complex, forming a pink line (“T”). Any sample will cause a pink colored line to appear in the control zone (“C”). This line is formed by the binding of polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of HCG as low as 25mIU/ml can be detected.

CONTENTS, STORAGE AND STABILITY

Each box contains: 1 foil pouch and Instruction for use.

Each pouch contains: 1Step HCG Urine Pregnancy Test Cassette, 1 Droper and 1 Desiccant.

The test kit can be stored at room temperature (39F- 86F; 4℃-30℃) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.  Do not freeze.

MATERIALS REQUIRED BUT NOT PROVIDED

Specimen collection container, Timer

PRECAUTIONS

1. 1.      FOR IN-VITRO DIAGNOSTIC USE ONLY (IVD), NOT for internal use
2. 2.      Read directions for use carefully before performing this test. Perform each step exactly as described.
3. 3.      Do not use beyond the expiration date marked on the foil pouch.
4. 4.      Each Cassette Test can only be used once; do not re-use the Cassette Test.
5. 5.      Do not use the Cassette Test if the foil pouch is damaged.
6. 6.      Once the foil pouch has been opened, the Cassette Test should be used immediately.
7. 7.      Discard each Cassette Test after use. Treat urine samples and used test devices as if they were potentially infectious. Avoid contact with skin.
8. 8.      KEEP OUT OF REACH OF CHILDREN.

 

绒毛膜促性腺激素（HCG）检测试纸（胶体金法）

 

使用说明书

 

【产品名称】

 

 通用名��：人绒毛膜促性腺激素（HCG）检测试纸（胶体金法）

 

 英文名称：One Step HCG Urine Pregnancy Test (Colloidal Gold)

 

【包装规格】

 

条型（袋装）：1人份/袋、1人份/盒、2人份/盒、5人份/盒、20人份/盒、50人份/盒、100人份/盒。

 

     (筒装): 25人份/筒  50人份/盒；25人份/筒  100人份/盒。

 

卡型：1人份/袋、1人份/盒、2人份/盒、5人份/盒、20人份/盒、40人份/盒。

 

笔型:1人份/袋、1人份/盒、2人份/盒、5人份/盒、20人份/盒、40人份/盒。

 

【预期用途】

 

人绒毛膜促性腺激素（HCG）检测试纸（胶体金法）用于定性检测人尿液中的人绒毛膜促性腺激素(HCG)。

 

人绒毛膜促性腺激素（HCG），是由胎盘的滋养层细胞分泌的一种糖蛋白，它是由α和β二聚体的糖蛋白组成。其中α-亚单位为垂体前叶激素所共有；β-亚单位是HCG所特异的。HCG的主要功能就是刺激黄体，有利于雌激素和黄体酮持续分泌以促进子宫蜕膜的形成，使胎盘生长成熟。HCG在妊娠的前8周增殖很快，以维持妊娠。在大约孕8周以后，HCG逐渐下降，直到大约20周达到相对稳定。利用HCG双抗体检测妊龄女性尿液中的HCG含量，在妊娠早期可快速得知结果，是辅助诊断的有效手段。

 

【检验原理】

 

本品系用人绒毛膜促性腺激素(HCG)抗体和抗鼠IgG分别固相硝酸纤维素膜和胶体金标记的抗HCG单克隆抗体及其它试剂粘合而成,应用免疫层析双抗体夹心法的原理定性检测人尿液中的绒毛膜促性腺激素(HCG)。当样本测试时,尿样在毛细作用下沿试纸吸样端向上层析,如是阳性,样本中的HCG与胶体金HCG抗体结合,然后继续往上层析,与固相在膜上的抗HCG抗体结合,在检测T区出现一条紫红色条带.如是阴性,则检测T区为没有紫红色条带出现。无论尿样中是否有HCG存在,一条紫红色条带都会在对照C区出现。此条带是显示试纸有效的内控标准。

 

【主要组成成分】

 

1.人绒毛膜促性腺激素（HCG）检测试纸（胶体金法）条/卡/笔                                               

 

2.说明书                                             1份  

 

3.干燥剂                                             1袋

 

4、滴管（如果适用）                                  1 个

 

HCG试纸条由PVC底板（胶板）、金标垫、反应膜、样品垫和吸水纸组成。金标垫上预包被有标记抗β-HCG单克隆抗体的胶体金；反应膜上的检测线位置包被有鼠抗α-HCG单克隆抗体，对照线位置包被有羊抗鼠IgG多克隆抗体。

 

【储存条件及有效期】

 

原包装于4℃～30℃避光干燥保存，不得冻存。产品自生产之日起有效期为24个月。试剂应在铝箔袋撕开后1小时内尽快使用。密封筒启封后试剂应1个月内用完。

 

【样本要求】

 

    采用一次性洁净容器收集任何时间的新鲜尿样。尿样若呈可见的混浊状，需先离心、过滤或待其沉淀后取上部清液检测。若不能及时送检，尿样标本在2℃-8℃冷藏可保存72小时。长期保存需冷冻于-20℃，忌反复冻融。

 

【检验方法】

 

   在进行检验前必须完整阅读使用说明书，使用前将原包装的测试条/测试卡卡/测试笔以及需检测的尿液样本平衡至室温。若打开包装，应在1小时内尽快使用。

 

   测试条：将测试条按箭头方向插入尿液标本中，至少3秒钟后取出平放于干净平整的台面上；或一直放在尿杯中，5分钟观察结果。（注意：尿液液面不能超过试纸条的警示标记线）。

 

   测试卡：将检测卡取出，水平放置，用吸管吸取尿样，滴加3滴尿样于加样孔内，5分钟观察结果。

 

  测试笔：使用前将检测笔取出，拔开封盖，测试时让尿液淋在检测笔的吸尿端上，时间不少于5秒（注意淋尿时不要淋湿显示窗口），然后套上封盖，继续平握检测笔或平放，5分钟观察结果。