体外诊断试剂激素类六项产品

激素常规六项联合临床检验性激素人促黄体生成素（LH）定量检测试剂盒人促卵泡生成素（FSH）定量检测试剂盒雌二醇（E2）定量检测试剂盒游离雌三醇（fE3）定量检测试剂盒孕酮（p）定量检测试剂盒睾酮（T）定量检测试剂盒泌乳素（PRL）定量检测试剂盒性激素常规六项概况性激素检测临床意义内分泌检测方法的对比美凯性激素产品的技术指标血清检查同类产品检测方法的对比介绍内容内分泌调节机制垂体：促激素，泌乳素肾上腺：少量雌、雄性激素卵巢：雌激素，孕激素睾丸：雄性激素内分泌与性激素内分泌系统，分泌各种激素和神经系统一起调节人体的代谢和生理功能。正常情况下各种激素是保持平衡的，如因某种激素分泌的过多或过少，就会造成内分泌失调，会引起相应的临床表现。性激素异常危害月经不调、痛经、闭经皮肤恶化不孕不育乳腺增生、子宫肌瘤肥胖综合征癌症器官功能（低下）亢进白发、早衰、耳鸣、精神萎靡降低人体免疫，引发疾病感染性早熟（迟缓）女性生殖周期紊乱不孕不育孕期监测假性性表象生殖系统疾病内分泌治疗过程监测性激素检测的临床意义性激素疾病现状女性25岁以后，身体状况开始出现下滑,30岁以上的女性人群中，乳房肿块的患病率高达38.8%～49.3%，乳房肿块有可能转化为乳腺癌。而子宫肌瘤的患病率也高达20%，随着不孕不育比例的上升，基于性激素分泌失调的发病率已经占到了不孕症的15%～25%左右，女性朋友要做好积极的检查治疗，正在向低龄化进展，十几岁的女孩子，也已成为内分泌失调的威胁对象。激素类摄入，补品等，发育失调频增性激素类疾病诊断方法生化检查激素动态观察激素调节功能检查受体测定靶细胞功能检查X射线检测（性早熟）血清检查性激素常规六项检测方法简介通过其它手段确诊受试者测定血清激素水平激素水平异常治疗监测美凯性激素类试剂盒的优势性价比高检测方法简单，一台仪器就可以进行检测项目全稳定性好，检出率高体外诊断，无交叉传染美凯性激素检测方法的优势放射免疫测定法（RIA):有放射性酶免疫测定法（EIA):需样少，较高特异性和灵敏度时间分辨荧光免疫分析法（TRFIA)：灵敏、简便、对提高PGR参数检测准确性具有突出的优势电化学发光，仪器试剂昂贵化学发光法：敏感度高，甚至超过RIA，精密度和准确性均可与RIA相比，化学发光试剂作为标记物进行定量检测，试剂稳定，无毒害，测定耗时短不同方法学优劣势对比分析方法学检测原理操作步骤反应模式线性范围干扰因素检测结果酶免抗原抗体反应繁琐两步法较窄显色易受干扰，本底高，灵敏度低半定量电化学发光抗原抗体反应简单一步法宽反应池交叉污染定量时间分辨抗原抗体反应简单一步法宽荧光易受环境影响，操作要求高定量化学发光抗原抗体反应简单一步法较宽无定量市场推广优劣势对比分析方法学市场现状应用范围收费标准适用机型酶免逐步淘汰广泛低酶免分析仪电化学发光可选择性小广泛昂贵电化学发光仪时间分辨局限性大区域性高时间分辨仪化学发光市场主流广泛高化学发光仪美凯人促黄体生成素检测试剂盒-------化学发光法Φ美凯人促黄体生成素检测试剂盒性激素六项全套试剂盒37度热考核7天与4度试剂盒测定临床对比温度37度4度37度/4度临床0.8990.8571.0492.8442.6841.0594.3394.2451.0228.3507.6171.09611.41612.3450.92516.65916.5161.00929.69928.8631.02943.75242.3641.03372.85069.8941.042120.466115.9481.039平均比值1.030温度37度4度37度/4度临床1.351.370.9844.904.571.0706.376.101.0459.208.951.02812.3815.390.80420.4720.950.97730.3828.111.08140.5537.731.07583.3777.861.071126.85119.031.066平均比值1.020LHFSH性激素六项全套试剂盒37度热考核7天与4度试剂盒测定临床对比温度37度4度37度/4度临床36.7935.321.0485.5883.441.03159.22145.891.09284.78287.920.99361.81370.790.98540.70501.311.08720.53724.770.99981.151061.610.921673.421606.721.042725.522662.811.02平均比值1.018温度37度4度37度/4度临床0.880.881.0051.081.021.0612.662.690.9903.753.731.0065.435.470.9928.658.651.0009.399.291.01113.0312.011.08523.3422.221.05030.8229.661.039平均比值1.023PRLP性激素六项全套试剂盒37度热考核7天与4度试剂盒测定临床对比温度37度4度37度/4度临床15.5615.101.03138.9539.240.99379.2773.811.074243.11234.631.036366.44364.511.005406.00407.500.996573.19572.361.001757.29737.341.027867.90859.831.009959.23940.121.020平均比值1.019温度37度4度37度/4度临床0.800.761.0551.381.281.0802.012.100.9612.842.870.9903.563.551.0014.324.301.0055.455.401.0088.238.121.01312.2211.611.05218.4318.241.010平均比值1.017E2T临床考核采取与国外同类产品进行对比。具体方法时测定一定数量的样本，得出两者的相关曲线方程，计算相关系数和符合率。国外同类产品选用贝克曼·库尔特化学发光产品进行对比。参照各自标准选择40份血清/血浆样本，分别用本试剂盒和贝克曼定量检测试剂盒（化学发光法）进行测定。美凯全套试剂盒与贝克曼临床相关性临床编号.LH（mIU/ml）FSH（mIU/ml）P（ng/ml）T（ng/ml）PRL(µIU/ml)E2（pg/ml）美凯贝克曼美凯贝克曼美凯贝克曼美凯贝克曼美凯贝克曼美凯贝克曼10.840.760.750.770.550.490.500.5339.5640.2411.2111.0922.642.711.611.590.971.071.111.0152.4051.3721.9022.3233.753.772.592.571.311.271.381.4166.2067.8327.7528.0744.954.893.964.171.501.672.172.3273.6072.7631.7732.1955.965.875.095.121.791.633.463.0987.8088.7442.5942.0366.897.018.027.962.031.993.673.5599.11101.1463.8362.2177.407.4910.1710.543.343.474.494.63126.14125.7979.2580.1689.689.7713.2413.003.964.125.675.83172.75173.4597.3498.57911.4711.7817.8817.654.975.145.816.07208.73210.21130.07133.091013.6113.4121.5421.715.435.306.246.35267.20261.83169.35170.251116.8917.0124.7124.986.556.897.537.67316.71313.24197.27183.751219.0719.5426.1927.967.687.9710.7711.03398.34398.17241.33244.311336.8337.1232.1533.258.928.1011.2711.38445.33450.36349.38351.681442.6740.2840.7541.2510.1710.0912.9513.01574.70569.28404.76407.631557.0157.1059.6158.3311.6411.8713.4813.58609.64612.73480.25477.241669.9569.5468.3268.9614.5815.1214.7615.01908.72903.27571.80569.811786.4486.4389.1190.2416.0116.7815.8515.791397.281356.76657.01663.1618106.11107.0392.5791.1618.8519.0116.6316.561727.941734.69773.37781.2919123.47121.95110.35109.8525.7627.0117.1817.002478.752429.65880.22881.3120139.18140.32138.47139.1930.6930.7018.8619.032774.312779.58943.56950.23覆盖线性20份样本与某进口试剂对比E2开展500份样本与某进口试剂对比美凯试剂通用检测仪器及辅助设备仪器自动洗板机厦门天众达化学发光免疫分析仪北京科美东雅半自动化学发光仪郑州安图LUmo化学发光免疫分析仪Φ美凯试剂通用仪器电话：[phone]传真：[phone]地址：漯河市沙澧产业集聚区湘江西路与经五路交叉口邮编：462000公司网址：河南美凯生物科技有限公司