DIGITAL RESPONSE QUANTITATIVE HCG RAPID TEST

人慢性促性腺激素(HCG)的灵敏定量检测 在妇女保健方面的广泛效用，超出了对怀孕的检测。他们 可以用来预测自然流产和帮助 异位妊娠和多胎妊娠的检测。也许更多 重要的是，一种快速周转的全血hCG定量检测 在急诊室中，当一名妇女出现严重的 腹痛。主治医生需要迅速确定 病因与肾、肝、胆、阑尾或 宫外孕。 Metrika将展示一种扩展范围免疫的可行性 用于数字反应的化学定量hCG快速检测。这项测试 将快速(不到5分钟即可达到结果)、一次性使用和 一次性，可在实验室定量测定hCG 精确度和精密度。在它的最终形式，测试设备将是大约 信用卡的大小，并将结合廉价的微电子设备 和干试剂免疫化学放入一个完全自给自足的包装中。 可行性的关键问题将是实现非常广泛的动态 范围(hCG独有)除了高灵敏度、精度 低成本侧向芯吸免疫分析的准确性和特异性 测试设备。在没有血样前处理的情况下实现这些目标 否则稀释将需要在干试剂领域进行创新 免疫分析化学、制造和信号生成以及 检测技术，以前在一次性使用测试中未知。Metrika 将应用创新和专有解决方案来解决这些问题 将在第一阶段项目中评估这些问题的可行性。 建议的商业应用： 数字反应定量人绒毛膜促性腺激素的商业化应用 快速检测是在紧急情况下获得快速检测的地点 定量分析是有限的或根本不存在的。产科医生/ 妇科医生和急诊室医生将使用这项测试，它将 产生显著的经济和患者利益，包括改善 医疗点的医疗服务效率。

Sensitive quantitative assays for human chronic gonadotropin (hCG) have broad utility in women's health care beyond detection of pregnancy. They can be useful in predicting spontaneous abortions and aid in the detection of ectopic pregnancy and multiple gestation. Perhaps more importantly, a rapid-turnaround whole blood quantitative hCG test is crucial in the emergency room when a women presents with severe abdominal pain. The attending physician rapidly needs to determine if the cause is related to the kidney, liver, gall bladder, appendix, or to an ectopic pregnancy. Metrika will demonstrate the feasibility of an extended range immuno- chemistry for a Digital Response Quantitative hCG Rapid Test. This test will be rapid (less than 5 minutes to a result), single-use, and disposable, capable of quantitatively measuring hCG with laboratory accuracy and precision. In its final form, the test device will be about the size of a credit card and will combine inexpensive microelectronics and dry reagent immunochemistry into a totally self-contained package. The key issues for feasibility will be achieving a very wide dynamic range (unique to hCG) in addition to high sensitivity, precision, accuracy, and specificity, in a low cost lateral wicking immunoassay test device. Achieving these goals without blood sample pre-treatment or dilution will require innovation in the areas of dry reagent immunoassay chemistry, manufacturing, and signal generation and detection technology, previously unknown in single-use tests. Metrika will apply innovative and proprietary solutions to resolving these issues and will assess their feasibility within the Phase I project. PROPOSED COMMERCIAL APPLICATION: The commercial application of the Digital Response Quantitative hCG Rapid Test are in the urgent point of care sites where access to a rapid quantitative analysis is limited or non-existent. Obstetricians/ Gynecologists and emergency room physicians will use the test which will yield significant economic and patient benefits, including improving the efficiency of healthcare delivery at the point of care.