ADEXUSDx hCG毛细管血液检测

Qinwei Shi, Duane Poorman, K. Clark
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引用次数: 0

摘要

虽然许多定性的即时检测方法在商业上可用于妊娠检测,包括尿液和血清人绒毛膜促性腺激素(hCG)检测,但这些产品往往与假阴性结果的高风险相关,而且不容易使用。ADEXUSDx hCG检测只需要1滴(35-40 μ L)全血样本检测hCG,适用于毛细管血液检测。与使用来自育龄妇女的392个手指棒样本的Access Total &bgr;hCG (5th IS)检测相比,结果总体一致性为98.1%。对40名18至44岁的孕妇和40名非孕妇进行ADEXUSDx hCG测试。hCG测试产生100%的敏感性和100%的特异性。另外318名不同年龄组的未怀孕妇女的研究显示出99.7%的特异性。ADEXUSDx hCG测试是一种快速测试(10分钟),证明易于使用和临床性能,使其成为一种有用的护理点测试以及非处方测试。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Invited Product Profile ADEXUSDx hCG Capillary Blood Test
Abstract Although many qualitative point-of-care tests are commercially available for detection of pregnancy including urine and serum human chorionic gonadotropin (hCG) tests, these products are often associated with higher risk of false-negative results and are not easy to use. The ADEXUSDx hCG Test uses only 1 drop (35–40 &mgr;L) of whole blood sample for the detection of hCG, making it suitable for capillary blood testing. Comparison with Access Total &bgr;hCG (5th IS) assay using 392 finger stick samples from women of child-bearing age demonstrated an overall agreement of 98.1%. Performance of the ADEXUSDx hCG Test was prospectively evaluated in 40 pregnant and 40 nonpregnant women aged 18 to 44 years. The hCG test generated 100% sensitivity and 100% specificity. Study of additional 318 nonpregnant women in various age groups demonstrated 99.7% specificity. The ADEXUSDx hCG Test is a rapid test (10 minutes) with demonstrated ease of use and clinical performance, making it a useful point-of-care test as well as over-the-counter test.
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