加拿大IMI公司的皮肤固醇检测技术正在进行临床试验

一种新型病床旁边的检验方法(免除了样本从病房到实验室的传送过程 ，point-of-care，POC)检测方法不久将进行临床试验，该检测方法无需禁食或者抽血，而只要检测皮肤中固醇的含量（也被称作皮肤组织胆固醇，是反应冠状动脉疾病的指标）。

该系统称作Prevu(x) POC，是由两种检测方法发展而来：“Prevu(x)皮肤固醇试验LT”是一种在实验室进行的检测，使用医疗级别的粘合剂，利用正在申请的装置从手掌采集皮肤细胞样本。然后将该设备送入实验室检测皮肤固醇；第二种方法称作Prevu(x) PT，是一种单次使用、三分钟完成的家用检测方法。这两种检测方法都是由国际医疗创新公司(International Medical Innovations, Inc., IMI, Toronto, Canada; www.imimedical.com)研制成功的。

即将进行的多中心临床试验，包括600例计划进行冠状动脉血管造影检查的患者，以及100例年龄、性别匹配的作为对照的健康者。试验将在加拿大的多个地方进行，包括蒙特利尔心脏研究所。患者将接受两个系统的检测。同时也将采集空腹血清标本进行传统危险因子的检测。

“Prevu(x) POC是一种非侵入性的检测方法，能够当场获得结果。这将使得该系统能够有效鉴别出那些患冠状动脉疾病风险较高的患者，冠状动脉疾病是心脏病发作的头号病因，”蒙特利尔心脏研究所临床研究主任、蒙特利尔大学医学副教授Jean-Claude Tardif医生指出，“Prevu(x) LT系统对操作者而言则更加简单，如果能够获得批准，将使得皮肤固醇检测能够得到更广泛的使用。”Tardif医生是该研究的首席研究员。

Skin Sterol Test in Trial
 
A new point-of-care (POC) test soon to be in a clinical trial does not require fasting or drawing of blood but tests for the amount of sterol in the skin, also known as skin tissue cholesterol, as an indicator of coronary artery disease.

Called the Prevu(x) POC, the system has been developed in two test formats. The Prevu(x) Skin Sterol Test LT, a lab-processed test, samples skin cells from the palm of the hand, using a patent-pending device with medical-grade adhesive. The device is then sent to a lab where the surface is assessed for skin sterol. The second version is a single-use, three-minute home test, called Prevu(x) PT. Both were developed by International Medical Innovations, Inc. (IMI, Toronto, Canada; www.imimedical.com).

The multicenter trial, which will involve 600 patients scheduled for coronary angiography and 100 healthy age- and gender-matched controls, will be performed at multiple sites in Canada, including the Montreal Heart Institute. Patients will be tested on both systems. A fasting serum sample will also be taken and tested for traditional risk factors.

“Prevu(x) POC is noninvasive and delivers results quickly, which makes it a potentially effective tool to help identify patients who are at higher risk of coronary artery disease--the number one cause of heart attack,” noted Dr. Jean-Claude Tardif, director of Clinical Research at the Montreal Heart Institute and associate professor of medicine at the University of Montreal. “Prevu(x) LT is even simpler to administer, and, if proven successful, will make skin sterol testing even more widely available.” Dr. Tardif is the principal investigator in the study.