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  首頁 > 美迪醫訊 > Biosite公司診斷栓塞的TriageD二聚體檢測方法面世  

Biosite公司診斷栓塞的TriageD二聚體檢測方法面世

【?2004-12-21 發布?】 美迪醫訊
美迪網領先的醫療器械電子商務平臺

一種新型檢測方法被設計用于幫助診斷與評估那些易于發生血栓栓塞事件的患者,包括肺栓塞。這種檢測方法叫做Triage D二聚體檢測,已經獲得了美國藥品食品管理局的許可。

這種床邊診斷檢測方法是一種十分方便的檢測方法,能夠在急診科或者患者床邊進行。根據一項發表在《急診醫學年報》(2004:490-502)上的研究報道,在一項評估肺栓塞的床邊檢測臨床試驗方案中,使用當前正在使用的乳膠凝集試驗檢測D二聚體,評估肺栓塞的患者的數量增加一倍,而急診室觀察時間下降,無需進一步進行血管造影檢查。當前被漏診的肺栓塞病例比實際診斷病例要多,這是由于患者臨床癥狀模糊而且缺乏特異性。肺栓塞漏診率最高的是住院患者。尸體解剖結果顯示,多達60%的院內死亡患者有肺栓塞,但是這些患者中有70%都沒有能夠診斷出來。

Biosite公司(San Diego, CA, USA)首席科學官員、總拆Ken Buechler博士評論說:“肺栓塞會產生致命的后果,我們相信Triage D二聚體檢測,做為一種床邊檢測項目,能夠很好地幫助急診科醫生快速評估疑似肺栓塞患者,從而改進對患者的治療處理。”正是Biosite公司進行了Triage D二聚體檢測進行了商品化操作。

Test Aids Diagnosis of Embolism
 
A new test is intended as an aid in the assessment and evaluation of patients suspected of having thromboembolic events, including pulmonary embolism (PE). The test, called Triage D-Dimer test, has been cleared by the U.S. Food and Drug Administration (FDA).

This point-of-care (POC) diagnostic test is portable and can be used in the emergency department (ED) or at the patient’s beside. According to a study published in the Annals of Emergency Medicine (2004:490-502), a POC clinical protocol for the evaluation of PE, using an available latex-agglutination test for D-Dimer, doubled the number of patients evaluated for PE and decreased length of stay in the ED, without increasing the need for vascular imaging. Currently, more cases of PE are missed than are actually diagnosed because of vague and nonspecific symptoms. The highest incidence of unrecognized PE occurs in hospitalized patients. Autopsy results show that as many as 60% of patients dying in the hospital have had a PE, but the diagnosis has been missed in about 70% of the cases.

“Pulmonary embolism can be a highly lethal condition,” commented Ken Buechler, Ph.D., president and chief scientific officer of Biosite, Inc. (San Diego, CA, USA), which is commercializing the Triage D-Dimer test. “We believe the Triage D-Dimer test, used at the point of care, can play an important role in helping emergency department physicians rapidly evaluate patients with suspected pulmonary embolism, which should result in better patient management.”

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