一項(xiàng)I期雙盲對(duì)照的臨床試驗(yàn)涉及40例艾滋病病毒（HIV）陽性患者，目的是評(píng)估診斷艾滋病病毒的診斷系統(tǒng)。

在該項(xiàng)研究中，每例患者都將接受標(biāo)準(zhǔn)的病毒表型檢測(cè)，該檢測(cè)逐漸成為幫助醫(yī)生確定哪種藥物對(duì)HIV感染患者的優(yōu)勢(shì)病毒株不再有效的常規(guī)工具。這40例患者還將接受另一種抗病毒功效檢測(cè)，該檢測(cè)使用加拿大SpectraDigital公司（SDC，Guelp，Canada）推出的HIV SpectraPoint檢測(cè)法進(jìn)行。使用這種快速檢測(cè)方法，醫(yī)生在24小時(shí)內(nèi)就可以得到結(jié)果。這樣醫(yī)生可以在病毒變異成新的耐藥株之前，及時(shí)作出必要的治療選擇。

患者將會(huì)從這種快速檢測(cè)得到的資料中獲得實(shí)實(shí)在在的臨床效益，這種新型檢測(cè)手段將會(huì)替代傳統(tǒng)的耗時(shí)數(shù)周的檢測(cè)方法。與此同時(shí)，艾滋病醫(yī)生也對(duì)他們患者的病情有了更加精確及時(shí)的了解。

SpectraDigital公司總裁Satish Deshpande說：“這項(xiàng)小規(guī)模研究在我們HIV診斷學(xué)的研究進(jìn)展中是極其重要的一步。除了我們的初步研究目標(biāo)：即比較HIV SpectraPoint檢測(cè)法與標(biāo)準(zhǔn)病毒表型抵抗型檢測(cè)法之外，我們還將評(píng)估新型檢測(cè)方法在那些病毒負(fù)荷低于傳統(tǒng)檢測(cè)方法下限的患者中，檢測(cè)耐藥病毒株的能力。”

SDC研發(fā)了以細(xì)胞為基礎(chǔ)的技術(shù)用來解決在藥物研發(fā)、環(huán)境監(jiān)測(cè)以及醫(yī)學(xué)診斷等領(lǐng)域所遇到的各種難題。

New Diagnostic System for HIV

A phase I, double-blind controlled trial of a new diagnostic system for HIV involves 40 HIV-positive patients.
In the trial, each patient will receive a standard phenotype test, an increasingly common tool that can help doctors determine which drugs are no longer effective against the predominant strain in an HIV-infected patient. The same 40 subjects will also receive another antiviral efficacy test generated by the HIV SpectraPoint assay of SpectraDigital Corp. (SDC, Guelp, Canada). Doctors should have the results of this rapid test within 24 hours. This, in turn, allows essential treatment decisions to be made before the virus can develop new, unseen resistance patterns.
The hope is that patients will receive real clinical benefit from rapidly available data supplanting the traditional time window of weeks, and that HIV doctors will at the same time have a more accurate “snapshot” of their patient’s disease.
“This pilot study represents an important step in the development of our HIV diagnostics solutions,” said Satish Deshpande, president of SpectraDigital. “In addition to our primary objective of comparing HIV SpectraPoint to a standard phenotypic resistance assay, we also will determine the ability of our system to detect resistance among individuals with viral loads well below the limit of detection of traditional assays.”
SDC develops cell-based technologies to resolve various problems in drug development, environmental monitoring, and medical diagnostics.