捐獻(xiàn)的全血、血漿、器官和組織可通過對供體血液的檢測篩選HIV-1和丙肝病毒，此系統(tǒng)可直接檢測16個(gè)血液樣本。

全自動(dòng)化、高通量的Procleix Tigris系統(tǒng)可在14小時(shí)內(nèi)對1000個(gè)血液樣本進(jìn)行檢測。其高通量使所需樣本的含量很少，換句話說能增加檢測的靈敏性和血液的安全性。

美國Gen-Probe公司宣布其Procleix Tigris已得到了美國食品和藥物管理局（FDA）的許可。這是一個(gè)全自動(dòng)化的分子診斷儀器，可與Procleix Ultrio檢測聯(lián)合使用。2007年3月，F(xiàn)DA批準(zhǔn)了Gen-Probe公司的另一個(gè)檢測項(xiàng)目，Procleix西尼羅河病毒檢測，在Tigris系統(tǒng)上可進(jìn)行供體血液的篩選。

此系統(tǒng)和配套的測試項(xiàng)目也可檢測供體血液中的乙肝病毒，基于傳統(tǒng)的HBV表面抗原和核心抗體的血清學(xué)檢測。但此時(shí)對HBV的檢測還未得到許可，因?yàn)榇讼到y(tǒng)在早期設(shè)計(jì)是并沒有將該檢測模板納入檢測設(shè)計(jì)。

Gen-Probe總裁兼CEO說：“隨著Procleix Ultrio分析可在Procleix Tigris系統(tǒng)上完成，用戶可通過全自動(dòng)、高通量的系統(tǒng)避免供體血液所帶來的潛在風(fēng)險(xiǎn)。此系統(tǒng)在最大提高檢測效率的同時(shí)最大可能地減少了由于手工所出現(xiàn)的錯(cuò)誤。”

Gen-Probe公司的血液篩選產(chǎn)品以Chiron在全球范圍內(nèi)注冊。


Fully Automated High Throughput System Screens Donated Blood

Donated blood, plasma, organs, and tissue can be screened for HIV-1 and hepatitis C virus (HCV) in individual blood donations or in pools of up to 16 blood samples 

The fully automated, high-throughput Procleix Tigris system can process 1,000 blood samples in about 14 hours, a level of productivity that facilitates testing in smaller pool sizes, which in turn can increase assay sensitivity and blood safety. 

Gen-Probe Inc. (San Diego, CA, USA) has announced that the U.S. Food and Drug Administration (FDA) approved the company’s Procleix Tigris system, a fully automated molecular diagnostics instrument, for use with the Procleix Ultrio assay. In March of 2007, the FDA approved another Gen-Probe test, the Procleix WNV (West Nile virus) assay, to screen donated blood on the Tigris system. 

The system and assay also detect hepatitis B virus (HBV) in blood donations that are HBV-positive based on traditional serology tests for HBV surface antigen and core antibodies. This has not been approved at this time to screen donated blood for HBV, as the initial clinical studies were not designed to, and did not demonstrate HBV "yield." Yield is defined as HBV-infected blood donations that were intercepted by the Procleix Ultrio assay, but that were initially negative based on the serology tests. 

Henry L. Nordhoff, Gen-Probe’s chairman, president, and CEO said, "With the Procleix Ultrio assay on the Procleix Tigris system, customers can safeguard donated blood against dangerous viruses using a fully-automated, high-throughput system that maximizes the efficiency of testing and minimizes the potential for human error." 

Gen-Probe’s blood screening products are marketed worldwide by Chiron (Emeryville, CA, USA), a business unit of Novartis Vaccines and Diagnostics, Inc.