FDA批準(zhǔn)羅氏CMV檢測(cè) FDA Approves Roche's CMV Test

近日，羅氏宣布其公司用于Cobas 6800/8800分子診斷儀的Cobas巨細(xì)胞病毒檢測(cè)已通過(guò)美國(guó)FDA批準(zhǔn)。 Cobas巨細(xì)胞病毒檢測(cè)基于實(shí)時(shí)PCR技術(shù)，用于評(píng)估移植患者對(duì)治療的反應(yīng)。 羅氏公司表示，該公司的擴(kuò)展線性范圍從34.5 IU / mL到1E + 07 IU / mL，具有較強(qiáng)的跨基因型覆蓋率，并補(bǔ)充說(shuō)，該測(cè)試可大限度地減少變異性和復(fù)雜性測(cè)試，從而降低實(shí)驗(yàn)室開(kāi)發(fā)測(cè)試中實(shí)驗(yàn)室的工作量和風(fēng)險(xiǎn)。 羅氏說(shuō)，Cobas CMV檢測(cè)可以同時(shí)在Cobas 6800/8800系統(tǒng)上進(jìn)行HIV-1和HCV檢測(cè)。 它也被標(biāo)準(zhǔn)化為世界衛(wèi)生組織國(guó)際標(biāo)準(zhǔn)，用于改善醫(yī)院機(jī)構(gòu)CMV測(cè)試結(jié)果的協(xié)調(diào)統(tǒng)一。 羅氏診斷公司負(fù)責(zé)人Uwe Oberlaender在一份聲明中表示，通過(guò)第二代測(cè)試，“臨床醫(yī)生現(xiàn)在可以跨機(jī)構(gòu)獲得更快，更可靠，標(biāo)準(zhǔn)化的結(jié)果，這是優(yōu)化CMV管理移植決策所必要且重要的一步驟?！?

ROCHE
Roche today announced the US Food and Drug Administration has approved the company's Cobas cytomegalovirus test for use on the fully automated Cobas 6800 and 8800 systems.
The real-time PCR-ba[x]sed Cobas CMV test is for assessing how transplant patients on therapy respond to treatment. It offers an expanded linear rage from 34.5 IU/mL to 1E+07 IU/mL with robust coverage across genotypes, Roche said, adding that the test minimizes variability and complexity testing, reducing workload and risk for laboratories offering laboratory-developed tests.
The Cobas CMV test can be simultaneously run with HIV-1 and HCV assays on the Cobas 6800/8800 systems, Roche said. It also is standardized to the First World Health Organization International Standard for improving harmonization in CMV testing results across hospital institutions.
Uwe Oberlaender, head of Roche Diagnostics, said in a statement that with the second-generation test, "clinicians can now receive faster, more reliable, standardized results aligned across institutions. This is a required and important step toward optimizing CMV management decisions for transplant patients."