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AdvanDx
AdvanDx為危及生命的血流感染的診斷和治療提供先進(jìn)的分子診斷產(chǎn)品
一種剛面市的分子診斷檢驗(yàn)不到90分鐘就能在陽性血液培養(yǎng)物中鑒定出三種不同的革蘭氏陰性菌。

它與高靈敏度、高特異性的熒光原位雜交(FISH)結(jié)合,用肽核酸(PNA)探針靶向活細(xì)菌和活酵母中的菌種特異性核糖體核糖核酸(rRNA)。

這種GNR信號(hào)燈PNA FISH檢驗(yàn)可直接在含革蘭氏陰性桿菌的陽性血液培養(yǎng)物中同時(shí)鑒定大腸桿菌、肺炎克氏桿菌和綠膿桿菌。PNA探針的肽骨架具有獨(dú)特性質(zhì),能在極其復(fù)雜的樣本基質(zhì)(如血液和血液培養(yǎng)物)中使用FISH檢驗(yàn),這進(jìn)而有利于開發(fā)極簡(jiǎn)易但卻極準(zhǔn)確的檢驗(yàn),避免像其它核酸技術(shù)那樣需要進(jìn)行繁瑣的樣品制備。

該檢驗(yàn)產(chǎn)品由AdvanDX公司(Woburn, MA, USA; www.advandx.com)出品,已獲得美國(guó)食品藥品管理局(FDA; Silver Spring, MD, USA; www.fda.gov)的510(k)認(rèn)證。它的問世使AdvanDx公司的易用型PNA FISH分子診斷平臺(tái)如虎添翼,快速的檢驗(yàn)結(jié)果可以引導(dǎo)治療,使臨床醫(yī)生能盡早向革蘭氏陰性血流感染(BSI)患者提供有效治療。

GNR信號(hào)燈PNA FISH檢驗(yàn)將使微生物實(shí)驗(yàn)室能比傳統(tǒng)方法提前24-48小時(shí)識(shí)別并報(bào)告陽性血液培養(yǎng)物中的大腸桿菌、肺炎克氏桿菌和綠膿桿菌。如此快的結(jié)果將使臨床醫(yī)生占有先機(jī),為革蘭氏陰性血流感染患者選用恰當(dāng)而有效的療法,研究顯示這樣也許能改善臨床預(yù)后,減少不良事件的發(fā)生率,縮短住院時(shí)間。

AdvanDx is a leading provider of rapid and accurate molecular diagnostic tests for identification of pathogens causing critical infections in hospitalized patients. Our mission is to help healthcare providers optimize antibiotic therapy earlier in order to improve patient outcomes while limiting unnecessary antibiotic use and reducing hospital costs.

AdvanDx employs a unique, Whole Cell Analysis (WCA) approach to pathogen identification using our proprietary Peptide Nucleic Acid Fluorescence In Situ Hybridization (PNA FISH) technology platform. This technology enables fast and highly accurate single cell analysis for species, resistance and virulence marker identification of bacterial cells found in samples from patients with critical infections.

AdvanDx is the market leader in molecular testing of positive blood cultures enabling clinical microbiology labs to report pathogen identification results 48 to 72 hours earlier than with conventional testing methods. When used by physicians and pharmacists to ensure early, appropriate antibiotic therapy for patients with bloodstream infections (a.k.a. septicemia), AdvanDx’s PNA FISH? tests have been shown in clinical studies to reduce patient mortality, shorten length of stay (LOS) and lower hospital costs.
 

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