FDA批準首個可鑒別特異性致病菌檢測法上市

發布時間：2019-05-15 20:50 原文鏈接： FDA批準首個可鑒別特異性致病菌檢測法上市

美國食品與藥物管理局（FDA）于2012年6月27日批準首個可用于鑒定引起血流感染的12種不同細菌型的核酸檢測上市。該項檢測被命名為Verigene GP血培養核酸檢測（BC-GP），能夠在首次觀察到細菌增殖征象后數小時內，同時檢測細菌類別和3個相關耐藥基因。而傳統細菌鑒定方法則需要2至4天才能獲得同樣的結果。

該檢測方法可鑒別不同的葡萄球菌屬（包括耐甲氧西林金葡菌，MRSA），鏈球菌、腸球菌（包括耐萬古霉素腸球菌，VRE）以及李斯特菌。

FDA醫療器械和輻射健康中心主任Alberto Gutierrez指出：“血流感染通常需要進行抗生素治療，盡快為不同的患者選擇特定的抗生素是治療的根本，這項檢測手段能夠幫助醫生快速為患者選擇正確的抗生素。

血流感染是美國醫院最常見和最嚴重的疾病之一。細菌進入血流能夠導致嚴重的疾病，包括心臟、腎臟和其它重要器官的感染。如果不進行治療這些重要臟器的感染會導致包括死亡在內的嚴重后果。

FDA做出這項決定是基于一項納入1,642例患者血樣的研究，這些樣本血培養均發現革蘭陽性細菌。該研究對比了BC-GP和傳統的實驗室血培養方法，結果表明BC-GP與后者的檢測結果吻合度為93~100%。

FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections

Test makes it possible to identify potentially serious illness causing bacteria hours after a positive blood culture

The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods may require two to four days to produce bacterial identification and resistance results.

The Verigene GP Blood Culture Nucleic Acid Test (BC-GP) can identify different types of Staphylococcus, (including methicillin-resistant Staphylococcus aureus or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant Enterococci or VRE), and Listeria.

“Bloodstream infections are always treated with antimicrobial drugs, and it is essential to identify which antimicrobial drug is appropriate for a specific patient as quickly as possible,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA’s Center for Devices and Radiological Health. “This new test is an important tool that will help physicians treat patients quickly with the correct antibiotics.”

Bloodstream infections are one of the most common and serious illnesses found in U.S. hospitals. Bacteria entering the bloodstream can cause severe illness, including infections of the heart, kidney, and other vital organs. Without treatment, infection of vital organs can result in serious consequences, including death.

The FDA based its decision on a study of 1,642 patient blood samples obtained from incubated blood culture bottles that contained gram positive bacteria. The study included a comparison of BC-GP and traditional blood culture laboratory methods. The BC-GP results were consistent with traditional blood culture methods in 93 percent to 100 percent of the comparisons.

The Verigene is manufactured by Nanosphere Inc. of Northpook, Ill.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309