FDA批准VITEK MS质谱仪系统用于鉴定193种不同致病细菌和真菌
发布: 2017-02-02 06:51:25来源: 梅里埃诊断产品（上海）有限公司
【导读】FDA批准美国第一个质谱仪检测系统用于自动识别已知能导致人体严重疾病的细菌和酵母的上市。该质谱仪系统VITEK MS能鉴定出193不同微生物，可在一系列自动化测试过程中进行192种不同的测试，而且每个测试只需要大约一分钟。
2013年8月21日，FDA批准美国第一个质谱仪检测系统用于自动识别已知能导致人体严重疾病的细菌和酵母的上市。该质谱仪系统VITEK MS能鉴定出193不同微生物，可在一系列自动化测试过程中进行192种不同的测试，而且每个测试只需要大约一分钟。
谱仪系统VITEK MS可以鉴别诸如念珠菌、隐球菌和马拉色氏霉菌属组的酵母茵和葡萄球菌科、链球菌科、肠杆菌科、假单胞菌科和类杆属组的细菌，这些酵母茵和细菌跟皮肤感染、肺炎、脑膜炎和血液感染有关。HIV或AIDS、癌症治疗或器官移植后的抗排斥治疗损害或削弱免疫系统的患者特别容易受到这些细菌感染。
VITEK MS采用基质辅助激光解吸电离飞行时间质谱（MALDI-TOF MS）技术,该技术利用激光打破酵母和细菌标本成小颗粒,形成一个独特的微生物模型。VITEK MS在检测系统数据库自动将这些微生物模型与193种已知的酵母和细菌进行比对，从而鉴别微生物。
此与其他要求大量微生物繁殖来检测的鉴别方法相比，质谱分析方法只需要少量的酵母或细菌繁殖，所以只要微生物生长到可视程度后就可以马上开始检测，通常在在18到24小时内。传统的方法需要五天才能得出相同的鉴别结果。 FDA通过新型分类程序审查了VITEK MS，这是对一些新型低中度风险且不完全等同于已知合法市售的医疗设备的调控途径。
VITEK MS再临床上用于鉴别由人体标本培养得到的微生物，它与联合其它临床和实验室发现相互结合，从而辅助诊断细菌和真菌感染。
VITEK MS的制造商为北卡罗来纳州达勒姆的生物梅里埃公司。
原文链接：
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm365907.htm
New test system identifies 193 different yeasts and bacteria known to cause illness
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute.
The VITEK MS can identify yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceaefamilies, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. People with immune systems that are compromised or weakened by HIV/AIDS, cancer treatment, or anti-rejection therapy following an organ transplant are particularly vulnerable to these infections.
“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.”
The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry (MALDI-TOF MS). The technology uses a laser to break yeast and bacteria specimens into small particles that form a pattern unique to the microorganism. The VITEK MS automatically compares the microorganism pattern to 193 known yeasts and bacteria in the test system’s database to identify the microorganism.
Compared to other identification methods that require abundant organism growth for testing, mass spectrometry requires only a small amount of yeast or bacterial growth, so testing can start as soon as growth is visible, generally within 18 to 24 hours. Traditional methods can take up to five days to produce the same identification results.
The FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.
For the de novo petition, the FDA based its decision on the results of a study of 7,068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6 percent of the time (with 87.5 percent of microorganisms identified to species level). The VITEK MS provided a `‘no identification’` result for 3.2 percent of the microorganisms in the study. Of all test results, only 0.8 percent were incorrect and 2.4 percent were low discrimination with no correct result.
The VITEK MS is for clinical use for the identification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
The VITEK MS is manufactured by bioMerieux, Inc. in Durham, N.C.
For more information:
- FDA: Medical Devices
- FDA: Office of In Vitro Diagnostics and Radiological Health:
- Evaluation of Automatic Class III Designation (De Novo) Summaries:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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生物梅里埃公司创建于1963年，公司依赖自身的科技创新和工业生产资源，始终致力于研发作为医疗和工业用途的体外诊断产品。生物梅里埃的诊断系统由试剂、仪器和软件组成，主要围绕传染病、工业微生物控制、心血管病和肿瘤等四个战略领域来设计。 梅...