Proteomics: From Basic Research to Diagnostic Application. A Review of Requirements & Needs

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• 作者：Frank Vitzthum ; Fritz Behrens ; N. Leigh Anderson ; and John H. Shaw
• 刊名：Journal of Proteome Research
• 出版年：2005
• 出版时间：August 2005
• 年：2005
• 卷：4
• 期：4
• 页码：1086 - 1097
• 全文大小：185K
• 年卷期：v.4,no.4(August 2005)
• ISSN：1535-3907

文摘

For several years proteomics research has been expected to lead to the finding of new markers thatwill translate into clinical tests applicable to samples such as serum, plasma and urine: so-called invitro diagnostics (IVDs). Attempts to implement technologies applied in proteomics, in particular proteinarrays and surface-enhanced laser desorption ionization time-of-flight mass spectrometry (SELDI-TOFMS), as IVD instruments have initiated constructive discussions on opportunities and challenges inherentin such a translation process also with respect to the use of multi-marker profiling approaches andpattern signatures in IVD. Taking into account the role that IVD plays in health care, we describe IVDrequirements and needs. Subject to stringent costs versus benefit analyses, IVD has to provide reliableinformation about a person's condition, prognosis or risk to suffer a disease, thus supporting decisionson treatment or prevention. It is mandatory to fulfill requirements in routine IVD, including diseaseprevention, diagnosis, prognosis, and treatment monitoring or follow up among others. To fulfill IVDrequirements, it is essential to (1) provide diagnostic tests that allow for definite and reliable diagnosistied to a decision on interventions (prevention, treatment, or nontreatment), (2) meet stringentperformance characteristics for each analyte (in particular test accuracy, including both precision ofthe measurement and trueness of the measurement), and (3) provide adequate diagnostic accuracy,i.e., diagnostic sensitivity and diagnostic specificity, determined by the desired positive and negativepredictive values which depend on disease frequency. The fulfillment of essential IVD requirements ismandatory in the regulated environment of modern diagnostics. Addressing IVD needs at an earlystage can support a timely and effective transition of findings and developments into routine diagnosis.IVD needs reflect features that are useful in clinical practice. This helps to generate acceptance andassists the implementation process. On the basis of IVD requirements and needs, we outline potentialimplications for clinical proteomics focused on applied research activities.Keywords: in vitro diagnostic clinical chemistry clinical proteomics