Counterpoint: Food and Drug Administration guidance for C-reactive protein assays: matching claims with performance data.

نویسندگان

  • James V Callaghan
  • Steven I Gutman
چکیده

LM, et al. CDC/AHA workshop on markers of inflammation and cardiovascular disease: application to clinical and public health practice: report from the laboratory science discussion group. Circulation 2004;110:e545–9. 4. Ridker PM, Wilson PW, Grundy SM. Should C-reactive protein be added to metabolic syndrome and to assessment of global cardiovascular risk? Circulation 2004;109:2818–25. 5. US Food and Drug Administration. Review criteria for assessment of C-reactive protein (CRP), high sensitivity C-reactive protein, and cardiac C-reactive protein (cCRP) assays. 2005. http://www.fda. gov/cdrh/oivd/guidance/1246.pdf (accessed November 2005). 6. Kimberly MM, Vesper HW, Caudill SP, Cooper GR, Rifai N, Dati F, et al. Standardization of immunoassays for measurement of high-sensitivity C-reactive protein: phase I: evaluation of secondary reference materials. Clin Chem 2003;49:611–6. 7. Roberts WL, Sedrick R, Moulton L, Spencer A, Rifai N. Evaluation of four automated high-sensitivity C-reactive protein methods: implications for clinical and epidemiological applications. Clin Chem 2000;46:461–8. 8. Roberts WL, Moulton L, Law TC, Farrow G, Cooper-Anderson M, Savory J, et al. Evaluation of nine automated high-sensitivity C-reactive protein methods: implications for clinical and epidemiological applications: part 2. Clin Chem 2001;47:418–25.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Application of Epidemiological Data for Decision Making: Health Claims

The Nutrition Labeling and Education Act (NLEA), which amended the Federal Food, Drug, and Cosmetic Act in 1990, authorized the use of health claims that are based on significant scientific agreement in food labeling. In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements and created a legal framework for use of claims that is similar to the regulation of f...

متن کامل

US Food and Drug Administration regulations governing label claims for food products, including probiotics.

The US Congress has granted the Food and Drug Administration the authority to permit manufacturers to use claims in food labels that fit into the following broad categories: health claims, structure/function claims, nutrient content claims, and dietary guidance messages. This article outlines the scope and evolution of these claims and how they are used in the marketing of probiotics. Probiotic...

متن کامل

The Relationship Between Food Insecurity, C-Reactive Protein and Some Socio-Economic Variables in Type 2 Diabetes

Background Food insecurity can contribute to health and nutrition problems. Thus, determining its associated factors seems necessary in all societies. Objective The current this study determined the food insecurity, C-Reactive Protein (CRP) and some socio-economic factors in type 2 diabetic patients in Minoodar and Shohada comprehensive health centers of Qazvin in 2016. Methods This case-cont...

متن کامل

Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use an...

متن کامل

Survey of adherence to time standards to prevent food and drug interaction in the hospitalized patients

Nowadays, food and medicine are two key elements in treatment and prevention of diseases. It is necessary to pay attention to food and drug interactions in order to create ideal conditions for drug effects and provide normal nutritional status to prevent unwanted interactions between food and drug. This study aimed to investigate the range of observing standards of food and drug interactions in...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • Clinical chemistry

دوره 52 7  شماره 

صفحات  -

تاریخ انتشار 2006