Considerations for the planning and conduct of reproducibility studies of in vitro diagnostic tests for infectious agents

Biotechnology Annual Review

Volumn 9, Issue , 2003, Pages 249-258

  Derion, Toniann ^a  

^a ROCHE MOLECULAR SYSTEMS   (United States)

Author keywords

Clinical research PMA; Data management; In vitro diagnostic; Informed consent; IVD; Medical device; Monitoring; Panel parent; Precision; Premarket approval; Regulatory agency (ies) FDA; Reproducibility study; Unlinked specimens; Variability

Indexed keywords

ANTIINFECTIVE AGENT;

ANALYTICAL EQUIPMENT; CLINICAL RESEARCH; DIAGNOSTIC TEST; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; GENOTYPE; INFORMATION PROCESSING; REPRODUCIBILITY; REVIEW; HUMAN; IMMUNOLOGICAL PROCEDURES; IN VITRO STUDY; INFECTION; INSTRUMENTATION; LEGAL ASPECT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; QUALITY CONTROL; SAFETY; STANDARD; UNITED STATES;

BENCHMARKING; DEVICE APPROVAL; DIAGNOSTIC TESTS, ROUTINE; GUIDELINE ADHERENCE; GUIDELINES; HUMANS; IMMUNOLOGIC TESTS; INFECTION; PLANNING TECHNIQUES; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; UNITED STATES;

EID: 1542440408     PISSN: 13872656     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S1387-2656(03)09004-5     Document Type: Review

References (5)

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Premarket approval applications for in vitro diagnostic devices pertaining to Hepatitis C viruses (HCV): assays intended for diagnosis, prognosis, or monitoring of HCV infection, Hepatitis C, or other HCV-associated disease; draft guidance for industry and FDA. April 27, 2001.
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologies Evaluation and Research (CBER). Guidance for industry in the manufacture and clinical evaluation of in vitro tests to detect nucleic acid sequences of human immunodeficiency viruses types 1 and 2. December 1999.
3. NCCLS. Evaluation of precision performance of clinical chemistry devices; approved guidance, EP5-A. February 1999;19(2):1-43.
4. National Bioethics Advisory Commission (NABC). Research involving human biological materials: ethical issues and policy guidance. Rockville MD: NABC, 1999.
5. Gibbs J. Regulations and standards: human tissue acquisition: new regulatory and ethical issues. IVD Technol 2000;6(2):22-25.