NCCLS EP17-A Protocols for Determination of Limits of Detection and Limits....pdf

EP17-A Vol. 24 No. 34 Replaces EP17-P Vol. 24 No. 10 Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline This document provides guidance for determining the lower limit of detection of clinical laboratory methods, for verifying claimed limits, and for the proper use and interpretation of the limits. A guideline for global application developed through the NCCLS consensus process. NCCLS. Global Consensus Standardization for Health Technologies NCCLS is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues. NCCLS is based on the principle that consensus is an effective and cost- effective way to improve patient testing and healthcare services. In addition to developing and promoting the use of voluntary consensus standards and guidelines, NCCLS provides an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS An NCCLS document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The NCCLS voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most NCCLS documents are subject to two levels of consensus“proposed” and “approved.” Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate consensus level. Proposed An NCCLS consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a line- by-line review of its technical and editorial content. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents. NCCLS standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested parties obtained by following NCCLSs established consensus procedures. Provisions in NCCLS standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the NCCLS committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any NCCLS document. Address comments to the NCCLS Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in NCCLS projects. Please contact the NCCLS Executive Offices for additional information on committee participation. EP17-A ISBN 1-56238-551-8 Volume 24 Number 34 ISSN 0273-3099 Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline Daniel W. Tholen, M.S. Kristian Linnet, M.D., Ph.D. Marina Kondratovich, Ph.D. David A. Armbruster, Ph.D., DABCC, FACB Patricia E. Garrett, Ph.D. Robert L. Jones, Ph.D. Martin H. Kroll, M.D. Rudolf M. Lequin, Ph.D. Thomas J. Pankratz, Ph.D. G.A. Scassellati, Ph.D. Heinz Schimmel, Ph.D. Jane Tsai