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User Protocol for Evaluation of Qualitative Test Performance, 2nd Edition

CLSI EP12A2

User Protocol for Evaluation of Qualitative Test Performance, 2nd Edition

EP12-A2 | User Protocol for Evaluation of Qualitative Test Performance, 2nd Edition This document provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests. Guidance is provided for both precision and method-comparison studies. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement. This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content. Chairholder: Patricia E. Garrett, PhD Organization: SeraCare Life Sciences, Inc. Date of Publication: 01/25/2008 ISBN Number: 1-56238-654-9 Format: Approved Guideline Edition: Second Edition Pages: 64 Preview Sample Nonmember Price: $180.00 Membership discount will be applied at checkout. This document is available in electronic format only.

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Details

Chairholder: Patricia E. Garrett, PhD

Date of Publication: January 25, 2008

Order Code PDF: CLSI EP12A2E
ISBN Number: 1-56238-654-9

Order Code Print: print not available

Edition: Second

Pages: 64

CLSI EP12A2 Abstract

EP12-A2 | User Protocol for Evaluation of Qualitative Test Performance, 2nd Edition This document provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests. Guidance is provided for both precision and method-comparison studies. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement. This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content. Chairholder: Patricia E. Garrett, PhD Organization: SeraCare Life Sciences, Inc. Date of Publication: 01/25/2008 ISBN Number: 1-56238-654-9 Format: Approved Guideline Edition: Second Edition Pages: 64 Preview Sample Nonmember Price: $180.00 Membership discount will be applied at checkout. This document is available in electronic format only.

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