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Evaluation of Reagent Carryover Effects on Test Results, 1st Edition

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CLSI EP47

Evaluation of Reagent Carryover Effects on Test Results, 1st Edition

CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs.

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Details

Chairholder: Jesper Vestermark Johansen, PhD; Jeffrey E. Vaks, PhD

Date of Publication: September 11, 2024

Order Code PDF: CLSI EP47Ed1E
ISBN Number: 978-1-68440-250-2

Order Code Print: CLSI EP47Ed1
ISBN Number: 978-1-68440-249-6

Edition: First

Pages: 52

CLSI EP47 Abstract

Clinical and Laboratory Standards Institute EP47—Evaluation of Reagent Carryover Effects on Test Results provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments along with establishing that no significant reagent carryover occurs by a developer during the Establishment Stage of the Test Life Phases Model (see CLSI EP191). End-user laboratories can use CLSI EP47 to investigate if suspect results are caused by reagent carryover. Assessment and mitigation of carryover risk is described. CLSI EP47 is intended to promote uniformity in the evaluation of reagent carryover characteristics of medical laboratory measurement procedures across developers of in vitro diagnostic tests, regulatory organizations, and medical laboratories.

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