Standard Document
First Edition
Preexamination Processes

CLSI GP34

Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection

This document offers clear guidance on validation and verification testing for venous and capillary blood collection tubes.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2016.

December 31, 2010
Nancy Dubrowny, MS, MT(ASCP)SC

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Abstract

Clinical and Laboratory Standards Institute document GP34-A—Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline is a guideline for manufacturers of venous and capillary blood collection tubes and users of blood collection tubes for serum, plasma, and whole blood testing. GP34 provides guidelines for validation and verification of test (examination) performance.

Scope

This document provides step-by-step recommendations for validation and verification of venous and capillary blood collection devices. Capillary blood collection devices addressed in this document include only microcollection devices (see Section 3.2). It also includes guidance for ascertaining the acceptability/compatibility for clinical performance in chemistry, immunochemistry, hematology, and coagulation. This guideline does not address validation and verification for clinical performance in immunohematology, molecular diagnostics, arterial blood gas analysis, proteomics, or genomics. 

The focus and procedures of this document are for quantitative measurement only. For qualitative measurement, the study requires a different study design. 

This document is written for manufacturers of venous and capillary blood collection devices; assay/instrument manufacturers; all clinical laboratory personnel; and those who are responsible for acquisition, handling, and use of the equipment described in this document.

Product Details
GP34AE
1-56238-739-1
60
Additional Details

This document is available in electronic format only.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

Authors
Nancy Dubrowny, MS, MT(ASCP)SC
Elizabeth Armstrong, MT(ASCP)
Julie Berube, PhD
Raffick A. R. Bowen, MLT(CSMLS), PhD, DCl Chem, FCACB, DABCC
Yung W. Chan, MT(ASCP)
Daniel Hesselgesser, MT(ASCP)
Susan S. Smith
Ana K. Stankovic, MD, PhD, MSPH
Diane I. Szamosi, MA, MT(ASCP)SH
Abstract

Clinical and Laboratory Standards Institute document GP34-A—Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline is a guideline for manufacturers of venous and capillary blood collection tubes and users of blood collection tubes for serum, plasma, and whole blood testing. GP34 provides guidelines for validation and verification of test (examination) performance.

Scope

This document provides step-by-step recommendations for validation and verification of venous and capillary blood collection devices. Capillary blood collection devices addressed in this document include only microcollection devices (see Section 3.2). It also includes guidance for ascertaining the acceptability/compatibility for clinical performance in chemistry, immunochemistry, hematology, and coagulation. This guideline does not address validation and verification for clinical performance in immunohematology, molecular diagnostics, arterial blood gas analysis, proteomics, or genomics. 

The focus and procedures of this document are for quantitative measurement only. For qualitative measurement, the study requires a different study design. 

This document is written for manufacturers of venous and capillary blood collection devices; assay/instrument manufacturers; all clinical laboratory personnel; and those who are responsible for acquisition, handling, and use of the equipment described in this document.

Additional Details

This document is available in electronic format only.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

Authors
Nancy Dubrowny, MS, MT(ASCP)SC
Elizabeth Armstrong, MT(ASCP)
Julie Berube, PhD
Raffick A. R. Bowen, MLT(CSMLS), PhD, DCl Chem, FCACB, DABCC
Yung W. Chan, MT(ASCP)
Daniel Hesselgesser, MT(ASCP)
Susan S. Smith
Ana K. Stankovic, MD, PhD, MSPH
Diane I. Szamosi, MA, MT(ASCP)SH