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CLSI M53 A : 1ED 2011

CLSI M53 A : 1ED 2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION

Available format(s)

Hardcopy , PDF

Superseded date

08-24-2023

Language(s)

English

Published date

06-30-2011

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Background/Natural History/Virology
5 Initial Tests for HIV Infection
6 Supplemental HIV Tests
7 Special Situations
8 Algorithms
9 Test Results and Reporting
10 HIV Testing Quality Control
References
Appendix - Reporting Comments Suggested for Initial
           and Supplemental HIV Diagnostic Test Results
The Quality Management System Approach
Related CLSI Reference Materials

Gives guidance for laboratorians performing human immunodeficiency virus testing and for the interpretation of results by health care providers in advanced diagnostic laboratories.

This document provides an overview of the natural history and response to human immunodeficiency virus (HIV) infection, an in-depth review of initial and supplemental tests for the diagnosis of HIV infection, and initiation of a quality control (QC) program for HIV testing.

DevelopmentNote
Supersedes NCCLS M53 P. (07/2011)
DocumentType
Miscellaneous Product
ISBN
1-56238-758-8
Pages
104
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI GP44 A4 : 4ED 2010 PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS
CLSI MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
CLSI QMS03 A3 : 3ED 2009 TRAINING AND COMPETENCE ASSESSMENT
CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL

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Hardcopy - English
PDF - English
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