CLSI M53 A : 1ED 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION
Hardcopy , PDF
24-08-2023
English
30-06-2011
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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.
| 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Superseded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 |
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.
| 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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