美国临床和实验室标准学会_国内外标准网文献检索下载

1.[标准] Liquid Chromatography-Mass Spectrometry Methods, 2nd Edition

液相色谱-质谱法第2版

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI C62

发布时间：
2022-06-21

中标分类：
-

国标分类：
-

实施时间：

摘要： This document provides guidance to the clinical laboratorian for the reduction of interlaboratory variance and the evaluation of interferences, assay performance, and other pertinent characteristics of clinical assays. This guideline emphasizes particular areas related to assay development and presents a standardized approach for method verification that is specific to mass spectrometry technology.
2.[标准] Evaluation of Commutability of Processed Samples, 4th Edition, EP14Ed4E

处理样品的可交换性评估第4版 EP14Ed4E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI EP14

发布时间：
2022-07-14

中标分类：
-

国标分类：
-

实施时间：

摘要： This document provides guidance for evaluating the commutability of processed samples by determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.
3.[标准] Principles and Procedures for Blood Cultures, Second Edition

血液培养的原则和程序第二版

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI M47

发布时间：
2022-04-22

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline includes recommendations for collecting, transporting, and processing specimens for blood culture, as well as procedures for recovering pathogens from the blood of patients with suspected bacteremia or fungemia.
4.[标准] Laboratory Internal Audit Program, 2nd Edition

实验室内部审计计划第2版

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI QMS15

发布时间：
2022-05-31

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline provides recommendations for establishing a laboratory internal audit program to enhance the quality of laboratory services through continual improvement. An audit program defines the "who," "what," "when," "where," and "how" of meeting requirements for internal auditing, and the audit process describes the details of conducting individual laboratory internal audits.
5.[标准] Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline, Fifth Edition

累积抗菌药物敏感性试验数据的分析和呈现；批准的指南第五版

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI M39

发布时间：
2022-01-24

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline describes methods for recording and analyzing antimicrobial susceptibility test data, consisting of cumulative and ongoing summaries of susceptibility patterns of clinically significant microorganisms.
6.[标准] Implementing a Laboratory Test Under Emergency Use Conditions, 1st Edition, EP43Ed1E

在紧急使用条件下实施实验室试验第1版 EP43Ed1E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI EP43

发布时间：
2021-07-15

中标分类：
-

国标分类：
-

实施时间：

摘要： This white paper covers public health emergencies in general, the ways in which emergency use authorizations (EUAs) may be used, and the ramifications of EUAs for medical laboratories and other testing sites.
7.[标准] Molecular Methods for Genotyping and Strain Typing of Infectious Organisms, 1st Edition, MM24Ed1

传染生物基因分型和菌株分型的分子方法第1版 MM24Ed1

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI MM24

发布时间：
2021-09-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline provides a framework for facilitating consistency in reporting genotypes and bacterial, viral, and fungal strain typing and will assist laboratories that perform these studies and the professionals applying the results. Its purpose is to present not only the technologies used but also the criteria to be considered for design, verification, validation, and determination of clinical utility of such testing. These technologies are now used in many different contexts, including:Clinical care settingsPublic health investigations, particularly of emerging infectionsFood and pharmaceutical industriesEnvironmental analyses in the clinical settingRegulatory agenciesThis guideline is intended for manufacturers or laboratories that develop assays, laboratories that perform assays, clinicians who use the results to diagnose or manage patients, and agencies that regulate their use. This guideline:Is not intended for use by research laboratoriesIs not intended to provide manufacturing guidelinesDoes not discuss the development of standard reference materials for QC useIt is recommended that this guideline be used in conjunction with CLSI documents MM03, MM06, MM09, MM12, MM13, MM14, MM17, MM18, and MM22.
8.[标准] Dried Blood Spot Specimen Collection for Newborn Screening, 7th Edition, NBS01Ed7E

新生儿筛查用干血点样本采集第7版 NBS01Ed7E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI NBS01

发布时间：
2021-04-16

中标分类：
-

国标分类：
-

实施时间：

摘要： This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper section of the specimen collection device, and provides instructions on proper specimen drying, handling, and transport to ensure quality specimens are consistently obtained for newborn screening analysis.
9.[标准] Quantitative Measurement of Proteins and Peptides by Mass Spectrometry, 1st Edition, C64Ed1

蛋白质和肽的质谱定量测量第1版 C64Ed1

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI C64

发布时间：
2021-05-05

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline describes the design, development, and validation of quantitative assays for proteins and peptides by mass spectrometry.
10.[标准] Validation of Assays Performed by Flow Cytometry, 1st Edition, H62Ed1

通过流式细胞术进行的分析验证第1版 H62Ed1

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI H62

发布时间：
2021-10-27

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline includes validation strategies for cell-based assays performed by flow cytometry. This guideline also includes recommendations for instrument qualification and standardization and assay optimization. It also covers recommended practices for the examination and postexamination phases.
11.[标准] Development of Quality Control Ranges, Breakpoints, and Interpretive Categories for Antimicrobial Agents Used in Veterinary Medicine, 4th Edition, VET02Ed4E

兽医用抗菌剂质量控制范围、断点和解释类别的制定第4版 VET02Ed4E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI VET02

发布时间：
2021-01-20

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline discusses the necessary and recommended data for selecting appropriate quality control ranges, breakpoints, and interpretive categories for antimicrobial agents for veterinary use.
12.[标准] Newborn Screening for X-Linked Adrenoleukodystrophy, 1st Edition, NBS09Ed1

新生儿X-连锁肾上腺脑白质营养不良筛查第1版 NBS09Ed1

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI NBS09

发布时间：
2021-08-06

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline discusses the detection of X-linked adrenoleukodystrophy by population-based newborn screening using dried blood spot specimens to measure C26:0-lysophosphatidylcholine.
13.[标准] Principles and Procedures for Detection and Culture of Fungi in Clinical Specimens, 2nd Edition, M54Ed2E

临床标本中真菌检测和培养的原则和程序第2版 M54Ed2E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI M54

发布时间：
2021-01-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline includes protocols, quality control parameters, and interpretive criteria for culturing fungi and for detecting and identifying fungi in direct examinations.
14.[标准] Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd Edition, MM13Ed2E

分子方法样本的收集、运输、制备和储存第二版 MM13Ed2E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI MM13

发布时间：
2020-08-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.
15.[标准] Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition, EP06Ed2E

定量测量程序的线性评估第二版 EP06Ed2E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI EP06

发布时间：
2020-11-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline provides information for characterizing the linearity interval of a measurement procedure, validating a linearity interval claim (to be performed by the manufacturer), and verifying an established linearity interval claim (to be performed by the end user).
16.[标准] Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; VET03Ed2PK20E

从水生动物中分离的细菌的抗生素肉汤稀释和纸片扩散敏感性试验方法；从水生动物中分离的细菌的抗菌药物敏感性试验性能标准；VET03Ed2PK20E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI VET03 VET04 Package 2020

发布时间：
2020-05-20

中标分类：
-

国标分类：
-

实施时间：

摘要： This package includes:VET03 | Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 2nd EditionThis guideline provides the most up-to-date techniques for the determination of minimal inhibitory concentrations and zones of inhibition of aquatic bacteria and criteria for data interpretation and quality control testing.VET04 | Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 3rd EditionThis document includes updated tables for the Clinical and Laboratory Standards Institute veterinary antimicrobial susceptibility testing guideline VET03.
17.[标准] Collection of Capillary Blood Specimens, 7th Edition, CP42Ed7E

毛细血管标本采集第7版 CP42Ed7E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI GP42

发布时间：
2020-09-16

中标分类：
-

国标分类：
-

实施时间：

摘要： This standard provides procedures for collection of capillary blood specimens. Specifications for collection sites, puncture depth, and disposable devices used to collect, process, and transfer capillary blood specimens are also included.
18.[标准] The Cost of Quality in Medical Laboratories, 2nd Edition, QMS20Ed2E

《医学实验室的质量成本》第二版 QMS20Ed2E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI QMS20

发布时间：
2020-11-09

中标分类：
-

国标分类：
-

实施时间：

摘要： This guideline helps laboratories understand, apply, track, and manage the different types of quality costs that affect their processes, services, and financial well-being.
19.[标准] Point-of-Care Testing for Infectious Diseases, 1st Edition, POCT15Ed1E

传染病护理点检测第1版 POCT15Ed1E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI POCT15

发布时间：
2020-01-21

中标分类：
-

国标分类：
-

实施时间：

摘要： This report summarizes current knowledge of rapid and point-of-care testing practices used worldwide for infectious diseases.
20.[标准] Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 3rd Edition, VET04Ed3E

水生动物分离细菌的抗菌药物敏感性试验性能标准第3版 VET04Ed3E

发布单位：
美国-美国临床和实验室标准学会(US-CLSI)

标准状态：
现行

标准号：
CLSI VET04

发布时间：
2020-05-20

中标分类：
-

国标分类：
-

实施时间：

摘要： This document includes updated tables for the Clinical and Laboratory Standards Institute veterinary antimicrobial susceptibility testing guideline VET03.