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2021 CATALOG
Global Laboratory Standards for a Healthier World The Clinical and Laboratory Standards Institute (CLSI) is the global leader in the standardization of medical laboratory best practices that can help you deliver more accurate results and improved patient outcomes. CLSI supports health care professionals, In this catalog, you’ll find our full listing of laboratorians, IVD manufacturers, neutral consensus-based products that are pharmaceutical companies, and government easy to access, use, and enable everyone laboratories who need to meet the highest from medical technologists to quality control expectations for quality, accreditation, and managers to improve the outcomes of their regulatory compliance. We provide the best laboratory testing. CLSI documents and other access to the most timely laboratory practices products are offered in PDF, print, and/or and offer unsurpassed opportunities for our subscription format. members. 2 | CLSI Catalog 2021
What’s New?
EP06 | Evaluation of Linearity of Quantitative Measurement POCT05 | Performance Metrics for Continuous Interstitial
Procedure, 2nd Edition Glucose Monitoring, 2nd Edition
EP43 | Implementing a Laboratory Test Under Emergency Use POCT14 | Point-of-Care Coagulation Testing and
Conditions, 1st Edition Anticoagulation Monitoring, 2nd Edition
C64 | Quantitative Measurement of Proteins and Peptides by POCT15 | Point-of-Care Testing for Infectious Diseases, 1st
Mass Spectrometry, 1st Edition Edition
GP42 | Collection of Capillary Blood Specimens, 7th Edition QMS05 | Qualifying, Selecting, and Evaluating a Referral
Laboratory, 3rd Edition
LQMS Certificate Program | Updated
QMS20 | The Cost of Quality in the Medical Laboratory, 2nd
M23S | Development of In Vitro Susceptibility Testing Criteria Edition
and Quality Control Parameters, 1st Edition
QMS26 | Managing Laboratory Records, 1st Edition
M54 | Principles and Procedures for Detection and Culture of
Fungi in Clinical Specimens, 2nd Edition VET01S | Performance Standards for Antimicrobial Disk and
Dilution Susceptibility Tests for Bacteria Isolated From Animals,
M59 | Epidemiological Cutoff Values for Antifungal 5th Edition
Susceptibility Testing, 3rd Edition VET02 | Development of Quality Control Ranges, Breakpoints,
M60 | Performance Standards for Antifungal Susceptibility and Interpretive Categories for Antimicrobial Agents Used in
Testing of Yeasts, 2nd Edition Veterinary Medicine, 4th Edition
M61 | Performance Standards for Antifungal Susceptibility VET03 | Methods for Antimicrobial Broth Dilution and Disk
Testing of Filamentous Fungi, 2nd Edition Diffusion Susceptibility Testing of Bacteria Isolated From
M100 | Performance Standards for Antimicrobial Aquatic Animals, 2nd Edition
Susceptibility Testing, 31st Edition VET03S (VET04) | Performance Standards for Antimicrobial
MM13 | Collection, Transport, Preparation, and Storage of Susceptibility Testing of Bacteria Isolated From Aquatic
Specimens for Molecular Methods, 2nd Edition Animals, 3rd Edition
NBS01 | Dried Blood Spot Specimen Collection for Newborn VET09 | Understanding Susceptibility Test Data as a
Screening, 7th Edition Component of Antimicrobial Stewardship in Veterinary
Settings, 1st Edition
NBS09 | Newborn Screening for X-Linked
Adrenoleukodystrophy, 1st Edition
Coming Soon!
MM24 | Molecular Methods for Genotyping and Strain Typing of H62 | Validation of Assays Performed by Flow Cytometry,
Infectious Organisms, 2nd Edition 1st Edition
AUTO17 | Semantic Interoperability for In Vitro Diagnostic Systems, 1st For more details and up-to-date information
Edition
visit clsi.org/projects-in-progress.
EP39 | Surrogate Sample Framework, 1st Edition
CLSI Documents Helpful for COVID-19 Testing
Throughout the catalog you’ll see documents with a note in red that says “COVID-19 Related.” These
documents have been identified as helpful for the laboratory community’s use during the COVID-19
pandemic. To learn more about how they can help with COVID-19 testing, visit clsi.org/covid-19.
3 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org
Automation and Informatics
Document Pricing
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Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
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Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
AUTO15 | Autoverification of Medical Laboratory Results for Specific Disciplines, 1st Edition
This guideline includes detailed information for design, testing, validation, implementation,
1st Edition
AUTO15
Autoverification of Medical Laboratory Results
for Specific Disciplines and ongoing support of an autoverification algorithm system for use in the medical
laboratory.
This guideline includes detailed information for design,
testing, validation, implementation, and ongoing support of
an autoverification algorithm system for use in the medical
laboratory.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
AUTO16 | Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition
Laboratories and IVD manufacturers need to understand the connectivity challenges facing
1st Edition
AUTO16
Next-Generation In Vitro Diagnostic
Instrument Interface medical laboratories today. AUTO16 can help you improve interoperability and reduce
connectivity installation cost and time.
This standard applies to the exchange of analytical testing
data between in vitro diagnostic instruments and health care
informatics systems.
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.
AUTO01* | Laboratory Automation: Specimen AUTO04* | Laboratory Automation: Systems
Container/Specimen Carrier, 1st Edition Operational Requirements, Characteristics, and
Item Order Code: AUTO01AE Information Elements, 1st Edition
Item Order Code: AUTO04AE
AUTO02* | Laboratory Automation: Bar Codes for
Specimen Container Identification, 2nd Edition AUTO05* | Laboratory Automation:
Item Order Code: AUTO02A2E Electromechanical Interfaces, 1st Edition
Item Order Code: AUTO05AE
AUTO03* | Laboratory Automation:
Communications With Automated Clinical AUTO07* | Laboratory Automation: Data Content
Laboratory Systems, Instruments, Devices, and for Specimen Identification, 1st Edition
Information Systems, 2nd Edition Item Order Code: AUTO07AE
Item Order Code: AUTO03A2E
4 | CLSI Catalog 2021AUTO08* | Managing and Validating Laboratory AUTO15 | Autoverification of Medical Laboratory
Information Systems, 1st Edition Results for Specific Disciplines, 1st Edition
Item Order Code: AUTO08AE Item Order Code: AUTO15Ed1
AUTO09* | Remote Access to Clinical Laboratory AUTO16* | Next-Generation In Vitro Diagnostic
Diagnostic Devices via the Internet, 1st Edition Instrument Interface, 1st Edition
Item Order Code: AUTO09AE Item Order Code: AUTO16Ed1
AUTO10* | Autoverification of Clinical Laboratory LIS01* | Specification for Low-Level Protocol to
Test Results, 1st Edition Transfer Messages Between Clinical Laboratory
Item Order Code: AUTO10AE Instruments and Computer Systems, 2nd Edition
Item Order Code: LIS01A2E
AUTO11* | Information Technology Security of In
Vitro Diagnostic Instruments and Software Systems, LIS02* | Specification for Transferring Information
2nd Edition Between Clinical Laboratory Instruments and
Item Order Code: AUTO11A2E Information Systems, 2nd Edition
Item Order Code: LIS02A2E
AUTO12 | Specimen Labels: Content and Location,
Fonts, and Label Orientation, 1st Edition
Item Order Code: AUTO12A
AUTO13* | Laboratory Instruments and Data
Management Systems: Design of Software
User Interfaces and End-User Software Systems
Validation, Operation, and Monitoring, 2nd Edition
Item Order Code: AUTO13A2E
Reminder
Join our e-mail list to be the first to learn about new documents and volunteer
opportunities. Sign up today at clsi.org/email.
5 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.orgClinical Chemistry and Toxicology
Document Pricing
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Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus process.
Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
C34 | Sweat Testing: Sample Collection and Quantitative Chloride Analysis, 4th Edition
Ensuring your laboratory and clinical personnel are equipped to appropriately collect and
4th Edition
C34
Sweat Testing: Specimen Collection and
Quantitative Chloride Analysis
analyze chloride sweat samples is the best way to provide your patients with high quality
cystic fibrosis test results. Get your staff the resource they need with C34.
This guideline describes methods for all aspects of sweat testing,
including collection and analysis, results evaluation and reporting,
and quality control.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
C49 | Analysis of Body Fluids in Clinical Chemistry, 2nd Edition
Regulatory requirements for laboratories performing body fluid testing have changed.
2nd Edition
C49
Analysis of Body Fluids in Clinical Chemistry
Medical laboratories need to determine appropriate fluid types for testing and understand
performance limitations of testing methods.
This guideline provides information for the medical laboratory
for evaluating measurement procedures, as well as a strategy
to characterize assay performance, when applied to body
fluid matrixes. Key concepts that apply to the entire test cycle,
including preexamination, examination, and postexamination
phases of body fluid testing, are discussed.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
C24* | Statistical Quality Control for Quantitative C34 | Sweat Testing: Sample Collection and
Measurement Procedures: Principles and Quantitative Chloride Analysis, 4th Edition
Definitions, 4th Edition Item Order Code: C34Ed4
Item Order Code: C24Ed4E
C37* | Preparation and Validation of Commutable
C29* | Standardization of Sodium and Potassium Frozen Human Serum Pools as Secondary Reference
Ion-Selective Electrode Systems to the Flame Materials for Cholesterol Measurement Procedures,
Photometric Reference Method, 2nd Edition 1st Edition
Item Order Code: C29A2E Item Order Code: C37AE
C31* | Ionized Calcium Determinations: Precollection C38* | Control of Preanalytical Variation in Trace
Variables, Specimen Choice, Collection, and Element Determinations, 1st Edition
Handling, 2nd Edition Item Order Code: C38AE
Item Order Code: C31A2E
6 | CLSI Catalog 2021C39* | A Designated Comparison Method for the C52 | Toxicology and Drug Testing in the Clinical
Measurement of Ionized Calcium in Serum, Laboratory, 3rd Edition
1st Edition Item Order Code: C52Ed3
Item Order Code: C39AE
C56* | Hemolysis, Icterus, and Lipemia/Turbidity
C40* | Measurement Procedures for the Indices as Indicators of Interference in Clinical
Determination of Lead Concentrations in Blood and Laboratory Analysis, 1st Edition
Urine, 2nd Edition Item Order Code: C56AE
Item Order Code: C40A2E
C56AQG | Examples of Hemolyzed, Icteric, and
C42* | Erythrocyte Protoporphyrin Testing, Lipemic/Turbid Samples Quick Guide
1st Edition Item Order Code: C56AEQG
Item Order Code: C42AE Nonmember Rate: $20.00
C43* | Gas Chromatography/Mass Spectrometry C57* | Mass Spectrometry for Androgen and
Confirmation of Drugs, 2nd Edition Estrogen Measurements in Serum, 1st Edition
Item Order Code: C43A2E Item Order Code: C57Ed1D
C45* | Measurement of Free Thyroid Hormones, C58* | Assessment of Fetal Lung Maturity by the
1st Edition Lamellar Body Count, 1st Edition
Item Order Code: C45AE Item Order Code: C58AE
C46 | Blood Gas and pH Analysis and Related C61* | Determination of Serum Iron, Total Iron-
Measurements, 2nd Edition Binding Capacity and Percent Transferrin Saturation,
Item Order Code: C46A2 1st Edition
Item Order Code: C61AE
C48* | Application of Biochemical Markers of Bone
Turnover in the Assessment and Monitoring of Bone C62* | Liquid Chromatography-Mass Spectrometry
Diseases, 1st Edition Methods, 1st Edition
Item Order Code: C48AE Item Order Code: C62AE
C49 | Analysis of Body Fluids in Clinical Chemistry, C63 | Laboratory Support for Pain Management
2nd Edition Programs, 1st Edition
Item Order Code: C49Ed2 Item Order Code: C63Ed1
C50* | Mass Spectrometry in the Clinical Laboratory: C64 | Quantitative Measurement of Proteins and
General Principles and Guidance, 1st Edition Peptides by Mass Spectrometry, 1st Edition
Item Order Code: C50AE Item Order Code: C64Ed1
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Document Pricing
Nonmembers: $180 Level III Members: $90
Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus process.
Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
GP33 | Accuracy in Patient and Sample Identification, 2nd Edition
The processes required by regulatory bodies for ensuring accurate patient and specimen
2nd Edition
GP33
Accuracy in Patient and Specimen
Identification
identification are covered in GP33. Invaluable guidance on bar-code system implementation
and user training is included.
This standard specifies the processes required to ensure accurate
patient and specimen identification in manual and electronic
systems across the health care organization. Processes include
system design considerations, differences in requirements for
patients with or without identification bands, and provisions for
patients with communication barriers.
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.
GP49 | Developing and Managing a Medical Laboratory (Test) Utilization Management
1st Edition
Program, 1st Edition
GP49
Developing and Managing a Medical
Laboratory (Test) Utilization Management
Eliminate unnecessary testing and focus on performing appropriate tests that improve quality
and outcomes. Learn about implementing a test utilization management program in your lab
Program
with GP49.
This report provides guidance for initiating, developing, and
maintaining an effective test utilization program.
A CLSI report for US application.
GP05* | Clinical Laboratory Waste Management, GP17 | Clinical Laboratory Safety, 3rd Edition
3rd Edition Item Order Code: GP17A3 COVID-19 Related
Item Order Code: GP05A3E
GP20* | Fine Needle Aspiration Biopsy (FNAB)
GP05A3CL* | Waste Management Program – Audit Techniques, 2nd Edition
Checklist Item Order Code: GP20A2E
Item Order Code: GP05A3CLE
Nonmember Rate: $20.00 GP23* | Nongynecological Cytology Specimens:
Preexamination, Examination, and Postexamination
GP15* | Cervicovaginal Cytology Based on the Processes, 2nd Edition
Papanicolaou Technique, 3rd Edition Item Order Code: GP23A2E
Item Order Code: GP15A3E
GP33 | Accuracy in Patient and Sample
GP16 | Urinalysis, 3rd Edition Identification, 2nd Edition
Item Order Code: GP16A3 Item Order Code: GP33Ed2 COVID-19 Related
8 | CLSI Catalog 2021GP34 | Validation and Verification of Tubes for GP42A6QG* | Technique for Skin Puncture in Adults
Venous and Capillary Blood Specimen Collection, and Older Children Quick Guide
1st Edition Item Order Code: GP42A6QGE
Item Order Code: GP34A Nonmember Rate: $20.00
GP36* | Planning for Laboratory Operations During a GP44 | Procedures for the Handling and Processing
Disaster, 1st Edition of Blood Specimens for Common Laboratory Tests,
Item Order Code: GP36AE COVID-19 Related 4th Edition
Free for a limited time. Item Order Code: GP44A4 COVID-19 Related
GP39* | Tubes and Additives for Venous and GP45* | Studies to Evaluate Patient Outcomes,
Capillary Blood Specimen Collection, 6th Edition 1st Edition
Item Order Code: GP39A6E Item Order Code: GP45AE
GP40 | Preparation and Testing of Reagent Water in GP47 | Management of Critical- and Significant-Risk
the Clinical Laboratory, 4th Edition Results, 1st Edition
Item Order Code: GP40A4AMD Item Order Code: GP47Ed1
GP41 | Collection of Diagnostic Venous Blood GP48 | Essential Elements of a Phlebotomy Training
Specimens, 7th Edition Program, 1st Edition
Item Order Code: GP41Ed7 COVID-19 Related Item Order Code: GP48Ed1
GP41QG | Quality Venipuncture Quick Guide GP49 | Developing and Managing a Medical
Item Order Code: GP41Ed7QG Laboratory (Test) Utilization Management Program,
Nonmember Rate: $20.00 1st Edition
Item Order Code: GP49Ed1
GP42 | Procedures and Devices for the Collection of
Diagnostic Capillary Blood Specimens, 6th Edition
Item Order Code: GP42A6
Did you know?
Through our Partnerships program, CLSI provides international outreach services
and hands-on support to laboratories throughout the world, helping them achieve
sustainable quality with systems to better diagnose and treat patients with
infectious diseases.
See where we work and how we can help your laboratory at clsi.org/global-training.
9 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.orgHematology
Document Pricing
Nonmembers: $180 Level III Members: $90
Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus process.
Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
H48 | Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay, 2nd
2nd Edition
Edition
H48
Determination of Coagulation Factor
Activities Using the One-Stage Clotting Assay
Quantitative assays for measuring coagulant activity are important laboratory tools. Enhance
the precision and accuracy of patient clotting factor assay results with H48.
This guideline provides recommendations regarding the proper
collection and handling of specimens, reagents, controls,
calibrators, and materials needed to optimize factor assay testing.
It includes recommendations for good laboratory practices related
to analyzer and reagent performance, reference intervals, lot-to-
lot validation, and quality control. Assay limitations and sources of
errors and variability are also included.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
H52 | Red Blood Cell Diagnostic Testing Using Flow Cytometry, 2nd Edition
This guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-
March 2014
H52-A2
Red Blood Cell Diagnostic Testing
Using Flow Cytometry; Approved
Guideline—Second Edition
based assays on a flow cytometry platform. Points of validation and quality control, and
caveats of interpretation are also discussed.
This guideline addresses the diagnostic red blood cell (RBC) assays
performed as fluorescence-based assays on a flow cytometry
platform; including testing procedures for fetomaternal hemorrhage
detection, paroxysmal nocturnal hematuria screening, membrane
defect anemia testing for hereditary spherocytosis, and nucleated
RBC counting. Points of validation and quality control, and caveats of
interpretation are also discussed.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
H02* | Procedures for the Erythrocyte H20* | Reference Leukocyte (WBC) Differential
Sedimentation Rate Test, 5th Edition Count (Proportional) and Evaluation of Instrumental
Item Order Code: H02A5E Methods, 2nd Edition
Item Order Code: H20A2E
H07* | Procedure for Determining Packed Cell
Volume by the Microhematocrit Method, 3rd Edition H21 | Collection, Transport, and Processing of Blood
Item Order Code: H07A3E Specimens for Testing Plasma-Based Coagulation
Assays and Molecular Hemostasis Assays,
H15* | Reference and Selected Procedures for the 5th Edition
Quantitative Determination of Hemoglobin in Item Order Code: H21A5
Blood, 3rd Edition
Item Order Code: H15A3E H21A5QG* | H21-A5 Quick Guide
Item Order Code: H21A5QGE
Nonmember Rate: $20.00
10 | CLSI Catalog 2021H26* | Validation, Verification, and Quality H54* | Procedures for Validation of INR and Local
Assurance of Automated Hematology Analyzers, Calibration of PT/INR Systems, 1st Edition
2nd Edition Item Order Code: H54AE
Item Order Code: H26A2
H56* | Body Fluid Analysis for Cellular Composition,
H30* | Procedure for the Determination of 1st Edition
Fibrinogen in Plasma, 2nd Edition Item Order Code: H56AE
Item Order Code: H30A2E
H57* | Protocol for the Evaluation, Validation, and
H42* | Enumeration of Immunologically Defined Cell Implementation of Coagulometers, 1st Edition
Populations by Flow Cytometry, 2nd Edition Item Order Code: H57AE
Item Order Code: H42A2E
H58* | Platelet Function Testing by Aggregometry,
H43* | Clinical Flow Cytometric Analysis of 1st Edition
Neoplastic Hematolymphoid Cells, 2nd Edition Item Order Code: H58AE
Item Order Code: H43A2E
H59* | Quantitative D-dimer for the Exclusion of
H44* | Methods for Reticulocyte Counting Venous Thromboembolic Disease, 1st Edition
(Automated Blood Cell Counters, Flow Cytometry Item Order Code: H59AE
and Supravital Dyes), 2nd Edition
Item Order Code: H44A2E H60 | Laboratory Testing for the Lupus
Anticoagulant, 1st Edition
H47* | One-Stage Prothrombin Time (PT) Test and Item Order Code: H60A
Activated Partial Thromboplastin Time (APTT) Test,
2nd Edition H60AQG1* | Algorithmic Approach to Lupus
Item Order Code: H47A2E Anticoagulant Testing
Item Order Code: H60AQG1E
H48 | Determination of Coagulation Factor Nonmember Rate: $20.00
Activities Using the One-Stage Clotting Assay,
2nd Edition H60AQG2* | Criteria for the Laboratory Diagnosis of
Item Order Code: H48Ed2 the Lupus Anticoagulant
Item Order Code: H60AQG2E
H52 | Red Blood Cell Diagnostic Testing Using Flow Nonmember Rate: $20.00
Cytometry, 2nd Edition
Item Order Code: H52A2
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service to order your custom document package today. Member rates apply.
11 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.orgImmunology and Ligand Assay
Document Pricing
Nonmembers: $180 Level III Members: $90
Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus process.
Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
I/LA20 | Analytical Performance Characteristics, Quality Assurance, and Clinical Utility
3rd Edition
of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen
I/LA20
Analytical Performance Characteristics,
Specificities, 3rd Edition
Quality Assurance, and Clinical Utility
Give your laboratory staff the guidance they need for the clinical application of laboratory
of Immunological Assays for Human
Immunoglobulin E Antibodies of Defined
Allergen Specificities
assays used in the measurement of human IgE.
This report provides guidance for the design, analytical
performance, standardization, quality assurance, and clinical
application of laboratory assays used in the measurement
of human immunoglobulin E antibodies of defined allergen
specificity.
A CLSI report for global application.
I/LA26 | Performance of Single Cell Immune Response Assays, 2nd Edition
Learn about methods for intracellular cytokine evaluation, major histocompatibility complex
November 2013
I/LA26-A2
Performance of Single Cell Immune Response
Assays; Approved Guideline—Second Edition
multimer quantitation, and enzyme-linked immunospot technology for the assessment of
cellular proliferation with I/LA26.
This document contains methods of intracellular cytokine
evaluation, major histocompatibility complex multimer
quantitation, enzyme-linked immunospot technology, and
carboxyfluorescein succinimidyl ester tracking dye staining for
the assessment of cellular proliferation. It also provides basic
aspects of specimen collection, transport, and preparation;
results interpretation; and quality assurance and test validation
approaches.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
I/LA02* | Quality Assurance of Laboratory Tests for I/LA20S (I/LA37)* | Analytical Performance
Autoantibodies to Nuclear Antigens: (1) Indirect Characteristics and Clinical Utility of Immunological
Fluorescence Assay for Microscopy and (2) Microtiter Assays for Human Immunoglobulin E (IgE)
Enzyme Immunoassay Methods, 2nd Edition Antibodies and Defined Allergen Specificities,
Item Order Code: ILA02A2E 1st Edition
Item Order Code: ILA37Ed1E
I/LA20* | Analytical Performance Characteristics, Nonmember Rate: $80.00
Quality Assurance, and Clinical Utility of
Immunological Assays for Human Immunoglobulin I/LA21* | Clinical Evaluation of Immunoassays,
E Antibodies of Defined Allergen Specificities, 2nd Edition
3rd Edition Item Order Code: ILA21A2E
Item Order Code: ILA20Ed3E
12 | CLSI Catalog 2021I/LA23* | Assessing the Quality of Immunoassay I/LA30* | Immunoassay Interference by Endogenous
Systems: Radioimmunoassays and Enzyme, Antibodies, 1st Edition
Fluorescence, and Luminescence Immunoassays, Item Order Code: ILA30AE
1st Edition
Item Order Code: ILA23AE I/LA33* | Validation of Automated Systems
for Immunohematological Testing Before
I/LA25* | Maternal Serum Screening, 2nd Edition Implementation, 1st Edition
Item Order Code: ILA25A2E Item Order Code: ILA33AE
I/LA26* | Performance of Single Cell Immune I/LA34* | Design and Validation of Immunoassays
Response Assays, 2nd Edition for Assessment of Human Allergenicity of New
Item Order Code: ILA26A2E Biotherapeutic Drugs, 1st Edition
Item Order Code: ILA34AE
I/LA28* | Quality Assurance for Design Control and
Implementation of Immunohistochemistry Assays,
2nd Edition
Item Order Code: ILA28A2E
I/LA28A2QG* | Comparison of the Characteristics
of Immunoassays Such as Enzyme-Linked
Immunosorbent Assay and Immunohistochemistry
Quick Guide
Item Order Code: ILA28A2QGE
Nonmember Rate: $40.00
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13 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.orgMethod Evaluation
Document Pricing
Nonmembers: $180 Level III Members: $90
Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus process.
Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
EP34 | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution
1st Edition
and Spiking, 1st Edition
EP34
Establishing and Verifying an Extended
Measuring Interval Through Specimen
Establish, validate, or verify a dilution scheme that will provide an extended measuring
interval for specimens with concentrations above the analytical measuring interval of an in
Dilution and Spiking
vitro diagnostic measurement procedure.
It is often medically necessary to provide results for specimens
with concentrations above the analytical measuring interval of
an in vitro diagnostic measurement procedure. This guideline
helps manufacturers and laboratory scientists with establishing,
validating, or verifying a dilution scheme that will provide an
extended measuring interval for such specimens.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory
1st Edition
Measurement Procedures, 1st Edition
EP35
Assessment of Equivalence or Suitability
of Specimen Types for Medical Laboratory
Measurement Procedures
This guideline provides recommendations for assessing clinically equivalent performance
for additional similar-matrix specimen types and suitable performance for dissimilar-matrix
specimen types, such that the laboratory does not necessarily need to repeat the full
measurement procedure validation for each specimen type. The recommendations in this
This guideline provides recommendations for assessing clinically
equivalent performance for additional similar-matrix specimen
types and suitable performance for dissimilar-matrix specimen
types, such that the laboratory does not necessarily need to
guideline apply to both quantitative measurement procedures and qualitative examinations.
repeat the full measurement procedure validation for each
specimen type. The recommendations in this guideline apply
to both quantitative measurement procedures and qualitative
examinations.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
EP05 | Evaluation of Precision of Quantitative EP07S (EP37)* | Supplemental Tables for Interference
Measurement Procedures, 3rd Edition Testing in Clinical Chemistry, 1st Edition
Item Order Code: EP05A3 COVID-19 Related Item Order Code: EP37Ed1E
Nonmember Rate: $80.00
EP06* | Evaluation of the Linearity of Quantitative
Measurement Procedures: A Statistical Approach, EP09 | Measurement Procedure Comparison and
2nd Edition Bias Estimation Using Patient Samples, 3rd Edition
Item Order Code: EP06Ed2E COVID-19 Related Item Order Code: EP09Ed3c
EP07 | Interference Testing in Clinical Chemistry, EP10 | Preliminary Evaluation of Quantitative Clinical
3rd Edition Laboratory Measurement Procedures, 3rd Edition
Item Order Code: EP10A3AMD
Item Order Code: EP07Ed3 COVID-19 Related
14 | CLSI Catalog 2021EP12* | User Protocol for Evaluation of Qualitative EP24* | Assessment of the Diagnostic Accuracy
Test Performance, 2nd Edition of Laboratory Tests Using Receiver Operating
Item Order Code: EP12A2E COVID-19 Related Characteristic Curves, 2nd Edition
Item Order Code: EP24A2E
EP14 | Evaluation of Commutability of Processed
Samples, 3rd Edition EP25 | Evaluation of Stability of In Vitro Diagnostic
Item Order Code: EP14A3 Reagents, 1st Edition
Item Order Code: EP25A COVID-19 Related
EP15 | User Verification of Precision and Estimation
of Bias, 3rd Edition EP26 | User Evaluation of Between-Reagent Lot
Item Order Code: EP15A3 Variation, 1st Edition
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