CLSI Documents Helpful for COVID-19 Testing
The below list of documents have been identified as helpful for the laboratory community’s use during the COVID-19 pandemic.
Click the document areas below to view related documents, more information about their help with COVID-19 testing, and access their sample pages. We've made a handful of the documents below free for a limited time. There are also free webinars noted within the listings where you can learn more about the documents and their use.
Download a PDF Version of this List Additional COVID-19 Resources Free COVID-19 Documents
Method Evaluation
NOTE: Most COVID-19 devices (current or near future) will have an internal signal; therefore, CLSI documents EP05, EP07, EP12, EP17, EP18, EP25, and EP35 are recommended. If a signal is not available, the same CLSI documents are recommended but additional data analysis may be required.
CLSI EP05 | Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition
This document provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures.
EP05 provides study design of precision studies with regard to testing conditions. If the test has an internal signal, then analysis of the internal signal described in CLSI document EP05 is also recommended.
CLSI EP07 | Interference Testing in Clinical Chemistry, 3rd Edition
This guideline provides background information, guidance, and experimental procedures for investigating, identifying, and characterizing the effects of interferents on clinical chemistry test results.
EP07 provides study design of interference studies. If the test has an internal signal, then analysis of the internal signal described in EP07-A3 is also recommended.
Learn more about this document in our free overview webinar here.
This document provides guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates.
EP17 is also recommended for all types of COVID-19 assays.
Learn more about this document in our free overview webinar here.
CLSI EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources, 2nd Edition
This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes.
Creating a risk assessment for the new test will help you decide the extent of the validation or verification testing needed.
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 guideline apply to both quantitative measurement procedures and qualitative examinations.
EP35 is recommended for the evaluation of different types of specimens.
This practical guide is intended for the laboratory that is creating laboratory developed tests.
This guide will help you meet FDA requirements for a laboratory developed test.
Free for a limited time.
Molecular Diagnostics
CLSI MM03 | Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition
This report addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories.
This document includes verification and validation information.
Learn more about this document in our free overview webinar here.
CLSI MM06 | Quantitative Molecular Methods for Infectious Diseases, 2nd Edition
This document provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms. It also presents recommendations for quality assurance, proficiency testing, and interpretation of results.
This document includes verification and validation information.
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.
This document provides information on specimen collection, handling, and transport for molecular testing.
CLSI MM14 | Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition
This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.
This document will help you understand when you need proficiency testing/external quality assessment, and how to perform the testing.
Free for a limited time.
Learn more about this document in our free overview webinar here.
CLSI MM17 | Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition
Nucleic acid testing is one of the fastest growing fields in laboratory medicine. This guideline includes recommendations for analytical validation and verification of multiplex assays, with a review of biological and synthetic reference materials.
This document includes verification and validation information.
Learn more about this document in our free overview webinar here.
CLSI MM19 | Establishing Molecular Testing in Clinical Laboratory Environments, 1st Edition
This guideline provides comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.
This document includes detailed verification and validation information.
Learn more about this document in our free overview webinar here.
Microbiology
CLSI M29 | Protection of Laboratory Workers From Occupationally Acquired Infections, 4th Edition
Based on US regulations, this document provides guidance on the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and recommendations for the management of exposure to infectious agents.
Information on biological risk assessment is included.
CLSI M40 | Quality Control of Microbiological Transport Systems, 2nd Edition
This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.
This document provides information on viral specimen collection and transport.
Learn more about this document in our free overview webinar here.
Point-of-Care Testing
Point-of-care testing (POCT) provides more rapid test results than can be achieved in laboratory settings. Ensure your staff has the most up-to date guideline to produce reliable POCT results with POCT04.
This guideline will help you ensure that your point-of-care testing is being performed correctly.
CLSI POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care, 1st Edition
This document presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use.
This document will help you identify and eliminate errors in your point-of-care testing programs.
Free for a limited time.
CLSI POCT15 | Point-of-Care Testing for Infectious Diseases, 1st Edition
This report summarizes current knowledge of rapid and point-of-care testing practices used worldwide for infectious diseases.
This document will help you understand current practices in point-of-care testing for infectious diseases.
Other Documents
CLSI GP17 | Clinical Laboratory Safety, 3rd Edition
This document contains general recommendations for implementing a high-quality laboratory safety program.
This document will help you understand the safety practices that need to be in place in your laboratory.
CLSI GP36 | Planning for Laboratory Operations During a Disaster, 1st Edition
This document provides guidance for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters.
This document will help you develop and implement emergency preparedness plans.
Free for a limited time.
Learn more about this document in our free overview webinar here.
CLSI GP41 | Collection of Diagnostic Venous Blood Specimens, 7th Edition
This standard provides procedures for the collection of diagnostic specimens by venipuncture, including line collections, blood culture collection, and venipuncture in children.
Contains specific information (in Subchapter 5.4.1) on collection from patients in isolation.
CLSI QMS03 | Training and Competence Assessment, 4th Edition
This guideline provides a structured approach for developing effective laboratory personnel training and competence assessment programs.
This document will help you ensure that your training and competence assessment program are adequate.