LABMEDICO

martedì 14 settembre 2021

"Sample" is for measurement, "specimen" is for collection. "Primary sample" is misleading.

 The International Medical Device Regulators Forum (IMDRF) uses the term specimen. 1 WHO uses the term “specimen”. 2 CLSI in many documents uses the term “specimen”. 3 ILAC uses the term “specimen” in G18 and G26. 4

CDC uses the term “specimen”.5 ISO itself in several documents uses the term specimen even in the title.6

Therefore, "specimen” is the standard term in collection activities. “primary sample” is little more than a form of "slang"and can cause confusion with other terms.

sample” retains its value for statistical and measurement activities.

1Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Authoring Group: IMDRF IVD Working Group. Date: 21 January 2021 Common Data Elements for Medical Device Identification. Authoring Group: IMDRF RPS Working Group. Date: 24 March 2016 GHTF SG5 Clinical Performance Studies for IVD Medical Devices

GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices - 17 March 2011

GHTF SG1 - Principles of Safety and Performance of Medical Devices - May 2005

Glossary and Definitions of Terms Used in GHTF Documents

GHTF SG1 Definition of the Terms Medical Device' and In Vitro Diagnostics' Medical Device's

2World Health Organization. Regional Office for the Eastern Mediterranean. (‎1995)‎. Specimen collection and transport for microbiological investigation. https://apps.who.int/iris/handle/10665/119529 WHO Procedures for collection of clinical specimens (blood sample) during field investigation of suspected outbreaks. https://www.who.int/csr/resources/publications/ebola/blood-collect-en.pdf WHO/CDS/CSR/EDC/2000.4 Guidelines for the collection of clinical specimens during field investigation of outbreaks. https://apps.who.int/iris/bitstream/handle/10665/66348/WHO_CDS_CSR_EDC_2000.4.pdf?sequence=1

3EP35 Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition

AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard

AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

GP23-Ed2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes, Second Edition

GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline

GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition

GP41-Ed7 Collection of Diagnostic Venous Blood Specimens, Seventh Edition

GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition

GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition

H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition

M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline

MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline

4ILAC G26:11/2018 Guidance for the Implementation of a Medical Accreditation Scheme ILAC G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories

5CDC. Specimen Collection Guidelines. https://www.cdc.gov/urdo/downloads/speccollectionguidelines.pdf CDC. Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing. Updated Feb. 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html Submitting Specimens to CDC. https://www.cdc.gov/laboratory/specimen-submission/list.html

6ISO/TR 79:2015 Reference materials - Examples of reference materials for qualitative properties ISO/DIS 4307 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA ISO 6710:2017 Single-use containers for human venous blood specimen collection

ISO/FDIS 6717 In Vitro Diagnostic Medical Devices — Single-Use Containers For The Collection Of Specimens From Humans Other Than Blood

ISO 14971:2019 Medical devices — Application of risk management to medical devices

ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

ISO 17822:2020 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide

ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

ISO 23640:2011 In Vitro Diagnostic Medical Devices — Evaluation Of Stability Of In Vitro Diagnostic Reagents

ISO 21474-1:2020 In Vitro Diagnostic Medical Devices — Multiplex Molecular Testing For Nucleic Acids — Part 1: Terminology And General Requirements For Nucleic Acid Quality Evaluation

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

ISO 20184-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA

ISO 20184-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins

ISO 20186-2:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA

ISO 20186-3:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma

ISO 20166-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

ISO 20166-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins

ISO 20166-3:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

ISO 22367:2020 Medical laboratories — Application of risk management to medical laboratories

ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents