"Specimen" is the Standard term for Collection, "Sample" is the Standard term for Statistics and Measurement Methods

  • Società Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL)
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Background: ISO 15189:2012 point 3.15 defines the terms "primary sample" and "specimen" as synonyms. ISO/TC 212 WG1 started the activity “13.3 Harmonization of terminology across ISO TC212”. ISO/TS 20658:2017 in the same definition modified "specimen" in "sample". Besides "Term and definition" and "Bibliograhy" sections, ISO/TS 20658 has no recurrence of the term "primary sample" in the text, but the title of the is "Requirements for collection and transport of samples". ISO 15189 terms are inherited by several ISO documents, such as ISO 5798, generating unnecessary ambiguity between material to be collected and material (sample or aliquot) to be examined. Methods:We examined the documents of Clinical & Laboratory Standards Institute (CLSI), International Organization for Standardization (ISO), International Medical Device Regulators Forum (IMDRF), Global Harmonization Task Force (GHTF), World Health Organization (WHO), International Laboratory Accreditation Cooperation (ILAC), Centers for Disease Control and Prevention (CDC), European Committee for Standardization (CEN), and Health Level 7 (HL7) to find out the prevailing trend for the use of the words 'specimen', 'sample' and 'primary sample'. Results:CLSI changed all titles related to collection from “primary samples” to “specimen”. ISO 20916:2019 and ISO 6717:2021 deleted the term 'primary sample'. The IMDRF uses the term specimen in its harmonized guidance documents to mean a sample of biological origin intended for examination by a medical laboratory. WHO, ILAC, HL7, CDC, CEN/TS 17742:2021 and CEN/TS 17747:2021 use the term "specimen" for collection activities. ISO/IWA 15:2015, ISO 20184-1:2018 and ISO 20166-1:2018 defines also the term "aliquot". ISO 5492:2008 defines "sample" and "aliquot" as equivalent. ISO 15198:2004, ISO 3534-2:2006 and ISO/IEC/IEEE 24765:2017 define the statistical sample. CLSI GP33 distinguishes between the words 'specimen' and 'sample'. Conclusion: The trend in standard documents, in guidelines and in many documents is clear. “Sample” is the harmonized term for the measurement and statistical activities. “Specimen” is the harmonized term for the collection activities. "Primary sample" is almost never used in the text of official documents and leads to potential ambiguity. ----!/10594/presentation/487

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