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La Rivista Italiana della Medicina di Laboratorio 2019 Jul 15

DOI: 10.23736/S1825-859X.19.00023-9

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: Italian

ISO 17822, quality for examinations with nucleic acid amplification

Marco PRADELLA

SIPMeL, Castelfranco Veneto, Treviso, Italia


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ISO, the International Organization for Standardization, is preparing document ISO / TS 17822-2 on the quality control of nucleic acid amplification techniques (NAAT). ISO 17822-2 takes into consideration many aspects that affect quality. ISO 17822 prescribes the use of control materials and describes different types of them. ISO 17822-2 states that the laboratory shall decide the appropriate type and frequency of use of internal and external controls, but says however that the results must remain within the pre-established limits, without saying how the limits should be fixed. Worldwide quality control in medical laboratories is often not performed correctly. Quality costs represent 22% of the laboratory's direct costs. The SIPMeL Quality and Accreditation Commission has therefore produced its recommendations on quality control, with the transposition of ISO 15198: 2004, reconfirmed also in 2018. Diagnostic system manufacturers have a primary role in this activity. The guidelines for quality control are in the document Clinical Laboratory Standards Institute (CLSI) C24.


KEY WORDS: Quality control; Iso; Accreditation; NAAT; Microbiology

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