LABMEDICO

lunedì 25 settembre 2023

Critical issues in the glossary of CEN documents for NGS

 https://bit.ly/glossarioNGS

Criticità nel glossario dei documenti CEN per NGS
8° C ONGRESSO NAZIONALE SIPMeL - Riva del Garda, 9-11 Ottobre 2023
Poster n° 165

The European Committee for Standardisation (CEN) prepares two documents for examination workflows with NGS methods: CEN/TS 17981-2 (Examination of human RNA) and CEN/TS 17981-1 (Examination of human DNA). Critical points in the definitions of some glossary entries are studied here. In the CEN standards examined, clinical, metrological, numerical and nominal results are confused, even with internal contradictions. "Measurement sensitivity" should be applied to the numerical results of the steps that make up the NGS process, alongside the detection limit (3.29 LOD). Diagnostic sensitivity or comparability with other methods (PPA and NPA, VIM4 6.20) are different. 'Specificity' may be limited to clinical use, whereas the metrological word 'selectivity' is needed for measurement (VIM3 2.45). An ISO project (Guidance for emerging technologies) has just been initiated precisely because research methods, such as NGS, are often not designed for clinical applications. Therefore, emerging technologies entering medical laboratories should be screened from their glossary and filtered through the guidance of VIM, FDA and the statistical literature. --- Poster n° 165



lunedì 19 giugno 2023

UNI EN ISO 15189:2023: focus su POCT ed incertezza di misura

 UNI EN ISO 15189:2023: focus on POCT and measurement uncertainty

  • June 2023
  • Conference: ACCREDIA: The accreditation of medical laboratories in accordance with UNI EN ISO 15189:2023, Rome June 16, 2023, via Regina Margherita 262

giovedì 6 aprile 2023

Precisione e incertezza dei risultati: esempi di applicazione delle Raccomandazioni SIPMeL

Precision and uncertainty of results: examples of application of SIPMeL Recommendations

  • Conference: 6° Congresso Nazionale SIPMeL "La Centralità della Medicina di Laboratorio nei Percorsi Assistenziali" --- 1 - 3 - 13 - 15 dicembre 2021 (ore 14.00 – 19.30) in modalità virtual congress




martedì 4 aprile 2023

Nuove norme tecniche nazionali e internazionali per l'informatica del laboratorio medico: un quadro generale

 New national and international technical standards for medical laboratory informatics: an overview

  • February 2023

DOI: 10.23736/S1825-859X.23.00170-6

https://bit.ly/infoLabMed2023



lunedì 20 marzo 2023

POCT: l'aggiornamento delle normative

POCT: updating regulations

  • February 2023
  • Conference: LA GOVERNANCE DEI POCT NELL’EVOLUZIONE DELLA DIAGNOSTICA DECENTRATA - SIPMeL - 24 Febbraio 2023, Genova

Pacchetto ISO laboratori medici • Nuova ISO 15189 • POCT da 22870 a nuova 15189 con SIPMeL • POCT in nuova ISO 15189 ---- ISO package medical laboratories - New ISO 15189 - POCT 22870 to new 15189 with SIPMeL - POCT in new ISO 15189 

Novità sulle norme ISO per l'accreditamento del Point of Care

News on ISO standards for the accreditation of the Point of Care

  • October 2022
  • Conference: 7° CONGRESSO NAZIONALE SIPMeL Medicina di Laboratorio: nuove complessità e future strategie - Corso precongressuale 1 a cura del Gruppo di Studio Point of care testing (GdS-PoCT) Evoluzione della diagnostica decentrata: aumento della domanda, capacità di risposta e regolamentazione dei PoCT --- https://www.congressosipmel2022.it/

sabato 18 marzo 2023

New Guides for Uncertainty of Qualitative Results

  • The Journal of Applied Laboratory Medicine 8(1):217-218

  • The Eurachem/Cooperation on International Traceability in Analytical Chemistry (CITAC) guide “Evaluating Performance and Uncertainty in Qualitative Chemical Analysis” has recently been published (1).

    a number of criticisms of the guide have recently been reported, including the lack of the repeatability and reproducibility components for the accuracy of the methods (2).

     the International Organization for Standardization (ISO) has published ISO/TR 27877, which is devoted properly to statistical analysis for evaluating the precision of binary measurement methods and their results (3).

    The approach for medical laboratories should be simple, low burden, as designed by ISO 20914, but inclusive of qualitative tests (tests with nominal results), and tests with ordinal results alongside numerical results of the internal response signal(s).