Acreditacion sim portugal_13112018
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Conferencia a cargo de Inmaculada Solís, responsable de laboratorio de Iproma, explicando la acreditación por el método SIM (Separación Inmunomagnética) para detectar de forma rápida legionella en aguas, en la Jornada organizada por Frilabo en Lisboa el pasado 13 noviembre.
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Acreditacion sim portugal_13112018
- 1. Acreditação Método SIM Inma Solís Lisboa, 13 – Novembro - 2018
- 2. Index Introduction SIM - Legipid® Spanish Regulation Validation – Accreditation Uses Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 3. Lisboa, 13 – Novembro - 2018Acreditação Método SIM 01 Introduction Mission Offer a quality service specialized in environmental analysis and advice and industrial hygiene based on the experience and professionalism of our team, innovation, process efficiency and cutting-edge technology to meet the expectations of our customers, always responsibly with our environment . View To be a benchmark company in environmental analysis and industrial hygiene at the national level and to transfer our experience and acquired knowledge to the international field. Values and business culture Customer orientation | Quality assurance Efficient management | R & D + i | Competent professional staff Professional ethics | Equality 25 years of experience
- 4. Introduction Lisboa, 13 – Novembro - 2018Acreditação Método SIM IPROMA's commitment to R & D + i has been recognized through accreditation as an INNOVATIVE SME by the Ministry of Economy and the certification of its R & D + i management system according to the UNE 166.002 standard. R & D + i 01 MICROFILCER Development of self-cleaning ceramic microfilters by means of microwaves and application to the filtration of environmental samples. LIFE STO3RE (LIFE) Synergic TPAD and O3 process in WWTPs for Resource Efficient waste management. REMEB (Horizon 2020) Eco-friendly ceramic membrane bioreactor (MBR) based on recycled agricultural and industrial wastes for wastewater reuse. LEGIOLOUP Design of a rapid diagnostic system for the multiple detection of viable cells of Legionella spp, L. pneumophila and other pathogenic Legionella species by qPCR combined with PMA
- 5. 01 Introduction NEED: customer satisfaction Speed: agility in decision making Reliability: sensitive technique, good recovery, validation report Low cost: reagent + trial time + equipment + training Creditable: according to ISO 17025 by ENAC Suitable for the intended purpose Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 6. 01 Introducción NEED: intended purpose Determination Isolate Identificate Detect and quantify Tecnique The bacteria GROWS AMPLIFY nucleic acids SEPARATE and CONCENTRATE the bacteria Purpose Isolate Causal bacteria Confirm Causal bacteria Prevent Biological Risk 1-3 hours 8-24 hours 7-12 days Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 7. 01 Introduction Legipid PCR Culture 1h1h 24h 12 days Risk Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 8. 02 SIM – Legipid ® Year 2009 – Validation Kit Year 2010 – Intercolaborative program Year 2011 – Audit ENAC Qualitative Method Year 2011 – Certification AOAC Year 2013 – RD swimming pools (RD 742/2013) Year 2015 – NT 32 ENAC. Standardized Method Year 2017 – UNE 100030:2017 Year 2017 - Audit ENAC Quantitative Method Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 9. 02 SIM – Legipid ® Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 10. 02 103 104 102 102 Acreditação Método SIM Lisboa, 13 – Novembro - 2018 SIM – Legipid ®
- 11. 03 Spanish Regulation Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 12. 03 UNE-ISO 11731 OTRAS TÉCNICAS The laboratory must demonstrate compliance with technical requirements UNE-EN ISO / IEC 17025 Los ensayos de Legionella spp. Deben hacerse en base a la versión en vigor de la norma UNE-ISO 11731 o Por técnica que presente un protocolo validado por organismo competente de certificación nacional o internacional (PCR, método inmunomagnético, etc.) Acreditação Método SIM Lisboa, 13 – Novembro - 2018 Spanish Regulation
- 13. 04 Validation – Accreditation SIM – LEGIPID ® Certificate AOAC nº 111101 Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 14. 04 Validation – Accreditation Certificate AOAC nº 111101 Preliminary Validation: 2 laboratories ISO 17025 Sensitibility 95,3 % Especificity 88,4 % Falses positives 11,6 % Falses negatives 4,7 % Efficiency 92,4 % SIM – LEGIPID ® Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 15. 04 Validation – Accreditation SIM – LEGIPID ® Certificate AOAC nº 111101 Preliminary Validation: 2 laboratories ISO 17025 Intercolaborative Study: 12 laboratories 2 negative samples 2 samples with value 2,88 log 3 samples with value 3,82 log 2 samples with value 2,23 log 95,8 % concordance 91,7 % concordance 91,7 % concordance100 % concordance Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 16. 04 Validation – Accreditation SIM – LEGIPID ® Certificate AOAC nº 111101 Preliminary Validation: 2 laboratories ISO 17025 Intercolaborative Study: 12 laboratories Inclusivity / Exclusivity Study 64 strains of collection and environmental Legionella NO pneumophila 58 strains detected (91 % ) Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 17. 04 Validation – Accreditation SIM – LEGIPID ® Acreditação Método SIM Lisboa, 13 – Novembro - 2018 Recovery with real samples (without inoculation)
- 18. 04 Validation – Accreditation SIM – LEGIPID ® Certificate AOAC nº 111101 Preliminary Validation: 2 laboratories ISO 17025 Intercolaborative Study: 12 laboratories Inclusivity / Exclusivity Study Recovery with real samples (without inoculation) Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 19. 04 Validation – Accreditation SIM – LEGIPID ® Acreditação Método SIM Lisboa, 13 – Noviembre - 2018 Calibration Curve Y = 2.3061 * X * 4.9815
- 20. Lisboa, 13 – Novembro - 2018 04 Validation – Accreditation Acreditação Método SIM
- 21. Lisboa, 13 – Novembro - 2018 04 Validation – Accreditation Acreditação Método SIM
- 22. 04 Validation – Accreditation Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 23. 04 Quantitative Qualitative Recovery Reproducibility Detection Limit Acreditação Método SIM Lisboa, 13 – Novembro - 2018 Validation – Accreditation
- 24. 04 Validation – Accreditation Lisboa, 13 – Novembro - 2018
- 25. 04 Validation – Accreditation Lisboa, 13 – Novembro - 2018
- 26. 04 Quantitative Recovery Reproducibility 100 = XR SR P 100 = xr XR R Validation – Accreditation Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 27. 04 Uncertainty 2222 IrecIrutIrepIcepaI +++= medidaII = 2(log)exp I strain I recoveryI routineI repetibility Validation – Accreditation Acreditação Método SIM Lisboa, 13 – Novembro - 2018
- 28. 05 Acreditação Método SIM Treated effluent WWTP Changing rooms Hose 2 Hose 1 Boilers Machine Tank Well Uses: Legionella spp in industrial facilities Lisboa, 13 – Novembro - 2018
- 29. 05 Acreditação Método SIM Treated effluent WWTP Changing rooms Hose 2 Hose 1 Boilers Machine Tank Well Uses: Legionella spp in industrial facilities Lisboa, 13 – Novembro - 2018
- 30. 05 Acreditação Método SIM Uses: Legionella spp in beach DAY 0 … Pre-study DAY 1 DAY 3 DAY 2 DAY 8 Samples Positive Correction Re-sample Lisboa, 13 – Novembro - 2018
- 31. 05 Uses: Legionella spp in hospitals Acreditação Método SIM Validation and effectiveness of a rapid method for Legionella detection (Legipid®) in Health Centers Lisboa, 13 – Novembro - 2018
- 32. 05 Acreditação Método SIM Uses: Legionella spp in hospitals Global Standard + – Legipid + 20 0 20 – 8 45 53 28 45 73 IMMUNOMAGNETIC TEST PARAMETERS SENSITIVITY ESPECIFICITY PPV NPV 71.4 % 100.0% 100.0 % 84.9% Lisboa, 13 – Novembro - 2018
- 33. 05 Acreditação Método SIM INITIAL DIAGNOSIS FINAL EVALUATIONPOSITIVITY, % CLEANING DISINFECTION 4 MONTHS 29 SAMPLES 44 SAMPLES 10-15 days 24-48 hours 1-3 hours Legipid PCR Culture 55% 31% 17% 19% 11% 18% Uses: Legionella spp in hospitals Lisboa, 13 – Novembro - 2018