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https://www.readbyqxmd.com/read/29755687/clinical-application-of-targeted-next-generation-sequencing-for-colorectal-cancer-patients-a-multicentric-belgian-experience
#1
Nicky D'Haene, Quitterie Fontanges, Nancy De Nève, Oriane Blanchard, Barbara Melendez, Monique Delos, Marie-Françoise Dehou, Calliope Maris, Nathalie Nagy, Emmanuel Rousseau, Josse Vandenhove, André Gilles, Carine De Prez, Laurine Verset, Marie-Paule Van Craynest, Pieter Demetter, Jean-Luc Van Laethem, Isabelle Salmon, Marie Le Mercier
International guidelines made RAS (KRAS and NRAS) status a prerequisite for the use of anti-EGFR agents for metastatic colorectal cancer (CRC) patients. Daily, new data emerges on the theranostic and prognostic role of molecular biomarkers; this is a strong incentive for a validated, sensitive, and broadly available molecular screening test. Next-generation sequencing (NGS) has begun to supplant other technologies for genomic profiling. We report here our 2 years of clinical practice using NGS results to guide therapeutic decisions...
April 17, 2018: Oncotarget
https://www.readbyqxmd.com/read/29729139/toward-harmonization-of-clinical-molecular-diagnostic-reports-findings-of-an-international-survey
#2
Deborah A Payne, Katarina Baluchova, Graciela Russomando, Parviz Ahmad-Nejad, Cyril Mamotte, Francois Rousseau, Ron H N van Schaik, Kristin Marriott, Masato Maekawa, K C Allen Chan
BACKGROUND: The International Organization for Standardization (ISO) 15189 standard provides recommendations for the postexamination reporting phase to enhance quality in clinical laboratories. The purpose of this study was to encourage a broad discussion on current reporting practices for molecular diagnostic tests by conducting a global survey of such practices. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine's Committee for Molecular Diagnostics (IFCC C-MD) surveyed laboratories on selected ISO 15189 recommendations and topics...
May 5, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/29720490/implementing-a-quality-management-system-in-the-medical-microbiology-laboratory
#3
REVIEW
Roberta B Carey, Sanjib Bhattacharyya, Sue C Kehl, Larissa M Matukas, Michael A Pentella, Max Salfinger, Audrey N Schuetz
This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement...
July 2018: Clinical Microbiology Reviews
https://www.readbyqxmd.com/read/29684368/order-of-draw-practices-in-venous-blood-sampling-at-clinical-biochemistry-departments-in-the-danish-health-care-system
#4
Katja Kemp Jacobsen, Ida Brandt, Anne Vindahl Christensen, Bjørk Anine Rimsø, Camilla Julie Krøier, Michelle Sørensen, Julie Smith, Kathrine Overgaard Foss Jensen, Jeppe Madura Larsen
BACKGROUND: Deviation in blood collection procedures is a central source of preanalytical variation affecting overall analytical and diagnostic precision. The order of draw of venous sampling is suspected to affect analytical results, in particular for coagulation analysis. Here we compare the procedures in venous blood sampling among clinical biochemistry departments to assess the uniformity of order of blood draw and adherence to international guidelines in the Danish health care system...
April 20, 2018: Clinical Biochemistry
https://www.readbyqxmd.com/read/29623883/evaluation-of-the-coagulometer-sta-r-max-%C3%A2-stago-for-routine-coagulation-parameters
#5
Justine Brulé, Thomas Sinegre, Bruno Pereira, Marc G Berger, Anne-Françoise Serre-Sapin, Aurélien Lebreton
The STA R Max® is a fully automated multiparameter coagulometer using clotting (viscosity-based detection system), chromogenic and immunologic assays. STA R Max® is equipped with an innovative software (STA Coag Expert® ) designed to assist laboratory in accreditation. The aim of this study was to evaluate its performances for the certification according to ISO 15189 quality standard in the haemostasis unit of our university hospital. The following tests were evaluated: prothrombin time (PT), activated partial thromboplastin time (aPTT), kaolin cephalin clotting time (KCCT), fibrinogen, anti-Xa assay and D-dimers...
April 1, 2018: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/29622524/evaluation-of-procalcitonin-assay-on-the-abbott-architect-i2000-sr%C3%A2-analyzer
#6
Ahmed El Mouatani, Irina Rotaru, Jean-Louis Beaudeux, Carole Hennequin
Procalcitonin (PCT) is a useful biomarker for the diagnosis of bacterial infection. Its measurement is used routinely as a valuable tool for antibiotic treatment decision. The aim of this study is to assess the analytical performance of the new Architect Brahms PCT® reagents on the Abbott Architect i2000-SR® immuno-analyzer. The Architect PCT® assay was evaluated according to the modified SFBC protocol, in accordance with the NF EN ISO 15189 standard. Sixty two samples from patients hospitalized in Necker Hospital (Paris) have been tested with the evaluated method, and results were compared to those of the PCT Kryptor Brahms® method...
April 5, 2018: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/29561830/use-of-the-ion-pgm-and-the-genereader-ngs-systems-in-daily-routine-practice-for-advanced-lung-adenocarcinoma-patients-a-practical-point-of-view-reporting-a-comparative-study-and-assessment-of-90-patients
#7
Simon Heeke, Véronique Hofman, Elodie Long-Mira, Virginie Lespinet, Salomé Lalvée, Olivier Bordone, Camille Ribeyre, Virginie Tanga, Jonathan Benzaquen, Sylvie Leroy, Charlotte Cohen, Jérôme Mouroux, Charles Hugo Marquette, Marius Ilié, Paul Hofman
Background : With the integration of various targeted therapies into the clinical management of patients with advanced lung adenocarcinoma, next-generation sequencing (NGS) has become the technology of choice and has led to an increase in simultaneously interrogated genes. However, the broader adoption of NGS for routine clinical practice is still hampered by sophisticated workflows, complex bioinformatics analysis and medical interpretation. Therefore, the performance of the novel QIAGEN GeneReader NGS system was compared to an in-house ISO-15189 certified Ion PGM NGS platform...
March 21, 2018: Cancers
https://www.readbyqxmd.com/read/29548924/measurement-uncertainty-in-laboratory-reports-a-tool-for-improving-the-interpretation-of-test-results
#8
Andrea Padoan, Laura Sciacovelli, Ada Aita, Giorgia Antonelli, Mario Plebani
BACKGROUND: Measurement uncertainty (MU) estimation has been introduced by ISO 15189 for the accreditation of clinical laboratories. Although MU reporting is not required, its inclusion in medical reports is of potential assistance to physicians in results interpretation. METHODS: MU reporting was evaluated with respect to different test purposes, namely comparison with reference intervals (RI), patient monitoring or comparison with clinical decision limits. Clinical Biochemistry, Hematology, Coagulation and Clinical Immunology measurands were used as examples...
March 13, 2018: Clinical Biochemistry
https://www.readbyqxmd.com/read/29545112/validation-conform-iso-15189-of-assays-in-the-field-of-autoimmunity-joint-efforts-in-the-netherlands
#9
REVIEW
Leontine Mulder, Renate van der Molen, Carin Koelman, Ester van Leeuwen, Anja Roos, Jan Damoiseaux
ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity...
May 2018: Autoimmunity Reviews
https://www.readbyqxmd.com/read/29487890/method-validation-of-a-set-of-12-gem%C3%A2-premier%C3%A2-4000-blood-gas-analyzers-for-point-of-care-testing-in-a-university-teaching-hospital
#10
Charlotte Oris, Yoan Clavel, Matthieu Jabaudon, Annick Pialat, Hadj Abdelkader Mohamed, Frédérique Lioret, Vincent Sapin, Damien Bouvier
Background: Blood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, p CO2 , p O2 , Na+ , K+ , Cl- , Ca2+ , lactate, hemoglobin and oxyhemoglobin (O2 Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital...
March 2018: Practical Laboratory Medicine
https://www.readbyqxmd.com/read/29435781/fast-and-accurate-quantitative-organic-acid-analysis-with-lc-qtof-ms-facilitates-screening-of-patients-for-inborn-errors-of-metabolism
#11
Irene M L W Körver-Keularts, Ping Wang, Huub W A H Waterval, Leo A J Kluijtmans, Ron A Wevers, Claus-Dieter Langhans, Camilla Scott, Daphna D J Habets, Jörgen Bierau
Since organic acid analysis in urine with gaschromatography-mass spectrometry (GC-MS) is a time-consuming technique, we developed a new liquid chromatography-quadrupole time-of-flight mass spectrometry (LC-QTOF/MS) method to replace the classical analysis for diagnosis of inborn errors of metabolism (IEM). Sample preparation is simple and experimental time short. Targeted mass extraction and automatic calculation of z-scores generated profiles characteristic for the IEMs in our panel consisting of 71 biomarkers for defects in amino acids, neurotransmitters, fatty acids, purine, and pyrimidine metabolism as well as other disorders...
February 12, 2018: Journal of Inherited Metabolic Disease
https://www.readbyqxmd.com/read/29410246/how-to-accreditation-of-blood-cultures-proceedings-a-clinical-microbiology-approach-for-adding-value-to-patient-care
#12
REVIEW
B Lamy, A Ferroni, C Henning, C Cattoen, P Laudat
BACKGROUND: Quality assurance and quality management are driving forces for controlling blood culture best practices but should not be disconnected from the end-point target, i.e. patient value. AIMS: This article is intended to help microbiologists implement blood culture accreditation that is actually beneficial to patient management. SOURCES: Experience from a nationwide taskforce for promoting quality assurance and competence in clinical microbiology laboratories, guidelines on blood culture...
February 2, 2018: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29402416/what-information-on-measurement-uncertainty-should-be-communicated-to-clinicians-and-how
#13
REVIEW
Mario Plebani, Laura Sciacovelli, Daniela Bernardi, Ada Aita, Giorgia Antonelli, Andrea Padoan
The communication of laboratory results to physicians and the quality of reports represent fundamental requirements of the post-analytical phase in order to assure the right interpretation and utilization of laboratory information. Accordingly, the International Standard for clinical laboratories accreditation (ISO 15189) requires that "laboratory reports shall include the information necessary for the interpretation of the examination results". Measurement uncertainty (MU) is an inherent property of any quantitative measurement result which express the lack of knowledge of the true value and quantify the uncertainty of a result, incorporating the factors known to influence it...
February 2, 2018: Clinical Biochemistry
https://www.readbyqxmd.com/read/29199155/determination-of-procalcitonin-pct-in-micro-method-on-aqt90-flex%C3%A2-analyzer-and-in-vitro-stability-study
#14
Louis Mine, Morgane Petit, Valérie Nivet-Antoine, Jean-Louis Beaudeux, Carole Hennequin
Radiometer® has developed a point-of-care test for fast PCT measurement on whole blood in micromethod on a AQT90 FLEX® instrument. We have verified the analytical performances of the AQT90 FLEX® PCT assay in heparinized macrotube and EDTA microtube for pediatric use, according to modified French Society of Clinical Biology (SFBC) protocol to the requirements of the standard NF EN ISO 15189: 2012. The samples (n=61, 30 macrotubes, 31 microtubes) were analyzed by the Brahms Kryptor Compact Plus® reference method vs the AQT90 FLEX®...
January 1, 2018: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/29199153/retrospective-assessment-of-an-assisted-reproductive-technology-method
#15
Siham Aboulmakarim, Amal Benbella, Houyam Hardizi, Rachid Bezad
The validation of methods in medical biology is a fundamental step in which the laboratory defines its analytical objectives, characterizes the performance of the technique according to the level of quality it fixes and discusses the results obtained. The objective of this work is to contribute to respect the requirements of ISO 15189 in terms of performance verification of a manual qualitative technique of medically assisted procreation (PMA): morphological identification of the oocyte, the zygote and the embryo, harmonization of professional practices and assessment of competences by associating the bibliographic approach and above all by justifying its choices...
January 1, 2018: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/29129048/guidance-for-faecal-occult-blood-testing-quantitative-immunochemical-method-fit-hb-in-colorectal-cancer-screening-programmes
#16
Tiziana Rubeca, Stefano Rapi, Silvia Deandrea, Morena Malaspina, Basilio Ubaldo Passamonti, Elena Grassi, Anna Maria Cioccarelli, Enrico Marchetti, Michela Boni, Filippo Cellai, Marco Pradella, Franco Gattafoni, Sabrina Rotolo
BACKGROUND: in Italy, colorectal cancer screening is included as part of the Italian National Health Service - SSN (Servizio Sanitario Nazionale) Essential Levels of Care - LEA (Livelli Essenziali Assistenziali) and the European Guidelines, which specify quantitative FIT-Hb testing as the best strategy for organised screening programmes. To ensure consistent operating standards in Member States, European regulations require the implementation of certification and accreditation requirements for diagnostic and care-related processes...
September 2017: Epidemiologia e Prevenzione
https://www.readbyqxmd.com/read/29072175/iqc-laboratory-management-strategy-for-medical-biology
#17
Estelle Bugni, Richard Cohen, Cécile Mazellier
Medical biology laboratories rely especially on internal quality control (IQC) to monitor the performance of equipment and ensure results reliability. Strategies for these controls vary considerably from one laboratory to another. Some laboratories use Westgard's rules to detect drifts and are faced with a large number of false rejections caused by frequent runs of control samples and strategies that activate all rejection rules, regardless of the analyte considered. To minimize these rejections, some laboratories have combined several theories, sometimes despite the relevance of the resulting strategy...
December 1, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/28967954/deviation-management-key-management-subsystem-driver-of-knowledge-based-continuous-improvement-in-the-henry-ford-production-system
#18
Richard J Zarbo, Jacqueline R Copeland, Ruan C Varney
Objectives: To develop a business subsystem fulfilling International Organization for Standardization 15189 nonconformance management regulatory standard, facilitating employee engagement in problem identification and resolution to effect quality improvement and risk mitigation. Methods: From 2012 to 2016, the integrated laboratories of the Henry Ford Health System used a quality technical team to develop and improve a management subsystem designed to identify, track, trend, and summarize nonconformances based on frequency, risk, and root cause for elimination at the level of the work...
October 1, 2017: American Journal of Clinical Pathology
https://www.readbyqxmd.com/read/28879162/mozambique-s-journey-toward-accreditation-of-the-national-tuberculosis-reference-laboratory
#19
Sofia O Viegas, Khalide Azam, Carla Madeira, Carmen Aguiar, Carolina Dolores, Ana P Mandlaze, Patrina Chongo, Jessina Masamha, Daniela M Cirillo, Ilesh V Jani, Eduardo S Gudo
BACKGROUND: Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. METHODS: The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system...
2017: African Journal of Laboratory Medicine
https://www.readbyqxmd.com/read/28879149/development-and-implementation-of-the-caribbean-laboratory-quality-management-systems-stepwise-improvement-process-lqms-sip-towards-accreditation
#20
George Alemnji, Lisa Edghill, Giselle Guevara, Sacha Wallace-Sankarsingh, Rachel Albalak, Sebastien Cognat, John Nkengasong, Jean-Marc Gabastou
BACKGROUND: Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. OBJECTIVES: We report the development of a stepwise process for quality systems improvement in the Caribbean Region. METHODS: The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements...
2017: African Journal of Laboratory Medicine
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