Evaluation of the ABX Pentra 400: a newly available clinical chemistry analyser

2005 ◽  
Vol 43 (7) ◽  
Author(s):  
Pascal Coudène ◽  
Benjamin Marson ◽  
Stéphanie Badiou ◽  
Sébastien Flavier ◽  
Sébastien Anelli ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Specific Protein ◽  
National Committee ◽  
Ion Selective Electrodes ◽  
Spectrophotometric Measurement ◽  
Good Reliability ◽  
Expected Values ◽  
Substrate Concentrations

AbstractThe performance of the ABX Pentra 400, a new multiparametric analyser available for routine and specialised clinical chemistry analyses, was evaluated according to the National Committee for Clinical Laboratory Standards (NCCLS) and Valtec protocols. Substrate concentrations and enzyme activities were determined by spectrophotometric measurement after coloured reaction or UV detection-based reactions; electrolyte concentrations were determined with ion-selective electrodes, and specific protein concentrations were assayed by immunoturbidimetry. In total, 32 of the most common clinical chemistry parameters were evaluated under simulated routine conditions. The analytical performance of the system and the quality of the ABX Pentra reagent line were both examined in a single-site study. The ABX Pentra 400 was compared with the Olympus AU640, Konelab-Konepro, Beckman Coulter-Immage and Beckman Coulter-Access 2, depending on the tests available on these analysers. The coefficient of variation (CV) values were within expected values. Coefficients of correlation showed high correlation between the analysers compared. The influence of interfering substances was moderate. The practicability of the system was good. We conclude that good reliability and practicability make the ABX Pentra 400 system suitable for laboratories with various needs.

AxonTM Clinical Chemistry Analyzer Evaluated According to ECCLS Protocol

1992 ◽  
Vol 38 (10) ◽  
pp. 2096-2100 ◽  
Author(s):  
S Brenna ◽  
L Prencipe
Keyword(s):  
Alkaline Phosphatase ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Field Evaluation ◽  
Close Correlation ◽  
Good Reliability ◽  
European Committee ◽  
Human Sera ◽  
Data Points ◽  
Sodium And Potassium

Abstract We assessed the analytical performance of the Axon system (Bayer Diagnostici), according to the European Committee for Clinical Laboratory Standards guidelines, for assay of 12 analytes: cholesterol, creatinine, glucose, total protein, urea, uric acid, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine kinase, sodium, and potassium. The field evaluation lasted approximately 5 months and involved the collection of approximately 10,000 data points with the Axon. The following results were obtained: The highest CVs for controls and human sera at different concentration/activity values were 2.2% for within-run imprecision (n = 60; 3 days, pooled estimate) and 3.5% for the between-day imprecision (n = 20 days). Close correlation was found with results for patients' specimens assayed with comparative instruments (Hitachi 717 for substrates and enzymes, Beckman Synchron EL/E4A for electrolytes). No drift was observed during 8 h of operation. The linearity range was broad, sometimes exceeding the manufacturer's claims. No sample-, reagent-, or cuvette-related carryover was found. Measurement of control sera gave results within +/- 5% of the assigned values. We conclude that good reliability and practicability make the Axon system suitable for laboratories with various needs.

scholarly journals Determination of errors that compromise the quality of laboratory service in a tertiary hospital

2017 ◽  
Vol 8 (1) ◽  
pp. 64-70
Author(s):  
Kenneth Kipruto Kimengech ◽  
Stanley Kinge Waithaka ◽  
Jackson Onyuka ◽  
Christine Sekadde Kigondu
Keyword(s):  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Common Knowledge ◽  
Tertiary Hospital ◽  
Chemistry Laboratory ◽  
Laboratory Service ◽  
Laboratory Errors ◽  
Analytical Errors

Background: Clinical Laboratory testing is a highly complex process that entails numerous procedures. Although it has been known that laboratory testing services are safe, it is increasingly becoming a common knowledge that they are not that safe. Studies have indicated that there are a number of errors that occur due to laboratory testing processes. These errors may not be realized easily during the testing process, but they make significant impact on the results given.Aims and Objective: To determine the levels of pre-analytical, analytical, and post analytical errors found in the analysis of Clinical Laboratory specimen at Kenyatta National Hospital.Materials and Methods: A prospective and descriptive study was carried out at Clinical Chemistry Laboratory, Department of Laboratory Medicine, Kenyatta National Hospital. A total of 346 request forms, specimens/samples and dispatched results were scrutinized and errors documented as per the different variables in the different phases, over a period of three months and the findings were analyzed.Results: Results of the study showed that Preanalytical errors were most common with a frequency of 148(42.8%), followed by analytical errors 114 (32.9%) and post analytical errors 84 (24.3%), respectively.Conclusions: The study concludes that pre-analytical, analytical, and post analytical errors are errors that compromise the quality of laboratory service delivery, which impacts on the patient management and diagnosis. Clinical laboratory errors can be minimized if due diligence and professionalism is adhered in the laboratory.Asian Journal of Medical Sciences Vol.8(1) 2017 64-70

Assuring the quality of interpretative comments in clinical chemistry

2016 ◽  
Vol 54 (12) ◽  
Author(s):  
Samuel Vasikaran ◽  
Kenneth Sikaris ◽  
Eric Kilpatrick ◽  
Jane French ◽  
Tony Badrick ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Continuing Professional Development ◽  
Laboratory Staff ◽  
Laboratory Services ◽  
Method Of Assessment ◽  
The Impact ◽  
Eqa Schemes ◽  
Interpretative Comments

AbstractThe provision of interpretative advice on laboratory results is a post-analytic activity and an integral part of clinical laboratory services. It is valued by healthcare workers and has the potential to prevent or reduce errors and improve patient outcomes. It is important to ensure that interpretative comments provided by laboratory personnel are of high quality: comments should be patient-focused and answer the implicit or explicit question raised by the requesting clinician. Comment providers need to be adequately trained and qualified and be able to demonstrate their proficiency to provide advice on laboratory reports. External quality assessment (EQA) schemes can play a part in assessing and demonstrating the competence of such laboratory staff and have an important role in their education and continuing professional development. A standard structure is proposed for EQA schemes for interpretative comments in clinical chemistry, which addresses the scope and method of assessment including nomenclature and marking scales. There is a need for evidence that participation in an EQA program for interpretative commenting facilitates improved quality of comments. It is proposed that standardizing goals and methods of assessment as well as nomenclature and marking scales may help accumulate evidence to demonstrate the impact of participation in EQA for interpretative commenting on patient outcome.

The use of six sigma methodology to evaluate the analytical performances of clinical chemistry analyzers

2016 ◽  
Vol 43 (1) ◽  
pp. 1-8
Author(s):  
Özlem Gülbahar ◽  
Murat Kocabıyık ◽  
Mehmed Zahid Çıracı ◽  
Canan Demirtaş ◽  
Fatma Uçar ◽  
...  
Keyword(s):  
Six Sigma ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Total Quality ◽  
Biochemical Tests ◽  
Analytical Process ◽  
World Class ◽  
Six Sigma Methodology ◽  
Analytical Platforms

AbstractIntroduction:In our study, we aimed to evaluate the analytical process performances of the biochemistry tests in the analysis systems that were widely used in the clinical laboratories by using the six-sigma methodology.Methods:The analytical performances of four different analytical platforms (Beckman Coulter-Olympus AU2700, Abbott-Architect C8000, Roche-Cobas 8000, and Siemens-ADVIA 2400) running 18 biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, ALT, ALP, LDH, HDL-C, CaResults:The parameters that have σ≥6 which means in world class are HDL-C and ALP in all four systems, while only NaDiscussion and conclusion:To improvement and monitoring of the analytical process performance as a part of total quality of a clinical laboratory to provide continuous improving, sigma levels can be used as it is a reliable method.

Enzymatic determination of sodium, potassium, and chloride in abnormal (hemolyzed, icteric, lipemic, paraproteinemic, or uremic) serum samples compared with indirect determination with ion-selective electrodes

1994 ◽  
Vol 40 (8) ◽  
pp. 1528-1531 ◽  
Author(s):  
W Hübl ◽  
R Wejbora ◽  
I Shafti-Keramat ◽  
A Haider ◽  
P Hajdusich ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
National Committee ◽  
Ion Selective Electrodes ◽  
Serum Samples ◽  
Sodium Potassium ◽  
Indirect Determination ◽  
Enzymatic Determination ◽  
Uremic Serum ◽  
Enzymatic Methods

Abstract We evaluated the effect of hemolysis, icteric discoloration, lipemia, paraproteinemia, and uremia on enzymatic methods for determining sodium, potassium, and chloride, according to the National Committee for Clinical Laboratory Standards EP7-P proposals for testing interference from endogenous substances. The sodium, potassium, and chloride assays (reagent kits supplied by Boehringer Mannheim) were based on electrolyte-dependent beta-galactosidase, pyruvate kinase, and alpha-amylase, respectively. The results were compared with those obtained by indirect ion-selective electrodes (ISE), which in turn had been validated by flame photometry. We analyzed the samples with Hitachi 717, 737, and 911 chemistry analyzers and with an IL943 flame photometer. The enzymatic results were in good agreement with those by ISE, the interference-related differences generally being without clinical significance; however, none of the enzymatic methods could analyze grossly lipemic samples.

Harmonization of interpretative comments in laboratory hematology reporting: the recommendations of Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH-SIBioC)

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Sabrina Buoro ◽  
Giorgio Da Rin ◽  
Alessandra Fanelli ◽  
Giuseppe Lippi
Keyword(s):  
Molecular Biology ◽  
Working Group ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Clinical Information ◽  
Italian Society ◽  
World Health ◽  
Interpretative Comments ◽  
Laboratory Hematology

AbstractThe goal of harmonizing laboratory testing is contributing to improving the quality of patient care and ultimately ameliorating patient outcome. The complete blood and leukocyte differential counts are among the most frequently requested clinical laboratory tests. The morphological assessment of peripheral blood cells (PB) through microscopic examination of properly stained blood smears is still considered a hallmark of laboratory hematology. Nevertheless, a variable inter-observer experience and the different terminology used for characterizing cellular abnormalities both contribute to the current lack of harmonization in blood smear revision. In 2014, the Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH-SIBioC) conducted a national survey, collecting responses from 78 different Italian laboratories. The results of this survey highlighted a lack of harmonization of interpretative comments in hematology, which prompted the WGDH-SIBioC to develop a project on “Harmonization of interpretative comments in the laboratory hematology report”, aimed at identifying appropriate comments and proposing a standardized reporting system. The comments were then revised and updated according to the 2016 revision of the World Health Organization classification of hematologic malignancies. In summary, the purpose of revaluating comments was aimed at: (a) reducing their overall number, (b) standardizing the language, (c) providing information that could be easily comprehended by clinicians and patients, (d) increasing the quality of the clinical information, and (e) suggesting additional diagnostic tests when necessary.

scholarly journals ORGANIZATIONAL AND ECONOMIC ASPECTS OF CLINICAL AND LABORATORY ACTIVITIES - POSSIBILITIES AND PERSPECTIVES OF OPTIMIZATION

2019 ◽  
Vol 26 (6) ◽  
pp. 1721-1726
Author(s):  
Nikola Sabev ◽  
Denitsa Trancheva
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Healing Process ◽  
Professional Staff ◽  
World Health ◽  
Diagnostic Process ◽  
High Tech ◽  
Economic Aspects ◽  
Laboratory Activities

“Clinical Laboratory” is an independent medical specialty, a dynamic clinical discipline of a scientific and applied nature. Laboratory researches, the results of which are objective indicators of the state of the organism, are of great importance in terms of modern medicine. Laboratory analyses help to achieve, within certain limits, such a result that can be used for the purpose of making the necessary medical decisions. “Laboratory Medicine” is a complex specialty, covering different directions: clinical chemistry, laboratory haematology, immunology, immunohematology, biology, drug monitoring and laboratory toxicology. A wide varietyof techniques is used for the analysis of biological fluids, the composition and properties of different types of cells, tissues, organs and systems.According to World Health Organization (WHO)data, in the past 20 years, the rate of morbidity within the population of nosologic units requiring high technologies and accuracy of diagnostic tests has increased. Modern revolution in clinical medicine complicates research methods and, as a result, increases significantly their value and cost.Laboratory units are widely considered to determine the status of each national healthcare system. Effectiveness of laboratory diagnostic process can be ensured by two key elements – high-tech equipment and professional staff. A need exists for identifying and using internal reserves with a view to the optimization of work volume and structures of laboratory and diagnostic units, being a promising and the most realisticdirection in the contemporary socio-economic situation.The mission of Clinical Laboratory departments is focused both on the provision of fast, adequate and accurate medical-diagnostic assistance, as well as on making effective use of any available material and technical resources and personnel potential. The problem being studied, its importance and the analysis of Clinical Laboratory activity are an essential component of the vision for this activity: high quality of clinical and laboratory results, timely and accurate diagnosis, adequate, timely and effective medical decisions.Main activities such as management; documentation of researches assigned and carried out; financial and economic aspects related to the valuation of laboratory analyses; tracking cost and available options for their optimization; reasonable time reduction for the production of laboratory analyses; introducing new high-performance technological equipment to improve the quality of laboratory activities and optimize the healing process have been researched and analysed in the Clinical Laboratory of “Kanev” University Multi-Profile Hospital for Active Treatment, Ruse.

History of NIST's contributions to development of standard reference materials and reference and definitive methods for clinical chemistry

1995 ◽  
Vol 41 (9) ◽  
pp. 1306-1312 ◽  
Author(s):  
R Schaffer ◽  
G N Bowers ◽  
R S Melville
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Standard Reference Materials ◽  
National Bureau ◽  
Serum Samples ◽  
Clinical Laboratories ◽  
History Of ◽  
Primary Standards ◽  
Definitive Methods

Abstract The issuance of cholesterol as a Standard Reference Material (SRM) in 1967 started the National Institute of Standards and Technology (NIST; then named the National Bureau of Standards) on a major effort to help clinical laboratories establish and improve the quality of measurements they make. NIST now issues three kinds of SRMs for that purpose: analyte samples of certified purity as primary standards, serum samples having certified analyte concentrations as accuracy controls, and materials certified for calibrating instruments. In working with clinical laboratory scientists to establish Reference Methods (RMs) for measuring the analytes, NIST developed Definitive Methods (DMs) to use for evaluating RM accuracy and then used the DMs for assigning analyte values to its SRMs. The development of SRMs and DMs is discussed.

Results of the Survey of the Quality Assurance for Commercially Prepared Microbiology Media

2003 ◽  
Vol 127 (6) ◽  
pp. 661-665
Author(s):  
Ronald N. Jones ◽  
Karen Krisher ◽  
Deborah S. Bird
Keyword(s):  
Quality Assurance ◽  
Clinical Microbiology ◽  
Clinical Laboratory ◽  
The United States ◽  
National Committee ◽  
Sample Number ◽  
Threshold Rate ◽  
Diagnostic Microbiology ◽  
Local Laboratory

Abstract Context.—Beginning in 1985, state-of-the-art surveys by the College of American Pathologists (CAP) led to M22-A guidelines by the National Committee for Clinical Laboratory Standards (NCCLS) for quality assurance (QA) of various commercially prepared isolation and diagnostic microbiology media. Some medium types were declared exempt from routine QA testing by each laboratory user, but manufacturer QA was maintained and specified in great detail. No update has occurred in more than 15 years as more complex media have been introduced into clinical microbiology practice. Objective.—To reassess the quality of commercially prepared microbiology media in the United States for the revision of NCCLS document M22-A2. Methods.—A questionnaire was designed to conform to that used by the CAP in 1985 and 1988, and was updated by lists of 52 recently introduced diagnostic media. Queries included details of laboratory QA in the last 12 months, such as number of lots tested, number of items in a lot, number of items in a quality control (QC) sample, number of lots failed, and reasons for lot failure. All CAP Microbiology Surveys participants received the document in late 2001. Results.—Data from nearly 300 000 media lots representing 32.7 million medium items were received from more than 3000 CAP Surveys subscribers. Lot raw data failure rates for all media ranged from 0.10% to 9.87% (average, 1.01%). Failures with media having a significant QC experience (≥1000 lots or ≥100 000 items) adjusted for QC strain-based failures (so-called extrapolated failure rate) ranged from 0.04% to 1.34% (average, 0.40%). The threshold rate for QA exemption from 1985 analyses was expanded to 0.50% or less and now allows exemption of 27 media evaluated in this study. Local laboratory QA must remain in force (M22-A2) for the other 25 products. Conclusions.—Generated QA failure results from the CAP Microbiology Surveys supplement recent results of the NCCLS M22 Subcommittee that will lead to more practical media QA guidelines and could significantly decrease costs for clinical microbiology laboratories through focusing QC on a smaller number of the most at-risk diagnostic products.

scholarly journals Evaluation of Quality Control Data of Clinical Chemistry Parameters using Six Sigma Metrics Tool in Clinical Laboratory

2021 ◽  
pp. 305-309
Author(s):  
G. Anuradha ◽  
S. Santhinigopalakrishnan ◽  
S. Sumathy
Keyword(s):  
Quality Control ◽  
Six Sigma ◽  
Clinical Laboratory ◽  
Clinical Biochemistry ◽  
Clinical Chemistry ◽  
Control Data ◽  
Laboratory Performance ◽  
Clinical Biochemistry Laboratory ◽  
Quality Control Data

Background: Physicians rely on laboratory results for treating patients. So it is the duty of laboratories to assure quality of the results released. So laboratory performance should be validated to maintain the quality. Six sigma has now gained recent interest in monitoring the laboratory quality.This study was designed to gauge the clinical chemistry parameters based on six sigma metrics. Materials and Methods: In this retrospective study, both the internal and external quality control data of 26 clinical chemistry parameters were collected for a period of 6 months from June 2020 to November 2020 and the six sigma analysis was done at the Central clinical biochemistry laboratory of Chettinad Hospital and research institute. Results: AST, amylase, lipase, triglyceride, HDL, iron, magnesium, creatine kinase showed sigma values more than 6.Uric acid, total protein, ALT, direct bilirubin, GGT,cholesterol, cholesterol, calcium, TIBC and phosphorus shows sigma values between 3.5 to 6. Glucose, BUN, creatinine, albumin, Na, K, Chloride, showed sigma values less than 3.5. Conclusion: Six sigma metrics can help in improving the quality of laboratory performance and also helps to standardisethe actual amount of QC that is required by the laboratory for maintaining quality.

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