DOCSLIB.ORG

Analytical Technologies and Applications Clinica Chimica Acta

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Analytical Technologies and Applications Clinica Chimica Acta Clinica Chimica Acta 493 (2019) S13–S75 Contents lists available at SciVerse ScienceDirect Clinica Chimica Acta journal homepage: www.elsevier.com/locate/clinchim Analytical technologies and applications M001 Indeed, 30% of healthy men were outside the range. Establishment on reference range on 120 healthy subjects will thus be mandatory Verification of the reference intervals proposed by Abbott on for this parameter. Alinity CI in a population of healthy subjects from Liege, Belgium doi:10.1016/j.cca.2019.03.036 C. Bertholet, M. Lamtiri Laarif, L. Vranken, R. Gadisseur, S. Delcour, E. Cavalier Department of Clinical Chemistry, University Hospital of Liège, Belgium M002 Background-aim Evaluation and clinical implication of lactate measurement by amperometry and spectrophotometry Verification of Manufacturers'proposed reference intervals is an important step of a method validation. This can be done according to CLSI O.M. Diz Mellado, E. Melguizo Madrid, A. Sáez-Benito Godino EP28-A3 guidelines by running tests on a selected population of 20 healthy UGC Laboratorios, Hospital Universitario Puerta del Mar, Cádiz, Spain individuals. However, this process can be cumbersome or complicated for many laboratories. Depending on the analyte, the established reference Background-aim interval may be unique or vary according to age, sex, hormonal cycle or nychtemeral cycle. In this study, we aimed at verifying the reference Lactic acid is mainly a clinical sepsis marker, although it is also ranges proposed by Abbott on the new Alinity chemistry and immuno- associated with other pathologies (cardiovascular or shock). It is assays analyzer in a population of healthy Belgian subjects. produced in anaerobic glycolysis. High tissular levels leads to increased plasma concentration. Methods The different measurement techniques require specific samples. In order to avoid extra tubes we aim to measure lactate in total blood 80 healthy volunteers (20 women and 20 men N50 yo and b 50 yo) drained for blood gases. agreed to participate and gave blood after overnight fasting. Age of the Aim: Evaluate the concordance between lactate results in plasma population ranged between 24 and 70 years. We verified the reference and total blood samples. The patient's diagnostic classification will be intervals for basic chemistry (ions, liver enzymes, metabolites, proteins studied to check the diagnostic validity in order to use total blood and lipids) and a wide panel of immunoassays (cardiac markers, tumor sample instead of plasma. markers, fertility hormones, thyroid hormones and anemia panel). For fertility hormones, we checked references values for three groups: men, Methods postmenopausal and premenopausal women. We used EP-Evaluator software following the CLSI EP28-A3 guidelines. The reference values All samples analyzed in four months (648) were processed in announced by the manufacturer were accepted if a maximum of 10% of both analytical systems. Plasma was analyzed by spectrophotometry healthy patients were outside the range with 95% IC. (c501Roche Diagnostics®; reference values (RV):4.5–19.8 mg/dL) and total blood by amperometry (GEM 4000 Werfen®; RV:0,5–2 Results mM). The statistical analysis was done with SPSS 20.0. Kolmo- For basic chemistry, our results were in accordance with the gorovSmirnov, Spearman coefficient, Passing-Bablok, Bland-Altman reference values described by Abbott, with a maximum of 10% graphics, Lin Coefficient and Contingency tables (classifying the patients outside the interval, except for Cholinesterase. Only 5% of patients as positive or negative according to the RV, studying the healthy women were outside the range (2,88–12,67 kU/l) but 30% of Kappa index of concordance between techniques) were analyzed. healthy men were outside the range (4,93–10,93 kU/l). For the panels tested with immunoassays, all reference values were in Results agreement with Abbott's proposed values. The correlation coefficient of 0.99 indicates a strong positive Conclusions correlation. Passing-Bablok regression method: intercept 2,42; slope 0,97. Cusum test: significant deviation from linearity. Our results showed that we can use the reference values The differences analysis was done using Bland-Altman graph: described by Abbott for all parameters, except Cholinesterase. average difference: 2.4 mg/dL (4.2 to 9.1), presenting a continuous 0009-8981/$ – see front matter Abstracts / Clinica Chimica Acta 493 (2019) S13–S75 bias throughout the gap. Lin coefficient was 0.9733, being substantial we calculated the ratio we didn't found changes in the clinic decision according to the McBride scale. limit, nevertheless it should be more carefully studied in the Contingency table shows 80% of concordant results. The remain- borderline ratio values of 20%. ing 20% indicates higher levels for amperometric technique in grey zone. The Kappa index (0.79) shows a good concordance. doi:10.1016/j.cca.2019.03.038 Conclusions M004 A strong correlation and a global concordance are observed between methods. Total blood samples tend to a greater degree of Comparison study of basic hemostasis by two coagulometers pathological classification. Concordance in grey zone is not perfectly. The lack of linearity makes impossible the use of regression line. A. Espuch-Oliverb, G.A. De Vicente Lópezb, M.d.M. Maldonado The addition of fluoride to plasma slows down the production of Montoroa, C. Miralles Adella, J.M. Villa Suáreza, T. De Haro Muñoza lactate. It is recommended to analyse plasma lactate, restricting the aHospital Universitario San Cecilio de Granada, Spain total blood analysis to critical or paediatric patients. bHospital Universitario Virgen de las Nieves de Granada, Spain doi:10.1016/j.cca.2019.03.037 Background-aim The Atellica® COAG 360 System is a new automated high volume M003 coagulation analyzer that employ five different methodologies on one platform to study the basic and special hemostasis. A method Limit of in vitro stability of PSA and free PSA in our current comparison study was carried-out between two coagulometers, workflow Atellica® COAG 360 System and Sysmex® CS-5100 System from Siemen Healthineers®. The aim is to evaluate the clinical concor- N. FaÑanas Rodriguez, S. Diez Espiga, A. Moyano Martinez, A. dance between both analyzers for basic hemostasis: Prothrombin Maiztegi Azpitarte, M. Iturralde Ros, R.A. Arrieta, L. MuÑoz Arduengo, Time (PT), activated Partial Thromboplastin Time (aPTT), D-DIMER M. Ortiz Espejo, C. Esparza Del Valle, R. Garcia Sardina (DD) and Fibrinogen according to the Clauss method (Fib). Hospital Universitario Marques de Valdecilla, Spain Methods Background-aim More than a thousand samples of blood plasma from real patients The in vitro stability of PSA during storage temperatures before in citrate tubes were processed in parallel the same day at both analysis may affect total and free PSA concentrations. The limit of analyzers. Results were exported to an excel spreadsheet and the days that these samples can be stored at fridge temperature (4 °C) as statistical analysis was performed with the MedCalc software specified by the manufacturer is 48 h but this information differs (v.13.3.0.0), including Pearson correlation coefficient (r), Passing- from other studies consulted. bablok lineal regression (slope and intercept) and Bland-Altman graphic. Methods Results So the objective of this study was to directly determine the short- term stability of tPSA and fPSA under the storage conditions available The results are shown below (Figures). DD mg/L: r = 0,9916 at our laboratory. In order to decide whether to add, under clinical (IC95% = 0,9853 to 0,9952), slope = 0,9272 (CI95% = 0,8852 to solicitation, a PSA determination or not to a storage sample or how 0,9678), intercept = 0,005 (IC95% = −0,02238 to 0,04640); p = to act when a delay in the analysis occurs. 0,91. TP sec: r = 0,9068 (CI95% = 0,8930 to 0,9189), slope = 0,7537 (CI95% = 0,7293 to 0,7789), intercept = 49,177 (CI95% = 23,473 to Results 73,628); p = 0,35. aPTT sec: r = 0,9610 (CI95% = 0,9554 to 0,9660), slope = 0,8335 (CI95% = 0,8142 to 0,8530), intercept = 37,194 Specimens were centrifuged within 2/4 h of collection and (CI95% = −32,330 to 41,947); p = 0,06. Fib mg/dL: r = 0,9840 analyzed at baseline, 24 h, 48 h, 72 h, 4 and 5 days, until analysis (CI95% = 0,9802 to 0,9870), slope = 10,177(CI95% = 0,9966 to they were stored at 4 °C. The samples were analyzed on the 10,390), intercept = −18,1358 (CI95% = −25,5100 to −11,2745); Siemmens Immulite 2000xpi analyzer. We choose three different p = 0,05. ranges of PSA concentrations, b4 ng/ml, between 4 and 10 ng/ml (where we analyzed the free PSA and calculated the ratio fPSA/tPSA) Conclusions and N10 ng/ml. We analyzed 20 samples of each concentrations. The linearity of aPTT could be corrected applying a negative Conclusions correction factor (−0.8) from valuesN30 s. Rest of parameters show a correct correlation due to the systematic error only appears in high We calculated the percentage of change in the tPSA values and or very high values that exceed the range of clinical significance. The found that, in none of the samples at any time, wasn't greater than bias could be ignored and the use of Atellica® can be validated. the Technical CV. We found a bigger stability that others reports. Although the changes were more important in the fPSA values, when doi:10.1016/j.cca.2019.03.039 Abstracts / Clinica Chimica Acta 493 (2019) S13–S75 M005 with the average concentration of glucose in blood and is limited by the erythrocyte lifespan of approximately 100 to 120 days. As a Use of Sebia ‘CAPILLARYS’ platform analysers for the putative result, HbA1c reflects the average blood glucose level during the 2 to identification of haemoglobin variants 3 months prior to analysis.
Load more

Recommended publications
  • A Comparison of the Erythrocyte Sedimentation Rate and Plasma Viscosity in Detecting Changes in Plasma Proteins
    J Clin Pathol: first published as 10.1136/jcp.30.4.345 on 1 April 1977. Downloaded from J. clin. Path., 1977, 30, 345-349 A comparison of the erythrocyte sedimentation rate and plasma viscosity in detecting changes in plasma proteins R. M. HUTCHINSON1 AND R. D. EASTHAM From the Department ofHaematology, Frenchay Hospital, Bristol SUMMARY The Westergren erythrocyte sedimentation rate (ESR) and plasma viscosity were compared in 114 patients and their correlations with total and differential plasma protein fractions were analysed. There is a linear correlation between these two screening tests. Higher correlation coefficients were obtained between the plasma viscosity and fibrinogen and alpha and gamma globulins than with the ESR. Albumin affected the two tests in opposite directions. The ESR was falsely increased by a fall in haemoglobin even within two standard deviations from the mean. Both tests gave an appreciable number of incorrect values-the plasma viscosity in 21 cases and the ESR in 33. The cause for these is discussed. It is concluded that the plasma viscosity is the more sensitive and reliable measure of changes in acute phase protein reactants and more useful for copyright. monitoring clinical progress. Following tissue injury or inflammation, the series of total and differential protein fraction estima commonest alteration in the concentrations of the tions on blood samples obtained from a group of various plasma proteins is the so-called acute phase patients, an attempt has been made to determine http://jcp.bmj.com/ plasma protein response. The protein fractions which which of these two tests gave the most direct indica- increase include fibrinogen (its concentration can tion of changes in the plasma proteins.
    [Show full text]
  • An Automated Method for Serum Bilirubin Determination
    J Clin Pathol: first published as 10.1136/jcp.21.2.196 on 1 March 1968. Downloaded from J. clin. Path. (1968), 21, 196-201 An automated method for serum bilirubin determination N. A. SIMMONS1 From the Department of Clinical Pathology, Guy's Hospital, London SYNOPSIS A method for the determination of both direct and indirect serum bilirubin on the AutoAnalyzer is described which has a number of advantages over the automated method that is currently recommended. It gives total bilirubin results which are similar to those obtained with the equivalent manual method and direct bilirubin results which are usually about 10 % lower. The effect of haemolysis on estimations was investigated. It has little influence on the total, but significantly lowers the direct bilirubin results. Simple methods for the preparation of true bilirubin standards and a stable control serum are described. In a very careful study Nosslin (1960) showed that the for which values were consequently low. Thirdly, method of Jendrassik and Grof (1938) for the haemolysis reduced the values for total bilirubin. estimation of total serum bilirubin had many advan- Nosslin (1960) did not use ascorbic acid in the total tages over other methods and that a modification of bilirubin procedure. Michaelsson (1961) showed that copyright. it gave a direct reaction which was the best available its inclusion miinimized the effect of haemolysis. He index of conjugated bilirubin in the serum. went on to show that the other disadvantages could In the total bilirubin method the serum was mixed be overcome ifall three reagents, ascorbic acid, diazo with a buffered caffeine solution which acted as an reagent, and accelerator, were all included in all three accelerator and then with diazo reagent.
    [Show full text]
  • Blood Ph, Gases, and Electrolytes
    NBS SPECIAL PUBLICATION 450 U.S. DEPARTMENT OF COMMERCE / National Bureau of Standards NATIONAL BUREAU OF STANDARDS The National Bureau of Standards^ was established by an act of Congress March 3, 1901. The Bureau's overall goal is to strengthen and advance the Nation's science and technology and facilitate their effective application for public benefit. To this end, the Bureau conducts research and provides: (1) a basis for the Nation's physical measurement system, (2) scientific and technological services for industry and government, (3) a technical basis for equity in trade, and (4) technical services to pro- mote public safety. The Bureau consists of the Institute for Basic Standards, the Institute for Materials Research, the Institute for Applied Technology, the Institute for Computer Sciences and Technology, the Office for Information Programs, and the Office of Experimental Technology Incentives Program. THE INSTITUTE FOR BASIC STANDARDS provides the central basis within the United States of a complete and consist- ent system of physical measurement; coordinates that system with measurement systems of other nations; and furnishes essen- tial services leading to accurate and uniform physical measurements throughout the Nation's scientific community, industry, and commerce. The Institute consists of the Office of Measurement Services, and the following center and divisions: Applied Mathematics — Electricity — Mechanics — Heat — Optical Physics — Center for Radiation Research — Lab- oratory Astrophysics^ — Cryogenics" — Electromagnetics" — Time and Frequency". THE INSTITUTE FOR MATERIALS RESEARCH conducts materials research leading to improved methods of measure- ment, standards, and data on the properties of well-characterized materials needed by industry, commerce, educational insti- tutions, and Government; provides advisory and research services to other Government agencies; and develops, produces, and distributes standard reference materials.
    [Show full text]
  • Laboratory Management, Accreditation, Quality Assurance
    Clinica Chimica Acta 493 (2019) S497–S532 Contents lists available at SciVerse ScienceDirect Clinica Chimica Acta journal homepage: www.elsevier.com/locate/clinchim Laboratory management, accreditation, quality assurance M294 M295 International external quality evaluation on new sweat test Evaluation and comparison of HbA1c determination methods analyzer: ISEsweat II O.M. Diz Mellado, M. Calero Ruiz, M. Rico Rodríguez R. Camero UGC Laboratorios, Hospital Universitario Puerta del Mar, Cádiz, Spain Tecnicas Cientificas Para Laboratorio, Spain Background-aim Background-aim Hemoglobin A1c is formed by an uncatalyzed reaction between Introduction. The concentration of chloride in sweat remains the gold the blood glucose and some Hemoglobin A amino acids. This reaction standard for confirming the diagnosis of Cystic Fibrosis. The sweat test is a is proportional to the concentration of blood glucose. HbA1c is tedious laboratory test that traditionally requires 3 correlative steps: formed in two steps by the nonenzymatic reaction of glucose with stimulation, collection and analysis. A new sweat chloride analyzer that the N-terminal amino group of the ® chain of normal adult allows the direct determination of chloride in sweat using disposable hemoglobin (HbA). Glycated hemoglobin is a parameter that cards could reduce the handling of samples and facilitate the sweat test. estimates the average of blood glucose measurements in the last 2- 3 months. Objectives. To compare the analytical performance of the new Compare two automated analytical systems to measure HbA1c in ISEsweat II sweat chloride analyzer with traditional laboratory order to evaluate if they are interchangeable. methods through participation in an international program of external quality assessment. Methods Methods 100 samples are obtained from the hospital and from the primary care area of our center.
    [Show full text]
  • Serum Indices and Interferences
    International Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | April 2019 | Volume 9 | Issue 2 | Page 43-46 Usha Adiga, serum indices and interferences Serum Indices – A tool to Measure Interfering Substances in Blood Samples Usha Adiga Professor, Department of Biochemistry, KS Hegde Medical Academy, Nitte –Deemed to be University, Mangalore, Karnataka, India. ABSTRACT Objectives: Aim of the study was to evaluate the degree of hemolysis, turbidity, and interference by bilirubin by measuring hemolytic, lipemic and icteric indices of the received blood samples in the clinical biochemistry laboratory for routine investigations. Methods: The study was carried out in the Clinical Biochemistry laboratory in January 2016. Total of 695 blood samples were collected and evaluated in autoanalyzer, transasia XL-640. Serum indices (SI) values were assayed and categorized based on their concentration. Percentage of the sample in each category was calculated. Results: Percentage of non-hemolyzed samples was minimum (0.58%), a majority of the samples were non-lipemic (68.3%), and 37% of samples were non-icteric, suggesting that maximum interference is due to hemolysis. The study results quantified the extent of interference by each interfering substance. Conclusion: Estimation of serum indices in an automated analyzer overcomes the limitations of visual estimation of interfering substances. It also provides a more objective and accurate estimation of the interfering substance. Key Words: interference in the analysis, hemolytic index, lipemic index, icteric index eIJPPR 2019; 9(2):43-46 HOW TO CITE THIS ARTICLE: Usha Adiga (2019). “Serum Indices – A tool to Measure Interfering Substances in Blood Samples”, International Journal of Pharmaceutical and Phytopharmacological Research, 9(2), pp.43-46.
    [Show full text]
  • Use of Anticoagulants in Diagnostic Laboratory Investigations
    WHO/DIL/LAB/99.1 Rev.2 Original :ENGLISH Distr.:GENERAL WORLD HEALTH ORGANIZATION USE OF ANTICOAGULANTS IN DIAGNOSTIC LABORATORY INVESTIGATIONS 2002 WHO/DIL/LAB/99.1 Rev.2 Page 2 © World Health Organization This document is not a formal publication of the World Health Organization (WHO), but all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced or translated, in part or in whole, but not for sale or for use in conjunction with commercial purposes. The views expressed by named authors are solely the responsibility of those authors. WHO/DIL/LAB/99.1 Rev.2 Original :ENGLISH Distr.:GENERAL USE OF ANTICOAGULANTS IN DIAGNOSTIC LABORATORY INVESTIGATIONS & Stability of blood, plasma and serum samples Contributors: G. Banfi, Milan, Italy H. Kitta, Usingen, Germany K. Bauer, Vienna, Austria D. Klahr, Tuttlingen, Germany W.Brand, Nümbrecht, Germany D. Kolpe, Nümbrecht-Elsenroth, Germany M.Buchberger, Kremsmünster, Austria J. Kukuk, Limburg, Germany A. Deom, Geneva, Switzerland T. Kunert-Latus, Leuven, Belgium W.Ehret, Augsburg, Germany* M.Lammers, Marburg, Germany W.D. Engel, Mannheim, Germany E.A. Leppänen, Helsinki, Finland F. da Fonseca-Wollheim, Berlin, Germany* P. Mikulcik, Fernwald, Germany C.G. Fraser, Dundee, Scotland S. Narayanan, New York, USA V.J. Friemert, Deisenhofen, Germany M. Neumaier, Hamburg, Germany S. Golf, Giessen, Germany M.A. Peça Amaral Gomes, Lisbon, Portugal H.Gross, Hanau, Germany R. Probst, Munich, Germany W.G. Guder, München ,Germany** Y. Schmitt Darmstadt, Germany* G. Gunzer, Clare, Ireland O. Sonntag, Neckargemünd, Germany P. Hagemann, Zürich, Switzerland G. Töpfer, Görlitz, Germany* W. Heil, Wuppertal, Germany* R.
    [Show full text]
  • Validation of High-Throughput Methods for Measuring Blood Urea Nitrogen and Urinary Albumin Concentrations in Mice
    Comparative Medicine Vol 56, No 6 Copyright 2006 December 2006 by the American Association for Laboratory Animal Science Pages 482-486 Validation of High-throughput Methods for Measuring Blood Urea Nitrogen and Urinary Albumin Concentrations in Mice Susan Grindle,1 Cheryl Garganta,2 Susan Sheehan,1 Joe Gile,1 Andree Lapierre,1 Harry Whitmore,1 Beverly Paigen,1 and Keith DiPetrillo1,†,* Chronic kidney disease is a substantial medical and economic burden. Animal models, including mice, are a crucial component of kidney disease research; however, recent studies disprove the ability of autoanalyzer methods to accurately quantify plasma creatinine levels, an established marker of kidney disease, in mice. Therefore, we validated autoanalyzer methods for measuring blood urea nitrogen (BUN) and urinary albumin concentrations, 2 common markers of kidney disease, in samples from mice. We used high-performance liquid chromatography to validate BUN concentrations measured using an autoanalyzer, and we utilized mouse albumin standards to determine the accuracy of the autoanalyzer over a wide range of albumin concentrations. We observed a significant, linear correlation between BUN concentrations measured by autoanalyzer and high-performance liquid chroma- tography. We also found a linear relationship between known and measured albumin concentrations, although the autoanalyzer method underestimated the known amount of albumin by 3.5- to 4-fold. We confirmed that plasma and urine constituents do not interfere with the autoanalyzer methods for measuring BUN and urinary albumin concentrations. In addition, we verified BUN and albuminuria as useful markers to detect kidney disease in aged mice and mice with 5/6-nephrectomy. We conclude that autoana- lyzer methods are suitable for high-throughput analysis of BUN and albumin concentrations in mice.
    [Show full text]