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Laboratory Management, Accreditation, Quality Assurance

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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. For the HbA1c analysis are used two Methods and materials. The chloride of 24 blind samples with methods:Turbidimetric Inhibition Immunoassay (C obas 6000, c501, disposable sensor cards on the ISEsweat II sweat chloride analyzer Roche Diagnostics®) and High Performance Liquid Chromatography (RIQAS sweat testing program from Randox Laboratories, Ltd) was (HPLC) (ADAMS HA8180V A. Menarini Diagnostics® ). Everyday the evaluated monthly during 2 years. analyzers are tested with two control levels (low and high). The EDTA anticoagulant tube is used for HbA1c measurement. Results Imprecision, linearity, detection limit, functional sensitivity and correlation studies are analyzed. The results of the ISEsweat II analyzer were compared with 41 laboratories, using 5 different chloride determination methods (Coulom- Results etry, Colorimetry, Titrimetry, Direct ISE Potentiometry, Indirect ISE Potentiometry) from 15 countries belonging to 3 continents. The cycle Linearity study: y= 0,998× + 0,143 (correlation coefficient: 0,999). average absolute SDI for cycle1 was 1.02, and for cycle2 was 0.46. Detection limit: 4.7% Functional sensitivity: A blood sample is used with a known Conclusions result of HbA1c (6,5%). This level is the one used to considered if diabetes is or not well controlled. The variation coefficient at this The analytical performance of ISEsweat is comparable to that of concentration is b0.01. conventional laboratory analytical methods for analyzing chloride in Correlation study: y=1,015× + 0,121 (correlation coefficient: sweat. On RIQA’s EQA an “acceptable performance” it’s a value for cycle 0,998). average absolute SDI below 2, on our cases it was 1.02 and 0.46. The results obtained confirm the validity of the new ISEsweat II sweat Conclusions chloride analyzer as an alternative to traditional laboratory methods approved in the current guidelines for the diagnosis of cystic fibrosis. A good correlation was observed between HPLC and inmunoturbidimetric methods, therefore are interchangeable and doi:10.1016/j.cca.2019.03.1047 acceptable for the diabetes control. 0009-8981/$ – see front matter Abstracts / Clinica Chimica Acta 493 (2019) S497–S532 The limit detection indicated that values l^ess or equal than 4.7 M297 can not be reported accurately. It is possible to conclude that the HbA1c determination, by HPLC Management of demand of AST in outpatient patients fulfills the required requirements for the diabetes control from the technical point of view, and therefore, its use and implementation in D. González Benito, S. García Castañón, C. Sopeña Sánchez, V. García the routine of the clinical laboratory is possible. Moreira, F.J. Cepeda Piorno, C. Alberdi García Del Castillo, A. Llorente One limitation of the study is that patients with variants or anemia Torres, E. Fernández Rodríguez have been studied, so no conclusions can be drawn in these groups. Clinical Analysis Department, University Hospital Of Cabueñes, Gijón, Spain doi:10.1016/j.cca.2019.03.1048 Background-aim ALT, AST and GGT determinations are useful in the diagnosis and fi M296 follow-up of hepatic diseases. Its use has signi cantly increased during last years. Its essential is appropriate use, avoiding the Study of laboratory tests requests to an emergency laboratory unnecessary parameter determination, and its application will be fi from a general hospital emergency department adequate to the scienti c evidence. The aim of this study is to determine the effect that would be obtained after protocol implementation of AST refusement in B. Garcia-San Vicente, D. Martinez, A. Calderon, B. Fernandez, M. patients with average values of ALT and GGT, in a sample of Gonzalez, P. Muñoz, I. Palacios, L. Pastor outpatients of our Health Area. Hospital Universitario de Alava, Vitoria-Gasteiz, Spain Methods Background-aim An observational retrospective study was performed for all the Introduction. Urgent attention is a main and valuable issue for received requests from Primary and Specialized Care during the last health services. As it is a complex assistance, adecuated test term of 2017 in patients over the age of 18 years and with ALT, AST and laboratory request is prioritary to ensure an appropriated and GGT results. Hemolized samples were excluded, and also patients with a affordable patient management. diagnosis of liver disease or those who attend the Digestive Department Objectives: The aim of this work is to evaluate the appropriate- were excluded. Blood tests with average values of ALT and GGT were ness of the urgent Laboratory tests requested from the Emergency selected: ALT: 4-41 U/L, GGT men: 2-30 U/L and GGT women 1-24 U/L. Department to the Emergency Laboratory of the Hospital. The concentration measurement of ALT, AST and GGT was performed in blood samples in the ADVIA 2400 Clinical Chemistry Methods System. Normal values were considered as follows: AST: 4-41 U/L for fi men and 4-35 U/L for women. Methods^. We quanti ed the number of petitions and tests requested to the Emergency Laboratory from the Emergency Results Department within last year, 2018, and calculated AST/ALT, Urea/ Creatinine and CK/Troponine ratios to assess the proper demand. From the 11445 tests with results for AST, ALT and GGT, 7036 (61.48%) had average values for ALT and GGT. From those, 63 (0.90%) Results had AST values higher than normal. Gender distribution: 29 (1.09%) from 2658 tests in men, and 34 (0.78%) from 4378 sample in women. 18 We processed 36767 petitions, 23175 venous samples, 9257 urine samples had nontypical values of AST, from those, 14 belong to patients samples, 2397 arterial samples, 1897 respiratory samples, 27 cerebro- with hepatic diseases as hepatitis or liver cancer but that had not been spinal fluid samples and 20 other biological fluids samples. The most indicated in their diagnosis, and only four had no explanation. requested tests were : ions (Na,K), 21157; Creatinine,21100; Glucose, 2108; Complete blood count (CBC)20966; Protrombine ratio, 18516; C Conclusions Reactive Protein (CRP), 18487; Urea, 17829; Activated Partial Tromboplastine ratio,13885; ALT,133102; AST,11917; Urinalysis,7987; 61.48% of the AST requests would not have been performed if the Amilase, 4575; LDH,4240; Troponine,3890; Blood gas, 3940; BT,3421; protocol had implemented. The 99.10% AST requests with normal CK, 3101; BNP,2327;Procalcitonine 1647 and Calcium, 1484. values of ALT and GGT do not yield any benefit so the test performation AST/ALT ratio was 0.91 (desirable b0.25) , urea/creatinine ratio is not justified in outpatients without previous hepatic disease. was 0.85 (desirable b0.1) and CK/Troponine 0.80(desirableb1) This protocol implementation would help to use more efficiently the AST test with a cost decrease and a work overloaded reduction. Conclusions doi:10.1016/j.cca.2019.03.1050 Most petitions covered Ions, Creatinine, Glucose and CBC AST/ ALT and Urea/Creatinine ratios were too far from desirable values CK/^Troponine ratio was whithin desirable limits M298 We should implement actions to improve a proper demand and agree suitable protocols with the Emergency Department Verification of common biochemical reference intervals on Alinity ci in Karachi, Pakistan doi:10.1016/j.cca.2019.03.1049 F. Kanani, M. Zubairi, U. Ata, A.H. Kazmi The Indus Hospital, Pakistan Abstracts / Clinica Chimica Acta 493 (2019) S497–S532 Background-aim Background-aim Alinity ci was recently launched internationally by Abbott The term six sigma means 99.9997% accuracy or 3.4 defect rates Diagnostics. We were amongst the first to install these analyzers on per million transactions. In laboratory studies, sometimes false Accelerator a3600 in Pakistan. It is
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