Correlation between sodium, potassium, hemoglobin, hematocrit, and glucose values as measured by a laboratory autoanalyzer and a blood gas analyzer.

INTRODUCTION: Blood gas analyzers can be alternatives to laboratory autoanalyzers for obtaining test results in just a few minutes. We aimed to find out whether the results from blood gas analyzers are reliable when compared to results of core laboratory autoanalyzers. MATERIALS AND METHODS: This retrospective, single-centered study examined the electronic records of patients admitted to the emergency department of a tertiary care teaching hospital between May 2014 and December 2017. Excluded from the study were patients under 18 years old, those lacking data, those who had any treatment before the laboratory tests, those whose venous gas results were reported more than 30 minutes after the blood sample was taken and for whom any of the laboratory tests were performed at a different time, and recurrent laboratory results from a single patient. RESULTS: Laboratory results were analyzed from a total of 31,060 patients. The correlation coefficients for sodium, potassium, hemoglobin, hematocrit, and glucose levels measured by a blood gas analyzer and a laboratory autoanalyzer were 0.725, 0.593, 0.982, 0.958, and 0.984, respectively; however, there were no good, acceptable agreement limits for any of the parameters. In addition, these results did not change according to the different pH stages (acidosis, normal pH and alkalosis). CONCLUSION: The two types of measurements showed a moderate correlation for sodium and potassium levels and a strong correlation for glucose, hemoglobin, and hematocrit levels, but none of the levels had acceptable agreement limits. Clinicians should be aware of the limitations of blood gas analyzer results.

Validation of Sysmex XT-2000iV analyzer-generated quantitative bone marrow differential counts in cynomolgus monkeys, Beagle dogs, and CD-1 mice.

BACKGROUND: In a previous study, the validation of rat bone marrow (BM) collection, processing, and analysis using the Sysmex XT-2000iV (Sysmex Corporation, Kobe, Japan) hematology analyzer showed that the Sysmex hematology analyzer produced BM differential counts that were comparable to those obtained with microscopic differential counts. OBJECTIVE: This study was conducted to expand the validation of the Sysmex TNCC (total nucleated cell count) and 5-part BM differential in cynomolgus monkeys, Beagle dogs, and CD-1 mice, which are alternate species that are also frequently used in preclinical safety studies. METHODS: The Sysmex 5-part BM differential counts were generated with a two-step process, whereby proliferating and maturing erythroid and myeloid cells were determined by preset gating and lymphocytes were determined using species-specific B- and T-lymphocyte antibodies and a magnetic cell-sorting method (MACS). Agreement with microscopic myelograms with 500-cell differential counts was determined from BM suspensions of 62 cynomolgus monkeys, 47 Beagle dogs, and 44 CD-1 mice. RESULTS: The correlation coefficients between methods for myeloid to erythroid (M:E) ratios in all three species was > 0.928. The Bland-Altman differences between methods were approximately ± 0.3 units for the M:E ratio in dogs and mice, and +0.6 and -0.4 in monkeys. The upper limits of agreement for all three species were ≤7% for maturing myeloid cells, ≤6% for maturing erythroid cells, and ≤4% for proliferating myeloid cells, proliferating erythroid cells, and lymphocytes. CONCLUSIONS: The Sysmex XT-2000iV produces an automated M:E ratio and a 5-part differential count equivalent to microscopic differential counts in cynomolgus monkeys, Beagle dogs, and CD-1 mice.

Comparison of Enterprise Point-of-Care and Nova Biomedical Critical Care Xpress analyzers for determination of arterial pH, blood gas, and electrolyte values in canine and equine blood.

BACKGROUND: Point-of-care analyzers can provide a rapid turnaround time for critical blood test results. Agreement between the Enterprise Point-of-Care (EPOC) and bench-top laboratory analyzers is important to determine the clinical reliability of the EPOC. OBJECTIVES: The aim of the study was (1) to evaluate the precision (repeatability) of blood gas values measured by the EPOC and (2) to determine the level of agreement between the EPOC and Nova Critical Care Express (Nova CCX) for the assessment of arterial pH, blood gases, and electrolyte variables in canine and equine blood. METHODS: Arterial blood samples from dogs were analyzed on the EPOC and Nova CCX analyzers to determine precision and agreement of pH, PaCO2 , PaO2 , and HCT. The same analytes plus Na+ , K- , and Cl- were analyzed for agreement using equine blood. Statistical analyses included assessment of precision using the coefficient of variation (CV%), and agreement using the Deming regression, Pearson correlation, and Bland-Altman plots. RESULTS: Both analyzers provided precise results of pH, PaCO2 , PaO2, and HCT, meeting CV% quality requirement values. In both species, Deming regression results were acceptable and correlation values were above 0.93 for arterial pH and blood gases, but lower for sodium and chloride. Bland-Altman plots demonstrated varying degrees of bias, but good agreement between the 2 analyzers was seen when arterial blood gases and electrolytes were measured, except for PaCO2 and Cl-. CONCLUSION: The EPOC analyzer provides consistent, reliable results for canine arterial blood gas values and for equine arterial blood gas and electrolyte values. Cl- results could be acceptable with the application of a correction factor, but the PaCO2 results were more variable.

AutoSeqMan: batch assembly of contigs for Sanger sequences.

With the wide application of DNA sequencing technology, DNA sequences are still increasingly generated through the Sanger sequencing platform. SeqMan (in the LaserGene package) is an excellent program with an easy-to-use graphical user interface (GUI) employed to assemble Sanger sequences into contigs. However, with increasing data size, larger sample sets and more sequenced loci make contig assemble complicated due to the considerable number of manual operations required to run SeqMan. Here, we present the 'autoSeqMan' software program, which can automatedly assemble contigs using SeqMan scripting language. There are two main modules available, namely, 'Classification' and 'Assembly'. Classification first undertakes preprocessing work, whereas Assembly generates a SeqMan script to consecutively assemble contigs for the classified files. Through comparison with manual operation, we showed that autoSeqMan saved substantial time in the preprocessing and assembly of Sanger sequences. We hope this tool will be useful for those with large sample sets to analyze, but with little programming experience. It is freely available at https://github.com/ Sun-Yanbo/autoSeqMan.

Evaluation of the delta neutrophil index from an automated blood cell analyser in septic dogs.

Immature granulocytes (IG) are a marker of severe inflammatory states in human beings and animals, and have been linked to a diagnosis of sepsis and poor prognosis. The delta neutrophil index (DNI), automatically calculated by a haematological analyser, provides an estimate of circulating IG. In particular, an increased DNI value has been associated with the severity of sepsis, and mortality, in critically ill human beings. The aims of this study were to determine the DNI reference interval (RI) in healthy dogs, and to evaluate its diagnostic and prognostic significance in dogs with sepsis. A total of 118 dogs with sepsis undergoing a complete blood cell count (CBC) at the time of hospital admission were included retrospectively. Dogs with sepsis were compared to 20 dogs with primary immune-mediated haemolytic anaemia (IMHA) and 99 healthy controls. The DNI RI was set from 0 to 9.2%. The DNI was significantly higher in dogs with sepsis compared to dogs with IMHA and healthy dogs (P<0.001), and significantly higher in dogs with septic shock compared to septic dogs without circulatory failure (P<0.03). No differences were detected between survivors (78/118) and non-survivors (40/118). Septic dogs with a DNI above the RI had significantly higher frequencies of IG and toxic neutrophil changes on manual blood smear evaluation (P=0.03 and P<0.001, respectively). The DNI had a fair performance in identifying dogs with sepsis in this population and predicted septic shock. Larger prospective studies are needed to validate DNI measurement in dogs and to test its clinical utility.

Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing. Final rule.

This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.

Evaluation of mouse red blood cell and platelet counting with an automated hematology analyzer.

An evaluation of mouse red blood cell (RBC) and platelet (PLT) counting with an automated hematology analyzer was performed with three strains of mice, C57BL/6 (B6), BALB/c (BALB) and DBA/2 (D2). There were no significant differences in RBC and PLT counts between manual and automated optical methods in any of the samples, except for D2 mice. For D2, RBC counts obtained using the manual method were significantly lower than those obtained using the automated optical method (P<0.05), and PLT counts obtained using the manual method were higher than those obtained using the automated optical method (P<0.05). An automated hematology analyzer can be used for RBC and PLT counting; however, an appropriate method should be selected when D2 mice samples are used.

Exactitud y concordancia entre glucómetros: un estudio en condiciones habituales de práctica clínica / Accuracy and reliability between glucose meters: a study under normal clinical practice conditions

Introducción. Los glucómetros demuestran habitualmente una gran exactitud, y en la práctica, la glucemia capilar y la glucemia plasmática (GP) son utilizadas indistintamente. Sin embargo, numerosas variables pueden afectar la validez de estos aparatos. El objetivo de este estudio fue conocer la exactitud y la concordancia de 3 glucómetros utilizados en las consultas de un EAP. Material y métodos. De 59 participantes se obtuvieron una muestra de sangre venosa y una gota de sangre capilar, que fue analizada en 3 glucómetros: 2 FreeStyle® Optium (OP1 y OP2) y un Accu-Chek® Aviva. El valor de referencia fue la GP y fueron analizados asimismo el hematocrito y los niveles plasmáticos de urea, bilirrubina, ácido úrico y triglicéridos. Se utilizaron la regresión de Passing-Bablok para la exactitud, y el coeficiente de correlación intraclase y el método Bland-Altman para la concordancia. Se ha considerado el estándar actual (American Diabetes Association) de un error tolerado de±5%. Resultados. La diferencia de medias±desviación estándar (mg/dL) y el error sistemático fueron: 5,8±7 y 5,8% (OP1); 6,2±8 y 5,9% (OP2); 8,3±8 y 6,3% (Accu-Chek®). El par más concordante fue OP1/OP2, con un coeficiente de correlación intraclase=0,97, sesgo=−0,4mg/dL y una amplitud de los límites de acuerdo con el 95%=28,6mg/dL. Se observaron los mayores grados de exactitud y de concordancia en rangos glucémicos elevados (GP≥126mg/dL). Conclusiones. Aunque mostraron una diferencia de medias clínicamente aceptable respecto a la GP, los 3 glucómetros incumplieron el estándar actual de la American Diabetes Association. Es recomendable la realización periódica de controles de calidad de estos dispositivos (AU)

Introduction. The glucose meters usually show a high accuracy, and in clinical practice, capillary and plasma glucose (PG) are used interchangeably. However, many variables can affect the validity of these devices. The aim of this study was to determine the accuracy and reliability of 3 glucose meters that are currently used in a primary care centre. Material and methods. A sample of venous blood and a drop of capillary blood were obtained from 59 participants. The drop was analysed in 3 glucose meters: 2 FreeStyle® Optium (OP1 and OP2), and one Accu-Chek® Aviva. The PG acted as the reference value, and the haematocrit and plasma levels of urea, bilirubin, uric acid and triglycerides were also analysed. We used the Passing-Bablok regression for accuracy and the intraclass correlation coefficient and the Bland-Altman method for reliability. The current American Diabetes Association standard of a total error of±5% was applied. Results. Differences in mean±standard deviation (mg/dL) and the systematic error were 5.8±7 and 5.8% (OP1); 6.2±8 and 5.9% (OP2); 8.3±8 and 6.3% (Accu-Chek®). The OP1/OP2 pair showed the highest level of reliability, with an intraclass correlation coefficient=0.97, bias=−0.4mg/dL, and a width of the 95% limits of agreement of 28.6mg/dL. The highest levels of accuracy and reliability were observed in high glucose ranges (PG≥126mg/dL). Conclusions. Despite their clinically acceptable mean difference compared to the PG, the 3 glucose meters did not fulfill the current American Diabetes Association standard. The regular performance of quality control tests of these devices is recommended (AU)

Comparison of different methods for measurement of electrolytes in patients admitted to the intensive care unit.

OBJECTIVES: To investigate whether electrolyte levels measured by using blood gas analyzers (ABG) and auto-analyzers (AA) are equivalent and can be used interchangeably. METHODS: This observational prospective study was conducted in 100 patients admitted to the Intensive Care Unit, Adnan Menderes University School of Medicine, Aydin, Turkey, between March and August 2014. Samples for both AA and ABG analyzers were collected simultaneously from invasive arterial catheters of patients. The electrolyte levels were measured by using 2 methods. RESULTS: The mean sodium level measured by ABG was 136.1 ± 6.3 mmol/L and 137.8 ± 5.4 mmol/L for AA (p=0.001). The Pearson's correlation coefficient was 0.561 (p less than 0.001). The Bland-Altman 95% limits of agreement were -9.4 to 12.6 mmol/L. The mean potassium levels measured by ABG was 3.4 ± 0.7 mmol/L and AA was 3.8 ± 0.7 mmol/L (p=0.001). The Bland-Altman comparison limits were -0.58 to 1.24 and the associated Pearson's correlation coefficient was 0.812 (p less than 0.001). CONCLUSION: The results of the 2 analyzing methods, in terms of sodium, were not equivalent and could not be used interchangeably. However, according to the statistical analyses results, by including, but not blindly trusting these findings, urgent and vital decisions could be made by the potassium levels obtained from the BGA, but a simultaneous follow-up sample had to be sent to the central laboratory for confirmation.

Adaptación y validación al español del cuestionario de percepción infantil CPQ-Esp11-14 en población comunitaria chilena / Adaptation and validation of the spanish versión of child perception questionnaire CPQ-Spn11-14 in a chilean community population

Fundamentos. Con el fin de medir de forma válida la calidad de vida relacionada con la salud oral en escolares, el objetivo de este trabajo fue adaptar y validar el CPQ11-14 al español y confirmar los cuatro dominios de CPQ-Esp11-14 en su versión completa y abreviada de 16 y 8 ítems. Métodos. El instrumento fue traducido y adaptado al español, posteriormente fue administrado a 288 jóvenes de 12 años que asisten a escuelas públicas. Se realizó un examen bucodental para medir historia de caries con el índice CAOD. Se evaluó la estructura conceptual de las escalas con el análisis factorial y se evaluó la consistencia interna con Alpha de Crombach, estabilidad temporal test-retest con Coeficiente de correlación intraclase y la validez concurrente con la correlación del puntaje del CPQ-Esp11-14 con la historia de caries. Resultados: Las cinco medidas usadas para confirmar la estructura de los factores de la versión de 37 ítems mostraron valores fuera del rango de ajuste del modelo. La versión de 16 y 8 ítems presentó los indicadores dentro de valores que indican ajuste del modelo. La consistencia interna de la escala completa y versiones de 16 y 8 ítems medida con Alpha de Crombach fue mayor a 0,6. Todas las versiones tuvieron coeficiente de correlación intraclase superior a 0,81, excepto en subescala limitaciones funcionales de la versión a de 16 ítems. La correlación Rho de Spearman fue significativa entre CAOD y puntaje del cuestionario, excepto para síntomas orales de la versión total y la versión a y b de la escala de 16 ítems. Conclusiones: la estructura hipotética de los factores fue confirmada por el AFC para las versiones de 16 y 8 ítems. La información que contiene los ítems de las versiones abreviadas permite medir la calidad de vida relativa a la salud en niños chilenos (AU)

Background: In order to validly measure the oral health related quality of life in school age children it is necessary to adapt and validate the CPQ 11-14 for Spanish language. To confirm the four domains of CPQ-Esp 11-14 for the full and abbreviated version of 16 and 8 items. Methods: The instrument was translated into Spanish and culturally adapted. It was administered to 288 12 year-old children attending public schools. Dental caries experience was measure with the DMFT index. The conceptual structure of the scales was assessed by the AFC. It was also evaluated: internal consistency with Cronbach ‘s alpha, test- retest temporal stability with intraclass correlation coeficient, and concurrent validity with correlation of score CPQ-Esp 11-14 with caries experience. Results: The five measures used to confirm the structure of the factors on the version of 37 items showed values outside the range of the model fit. Version 16 and 8 items obtained indicators within values indicating the model fit. The internal consistency of full scale and versions 16 and 8 items were measured with Cronbach Alpha wich was higher than 0.6. All versions had intraclass correlation coefficient above 0.81, except for functional limitations of the subscale version a of 16 items. The Rho Spearman correlation was significant between CAOD and the score the questionnaire, except for oral symptoms and full version b version of 16 items. Conclusions: The hypothetical factor structure was confirmed by the CFA for 16 and 8 items versions. The information contained in abbreviated items allows measuring oral health related quality of life in Chilean children (AU)

Cerebrospinal fluid protein and glucose examinations and tuberculosis:Will laboratory safety regulations force a change of practice?

Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations.

Automated urine screening devices make urine sediment microscopy in diagnostic laboratories economically viable.

Automated urinalysis devices are reproducible, accurate and faster than the standard manual microscopy. Economic analysis has shown that decreases in turn-around-time and labour cost savings offered by these devices make them more economic than manual microscopy.

Detecting endotoxin activity in bovine serum using an automated testing system.

The aim of the present study was to compare the ability of the commercially available portable test system (PTS(TM)) to detect endotoxin activity in bovine serum, with that of the traditional LAL-kinetic turbidimetric (KT) and chromogenic (KC) assays. Prior to testing, serum samples, which were obtained from endotoxin-challenged cattle, were diluted 1:20 in endotoxin-free water and heated to 80°C for 10 min. The performance of the PTS(TM) was not significantly different from that of the traditional LAL-based assays. The results using PTS(TM) correlated with those using KT (r(2)=0.963, P<0.001) or KC assays (r(2)=0.982, P<0.001). Based on these findings, the PTS(TM) could be applied as a simplified system to assess endotoxin activity in bovine serum.

[Development of automatic urine monitoring system].

An automatic urine monitoring system is presented to replace manual operation. The system is composed of the flow sensor, MSP430f149 single chip microcomputer, human-computer interaction module, LCD module, clock module and memory module. The signal of urine volume is captured when the urine flows through the flow sensor and then displayed on the LCD after data processing. The experiment results suggest that the design of the monitor provides a high stability, accurate measurement and good real-time, and meets the demand of the clinical application.

[Development and analytical validation according COFRAC recommendations of pyruvate and ketone body assay on open automated analyser]. / Mise au point et validation en portée B selon les recommandations du Cofrac d'un dosage de pyruvate et de corps cétoniques sur un automate ouvert.

Measurements of pyruvate and ketones bodies (acetoacetate and 3-hydroxybutyrate) are essential to the investigation of intermediary metabolism. Indeed, their blood levels reflect energy balance influenced by nutritional status. This balance can be disturbed in certain diseases such as diabetes and some inherited metabolic disorders. We have developed methods for assays on open automated biochemistry analyser, Konelab 20 XT (ThermoFischer, Whaltham USA), using kits marketed by Sobioda (Montbonnot, France) for pyruvate and Wako Chemicals GmbH (Neuss, Germany) for ketones, on deproteinised blood sample. We have validated the performance of these three quantitative methods using NF EN ISO 15189 (range B) standard criteria. We obtain satisfactory results concerning fidelity (precision measured as within and between batch CVs are respectively less than 7% and less than 6%), measuring ranges (from 7.7 to 228 µmol/L for pyruvate and from 22.6 to 650 µM for total ketone bodies), accuracy (10.4 µmol/L in physiological range for pyruvate and 7.1 µmol/L for 3-hydroxybutyrate) and comparing methods (versus manual assay with spectrophotometry on Uvikon XL). Establishment of reference ranges (35 to 74 µmol/L for pyruvate, less than 100 µM for 3-hydroxybutyrate and less than 44 µmol/L for acetoacetate) and reagents stability study (up to 12 weeks if frozen) have enabled us to finalize method validation and to add these assays to our routine laboratory repertoire.