Does the number of plasma separator tube inversions alter clinical chemistry and immunoassay test results on a Roche Cobas 8000 clinical chemistry platform?

2020 ◽  
Author(s):  
Raffick A.R. Bowen ◽  
Vanessa Esguerra ◽  
Maria Walker
Keyword(s):  
Clinical Chemistry ◽  
Test Results ◽  
Roche Cobas

scholarly journals Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Blood Collection ◽  
Test Results ◽  
Sample Collection ◽  
Rapid Separation ◽  
Cell Counts ◽  
Collection Device ◽  
Precision Study ◽  
Clinically Significant ◽  
Blood Specimens

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.

scholarly journals Personalized Reference Intervals in Laboratory Medicine: A New Model Based on Within-Subject Biological Variation

2020 ◽  
Author(s):  
Abdurrahman Coşkun ◽  
Sverre Sandberg ◽  
Ibrahim Unsal ◽  
Coskun Cavusoglu ◽  
Mustafa Serteser ◽  
...  
Keyword(s):  
Steady State ◽  
Personalized Medicine ◽  
Clinical Chemistry ◽  
Reference Interval ◽  
Reference Intervals ◽  
Biological Variation ◽  
Test Results ◽  
Steady State Condition ◽  
Laboratory Test Results ◽  
Measurement Results

Abstract Background The concept of personalized medicine has received widespread attention in the last decade. However, personalized medicine depends on correct diagnosis and monitoring of patients, for which personalized reference intervals for laboratory tests may be beneficial. In this study, we propose a simple model to generate personalized reference intervals based on historical, previously analyzed results, and data on analytical and within-subject biological variation. Methods A model using estimates of analytical and within-subject biological variation and previous test results was developed. We modeled the effect of adding an increasing number of measurement results on the estimation of the personal reference interval. We then used laboratory test results from 784 adult patients (>18 years) considered to be in a steady-state condition to calculate personalized reference intervals for 27 commonly requested clinical chemistry and hematology measurands. Results Increasing the number of measurements had little impact on the total variation around the true homeostatic set point and using ≥3 previous measurement results delivered robust personalized reference intervals. The personalized reference intervals of the study participants were different from one another and, as expected, located within the common reference interval. However, in general they made up only a small proportion of the population-based reference interval. Conclusions Our study shows that, if using results from patients in steady state, only a few previous test results and reliable estimates of within-subject biological variation are required to calculate personalized reference intervals. This may be highly valuable for diagnosing patients as well as for follow-up and treatment.

An evaluation of the detection capacity of a computer-assisted real-time delta check system.

1979 ◽  
Vol 25 (6) ◽  
pp. 870-872 ◽  
Author(s):  
P P Sher
Keyword(s):  
Real Time ◽  
Clinical Condition ◽  
Clinical Chemistry ◽  
Chemistry Laboratory ◽  
Computer Assisted ◽  
Test Results ◽  
Laboratory Staff ◽  
Laboratory Errors ◽  
Clinical Chemistry Laboratory ◽  
Check System

Abstract We developed of computer programs to evaluate the clinical reliability of test results by comparing each new result with previous results for the same patient, and to signal discrepancies in real time. These "delta check" discrepancies are noted, and they must be reviewed by the laboratory staff before results can appear on a patient's record. During a month, I reviewed 1403 such delta check messages and detected 55 (3.9%) that could not be explained on the basis of the patient's clinical condition. Of these, 23 represented true laboratory errors, which were corrected. The recognition of discrepancies before they appear on patients' reports has facilitated the operation of the clinical chemistry laboratory. Mislabeled and otherwise mishandled specimens are discovered before erroneous results appear on a patient's record.

scholarly journals European survey on preanalytical sample handling – Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EF

2019 ◽  
Vol 29 (2) ◽  
pp. 334-345 ◽  
Author(s):  
Janne Cadamuro ◽  
Michael Cornes ◽  
Ana-Maria Simundic ◽  
Barbara de la Salle ◽  
Gunn B.B. Kristensen ◽  
...  
Keyword(s):  
Online Survey ◽  
Clinical Chemistry ◽  
Internal Quality ◽  
Therapeutic Drug ◽  
European Federation ◽  
Test Results ◽  
Blood Samples ◽  
Sensitive Parameters ◽  
Disease Testing

Introduction: No guideline currently exists on how to detect or document haemolysis, icterus or lipemia (HIL) in blood samples, nor on subsequent use of this information. The EFLM WG-PRE has performed a survey for assessing current practices of European laboratories in HIL monitoring. This second part of two coherent articles is focused on HIL. Materials and methods: An online survey, containing 39 questions on preanalytical issues, was disseminated among EFLM member countries. Seventeen questions exclusively focused on assessment, management and follow-up actions of HIL in routine blood samples. Results: Overall, 1405 valid responses from 37 countries were received. A total of 1160 (86%) of all responders stating to analyse blood samples - monitored HIL. HIL was mostly checked in clinical chemistry samples and less frequently in those received for coagulation, therapeutic drug monitoring and serology/infectious disease testing. HIL detection by automatic HIL indices or visual inspection, along with haemolysis cut-offs definition, varied widely among responders. A quarter of responders performing automated HIL checks used internal quality controls. In haemolytic/icteric/lipemic samples, most responders (70%) only rejected HIL-sensitive parameters, whilst about 20% released all test results with general comments. Other responders did not analysed but rejected the entire sample, while some released all tests, without comments. Overall, 26% responders who monitored HIL were using this information for monitoring phlebotomy or sample transport quality. Conclusion: Strategies for monitoring and treating haemolytic, icteric or lipemic samples are quite heterogeneous in Europe. The WG-PRE will use these insights for developing and providing recommendations aimed at harmonizing strategies across Europe.

scholarly journals European views on patients directly obtaining their laboratory test results

2015 ◽  
Vol 53 (12) ◽  
Author(s):  
Ian D. Watson ◽  
Joanna Siodmiak ◽  
Wytze P. Oosterhuis ◽  
Joel Corberand ◽  
Per E. Jorgensen ◽  
...  
Keyword(s):  
Information Technologies ◽  
Clinical Chemistry ◽  
Information Age ◽  
Negative Attitude ◽  
Laboratory Medicine ◽  
European Federation ◽  
Test Results ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
Changing Practices

AbstractMedicine is a highly professionalized endeavour, by tradition centred on the authority of physicians. Better education and the advent of the information age cater for increased demands on society in general and on health care in particular to enable people to make informed decisions regarding themselves. Participation in medical decisions requires informed knowledge which is hard to obtain without substantial and time consuming professional help.We performed a survey amongst the member organizations of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in order to investigate the recognition and preparedness of providing help to patients in interpreting their laboratory results.Out of 40 EFLM Member Societies, 27 sent their responses to the survey. In most cases the first line delivery of laboratory results to physicians is by computer link (63%). Patients receive their laboratory results on demand from their physician in 60% of cases. However, 34% of laboratory specialists showed a negative attitude for delivering laboratory results to patients. Yet, in 48% of countries 1–5 patients per day ask a laboratory specialist about the significance of laboratory results outside the reference range. When patients are informed about the purpose of laboratory testing, they seek information primarily from their physician, followed by the internet and the Specialist in Laboratory Medicine.Changing practices increasingly enabling patient access to their records are on the increase facilitated by recent innovations in information technologies. Successful transfer of some of the responsibilities of physicians, demands a mutual triangular dialogue between the patient, their physician and laboratory medicine.

scholarly journals Effects of different centrifugation conditions on clinical chemistry and Immunology test results

2011 ◽  
Vol 11 (1) ◽  
Author(s):  
Elisabeth I Minder ◽  
Adrian Schibli ◽  
Dagmar Mahrer ◽  
Predrag Nesic ◽  
Kathrin Plüer
Keyword(s):  
Clinical Chemistry ◽  
Test Results

Bilirubin interferences on clinical chemistry Roche Cobas C 702 assays

2019 ◽  
Vol 493 ◽  
pp. S48-S49
Author(s):  
F. Bustos-Guadaño ◽  
J.L. Martín-Calderón ◽  
M. Maiques-Camarero ◽  
R. Muñoz-Jara ◽  
A. Cantalejo-Gutiérrez ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Roche Cobas

Establishment of reference intervals of clinical chemistry analytes for the adult population in Saudi Arabia: a study conducted as a part of the IFCC global study on reference values

2016 ◽  
Vol 54 (5) ◽  
Author(s):  
Anwar Borai ◽  
Kiyoshi Ichihara ◽  
Abdulaziz Al Masaud ◽  
Waleed Tamimi ◽  
Suhad Bahijri ◽  
...  
Keyword(s):  
Reference Values ◽  
Clinical Chemistry ◽  
Adult Population ◽  
Parametric Method ◽  
Reference Intervals ◽  
Test Results ◽  
Upper Limits ◽  
High Prevalence ◽  
Global Study ◽  
Non Parametric

AbstractBackground:This study is a part of the IFCC-global study to derive reference intervals (RIs) for 28 chemistry analytes in Saudis.Method:Healthy individuals (n=826) aged ≥18 years were recruited using the global study protocol. All specimens were measured using an Architect analyzer. RIs were derived by both parametric and non-parametric methods for comparative purpose. The need for secondary exclusion of reference values based on latent abnormal values exclusion (LAVE) method was examined. The magnitude of variation attributable to gender, ages and regions was calculated by the standard deviation ratio (SDR). Sources of variations: age, BMI, physical exercise and smoking levels were investigated by using the multiple regression analysis.Results:SDRs for gender, age and regional differences were significant for 14, 8 and 2 analytes, respectively. BMI-related changes in test results were noted conspicuously for CRP. For some metabolic related parameters the ranges of RIs by non-parametric method were wider than by the parametric method and RIs derived using the LAVE method were significantly different than those without it. RIs were derived with and without gender partition (BMI, drugs and supplements were considered).Conclusions:RIs applicable to Saudis were established for the majority of chemistry analytes, whereas gender, regional and age RI partitioning was required for some analytes. The elevated upper limits of metabolic analytes reflects the existence of high prevalence of metabolic syndrome in Saudi population.

scholarly journals Design and Development of Microcontroller-Based Clinical Chemistry Analyser for Measurement of Various Blood Biochemistry Parameters

2005 ◽  
Vol 2005 (4) ◽  
pp. 223-229 ◽  
Author(s):  
S. R. Taneja ◽  
R. C. Gupta ◽  
Jagdish Kumar ◽  
K. K. Thariyan ◽  
Sanjeev Verma
Keyword(s):  
High Performance ◽  
Clinical Chemistry ◽  
Blood Parameters ◽  
Renal Diseases ◽  
Test Results ◽  
Biochemical Tests ◽  
Medical College ◽  
Blood Biochemical ◽  
Optical Module ◽  
Interface Devices

Clinical chemistry analyser is a high-performance microcontroller-based photometric biochemical analyser to measure various blood biochemical parameters such as blood glucose, urea, protein, bilirubin, and so forth, and also to measure and observe enzyme growth occurred while performing the other biochemical tests such as ALT (alkaline amino transferase), amylase, AST (aspartate amino transferase), and so forth. These tests are of great significance in biochemistry and used for diagnostic purposes and classifying various disorders and diseases such as diabetes, liver malfunctioning, renal diseases, and so forth. An inexpensive clinical chemistry analyser developed by the authors is described in this paper. This is an open system in which any reagent kit available in the market can be used. The system is based on the principle of absorbance transmittance photometry. System design is based around 80C31 microcontroller with RAM, EPROM, and peripheral interface devices. The developed system incorporates light source, an optical module, interference filters of various wave lengths, peltier device for maintaining required temperature of the mixture in flow cell, peristaltic pump for sample aspiration, graphic LCD display for displaying blood parameters, patients test results and kinetic test graph, 40 columns mini thermal printer, and also 32-key keyboard for executing various functions. The lab tests conducted on the instrument include versatility of the analyzer, flexibility of the software, and treatment of sample. The prototype was tested and evaluated over 1000 blood samples successfully for seventeen blood parameters. Evaluation was carried out at Government Medical College and Hospital, the Department of Biochemistry. The test results were found to be comparable with other standard instruments.

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