scholarly journals Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

2019 ◽  
Vol 65 (6) ◽  
pp. 791-797 ◽  
Author(s):  
Tone Bukve ◽  
Sverre Sandberg ◽  
Wenche S Vie ◽  
Una Sølvik ◽  
Nina G Christensen ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Whole Blood ◽  
External Quality Assessment ◽  
Point Of Care ◽  
C Reactive Protein ◽  
External Quality ◽  
Reactive Protein ◽  
Target Value ◽  
Reference Target ◽  
Deming Regression

Abstract BACKGROUND The optimal situation in external quality assessment (EQA) is to use commutable materials. No previous study has examined the commutability of a whole-blood material for point-of-care (POC) testing. The aim of this study was to determine the commutability of the Norwegian Quality Improvement of Laboratory Examinations (Noklus) organization's “in-house” whole-blood EQA material for C-reactive protein (CRP), glucose, and hemoglobin for frequently used POC instruments in Norway and to determine the possibility of using a common target value for each analyte. METHODS The study was performed according to the Clinical and Laboratory Standards Institute guidelines. The EQA material was pooled stabilized EDTA venous whole-blood containing different concentrations of the analytes. The EQA material and native routine patient samples were analyzed using 17 POC and 3 hospital instruments. The commutability was assessed using Deming regression analysis with 95% prediction intervals for each instrument comparison. RESULTS The EQA material was commutable for all CRP and hemoglobin POC instruments, whereas for glucose the material was commutable for all POC instruments at the lowest concentration analyzed [126.0 mg/dL (7.0 mmol/L)] and for 3 POC instruments at all of the concentrations analyzed. CONCLUSIONS Noklus EQA participants using CRP and hemoglobin POC instruments now receive results that are compared with a reference target value, whereas the results for participants using glucose POC instruments are still compared with method-specific target values. Systematic deviations from a reference target value for the commutable glucose POC instruments can be calculated, and this additional information can now be offered to these participants and to the manufacturers.

scholarly journals Evaluation of INSTAND e.V.’s external quality assessment for C-reactive protein and procalcitonin

PLoS ONE ◽  
2019 ◽  
Vol 14 (8) ◽  
pp. e0221426 ◽  
Author(s):  
Nathalie Wojtalewicz ◽  
Ingo Schellenberg ◽  
Klaus-Peter Hunfeld
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
C Reactive Protein ◽  
External Quality ◽  
Reactive Protein

The application of Six Sigma to perform quality analyses of plasma proteins

2019 ◽  
Vol 57 (2) ◽  
pp. 121-127
Author(s):  
Fumeng Yang ◽  
Wenjun Wang ◽  
Qian Liu ◽  
Xizhen Wang ◽  
Guangrong Bian ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Assessment ◽  
Six Sigma ◽  
Plasma Proteins ◽  
External Quality Assessment ◽  
Internal Quality ◽  
C Reactive Protein ◽  
External Quality ◽  
Reactive Protein ◽  
Assessment Standards

Background The Six Sigma theory is an important tool for laboratory quality management. It has been widely used in clinical chemistry, haematology and other disciplines. The aim of our study was to evaluate the analytical performance of plasma proteins by application of Sigma metric and to compare the differences among three different allowable total errors in evaluating the analytical performance of plasma proteins. Methods Three different allowable total error values were used as quality goals. Data from an external quality assessment were used as bias, and the cumulative coefficient of variation in internal quality control data was used to represent the amount of imprecision during the same period. Sigma metric of analytes was calculated using the above data. The quality goal index was calculated to provide corrected measures for continuous improvements in analytical quality. Results The Sigma metric was highest using the external quality assessment standards of China: it was sigma ≥6 or higher in 57.1% of plasma proteins. But Sigma metric was lower by using RiliBÄK or biological variation standards. IgG, C3 and C-reactive protein all required quality improvements in imprecision. A single-rule 13s for internal quality control was recommended for IgA, IgM, C4 and rheumatoid factor, whereas multiple rules (13s/22s/R4s) were recommended for IgG, C3 and C-reactive protein, according to the external quality assessment standards of China. Conclusions Different quality goals can lead to different Sigma metric for the same analyte. As the lowest acceptable standard in clinical practice, the external quality assessment standard of China can guide laboratories to formulate reasonable quality improvement programmes.

scholarly journals Feasibility for aggregation of commutable external quality assessment results to evaluate metrological traceability and agreement among results

2021 ◽  
Vol 59 (1) ◽  
pp. 117-125
Author(s):  
Eline A. E. van der Hagen ◽  
Cas Weykamp ◽  
Sverre Sandberg ◽  
Anne V. Stavelin ◽  
Finlay MacKenzie ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Metrological Traceability ◽  
Relative Difference ◽  
Global Scale ◽  
External Quality ◽  
Aggregated Data ◽  
Target Value ◽  
Reference Target ◽  
Eqa Schemes

AbstractObjectivesExternal quality assessment (EQA) with commutable samples is used for assessing agreement of results for patients’ samples. We investigated the feasibility to aggregate results from four different EQA schemes to determine the bias between different measurement procedures and a reference target value.MethodsWe aggregated EQA results for creatinine from programs that used commutable EQA material by calculating the relative difference between individual participant results and the reference target value for each sample. The means and standard errors of the means were calculated for the relative differences. Results were partitioned by methods, manufacturers and instrument platforms to evaluate the biases for the measurement procedures.ResultsData aggregated for enzymatic methods had biases that varied from −8.2 to 3.8% among seven instrument platforms for creatinine at normal concentrations (61–85 μmol/L). EQA schemes differed in the evidence provided about the commutability of their samples, and in the amount of detail collected from participants regarding the measurement procedures which limited the ability to sub-divide aggregated data by instrument platforms and models.ConclusionsEQA data could be aggregated from four different programs using different commutable samples to determine bias among different measurement procedures. Criteria for commutability for EQA samples as well as standardization of reporting the measurement methods, reagents, instrument platforms and models used by participants are needed to improve the ability to aggregate the results for optimal assessment of performance of measurement procedures. Aggregating data from a larger number of EQA schemes is feasible to assess trueness on a global scale.

Development of a point-of-care assay system for high-sensitivity C-reactive protein in whole blood

2003 ◽  
Vol 332 (1-2) ◽  
pp. 51-59 ◽  
Author(s):  
Jae Soon Ahn ◽  
Sunga Choi ◽  
Sang Ho Jang ◽  
Hyuk Jae Chang ◽  
Jae Hoon Kim ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
High Sensitivity ◽  
Assay System ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Point Of Care Assay

scholarly journals Accuracy of HbA1c as Monitored by External Quality Assessment and Compared With Patient Mean Values

2018 ◽  
Vol 12 (4) ◽  
pp. 771-779 ◽  
Author(s):  
Gunnar Nordin
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Small Variation ◽  
Specific Method ◽  
External Quality ◽  
Swedish Population ◽  
Mean Values ◽  
Hba1c Test ◽  
Performance Specifications

Background: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. Methods: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database. The results are compared to current analytical performance specifications (APS) and to the mean HbA1c levels for the Swedish population of persons with type 2 diabetes. Results: The accuracy of the HbA1c test has improved during the period. The hospital lab methods used in Sweden now fulfil APS agreed by professional organizations in Sweden. The accuracy for point-of-care tests (POCT) methods vary over time and fulfil APS for some periods. The bias found for some of the methods might explain changes seen in patient mean values for HbA1c in Sweden during the period 2007-2017. Conclusions: The global standardization of HbA1c has resulted in an improved comparability for HbA1c-results worldwide. But even small variation in trueness for the methods in use might have important impact on mean HbA1c values for cohorts of patients. When a systematic error is observed for a specific method it is therefore essential that manufacturers correct the method without delay.

Rapid C-reactive protein determination in whole blood with a White Light Reflectance Spectroscopy label-free immunosensor for Point-of-Care applications

2018 ◽  
Vol 260 ◽  
pp. 282-288 ◽  
Author(s):  
Georgios Koukouvinos ◽  
Dimitrios Goustouridis ◽  
Konstantinos Misiakos ◽  
Sotirios Kakabakos ◽  
Ioannis Raptis ◽  
...  
Keyword(s):  
White Light ◽  
Whole Blood ◽  
Point Of Care ◽  
Reflectance Spectroscopy ◽  
Label Free ◽  
C Reactive Protein ◽  
Protein Determination ◽  
Reactive Protein ◽  
Light Reflectance
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