Glycated Hemoglobin Measurement: Comparison of Three Methods Versus High Performance Liquid Chromatography

2021 ◽  
pp. 193229682199717
Author(s):  
María Zulema Chaila ◽  
Matías Viniegra ◽  
Juan José Gagliardino ◽  
Alfredo Martínez ◽  
María Gabriela Simesen de Bielke ◽  
...  
Keyword(s):  
High Performance ◽  
Glycated Hemoglobin ◽  
Clinical Chemistry ◽  
Intraclass Correlation ◽  
Method Comparison ◽  
Control Program ◽  
International Federation ◽  
High Complexity ◽  
Quality Control Program ◽  
Mean Values

Background: HbA1c result provide information on metabolic control in diabetes mellitus (DM) and could also be used for its diagnosis. For its determination, the laboratory must be certified by the National Glycohemoglobin Standardization Program (NGSP) or the International Federation of Clinical Chemistry (IFCC) and comply with a strict quality control program. Aims: To determine the correlation and agreement between HbA1c results measured by three analytical methods (enzymatic, turbidimetric, and capillary electrophoresis) versus HPLC. Methods: Method comparison—1245 samples from equal number of subjects at 45 Association of High Complexity Laboratories (Asociación de Laboratorios de Alta Complejidad—ALAC) centers, centralizing sample processing and operator. Statistical analysis—analysis of variance (ANOVA) and nonparametric Friedman ANOVA test for related samples, means, and medians. Correlation and concordance—Pearson’s correlation and linear regression, intraclass correlation coefficient (Passing and Bablock and Bland and Altman). Results: The comparison of mean values obtained by the four methods showed statistically significant, but clinically irrelevant, differences: HbA1c by HPLC versus Electrophoresis 0.06% (0.42 mmol/mol) P = .000 (± 1.96 DS -0.070 -0.047), Enzymatic 0.087% (1 mmol/mol) P = .000 (± 1.96 DS 0.077 0.098), Turbidimetric 0.056% (0.38 mmol/mol) P = 0.000 (± 1.96 DS -0.067 -0.044). Their concordance showed intraclass correlation of single measures of 0.982 P < .001 (95% CI 0.987 - 0.9838). Conclusions: The three methods present low variability and high correlation versus the HPLC.

scholarly journals Comparison of Turbidimetric Inhibition Immunoassay, High-Performance Liquid Chromatography, and Capillary Electrophoresis Methods for Glycated Hemoglobin Determination

2020 ◽  
Vol 51 (6) ◽  
pp. 579-584
Author(s):  
Mehwish Gilani ◽  
Mohammad Aamir ◽  
Ammad Akram ◽  
Zujaja Hina Haroon ◽  
Aamir Ijaz ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Glycated Hemoglobin ◽  
Clinical Chemistry ◽  
Method Comparison ◽  
Armed Forces ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
The Mean

Abstract Objective The purpose of this study was to compare the performances of and evaluate the agreement among glycated hemoglobin values analyzed by using National Glycohemoglobin Standardization Program-certified and International Federation of Clinical Chemistry-standardized analyzers. This cross-sectional study was conducted at the Armed Forces Institute of Pathology, Department of Chemical Pathology from March 2019 to May 2019. Methods Glycated hemoglobin (HbA1c) was measured in the blood specimens from 100 patients on an ADVIA 1800 by a turbidimetric inhibitory immunoassay (TINIA), Sebia instrument by electrophoresis, and Bio-Rad Variant II Turbo system by high-performance liquid chromatography (HPLC). Quantitative variables were calculated as the mean ± standard deviation (SD). Precision and method comparisons were carried out according to Clinical and Laboratory Standards Institute recommendations. The results obtained from each analyzer were compared by correlation analysis. Method comparison was done by linear regression and Bland-Altman plots using the SPSS software version 24. Results The mean ± SD HbA1c values from TINIA, electrophoresis, and HPLC were 7.188% ± 1.89%, 7.164% ± 1.866%, and 7.160% ± 1.85%, respectively. The between-run coefficients of variation for TINIA, electrophoresis, and HPLC were 0.64%, 0.61%, and 0.60%, respectively. All 3 showed good correlation (TINIA, R2 = .994, P = .00; electrophoresis, R2 = .992, P = 0.00; and HPLC, R2 = .994, P = 0.00). Conclusion The good clinical agreements of HbA1c and strong correlations between analyzers indicate that these analyzers can be used interchangeably.

Analytical Bias in a Quality Control Scheme

1969 ◽  
Vol 15 (11) ◽  
pp. 1039-1044 ◽  
Author(s):  
John R Allen ◽  
Rachel Earp ◽  
E Christis Farrell ◽  
H D Grümer
Keyword(s):  
Quality Control ◽  
Clinical Chemistry ◽  
Control Program ◽  
Chemistry Laboratory ◽  
Quality Control Program ◽  
Control Scheme ◽  
Clinical Chemistry Laboratory ◽  
Random Times ◽  
Quality Control Scheme ◽  
Control Samples

Abstract A quality control program utilizing both "known" and "blind" control specimens was analyzed in the routine clinical chemistry laboratory. The results obtained with the control samples of 18 automated and nonautomated procedures demonstrated the presence of analytical bias. Only through the evaluation of blind control samples tested at random times can a reliable measure of the proficiency of the laboratory be achieved.

Comparison of the International Federation of Clinical Chemistry and Japan Diabetes Society reference methods for conversion to the National Glycohemoglobin Standardization Program values

2019 ◽  
Vol 56 (4) ◽  
pp. 508-514
Author(s):  
Katsuyuki Nakajima ◽  
Isao Koyama ◽  
Makoto Watanabe ◽  
Masakazu Nakamura ◽  
Yoshihiro Miyamoto ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Method Comparison ◽  
Reference Method ◽  
International Federation ◽  
Haemoglobin A1c ◽  
Regression Equations ◽  
National Programmes ◽  
The Us ◽  
Level 1 ◽  
The Relationship

Background The national programmes for the harmonization of haemoglobin A1c measurement in the US and Japan are based on differently designated comparison methods. The future basis for international standardization is expected to be the reference system developed by the International Federation of Clinical Chemistry (IFCC) Working Group on haemoglobin A1c Standardization. The aim of the present study is to compare the relationship between the IFCC reference method (RM) and Japanese Diabetes Society (JDS) RM used for the conversion to the National Glycohemoglobin Standardization Program (NGSP) values. Methods Three different method-comparison studies were performed. All blood samples were measured at the National Cerebral and Cardiovascular Centers (Lipid Reference Laboratories) that serve as Level 1 reference laboratories of the NGSP Network. Regression equations were calculated for the IFCC RM and JDS RM for the conversion to NGSP values. Results Differences were found between the haemoglobin A1c values of the IFCC RM and those of JDS. However, in all cases, the relationships of the IFCC RM and JDS RM were linear and commutable. The relationship is described by the following regression equations: NGSP-HbA1c = 0.915(IFCC-HbA1c) + 2.15% (r2 = 0.998); JDS/JSCC-HbA1c = 0.927(IFCC-HbA1c) + 1.73% (r2 = 0.997). Conclusion There is a firm and reproducible link between the IFCC and JDS-HbA1c values. However, the values calibrated by JDS RM were consistently and significantly higher than the IFCC values (0.1–0.2%) when used for conversion to the NGSP values.

scholarly journals Bioassay for Determining Voriconazole Serum Levels in Patients Receiving Combination Therapy with Echinocandins

2015 ◽  
Vol 60 (1) ◽  
pp. 632-636 ◽  
Author(s):  
Maria Siopi ◽  
Efthymios Neroutsos ◽  
Kalliopi Zisaki ◽  
Maria Gamaletsou ◽  
Maria Pirounaki ◽  
...  
Keyword(s):  
Quality Control ◽  
Combination Therapy ◽  
High Performance ◽  
Rank Correlation ◽  
Control Program ◽  
External Quality Control ◽  
Serum Samples ◽  
External Quality ◽  
Quality Control Program ◽  
Content Type

ABSTRACTVoriconazole levels were determined with high-performance liquid chromatography (HPLC) and a microbiological agar diffusion assay using aCandida parapsilosisisolate in 103 serum samples from an HPLC-tested external quality control program (n= 39), 21 patients receiving voriconazole monotherapy (n= 39), and 7 patients receiving combination therapy (n= 25). The results of the bioassay were correlated with the results obtained from the external quality control program samples and with the HPLC results in sera from patients on voriconazole monotherapy and on combination therapy with an echinocandin (Spearman's rank correlation coefficient [rs], > 0.93; mean ± standard error of the mean [SEM] % difference, <12% ± 3.8%).

scholarly journals Glycated hemoglobin a1c as a modern biochemical marker of glucose regulation

2014 ◽  
Vol 67 (9-10) ◽  
pp. 339-344 ◽  
Author(s):  
Suncica Kojic-Damjanov ◽  
Mirjana Djeric ◽  
Nevena Eremic-Kojic
Keyword(s):  
Blood Glucose ◽  
Hemoglobin A1c ◽  
Glycated Hemoglobin ◽  
Clinical Chemistry ◽  
Microvascular Complications ◽  
Reference Method ◽  
Laboratory Medicine ◽  
International Federation ◽  
Glycated Hemoglobin A1c ◽  
Diagnostic Criterion

Glycated Hemoglobin Structure and Synthesis of Molecule. Glycated hemoglobin A1c, the major fraction of glycated hemoglobin, is formed by irreversible nonenzymatic glycation. Its concentration depends only on the life span of red blood cells and blood glucose levels. Clinical Significance of Glycated Hemoglobin A1c. It is the key parameter for monitoring the regulation of diabetes and for assessing the risk of microvascular complications. It is a diagnostic criterion for diabetes as well. Its concentration reflects the average value of blood glucose over the last two to three months. The estimated average glucose, a new parameter which facilitates the patient?s self-monitoring of diabetes, can be calculated from its value. Methods for Determining Glycated Hemoglobin A1c and their Standardization. Immunoassay and ion-exchange chromatography are commonly used methods for the glycated hemoglobin determination in routine laboratory practice. The advantage of immunoassay is that there is no need for the sample pretreatment in order to eliminate unstable glycated hemoglobin A1c intermediary forms, and the possibility of false positive results is lower. The current program of standardization requires traceability to the International Federation of Clinical Chemistry and Laboratory Medicine reference method. Reporting and Interpretation of Results of Glycated Hemoglobin A1c Determination. Glycated Hemoglobin A1c can be reported as % or as mmol/mol. In our country, it is recommended to use the International Federation of Clinical Chemistry and Laboratory Medicine units (mmol/mol). When interpreting the results, the potential causes of falsely high or low values must always be taken into consideration. Recommendations for Clinical Practice. Periodic determinations of glycated hemoglobin A1c are recommended for monitoring of diabetes regulation. Additionally, the determination is recommended for the diagnosis of diabetes. The target value for the prevention of microvascular complications is < 7% and the diagnostic criterion for diabetes is ? 6.5%.

A reference material for traceability of aspartate aminotransferase (AST) results

2005 ◽  
Vol 43 (5) ◽  
Author(s):  
Georges Férard ◽  
Françoise Imbert-Bismut ◽  
Djamila Messous ◽  
Annie Piton ◽  
Shigeru Ueda ◽  
...  
Keyword(s):  
Reference Material ◽  
Viral Hepatitis ◽  
Coefficient Of Variation ◽  
Aspartate Aminotransferase ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
International Federation ◽  
Mean Values ◽  
Reference Procedure ◽  
Primary Reference

AbstractStandardization of aspartate aminotransferase (AST) determination is highly desirable for inter-laboratory comparison. Serum AST mean values for 20 patients suffering from viral hepatitis showed an inter-laboratory (n=13) variation of 9.4%. Part of this variation was due to two laboratories using procedures without pyridoxal-5′-phosphate. A traceable AST value was assigned to an enzyme calibrator (EC) through the appropriate International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) primary reference procedure. The EC was commutable for seven routine methods. Common calibration using the EC reduced the inter-laboratory coefficient of variation (CV=5.9%

Study Of The Ratio Expression For Prothrombin Time And Activated Partial Thromboplastin Time Results

1981 ◽  
Author(s):  
R Leclercq
Keyword(s):  
Prothrombin Time ◽  
Partial Thromboplastin Time ◽  
Control Program ◽  
Activated Partial Thromboplastin Time ◽  
Quality Control Program ◽  
Measuring Device ◽  
Mean Values ◽  
Level 1 ◽  
Control Plasma ◽  
Level 2

Prothrombin time (PT) and activated partial thromboplastin time (APTT) results are statistically different, not only in function of reagent used but also, with a same reagent, in function of the degree of automation of the measuring device. It has been claimed that using time ratio of pathological to normal samples would reduce these discrepancies.In a national voluntary quality control program using Verify Citrate Normal and Pathological I/II plasmas, pairs of results obtained in the same analytical batch were computed to compare mean values and reproducibility of ratios and seconds for both PT (n=1764) and APTT (n=1392). Results were screened simultaneously for origin of reagent and measuring technique.Concerning PT, the ratio expression did not improve the intralaboratory dispersion of results for both pathologies levels. Neither in group comparisons between couples reagent-device, nor for the whole set of pooled values, a significant improvement of the dispersion of the ratio results could be observed if compared to the dispersion expressed in seconds. In the 6 groups reagent-instrument, difference between average values was never greater than 1.0 sec for the Normal control plasma (mean: 11.7 sec), 2.4 sec for the level 1 plasma (mean: .18.9 sec) and 4.9 sec for plasma level 2 (mean: 29.3 sec).Concerning APTT, dispersion was strongly enhanced in semi-automated equipments. Chemical activators gave times longer than the particulate ones. Here again, no significant improvement was offered by the ratios.In conclusion, ratio expression of PT’s and APTT’s results does not abolish the influence of the couples ‘origin of reagent’ - ‘automation of measuring device’.

Feasibility of centralized measurements of glycated hemoglobin in the Diabetes Control and Complications Trial: a multicenter study. The DCCT Research Group.

1987 ◽  
Vol 33 (12) ◽  
pp. 2267-2271 ◽  
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Glycated Hemoglobin ◽  
Multicenter Trial ◽  
Diabetes Control ◽  
Mean Values ◽  
Hb A1c ◽  
Control Procedures ◽  
Over Time

Abstract A method for measuring glycated hemoglobin (Hb A1c) and an accompanying method of specimen transport to a central laboratory were developed for the multicenter Diabetes Control and Complications Trial (DCCT). In the DCCT, results for Hb A1c are used to assess chronic glycemic control for data collection and patient management. During the feasibility phase of the trial, central (CHL) and backup laboratories using automated, "high-performance" ion-exchange liquid-chromatographic methods were established. Whole-blood samples were stored (4 degrees C) at each of the 21 clinical centers for up to 72 h before air-express shipment to the CHL. Quality-control procedures included daily analyses of three calibration specimens. A pooled hemolysate was assayed frequently over time as a long-term quality control (LTQC). After 18 months, within- and between-run CVs were less than 6%. Mean values for split duplicate samples assayed in a masked fashion at the CHL were nearly identical. LTQC results indicated no significant assay drift over time. More than 6000 samples were assayed (mean interval between obtaining the blood sample and completing the assay: less than six days). Hb A1c evidently can be precisely and reliably measured in the context of a long-term, multicenter trial such as the DCCT.

scholarly journals Relationship Of Glycated Haemoglobin (Hba1c) And Glucose In Streptozotocininduced Wistar Rats Is Determined By Linear Regression

2013 ◽  
Vol 3 (3) ◽  
pp. 1-5
Author(s):  
George Gborienemi Simeon ◽  
AA Uwakwe ◽  
GO Ibeh
Keyword(s):  
Diabetes Mellitus ◽  
Plasma Glucose ◽  
High Performance ◽  
Glycated Hemoglobin ◽  
Medical Science ◽  
Glycated Haemoglobin ◽  
Citrate Buffer ◽  
Liquid Chromatograph ◽  
Mean Values ◽  
Relationship Of

Objective To evaluate the relationship of glucose and glycated haemoglobin (HbA1C) in type 1 diabetes model induced by streptozotocin. Research Design and Methods Induction of diabetes mellitus was achieved through the intraperitoneal injection of 70mg/kg body weight of streptozotocin dissolved in 1m citrate buffer pH 4.5 twice daily for 2 days. A total number of thirty rats were used selected among those that have exceeded glucose threshold (>10.0mmol/l) 2 weeks after streptozotocin induction. All rats weighed between 240-300g. Samples for fasting plasma glucose and glycated haemoglobin were collected at the tail vein. Glucose was determined by the glucose oxidase method and HbA1C was determined by High Performance Liquid Chromatograph (HPLCEsi/ ms) with uv detection. Data was analysed by one way and two way analysis of variance using SPSS version. Results Significant linear relationship was demonstrated between plasma glucose level and glycated haemoglobin which could be predictive of risk of developing diabetes. Control samples had values within reference range, glucose (3.5-6.5 mmol/l) and glycated hemoglobin (4.3-7%). However diabetic test rats elicited values that varied significantly with time. Test result confirms the fact that higher mean values of plasma glucose in diabetic (positive) controls were due to the effect of streptozotocin. Conclusion Plasma glucose and glycated hemoglobin show positively mutual relationship and can be used in early diagnosis of diabetes mellitus. Using correlation coefficient and regression enhances measurement of the strength of the bivariate association and is predictive. Asian Journal of Medical Science, Volume-3 No-3 (2012), Page 1-5 DOI: http://dx.doi.org/10.3126/ajms.v3i3.4816

Sign in / Sign up

Export Citation Format

Share Document