Startseite Medizin Evaluation of enzymatic BM Test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay
Artikel
Lizenziert
Nicht lizenziert Erfordert eine Authentifizierung

Evaluation of enzymatic BM Test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay

  • Jehoon Lee , Myungshin Kim , Hyojin Chae , Yeongsic Kim , Hae-il Park , Yonggoo Kim , Hyunyoung Chi und Hi Jeong Kwon EMAIL logo
Veröffentlicht/Copyright: 30. Juli 2013
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 51 Heft 11

Abstract

Background: A novel enzymatic HbA1c assay was introduced for use in an automated chemistry analyzer. With this unique method, HbA1c and plasma glucose can be measured from the same EDTA tube. We evaluated the analytical performance of this enzymatic HbA1c assay in a JCA-BM6010/C analyzer and compared the HbA1c values with the results from other widely used methodological instruments.

Methods: The imprecision, linearity, carry-over and concordance rate of the enzymatic HbA1c test (BM Test HbA1c) using the JCA-BM6010/C analyzer were evaluated. Three hundred and seventy-seven specimens with HbA1c concentrations from 16 to 133 mmol/mol were used for a comparison study with two high performance liquid chromatography methods: Variant II Turbo and Tosoh HLC 723 G8 and the AutoLab Hemoglobin A1c immunoturbidimetry reagent using a Hitachi 7600-110. Forty specimens were used for the glucose method comparison.

Results: The HbA1c coefficients of variation of the within-run imprecision for low and high levels were 0.6% and 0.4%, respectively. The linearity of the BM Test HbA1c using the JCA-BM6010/C analyzer was excellent in the range between 31 mmol/mol and 143 mmol/mol. The carry-over rate was 0.2%. The relationships between the BM test and the other three methods were 0.916×Tosoh G8+3.644, r=0.986; 0.887×Bio-Rad Variant II+1.896, r=0.972; and 0.941×AutoLab+4.532, r=0.977. The concordance rates using a cut-off of 48 mmol/mol were 91.5% with Tosoh G8, 82.8% with Bio-Rad Variant II, and 91.0% with AutoLab. The simultaneously assayed plasma glucose with HbA1c was 1.002×Routine plasma glucose+0.625, r=1.000

Conclusions: The enzymatic BM Test HbA1c in the JCA-BM6010/C analyzer showed excellent precision and linearity, and a minimal carry-over rate. The simultaneously assayed plasma glucose analysis showed good performance.

Keywords: diabetes; enzymatic HbA1c assay; evaluation; glucose; HbA1c; multicenter study
Corresponding author: Hi Jeong Kwon, MD, PhD, Department of Laboratory Medicine, St. Paul’s Hospital, 180 Wangsan-ro, Dongdaemun-gu, Seoul, 130-709, Korea, Phone: +82 2 9582394, Fax: +82 2 9578836, E-mail:

References

1. Lippi G, Targher G. Glycated hemoglobin (HbA1c): old dogmas, a new perspective? Clin Chem Lab Med 2010;48:609–14.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000277391800006&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1515/CCLM.2010.144Suche in Google Scholar PubMed

2. Sacks DB. Diabetes mellitus. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical chemistry and molecular diagnostics, 5th ed. St. Louis: Elsevier Saunders, 2012:1441–7.10.1016/B978-1-4160-6164-9.00046-9Suche in Google Scholar

3. International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009;32:1327–34.10.2337/dc09-9033Suche in Google Scholar PubMed PubMed Central

4. American Diabetes Association. Standards of medical care in diabetes – 2010. Diabetes Care 2010;33(Suppl 1):S11– 61.10.2337/dc10-S011Suche in Google Scholar PubMed PubMed Central

5. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047–53.10.2337/diacare.27.5.1047Suche in Google Scholar PubMed

6. Chapelle JP, Teixeira J, Maisin D, Assink H, Barla G, Stroobants AK, et al. Multicenter evaluation of the Tosoh HbA1c G8 analyser. Clin Chem Lab Med 2010;48:365–71.10.1515/CCLM.2010.062Suche in Google Scholar PubMed

7. Weykamp C, Lenters-Westra E, van der Vuurst H, Slingerland R, Siebelder C, Visser-Dekkers W. Evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser for HbA1c. Clin Chem Lab Med 2011;49:647­–51.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000289464200010&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1515/CCLM.2011.096Suche in Google Scholar PubMed

8. Sacks DB. Hemoglobin variants and hemoglobin A1c analysis: problem solved? Clin Chem 2003;49:1245–7.10.1373/49.8.1245Suche in Google Scholar PubMed

9. Sakurabayashi I, Watano T, Yonehara S, Ishimaru K, Hirai K, Komori T, et al. New enzymatic assay for glycohemoglobin. Clin Chem 2003;49:269–74.10.1373/49.2.269Suche in Google Scholar PubMed

10. Jeppsson JO, Kobold U, Barr J, Finke A, Hoelzel W, Hoshino T, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med 2002;40:78–89.10.1515/CCLM.2002.016Suche in Google Scholar PubMed

11. NCCLS. Evaluation of precision performance of quantitative measurement methods; approved guideline, 2nd ed. NCCLS document EP5-A2. Wayne, PA: NCCLS, 2004.Suche in Google Scholar

12. NCCLS. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. NCCLS document EP6-A. Wayne, PA: NCCLS, 2003.Suche in Google Scholar

13. CLSI. Preliminary evaluation of quantitative clinical laboratory measurement procedures; approved guideline, 3rd ed. CLSI document EP10-A3. Wayne, PA: CLSI, 2006.Suche in Google Scholar

14. CLSI. Method comparison and bias estimation using patient samples; approved guideline-second edition. CLSI document EP9-A2. Wayne, PA: CLSI, 2002.Suche in Google Scholar

15. Little RR, Rohlfing CL, Sacks DB for the National Glycohemoglobin Standardization Program (NGSP) steering committee. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem 2011;57:205–14.10.1373/clinchem.2010.148841Suche in Google Scholar PubMed

16. Hirokawa K, Nakamura K, Kajiyama N. Enzymes used for the determination of HbA1c. FEMS Microbiol Lett 2004;235:157–62.10.1111/j.1574-6968.2004.tb09581.xSuche in Google Scholar PubMed

17. Akazawa S, Karino T, Yoshida N, Katsuragi T, Tani Y. Functional analysis of fructosyl-amino acid oxidases of Aspergillus oryzae. Appl Environ Microbiol 2004;70:5882–90.10.1128/AEM.70.10.5882-5890.2004Suche in Google Scholar PubMed PubMed Central

18. Liu L, Hood S, Wang Y, Bezverkov R, Dou C, Datta A, et al. Direct enzyme assay for %HbA1c in human whole blood samples. Clin Biochem 2008;41:576–83.10.1016/j.clinbiochem.2008.01.013http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000255262300021&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f3Suche in Google Scholar PubMed

19. Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2011;57:e1–47.10.1373/clinchem.2010.161596Suche in Google Scholar PubMed

20. National Glycohemoglobin Standardization Program. Factors that interfere with HbA1c test results. Updated Mar 2013. http://www.ngsp.org/factors.asp. Accessed on 22 June, 2013.Suche in Google Scholar
Received: 2013-03-30
Accepted: 2013-07-02
Published Online: 2013-07-30
Published in Print: 2013-11-01

©2013 by Walter de Gruyter Berlin Boston

Artikel in diesem Heft

  1. Letter to the Editor
  2. Elevated level of cell-free plasma DNA is associated with advanced-stage breast cancer and metastasis
  3. Is procalcitonin a reliable marker of sepsis in critically ill septic patients undergoing continuous veno-venous hemodiafiltration with “high cut-off” membranes (HCO-CVVHDF)?
  4. Challenging our serological algorithm for celiac disease (CD) diagnosis by the ESPGHAN guidelines
  5. Preanalytical quality control in a university hospital in China
  6. Racial differences and relationships between gestational thyrotropin and free thyroxine in a multiracial Asian population
  7. Analytical performance and method comparison study of the total homocysteine immunoassay on the AIA 600II analyser
  8. Easy verification of clinical chemistry reference intervals
  9. The Elecsys® Vitamin B12 assay is not affected by anti-intrinsic factor antibodies
  10. Chemiluminescence-based cobalamin assay errors: background and perspectives
  11. Congress Abstracts
  12. Abstracts IV Italian Great Network Congress Rome, 14th–18th October 2013*)
  13. Masthead
  14. Masthead
  15. Editorial
  16. Making colorectal cancer screening FITTER for purpose with quantitative faecal immunochemical tests for haemoglobin (FIT)
  17. From “panic” to “critical” values: which path toward harmonization?
  18. Review
  19. Cerebrospinal fluid analyses for the diagnosis of subarachnoid haemorrhage and experience from a Swedish study. What method is preferable when diagnosing a subarachnoid haemorrhage?
  20. Opinion Paper
  21. False myths and legends in laboratory diagnostics
  22. General Clinical Chemistry and Laboratory Medicine
  23. National survey on critical values notification of 599 institutions in China
  24. Influence of physical properties of cuvette surface on measurement of serum lipase
  25. Red cell indices: differentiation between β-thalassemia trait and iron deficiency anemia and application to sickle-cell disease and sickle-cell thalassemia
  26. Measurement of immature platelets with Abbott CD-Sapphire and Sysmex XE-5000 in haematology and oncology patients
  27. Performance characteristics of consensus approaches for small and minor paroxysmal nocturnal hemoglobinuria clone determination by flow cytometry
  28. Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener’s)
  29. The integration of the detection of systemic sclerosis-associated antibodies in a routine laboratory setting: comparison of different strategies
  30. Reference Values and Biological Variations
  31. Reference interval studies: what is the maximum number of samples recommended?
  32. Short-term estimation and application of biological variation of small dense low-density lipoproteins in healthy individuals
  33. Cancer Diagnostics
  34. Diagnostic inconsistency of faecal immunochemical tests for haemoglobin in population screening of colorectal cancer
  35. Cardiovascular Diseases
  36. Comparison of the 99th percentiles of three troponin I assays in a large reference population
  37. Assessment of plasma aminothiol levels and the association with recurrent atherothrombotic events in patients hospitalized for an acute coronary syndrome: a prospective study
  38. Diabetes
  39. The relationship between estimated average glucose and fasting plasma glucose
  40. Evaluation of enzymatic BM Test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay
https://doi.org/10.1515/cclm-2013-0238
Schlagwörter für diesen Artikel
diabetes; enzymatic HbA1c assay; evaluation; glucose; HbA1c; multicenter study

Artikel in diesem Heft

  1. Letter to the Editor
  2. Elevated level of cell-free plasma DNA is associated with advanced-stage breast cancer and metastasis
  3. Is procalcitonin a reliable marker of sepsis in critically ill septic patients undergoing continuous veno-venous hemodiafiltration with “high cut-off” membranes (HCO-CVVHDF)?
  4. Challenging our serological algorithm for celiac disease (CD) diagnosis by the ESPGHAN guidelines
  5. Preanalytical quality control in a university hospital in China
  6. Racial differences and relationships between gestational thyrotropin and free thyroxine in a multiracial Asian population
  7. Analytical performance and method comparison study of the total homocysteine immunoassay on the AIA 600II analyser
  8. Easy verification of clinical chemistry reference intervals
  9. The Elecsys® Vitamin B12 assay is not affected by anti-intrinsic factor antibodies
  10. Chemiluminescence-based cobalamin assay errors: background and perspectives
  11. Congress Abstracts
  12. Abstracts IV Italian Great Network Congress Rome, 14th–18th October 2013*)
  13. Masthead
  14. Masthead
  15. Editorial
  16. Making colorectal cancer screening FITTER for purpose with quantitative faecal immunochemical tests for haemoglobin (FIT)
  17. From “panic” to “critical” values: which path toward harmonization?
  18. Review
  19. Cerebrospinal fluid analyses for the diagnosis of subarachnoid haemorrhage and experience from a Swedish study. What method is preferable when diagnosing a subarachnoid haemorrhage?
  20. Opinion Paper
  21. False myths and legends in laboratory diagnostics
  22. General Clinical Chemistry and Laboratory Medicine
  23. National survey on critical values notification of 599 institutions in China
  24. Influence of physical properties of cuvette surface on measurement of serum lipase
  25. Red cell indices: differentiation between β-thalassemia trait and iron deficiency anemia and application to sickle-cell disease and sickle-cell thalassemia
  26. Measurement of immature platelets with Abbott CD-Sapphire and Sysmex XE-5000 in haematology and oncology patients
  27. Performance characteristics of consensus approaches for small and minor paroxysmal nocturnal hemoglobinuria clone determination by flow cytometry
  28. Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener’s)
  29. The integration of the detection of systemic sclerosis-associated antibodies in a routine laboratory setting: comparison of different strategies
  30. Reference Values and Biological Variations
  31. Reference interval studies: what is the maximum number of samples recommended?
  32. Short-term estimation and application of biological variation of small dense low-density lipoproteins in healthy individuals
  33. Cancer Diagnostics
  34. Diagnostic inconsistency of faecal immunochemical tests for haemoglobin in population screening of colorectal cancer
  35. Cardiovascular Diseases
  36. Comparison of the 99th percentiles of three troponin I assays in a large reference population
  37. Assessment of plasma aminothiol levels and the association with recurrent atherothrombotic events in patients hospitalized for an acute coronary syndrome: a prospective study
  38. Diabetes
  39. The relationship between estimated average glucose and fasting plasma glucose
  40. Evaluation of enzymatic BM Test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay
Jetzt anmelden und 20% sparen
Institutioneller Zugang
Wie funktioniert Authentifizierung?
Haben Sie eine Idee, wie wir unsere Website verbessern können?
Bitte schreiben Sie uns.
© 2025 De Gruyter Brill
Heruntergeladen am 30.12.2025 von https://www.degruyterbrill.com/document/doi/10.1515/cclm-2013-0238/html
Button zum nach oben scrollen