Clinical Utility and Cross-Reactivity of Insulin and C-Peptide Assays by the Lumipulse G1200 System
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background: Measurement of insulin and C-peptide concentrations is important for deciding whether insulin treatment is required in diabetic patients. We aimed to investigate the analytical performance of insulin and C-peptide assays using the Lumipulse G1200 system (Fujirebio Inc., Tokyo, Japan). Methods: We examined the precision, linearity, and cross-reactivity of insulin and C-peptide using five insulin analogues and purified proinsulin. A method comparison was conducted between the Lumipulse G1200 and Roche E170 (Roche Diagnostics, Mannheim, Germany) systems in 200 diabetic patients on insulin treatment. Reference intervals for insulin and C-peptide concentrations were determined in 279 healthy individuals. Results: For insulin and C-peptide assays, within-laboratory precision (% CV) was 3.78–4.14 and 2.89–3.35%, respectively. The linearity of the insulin assay in the range of 0–2,778 pmol/L was R²=0.9997, and that of the C-peptide assay in the range of 0–10 nmol/L was R²=0.9996. The correlation coefficient (r) between the Roche E170 and Lumipulse G1200 results was 0.943 (P<0.001) for insulin and 0.996 (P<0.001) for C-peptide. The mean differences in insulin and C-peptide between Lumipulse G1200 and the Roche E170 were 19.4 pmol/L and 0.2 nmol/L, respectively. None of the insulin analogues or proinsulin showed significant cross-reactivity with the Lumipulse G1200. Reference intervals of insulin and C-peptide were 7.64–70.14 pmol/L and 0.17–0.85 nmol/L, respectively. Conclusions: Insulin and C-peptide tests on the Lumipulse G1200 show adequate analytical performance and are expected to be acceptable for use in clinical areas.
Abstract
Background: Measurement of insulin and C-peptide concentrations is important for deciding whether insulin treatment is required in diabetic patients. We aimed to investigate the analytical performance of insulin and C-peptide assays using the Lumipulse G1200 system (Fujirebio Inc., Tokyo, Japan). Methods: We examined the precision, linearity, and cross-reactivity of insulin and C-peptide using five insulin analogues and purified proinsulin. A method comparison was conducted between the Lumipulse G1200 and Roche E170 (Roche Diagnostics, Mannheim, Germany) systems in 200 diabetic patients on insulin treatment. Reference intervals for insulin and C-peptide concentrations were determined in 279 healthy individuals. Results: For insulin and C-peptide assays, within-laboratory precision (% CV) was 3.78–4.14 and 2.89–3.35%, respectively. The linearity of the insulin assay in the range of 0–2,778 pmol/L was R²=0.9997, and that of the C-peptide assay in the range of 0–10 nmol/L was R²=0.9996. The correlation coefficient (r) between the Roche E170 and Lumipulse G1200 results was 0.943 (P<0.001) for insulin and 0.996 (P<0.001) for C-peptide. The mean differences in insulin and C-peptide between Lumipulse G1200 and the Roche E170 were 19.4 pmol/L and 0.2 nmol/L, respectively. None of the insulin analogues or proinsulin showed significant cross-reactivity with the Lumipulse G1200. Reference intervals of insulin and C-peptide were 7.64–70.14 pmol/L and 0.17–0.85 nmol/L, respectively. Conclusions: Insulin and C-peptide tests on the Lumipulse G1200 show adequate analytical performance and are expected to be acceptable for use in clinical areas.
참고문헌 (38)
- Guariguata L, "Global estimates of diabetes prevalence for 2013 and projections for 2035", Diabetes Res Clin Pract, 103, pp.137~149 (2014)
- 김상용, "It’s Still Not Too Late to Make a Change: Current Status of Glycemic Control in Korea", Diabetes and Metabolism Journal, 38(3), pp.194~196 (2014), 대한당뇨병학회[DOI]
- 송선옥, "Epidemiology of Type 1 Diabetes Mellitus in Korea through an Investigation of the National Registration Project of Type 1 Diabetes for the Reimbursement of Glucometer Strips with Additional Analyses Using Claims Data", Diabetes and Metabolism Journal, 40(1), pp.35~45 (2016), 대한당뇨병학회[DOI]
- American Diabetes Association, "Classification and diagnosis of diabetes", Diabetes Care, 39(S1), pp.S13~S22 (2016)
- Jones AG, "The clinical utility of C-peptide measurement in the care of patients with diabetes", Diabet Med, 30, pp.803~817 (2013)
- Oram RA, "A type 1 diabetes genetic risk score can aid discrimination between type 1 and type 2 diabetes in young adults", Diabetes Care, 39, pp.337~344 (2016)
- Clark PM, "Assays for insulin, proinsulin(s) and C-peptide", Ann Clin Biochem, 36(Pt 5), pp.541~564 (1999)
- Marcovina S, "Standardization of insulin immunoassays: report of the American Diabetes Association Workgroup", Clin Chem, 53, pp.711~716 (2007)
- Jones AG, "Assessment of endogenous insulin secretion in insulin treated diabetes predicts postprandial glucose and treatment response to prandial insulin", BMC Endocr Disord, 12, pp.6~ (2012)
- Dayaldasani A, "Cross-reactivity of insulin analogues with three insulin assays", Ann Clin Biochem, 52, pp.312~318 (2015)
- Heald A, "Most commercial insulin assays fail to detect recombinant insulin analogues", Ann Clin Biochem, 43, pp.306~308 (2006)
- Sapin R, "Insulin assays: previously known and new analytical features", Clin Lab, 49, pp.113~121 (2003)
- Nakahara Y, "Comparative study of three blood insulin measuring reagents with different measurement principles", Okayama J Med Technol, 51, pp.1~6 (2015)
- Nalbantoglu Elmas O, "Importance of insulin immunoassays in the diagnosis of factitious hypoglycemia", J Clin Res Pediatr Endocrinol, 6, pp.258~261 (2014)
- CLSI, "Evaluation of precision of quantitative measurement procedures; approved guideline. CLSI EP05-A3", Clinical and Laboratory Standards Institute, ~ (2014)
- CLSI, "Evaluation of the linearity of quantitative measurement procedures: A statistical approach; approved guideline. CLSI EP06-A", Clinical and Laboratory Standards Institute, ~ (2003)
- CLSI, "Method comparison and bias estimation using patient samples; approved guideline. (Interim Revision). CLSI EP09-A2-IR", Clinical and Laboratory Standards Institute, ~ (2013)
- CLSI, "Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. CLSI C28-A3c", Clinical and Laboratory Standards Institute, ~ (2010)
- Bland JM, "Statistical methods for assessing agreement between two methods of clinical measurement", Lancet, 1, pp.307~310 (1986)
- Ozturk O, "Using biological variation data for reference change values in clinical laboratories", Biochem Anal Biochem, 1, pp.e106~ (2012)
- Ochocinska A, "Evaluation of the immunoradiometric and electrochemiluminescence method for the measurement of serum insulin in children", J Immunoassay Immunochem, 37, pp.243~250 (2016)
- Loh TP, "Comparison of three routine insulin immunoassays: implications for assessment of insulin sensitivity and response", Clin Chem Lab Med, 55, pp.e72~e75 (2017)
- Chevenne D, "Insulin assays and reference values", Diabetes Metab, 25, pp.459~476 (1999)
- Owen WE, "Cross-reactivity of three recombinant insulin analogs with five commercial insulin immunoassays", Clin Chem, 50, pp.257~259 (2004)
- Parfitt C, "Commercial insulin immunoassays fail to detect commonly prescribed insulin analogues", Clin Biochem, 48, pp.1354~1357 (2015)
- Hirsch IB, "Insulin analogues", N Engl J Med, 352, pp.174~183 (2005)
- Vajo Z, "Genetically engineered insulin analogs: diabetes in the new millenium", Pharmacol Rev, 52, pp.1~9 (2000)
- 김세림, "재조합 인슐린 치료 중 발생한 혈중 인슐린농도의 비정상적 상승 증례에 대한 고찰", Laboratory Medicine Online, 3(1), pp.56~59 (2013), 대한진단검사의학회
- 김세림, "The Effects of Anti-insulin Antibodies and Cross-reactivity with Human Recombinant Insulin Analogues in the E170 Insulin Immunometric Assay", Annals of Laboratory Medicine, 31(1), pp.22~29 (2011), 대한진단검사의학회
- Sapin R, "Elecsys insulin assay: free insulin determination and the absence of cross-reactivity with insulin lispro", Clin Chem, 47, pp.602~605 (2001)
- Moriyama M, "Performance evaluation and cross-reactivity from insulin analogs with the ARCHITECT insulin assay", Clin Chem, 52, pp.1423~1426 (2006)
- Glenn C, "Cross-reactivity of 12 recombinant insulin preparations in the Beckman Unicel DxI 800 insulin assay", Ann Clin Biochem, 47, pp.264~266 (2010)
- Kalathil S, "Variable characteristics with insulin assays", Pract Diabetes, 30, pp.118~120 (2013)
- Vieira JG, "Cross-reactivity of new insulin analogs in insulin assays", Arq Bras Endocrinol Metabol, 51, pp.504~505 (2007)
- Agin A, "Glargine blood biotransformation: in vitro appraisal with human insulin immunoassay", Diabetes Metab, 33, pp.205~212 (2007)
- Song D, "Cross-reactivity of Actrapid and three insulin analogues in the Abbott IMx insulin immunoassay", Ann Clin Biochem, 44, pp.197~198 (2007)
- Neal JM, "Insulin immunoassays in the detection of insulin analogues in factitious hypoglycemia", Endocr Pract, 14, pp.1006~1010 (2008)
- Palmer JP, "C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001", Diabetes, 53, pp.250~264 (2004)