Analytical performances of SEBIA Capillarys 2 Flex Piercing® and Capillarys 3 Tera® in HbA1c assay

Analytical performances of SEBIA Capillarys 2 Flex Piercing® and Capillarys 3 Tera® in HbA1c assay

Analytical performances of SEBIA Capillarys 2 Flex Piercing and Capillarys 3 Tera have been recently evaluated by a working group from Brussels, Belgium. Two HPLC devices Tosoh G8 (Tosoh Corporation, Japan) and Bio-Rad D-100 (Irvine, CA) have been used as comparison instruments for  SEBIA Capillarys 2 Flex Piercing and Capillarys 3 Tera, respectively.

For all instruments, the analytical performances have been established in term of imprecision (CV %), absolute bias, and linearity, according to the international guidelines and Scientific Institute of Public Health (WIV-ISP) Criteria (2014). Recent international guidelines for laboratory analysis of HbA1c for diagnosis and monitoring of diabetes recommend that within and between laboratory CV should be less than 2% and 3.5%, respectively.

Capillarys 2 Flex Piercing® SEBIA France

 

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A total imprecision (CV) of 2.4% for HbA1c levels of 35 mmol/mol and 1.8% for 85 mmol/mol have been demonstrated. A bias ≤ 1 mmol/mol have been achieved by SEBIA Capillarys 2 Flex Piercing compared to a bias ≤ 4 mmol/mol for Tosoh G8.

Capillarys 2 Flex Piercing SEBIA France was not prone to common interferences: labile HbA1c (28 mmol/L glucose), carbamylated Hb cHb (1 mmol/L potassium cyanate KCNO), bilirubin (280μmol/L), and triglycerides (26 mmol/L). The most common Hb variants were clearly separated on Capillarys 2 Flex Piercing SEBIA and do not interfere in HbA1c. On Tosoh G8, HbS and HbC were clearly separated from other fractions. By contrast,Hb D elutes just after HbA and HbE coelutes with HbA. In addition, Tosoh G8 device showed significant bias for carbamylated Hb (at high concentration of KCNO) due to the appearance of cHb in the peak of labile HbA1c.

Linearity has been demonstrated for a range of HbA1c levels between 29- 152 mmol/mol.

A good agreement between venous and capillary blood samples as well as stability of capillary blood samples at room temperature at least 5 days before being assayed have been demonstrated.

A long term performance of SEBIA Capillarys 2 Flex Piercing has been evaluated in two different centers in Canada. The results published in 2016 have demonstrated that SEBIA capillary electrophoresis is more robust than 2 immunoassay based methods (Roche Cobas Integra 800® and Beckman Synchron DXC ®). A CV of 1.33% and 1.32% have been showed for SEBIA Capillarys 2 Flex Piercing in the two centers compared with 2.66% and 3.92% for Roche Cobas Integra 800, and Beckman Synchron DXC, respectively.

 

Capillarys 3 Tera ® SEBIA France

 

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Capillarys 3 Tera SEBIA showed excellent precision (total CV < 2%, IFCC units) and bias < 0.3% or 3 mmol/mol at HbA1c levels of 5% (31 mmol/mol), 8% (64 mmol/mol), and 11% (97 mmol/mol).

Linearity was demonstrated for HbA1c values ranging from 3.8% (18 mmol/mol) to 18.5% (179 mmol/mol). A mean difference of 0.25% (2.6 mmol/mol) has been reported for SEBIA Capillarys 3 Tera vs Tosoh HLC-723G7 compared with 0.33 % (3.6 mmol/mol) for Bio-Rad D-100 vs Tosoh HLC-723G7.

No interferences by labile HbA1c (< 10 g/L glucose), carbamylated Hb (≤ 0.5 mmol/L KCNO), bilirubin (≤ 15 mg/dL), triglycerides (≤ 3,360 mg/dL), and Hb variants (Hb S, Hb C, Hb D, Hb E, Hb O-Arabe, Hb SC, Hb SS, Hb CD, Hb G Philadelphia, Hb S/HbG Philadelphia, Hb J-Toronto, HbEE)  have been reported for Capillarys 3 Tera SEBIA France. On the SEBIA Capillarys 3 Tera, Hb S, Hb C, Hb D, Hb E were clearely separated, while on Bio- Rad D-100 Hb D and Hb E eluted shortly after HbA0 peak.

 

Conclusions

All these data demonstrate that SEBIA capillary electrophoresis is more robust and accurate method and Capillarys 2 Flex Piercing and Capillarys 3 Tera SEBIA instruments meet the more stringent analytical performances and ISO 15189 criteria and can be implemented in routine practice both on venous and capillary blood samples. The detection of HB variants during HbA1c assay is an important advantage of SEBIA capillary electrophoresis.

 

References

  1. Herpol M et al.- Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D100 systems for the measurement of hemoglobin HbA1c. Am J Clin Pathol 2016 146(1): 67-77.
  2. Guerin R, et al- Evaluation of the long- term imprecision of the Capillarys 2 Flex Piercing® with serial differences in patient hemoglobin A1c data: A comparison with two common immunoasays. Clin Biochem, 2016; 49(6): 502- 4.
  3. Jaisson B, et al. – First evaluation of Capillarys 2 Flex Piercing ® SEBIA as a new analyzer for Hb A1c by capillary electrophoresis. Clin Chem Lab MED, 2011; 50(10):1769-75.