Diabetes, a prevalent global group of metabolic diseases, is characterized by hyperglycemia, which can lead to potential complications with prolonged exposure. Treatment goals involve lowering blood sugar levels and preventing future complications, with glycated hemoglobin, HbA1c serving as a marker for treatment control. HbA1c, forms when glucose binds to hemoglobin, aids in treatment monitoring. This study aimed to validate capillary HbA1c analysis on the Cobas Pro analyzer to comply with new in vitro diagnostic (IVD) regulations and streamline processes. Unlike the high-performance liquid chromatography method, (HPLC) to be replaced, all reagents used in the Cobas Pro are IVD-marked. Transitioning to capillary HbA1c analysis involves a change in measurement principle. The current method utilizes ion exchange chromatography with photometric detection, while the Cobas Pro employs turbidimetric inhibition immunoassay. The correlation coefficient for 31 capillary blood samples between the methods was 0.97, with most data points falling within the confidence interval. Despite obtaining a statistically significant difference from the paired ttest, the difference between the measurement values did not exceed 3 mmol/mol, which is the proposed clinical threshold. Comparison of capillary and venous blood analyzed with Cobas Pro yielded a linear correlation of 0.99, with no significant difference found by the paired ttest. A coefficient of variation (CV) under 4% was achieved for controls on the Cobas Pro. The primary advantage of transitioning the method was that it complied with IVDR regulations and enhances patient safety. Based on these results, the method is deemed safe for implementation.
| Identifer | oai:union.ndltd.org:UPSALLA1/oai:DiVA.org:uu-532798 |
| Date | January 2024 |
| Creators | Näslund, Mikaela |
| Publisher | Uppsala universitet, Institutionen för medicinsk cellbiologi |
| Source Sets | DiVA Archive at Upsalla University |
| Language | Swedish |
| Detected Language | English |
| Type | Student thesis, info:eu-repo/semantics/bachelorThesis, text |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/openAccess |
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