Naslov
High-performance liquid chromatography for HbA1c in low-volume laboratories: analytical verification and method comparison study of Tosoh HLC-723GX analyzer

Autori
Ris, Marko ; Radišić Biljak, Vanja ; Božičević, Sandra ; Vučić Lovrenčić, Marijana

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Skup
The 4th Joint EFLM-UEMS Congress “Laboratory Medicine at the Clinical Interface”

Mjesto i datum
Varšava, Poljska, 21.09.2016. - 24.09.2016

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
HPLC, HbA1c, verification

Sažetak
Introduction: High-performance liquid chromatography (HPLC) determination of HbA1c has long been used as a reproducible and versatile analytical tool in clinical laboratories. However, the need for dedicated equipment and expertise limited its use to high-volume laboratories. Recently introduced user-friendly, fully automated benchtop HPLC analyzer (Tosoh HLC-723GX, Tosoh, Japan) enabled low-volume laboratories to provide equally reliable HbA1c results. The aim of this study was to perform analytical verification of Tosoh HLC-723GX analyzer and compare the results with both the reference capillary electrophoresis (CE) and the immunoassay (IA) procedure. Materials and Methods: The total imprecision of Tosoh HLC-723GX was verified in accordance with CLSI EP15-A2 protocol using commercial control materials (C-QC) and pooled human whole blood samples (HWB). Comparison of HbA1c results was performed on 146 samples (3.214.4%/ 12-134 mmol/mol). HPLC-HbA1c results were compared to the automated CE (CE ; MiniCap Flex Piercing, Sebia, France) and IA (IA ; Tina-quant HbA1c Gen 2, Cobas Integra 400+, Roche Diagnostics, USA) procedures, respectively. Results: The total imprecision of HPLC-HbA1c was 1.25/1.91% (HbA1c = 4.8%/29 mmol/mol) and 0.51/0.63% (HbA1c = 97%/82mmol/mol) in C-QC, and 0.51/0.66% (HbA1c = 6.5%/47mmol/mol) and 0.65/0.87% (HbA1c = 10.7%/94 mmol/mol) in HWB samples, respectively. Bland-Altman analysis did not reveal any deviation of the results between HPLC and CE: 0.0% (95%Cl: -0.02927 to 0.02653%), while the average HbA1c deviation between HPLC and IA was -0.07% (95%Cl: -0.1039 to -0.02765). Conclusion: The performance of Tosoh HLC-723GX met the quality criteria for reliable clinical use, thereby representing a plausible analytical choice for HbA1c measurement in low-volume laboratories.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

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