Emoglobina glicata (HbA1c): confronto tra gli analizzatori Premier Hb9210 e ADAMStm A1c HA-8180V
Glycated hemoglobin (HbA1c): Comparison between Premier Hb9210 and ADAMStm A1c HA-8180V analyzers

AUTORI

ABSTRACT

Glycated hemoglobin (HbA1c): Comparison between Premier Hb9210 and ADAMStm A1c HA-8180V analyzers

Introduction: in this study we evaluated the analytical performance of the Trinity Biotech HbPremier Hb9210 (Bray, Ireland/Kansas city, US), a boronate affinity chromatography-based high performance liquid chromatography (HPLC) system for the measurement of glycated hemoglobin. The ADAMSTM A1c HA-8180V (ARKRAY, Inc., Kyoto, Japan) analyzer was used for the comparison.
Methods: three pool of blood (L1, L2, L3) and two control materials (B1, B2) were used to evaluate analytical precision of the HbPremier Hb9210, analyzing five replicates of each sample per day for five days. For the comparison, blood specimens were analyzed according to the Clinical and Laboratory Standard Institute (CLSI) guidelines. Both the available reference systems (IFCC, NGSP) were used.
Results: the total CVs of for low, medium and high values of the three pools (L1, L2, L3) were 0.68%, 1.72%, 1.31% respectively; and were 1.57%, 1.38% for low, and medium values (B1, B2) of the two controls when the values were expressed in mmol/mol (SI units) and 0.39%, 1.18%, 1.08% (L1, L2, L3), 0.95%, 1.07% (B1, B2) when the values were reported in % (NGSP units). Passing-Bablok regression used for the comparison of methods showed a small proportional error (slope 1.05, 95%CI: 1.02-1.07) using the IFCC reference system (mmol/mol); the error was not present with the NGSP (%). The bias found was -1.87 mmol/mol (95%CI: -4.33- 0.58) and -0.17% (95%CI: -0.39-0.05).
Discussion: the analytical performances of HbPremier Hb9210 have been successfully verified. The instrument performs well and provides results in good agreement with those obtained with the ADAMS analyzer.

BIBLIOGRAFIA