Comparative determination of glycated hemoglobin with direct photometric immunoassay and affi nity chromatography
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Дата
2012-06
Автори
Vucheva, E.
Genova, М.
Niagolov, Y.
Doncheva, N.
Peichinova, G.
Tsatchev, K.
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Издател
Централна медицинска библиотека, МУ София / Central Medical Library - MU Sofia
Резюме
Glycated hemoglobin (HbA1c) is the gold standard in long-term
assessment of glycaemic control in patients with diabetes mellitus (DM). Liquid
Chromatography-Isotope Dilution-Mass Spectrometry is a reference method for
HbA1c, but other methods used in practice need standardization and comparison.
This study was aimed to perform a comparative evaluation of the results from
HbA1c determination by direct immuno-photometric method (A) and affi nity chromatography
method (B). The study included 50 samples with values from all clinically
measurable areas. HbA1c in whole blood was studied using Olympus AU 400
analyzer and NycoCard READER II by, applying method A and method B, respectiovely.
The results are compared using the program Method Validator, as for the
reference method the chromatographic method was accepted. The imprecision in
series for method A has been traced in 10 parallel samples from two patients in
border and abnormal area of values. The inaccuracy was evaluated in normal and
pathological human control material for 25 consecutive days. The results from correlation
and regression analysis show linear regression coeffi cient r = 0.949, slope
= 0.919 and intercept = 0.59. Assessment of imprecision for method A shows CV
values of 1.21% and 1.91% for both cases, respectively. Accuracy monitoring of
method A with control materials shows d% 4.979 in the normal area, and 5.033 in
the pathological area. The results show high positive correlation and comparability
between the two methods. Direct immuno-photometric method has good accuracy
and precision and is applicable for analyzer Olympus AU 400.
Описание
Address for correspondence:
Assoc. Prof. Nadezhda Doncheva, MD, PhD;
Medical Institute − Ministry of Interior;
Department of Clinical Laboratory,
79 A, Skobelev str., 1606 Sofia,
Bulgaria.
tel: +3592 9821-416 ;
e-mail: ndon4eva@abv.bg
Ключови думи
Glycated haemoglobin, direct immuno-photometric method, affi nity chromatography method, NycoCard READER
Цитирания
E. Vucheva, М. Genova, Y. Niagolov, N. Doncheva, G. Peichinova and K. Tsatchev. Comparative determination of glycated hemoglobin with direct photometric immunoassay and affi nity chromatography - Acta medica bulgarica , 39, 2012, No 2, 3-10.