Method verification procedure of boric acid affinity method against high performance of liquid chromatography for glycated haemoglobin

Authors : Ranjith Kumar Chikine, Manoj Aravind Bhumi

DOI : 10.18231/j.ijcbr.2020.079

Volume : 7

Issue : 3

Year : 2020

Page No : 367-373

Aim: The aim of the study is to estimate the glycated hemoglobin (HbA1c) in Boric acid affinity method,
(Nycocard reader II) compare and correlate these values with those values of DCCT standardized method,
High Performance Liquid Chromatography (D-10, Biorad). As well as to check the boric acid affinity may
or not work as an alternative to the costly high performance liquid chromatography method for glycated
hemoglobin.
Materials and Methods: People visit the clinical laboratory of S.V.S medical college for their HbA1c, to
know their glycemic status. A total of40 subjects were included in this cross sectional study irrespective of
their glycemic condition after exclusion criteria. Subjects with either anaemia (Haemoglobin less or equal
10% was considered as anaemia)or underlying abnormal haemoglobinopathies or addiction of alcohol or
opiates or medication on salicylates and those not willing to give consent were not included. HbA1c levels
were measured by both the techniques on the same blood sample of individual participants.
Results: The mean SD age of the study group was 52 17.16 years. The HbA1c values of individuals
by HPLC method were between 4.7% - 14.3% were taken in this study. Their whole blood HbA1c
levels estimated by HPLC and boric acid affinity in terms of mean SD were 7.57 2.64 and 7.67
2.48 respectively. This difference was not statistically significant which indicates no value differences in
these two methods under standard conditions and trained techniques. A highly positive correlation was
established between these two methods as 0.98, which was statistically significant (p <0> Bablok regression analysis demonstrated similar performance of HPLC and BAA methods for estimating
HbA1c with Intercept close to zero and slope close to one. The precision of the boric acid affinity method
is not better than HPLC, but it is within IFCC suggested limits.
Conclusion: The study revealed that the Boric acid affinity and the HPLC methods show very strong
correlation and good agreement. Boric acid affinity performed acceptable precision. Though the HPLC
method is established as the gold standard for estimation of HbA1c, Boric acid affinity method can serve
as an alternative and suitable in minimal facility laboratories as it is cheaper and easier to analyse.

Keywords: Glycated Haemoglobin (HbA1c), High performance liquid, chromatography (HPLC), Boric acid affinity (BAA),
Precision study.


Citation Data