Hemoglobin A1C automatic analyzer comparisons between H50 and HA-8180v

Waraporn Bubpha, Autcharaporn Srisuwan, Palakorn Puttaruk and Kridsada Sirisabhabhorn**Corresponding author

Medical Technology Laboratory, Thammasat University Hospital, Pathumtani, Thailand 12120

Background: The reliability of percent glycosylated hemoglobin (HbA1C) is very significant for physician decision which useful for diabetic interpretationdue to better than glucose fasting blood. Even many machines are leaded to adding volume of efficiency but confidence available result from the new devicewhen compare with original instrument is still wondering.

Objective: To investigate the result of HbA1C comparison base on principle of high performance liquid chromatography (HPLC) between H50 (Mindray,Shenzhen, China) new instrument, with HA-8180v (ARKRAY, Inc., Kyoto, Japan) for introduce useful in routine analysis.

Material and Method: Total 1,197 EDTA blood samples in daily post-analysis which were obtained from Medical Technology, Thammasat UniversityHospital, Pathumtani. Using adequate volume of EDTA peripheral blood is 3 ml for measuring. Individual commercial quality control which including 2 levelsas percent of normal and variant Hb was run before analysis samples by the time. Measuring samples by parallel H50 and HA-8180v then print out the resultfor comparison analysis. T-test and Pearson’s correlation analysis by Stata software were used and described statistics.

Result: This study demonstrated the average (95% CI) of HbA1C % concentration of H50 and HA-8180v as 7.02 (6.93-7.11) and 6.96 (6.88-7.05) respectivelywith no difference significantly statistics (p=0.374). Pearson’s statistic analysis shown coefficient correlation (r) between 2 medical devices was 0.99, the excellentcorrelation level, and decorated equation in linear is (y) = 0.909x + 0.576.

Conclusion: The new model as H50 is very high consistent with HA-8180v - using our routine investigator - with acceptable in our laboratory condition.Interestingly, % insufficient Hb conc. from 2 devices are appear that may be defect from range limitation due to some variant Hb i.e. HbE disease, majorhemoglobinopathy in Thai’s population, should be explore further.Key words: HbA1C, Comparison, HPLC, H50, HA-8180v

Abstract

IntroductionThe glycosylated hemoglobin call as HbA1C that is a majority for

glucose monitoring in patient’s blood stream about 3 months which reasondue to regenerated program of red blood cell in their life span. [1] Thetemporary of erythrocyte life cycle is beneficial useful as blood glucosereference level, tolerance against BG level dramatic changing so, narrowrange of HbA1C percent must be careful for physician’s decision then over6.5% of level is needed medication [2]. Even many machines are comingusing in analysis but validation method is still essential compared withreliability machine. H50 (Mindray, Shenzhen, China) and HA-8180v(Arkray, Inc., Japan) are ion-exchange-based high-performance liquidchromatography (HPLC) [3] which desire to compare percent values forconfidential results

Table 1. Demographic data of comparisons 2 automatic analyzers between H50 with HA-8180v by test

y = 0.909x + 0.576R² = 0.993

0

2

4

6

8

10

12

14

16

18

20

0 5 10 15 20

H50(N = 1,197)

HA-8180v(N = 1,197)

EDTA bloodN = 1,197

Result

Analysis

Spearman’s correlation of coefficients (r); Hinkle et.al.,

1998

Correlation levels

.90 - 1.00 Very high or Excellent correlation

.70 - .90 High correlation

.50 - .70 Moderate correlation

.30 - .50 Low correlation

.00 - .30 Very low correlation

Discussion & Conclusion

References

Materials & Methods

The correlation data between H50 and HA-8180v in this study were demonstrated Pearson’scoefficient correlation of (r) as 0.99 which was classified in very high or excellent correlation accordingto table 2 and linear correlation graph was represented as picture 1.

This result is consist with same principle in prior studies such Yoo et al., 2014 that wereshown r = 0.9955. [4] In the principle of HPLC devices announce to distort measurement deal variantHb [5] especially HbE diseases [6], major type of variant Hb in Thailand [7] so, are need to investigatefurther by other principle ex. turbidimetric inhibition immunoassay (TINA) but hold disadvantage indelay releasing result and interference of some Hb variants types are remaining. In addition, HPLCtechnique machines are productivity in high through put (60 tests per hour) that suitable for use indiabetic screening before meeting physician.

Conclusion, H50 HbA1C automatic analyzer provide confidential ability in %HbA1Cmeasuring when compare other instrument as a same HPLC principle. Point analysis in groups ofvariant Hb should be careful and recognize to study further.

1. Tahara Y, Shima K. The response of GHb to stepwise plasma glucose change over time in diabetic patients. Diabetes Care. 1993;16(9):1313–4.2. Hoelzel W, Weykamp C, Jeppsson JO, et al; for the IFCC Working Group on HbA1c Standardization. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem. 2004;50:166-174.3. Haliassos, A, Drakopoulos I, Katristis D, Chiotinis N, Korovesis S, Makaris K. Measurement of glycated hemoglobin (HbA1c) with an automated POCT instrument in comparison with HPLC and automated immunochemistry method: evaluation of the influence of hemoglobin variants. Clin Chem Lab Med 2006; 44:223–227.4. Yoo EH, Kim B-I, Cho H-J. Performance Evaluation of the ARKRAY ADAMS A1c HA-8180. Lab Med Online. 2014 Jul;4(3):164-167. 5. Effects of hemoglobin (Hb) E and HbD traits on measurements of glycated Hb (HbA1c) by 23 methods.6. Diabetes Association Clinical Practice Recommendations. Diabetes Care 2014;37,suppl.1:S5-13. 7.Bachir D, Galacteros F. Hemoglobin E [Internet]. Paris (France): Orphanet Encyclopedia; 2004. Available from: http://www.orpha.net/data/patho/GB/uk-HbE.pdf

%HbA1C (N=1,197) P-value*

H50 HA-8180v

Average (95%CI)

7.02(6.93-7.11)

6.96(6.88-7.05)

0.374

* P-value > 0.05 is defined that no different significant statistic

Picture 1. Illustrated linear correlation graph of %HbA1C comparison of 2 devices between H50 and HA-8180v automatic analyzers

%HbA1C

%HbA1C

This study declared no conflicts and interest.