Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V

Abstract

ObjectivesTo evaluate the Bio-Rad D-100®, an HPLC analyzer for glycated hemoglobin (HbA1c) determination, and to compare its performance with the Menarini HA-8180V® and Sysmex G8®.MethodsMethod comparison was performed according to Clinical and Laboratory Standards Institute (CLSI) EP9-A2 guidelines. We selected 100 samples from the routine laboratory workload and analyzed them in duplicate with the three analyzers. The imprecision study was performed according to CLSI EP5-A2 guidelines for both inter-assay and intra-assay variability. Bias was assessed with external quality control material. To establish linearity, CLSI EP6-A protocol was followed.ResultsMethod comparison (95% confidence intervals in parentheses): D-100 vs G8: Passing-Bablok regression; y=0.973(0.963–0.983)×−0.07(−0.07−0.069); r=0.9989. Bland-Altman mean difference: −0.229%HbA1c (−0.256: −0.202); Relative bias plot: D-100/G8 vs D100-G8 mean ratio=0.971(0.967−0.975). D-100 vs HA-8180V: Passing-Bablok regression; y=0.944(0.932–0.958)×−0.078(0.024−0.173); r=0.9989. Bland-Altman mean difference: −0.363%HbA1c (−0.401: −0.325); Relative bias plot D-100/HA-8180V vs D100-HA-8180V mean ratio=0.955(0.952−0.958). Inter-assay coefficient of variation (CV): 0.81%. Intra-assay CV: 1.04% (low level), and 0.78% (high level). Bias against target value=2.332%. Linearity: r2=0.998 in the concentration range 4.4−13.9%HbA1c. Carry-over: 0.0024%.ConclusionsThe Bio-Rad D-100 shows good correlation with G8 and HA-8180V. There is a small proportional systematic difference (2.7% and 5.6%, respectively) in both comparisons. Inter and intra-assay CVs are both lower than the lowest CV obtained in studies performed with D-100 and other instruments.

Screening for Gestational Diabetes Mellitus by Measuring Glycated Hemoglobin Can Reduce the Use of the Glucose Challenge Test

“…The performance of the OGTT as a diagnostic test is very high; however, the sensitivity (S) of the GCT ranges between 70% and 88% for the 140 mg/dL cut-off point [6]. In addition, the reproducibility of the OGTT is low [7], especially when compared with that of other biomarkers such as glycated Hb (HbA 1c ) [8]. Furthermore, it is an important source of expense for laboratories and causes great inconvenience to pregnant women, as they must spend at least one hour in the hospital for the GCT.…”

Do Hospital Doctors Screen for Diabetes?

“…Only half of patients (11/23, 47.8 %) with newly detected DM received antidiabetic drug treatment at discharge. Patients with newly detected DM (n = 23) had a longer length of stay (median and interquartile range: 16 [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] versus 10 [8][9][10][11][12][13][14][15][16] days, p = 0.028) compared to patients without DM, while no such differences were found regarding in-hospital mortality.…”

“…Two glucose values measured during the study period were considered: 1) first glucose assessment and 2) highest value during hospitalization. Hba1c levels were assessed in EDTA whole blood using Bio-Rad D-100TM HbA1c testing system (Bio-Rad Laboratories, Hercules, CA, USA) [10]. As only seven patients had two HbA1c measurements during their stay, only the first HbA 1 c measurement was considered.…”

Analytical performance evaluation of the Norudia HbA1c assay

“…HbA 1c methods have previously been reported to show negative biases at higher HbA 1c concentrations. 7,8 Moreover, the accuracy of the 3 methods was compared using 13 reference samples provided by the KCDC, with corresponding target…”

“…According to the recent College of American Pathologists (CAP) proficiency testing survey results for HbA 1c , the HPLC method is one of the most common methods used for HbA 1c testing worldwide, 6 with the ability to detect common hemoglobin variants, one of its main advantages. However, rarer variants which coelute with the peaks of interest can still cause interference, in addition to issues with regard to negative intermethod differences at higher HbA 1c (>74.9 mmol/mol or >9% in NGSP units) concentrations 7,8 being pointed out as its limitations. Thus, continuous efforts to develop a HbA 1c assay with diagnostic accuracy near-equivalent to the IFCC-RMP, while being robust enough for routine use in the clinical laboratory, remain ongoing.…”