Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V
Objectives: To 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®. Methods: Method comparison was performed according to Clinical and Laboratory Standards Institute (CLSI) EP9-A2 guide...
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| Format: | Article |
| Language: | English |
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Elsevier
2016-08-01
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| Series: | Practical Laboratory Medicine |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352551716300154 |
| _version_ | 1819152520877965312 |
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| author | José María Maesa Patricia Fernández-Riejos Catalina Sánchez Mora María de Toro Paloma Menéndez Valladares Concepción González-Rodriguez |
| author_facet | José María Maesa Patricia Fernández-Riejos Catalina Sánchez Mora María de Toro Paloma Menéndez Valladares Concepción González-Rodriguez |
| author_sort | José María Maesa |
| collection | DOAJ |
| description | Objectives: To 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®. Methods: Method 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. Results: Method 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%. Conclusions: The 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. Keywords: Glycated hemoglobin, High performance liquid chromatography, Analyzer, Intra-assay variability, Inter-assay variability |
| first_indexed | 2024-12-22T14:50:36Z |
| format | Article |
| id | doaj.art-05bb801199d74dfb82d89fd0e9a0335d |
| institution | Directory Open Access Journal |
| issn | 2352-5517 |
| language | English |
| last_indexed | 2024-12-22T14:50:36Z |
| publishDate | 2016-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Practical Laboratory Medicine |
| spelling | doaj.art-05bb801199d74dfb82d89fd0e9a0335d2022-12-21T18:22:19ZengElsevierPractical Laboratory Medicine2352-55172016-08-0155764Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180VJosé María Maesa0Patricia Fernández-Riejos1Catalina Sánchez Mora2María de Toro3Paloma Menéndez Valladares4Concepción González-Rodriguez5Clinic Biochemistry Department, Virgen Macarena University Hospital, SpainCorresponding author.; Clinic Biochemistry Department, Virgen Macarena University Hospital, SpainClinic Biochemistry Department, Virgen Macarena University Hospital, SpainClinic Biochemistry Department, Virgen Macarena University Hospital, SpainClinic Biochemistry Department, Virgen Macarena University Hospital, SpainClinic Biochemistry Department, Virgen Macarena University Hospital, SpainObjectives: To 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®. Methods: Method 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. Results: Method 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%. Conclusions: The 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. Keywords: Glycated hemoglobin, High performance liquid chromatography, Analyzer, Intra-assay variability, Inter-assay variabilityhttp://www.sciencedirect.com/science/article/pii/S2352551716300154 |
| spellingShingle | José María Maesa Patricia Fernández-Riejos Catalina Sánchez Mora María de Toro Paloma Menéndez Valladares Concepción González-Rodriguez Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V Practical Laboratory Medicine |
| title | Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V |
| title_full | Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V |
| title_fullStr | Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V |
| title_full_unstemmed | Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V |
| title_short | Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V |
| title_sort | evaluation of bio rad d 100 hba1c analyzer against tosoh g8 and menarini ha 8180v |
| url | http://www.sciencedirect.com/science/article/pii/S2352551716300154 |
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