Performance evaluation of the glycated hemoglobin A1c analyzer for point-of-care testing compared with laboratory-based devices: a multicenter validation study.

Sep 02, 2024

Experts: Yiwen Zhou,Fan Yang,Mi Zhou,Baishen Pan,Beili Wang,Wei Guo,Wenqi Shao,Jing Zhu

In this dual-center study, we assessed the BioHermes A1C EXP M13 system for point-of-care (POC) HbA1c testing against two NGSP-certified HPLC instruments, the Bio-Rad D100 and Tosoh G8. Analyzing 605 samples, we evaluated the A1C EXP’s reproducibility, sensitivity, specificity and impact of anemia on HbA1c measurements. The device showed excellent reproducibility with CVs under 2.4% and high sensitivity and specificity for diabetes diagnosis-98.1% and 96.8% against D100, and 97.1% and 96.7% against G8. Passing-Bablok regression confirmed a close correlation between A1C EXP and the HPLC instruments, with equations = 0.10625 + 0.9688x (D100) and = 0.0000 + 0.1000x (G8), and Bland-Altman plots indicated mean relative differences of -1.4% (D100) and -0.4% (G8). However, in anemic samples, A1C EXP showed a negative bias compared to HPLC devices, suggesting that anemia may affect the accuracy of HbA1c results. The study indicates that A1C EXP is a reliable POC alternative to laboratory assays, albeit with considerations for anemic patients.

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ABOUT THE EXPERTS

Yiwen Zhou,Fan Yang,Mi Zhou,Baishen Pan,Beili Wang,Wei Guo,Wenqi Shao,Jing Zhu

Yiwen Zhou

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

Fan Yang

Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School, Branch of National Clinical Research Center for Metabolic Diseases, Nanjing, China.

Endocrine and Metabolic Disease Medical Center, Drum Tower Hospital affiliated to Nanjing University Medical School, Nanjing, China.

Mi Zhou

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

Baishen Pan

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Laboratory Medicine, Wusong Branch, Zhongshan Hospital, Fudan University, Shanghai, China.

Beili Wang

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Laboratory Medicine, Wusong Branch, Zhongshan Hospital, Fudan University, Shanghai, China.

Cancer Center, Shanghai Zhongshan Hospital, Fudan University, Shanghai, China.

Wei Guo

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Laboratory Medicine, Wusong Branch, Zhongshan Hospital, Fudan University, Shanghai, China.

Cancer Center, Shanghai Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Laboratory Medicine, Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen, China.

Wenqi Shao

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.

Jing Zhu

Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.