Comparison of Autolumo A2000 Plus and Architect i2000 for detection of hepatitis B virus serological markers
Xue-Dong Zhang,
Xue-Dong Song,
Jian-Hua Lu,
Yan Dai,
Bin Li,
Ping Zhu,
Er-Hei Dai,
Calvin Q. Pan,
Wei Chen
Affiliations
Xue-Dong Zhang
Department of Clinical Laboratory, the First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, China; Autobio Diagnostic Co.Ltd., Zhengzhou, China
Xue-Dong Song
Hebei Key Laboratory of Immune Mechanism of Major Infectious Diseases and New Technology of Diagnosis and Treatment, The Fifth Hospital of Shijiazhuang, Hebei Medical University, Shijiazhuang, China; Department of Laboratory Medicine, Handan Central Hospital, Hebei Medical University, Handan, China
Jian-Hua Lu
Hebei Key Laboratory of Immune Mechanism of Major Infectious Diseases and New Technology of Diagnosis and Treatment, The Fifth Hospital of Shijiazhuang, Hebei Medical University, Shijiazhuang, China
Yan Dai
Autobio Diagnostic Co.Ltd., Zhengzhou, China
Bin Li
Autobio Diagnostic Co.Ltd., Zhengzhou, China
Ping Zhu
Department of Laboratory Medicine, the Sixth Hospital of Shijiazhuang, Hebei, China
Er-Hei Dai
Hebei Key Laboratory of Immune Mechanism of Major Infectious Diseases and New Technology of Diagnosis and Treatment, The Fifth Hospital of Shijiazhuang, Hebei Medical University, Shijiazhuang, China
Calvin Q. Pan
Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China; Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Health, New York University Grossman School of Medicine, New York, USA; Corresponding author. Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University. Or No. 8, Jingshun East Street, Chaoyang District, Beijing, 100015, China.
Wei Chen
Department of Clinical Laboratory, the First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, China; Corresponding author. The First Affiliated Hospital of Xi'an Jiaotong University, Address: 277 West Yanta Road, Xi'an, Shaanxi, China.
Serological detection of hepatitis B virus markers plays a vital role in the diagnosis, treatment, prognosis, and therapeutic surveillance of hepatitis B. To compare the diagnostic performance of Autolumo A2000Plus and Abbott Architect i2000 systems in the detection of hepatitis B infection markers. A total of 6 HBV seroconversion panels and 743 participants were enrolled in this study, including 383 HBV-infected patients and 360 healthy adults. Clinical diagnostic information, laboratory results, and HBV genotyping were collected to evaluate the diagnostic performance of the A2000Plus and i2000 systems in detecting HBV infection markers. The results showed that the total percent agreement of HBV markers was all >90 % in both detection systems among the six seroconversion panels and 743 serum samples from the population. The χ2 values of the Chi-square test among hepatitis B virus serological markers in both analyzers were between 550.7 and 743.0, p < 0.0001. HBV marker consistency test results show perfect consistency between the two analyzers, with Kappa values ranging from 0.854 to 1.000. For specific samples, including Hepatitis B patients with Genotype C, chronic hepatitis B, hepatitis B-related cirrhosis, and hepatocellular carcinoma, spearman correlation analysis showed HBsAg correlation coefficients ranging from 0.8532 to 0.9745, p < 0.001 in both analyzers. In conclusion, Autolumo A2000Plus diagnostic performance in consistency and correlation is comparable to Abbott Architect i2000 when detecting markers of hepatitis B infection. The Autolumo A2000Plus system can be used as a reliable instrument for HBV marker detection.
