Zhang Xue-Dong, Song Xue-Dong, Lu Jian-Hua, Dai Yan, Li Bin, Zhu Ping, Dai Er-Hei, Pan Calvin Q, Chen Wei
Department of Clinical Laboratory, the First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, Shaanxi, China.
Autobio Diagnostic Co.Ltd., Zhengzhou, China.
Heliyon. 2024 Jun 8;10(14):e32698. doi: 10.1016/j.heliyon.2024.e32698. eCollection 2024 Jul 30.
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, < 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, < 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.
乙型肝炎病毒标志物的血清学检测在乙型肝炎的诊断、治疗、预后及治疗监测中发挥着至关重要的作用。为比较Autolumo A2000Plus和雅培Architect i2000系统在检测乙型肝炎感染标志物方面的诊断性能。本研究共纳入6个HBV血清转换面板和743名参与者，包括383例HBV感染患者和360名健康成年人。收集临床诊断信息、实验室结果及HBV基因分型，以评估A2000Plus和i2000系统在检测HBV感染标志物方面的诊断性能。结果显示，在六个血清转换面板及743份人群血清样本中，两种检测系统中HBV标志物的总一致率均>90%。两种分析仪中乙型肝炎病毒血清学标志物的卡方检验χ2值在550.7至743.0之间，P<0.0001。HBV标志物一致性检验结果显示两种分析仪之间具有完美的一致性，Kappa值范围为0.854至1.000。对于特定样本，包括C基因型乙型肝炎患者、慢性乙型肝炎、乙型肝炎相关肝硬化和肝细胞癌，Spearman相关性分析显示两种分析仪中HBsAg的相关系数范围为0.8532至0.9745，P<0.001。总之，在检测乙型肝炎感染标志物时，Autolumo A2000Plus在一致性和相关性方面的诊断性能与雅培Architect i2000相当。Autolumo A2000Plus系统可作为检测HBV标志物的可靠仪器。
