ECi/ECiQ和AxSYM全自动免疫系统的性能比较
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曾 争, 于 敏, 张乃临, 公维波
HBsAg;抗HCV;全自动免疫检测系统;性能比较曾争,于敏,张乃临,公维波.ECi,ECiQ和AxSYM全自动免疫系统的性能比较分析. 世界华人消化杂志2007;15(6)633-637,曾争,于敏,张乃临,公维波,通讯作者
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曾争, 于敏, 张乃临, 北京大学第一医院感染疾病科病毒研究室 北京市 100034
公维波, 中山大学达安基因股份有限公司 广东省广州市 510665
通讯作者: 曾争, 100034, 北京西城区西什库大街8号, 北京大学第一医院感染疾病科病毒研究室. zeng@bjmu.edu.cn
电话: 010-66551799 传真: 010-66551799
收稿日期: 2006-12-03 接受日期: 2007-01-17
Laboratory evaluation of the ECi/ECiQ and AxSYM automatic immunoassay system for detection of HBsAg and anti-hepatitis C virus
Zheng Zeng, Min Yu, Nai-Lin Zhang, Wei-Bo Gong
Zheng Zeng, Min Yu, Nai-Lin Zhang, Laboratory of Virology,Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China
Wei-Bo Gong,Da An Gene Corporation Limited, Sun Yat-sen University, Guangzhou 510665, Guangdong Province, China
Correspondence to:Zheng Zeng, Laboratory of Virology, Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China. zeng@bjmu.edu.cn
Received:2006-12-03 Accepted:2007-01-17
Abstract
AIM:To compare two automatic immunoassay systems (ECi/ECiQ and AxSYM) for monitoring serum HBsAg and anti-HCV, and to investigate the influencing factors on the clinical detection results.
METHODS: Twenty HBsAg- or anti-HCV-positive samples were mixed with normal healthy sera to Cut-Off value and the detection was repeated 40 times. After 50 mL gas was injected into the samples, bubble-detection test was performed 20 times. Linear correlation was analyzed by diluting HBsAg-positive samples with normal healthy sera in series.
RESULTS:The reproducibility (CV%) of ECi/ECiQ and AxSYM system was 3.57% and 3.87% for HBsAg, and 5.05% and 17.01% for anti-HCV, respectively. The bubble-detection rate of ECi/ECiQ and AxSYM system was 100% and 55% for HBsAg, and 35% and 15% for anti-HCV, respectively. There was no false-negative result for HBsAg with these two systems. There was also no false-negative result for anti-HCV with ECi/ECiQ system, but there was a false-negative rate of 70.6% for anti-HCV with AxSYM system. For linear analysis, positive HBsAg was still detected when diluted at a ratio of 1 to 40000 with ECI/ECiQ system or 1 to 10000 with AxSYM system, and their correlation coefficients were 0.996 and 0.938, respectively.
CONCLUSION:Both of ECi/ECiQ and AxSYM system are suitable for detecting HBsAg and anti-HCV in clinical laboratory. However, ECi/ECiQ system needs samples with a higher quality. For the “problem samples”, AxSYM system produced a higher false-negative rate. Generally, ECi/ECiQ system is superior to AxSYM system in sensitivity, accuracy and reproducibility.
Key Words: HBsAg; Anti-hepatitis; Automatic immnoassay; Performance
Zeng Z, Yu M, Zhang NL, Gong WB. Laboratory evaluation of the ECi/ECiQ and AxSYM automatic immunoassay system for detection of HBsAg and anti-hepatitis C virus. Shijie Huaren Xiaohua Zazhi 2007;15(6):633-637
摘要目的: 比较ECi/ECiQ和AxSYM系统对样品检测的重复性、气泡检出率及线性范围, 讨论其对临床检测结果的影响 ......
曾争, 于敏, 张乃临, 北京大学第一医院感染疾病科病毒研究室 北京市 100034
公维波, 中山大学达安基因股份有限公司 广东省广州市 510665
通讯作者: 曾争, 100034, 北京西城区西什库大街8号, 北京大学第一医院感染疾病科病毒研究室. zeng@bjmu.edu.cn
电话: 010-66551799 传真: 010-66551799
收稿日期: 2006-12-03 接受日期: 2007-01-17
Laboratory evaluation of the ECi/ECiQ and AxSYM automatic immunoassay system for detection of HBsAg and anti-hepatitis C virus
Zheng Zeng, Min Yu, Nai-Lin Zhang, Wei-Bo Gong
Zheng Zeng, Min Yu, Nai-Lin Zhang, Laboratory of Virology,Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China
Wei-Bo Gong,Da An Gene Corporation Limited, Sun Yat-sen University, Guangzhou 510665, Guangdong Province, China
Correspondence to:Zheng Zeng, Laboratory of Virology, Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China. zeng@bjmu.edu.cn
Received:2006-12-03 Accepted:2007-01-17
Abstract
AIM:To compare two automatic immunoassay systems (ECi/ECiQ and AxSYM) for monitoring serum HBsAg and anti-HCV, and to investigate the influencing factors on the clinical detection results.
METHODS: Twenty HBsAg- or anti-HCV-positive samples were mixed with normal healthy sera to Cut-Off value and the detection was repeated 40 times. After 50 mL gas was injected into the samples, bubble-detection test was performed 20 times. Linear correlation was analyzed by diluting HBsAg-positive samples with normal healthy sera in series.
RESULTS:The reproducibility (CV%) of ECi/ECiQ and AxSYM system was 3.57% and 3.87% for HBsAg, and 5.05% and 17.01% for anti-HCV, respectively. The bubble-detection rate of ECi/ECiQ and AxSYM system was 100% and 55% for HBsAg, and 35% and 15% for anti-HCV, respectively. There was no false-negative result for HBsAg with these two systems. There was also no false-negative result for anti-HCV with ECi/ECiQ system, but there was a false-negative rate of 70.6% for anti-HCV with AxSYM system. For linear analysis, positive HBsAg was still detected when diluted at a ratio of 1 to 40000 with ECI/ECiQ system or 1 to 10000 with AxSYM system, and their correlation coefficients were 0.996 and 0.938, respectively.
CONCLUSION:Both of ECi/ECiQ and AxSYM system are suitable for detecting HBsAg and anti-HCV in clinical laboratory. However, ECi/ECiQ system needs samples with a higher quality. For the “problem samples”, AxSYM system produced a higher false-negative rate. Generally, ECi/ECiQ system is superior to AxSYM system in sensitivity, accuracy and reproducibility.
Key Words: HBsAg; Anti-hepatitis; Automatic immnoassay; Performance
Zeng Z, Yu M, Zhang NL, Gong WB. Laboratory evaluation of the ECi/ECiQ and AxSYM automatic immunoassay system for detection of HBsAg and anti-hepatitis C virus. Shijie Huaren Xiaohua Zazhi 2007;15(6):633-637
摘要目的: 比较ECi/ECiQ和AxSYM系统对样品检测的重复性、气泡检出率及线性范围, 讨论其对临床检测结果的影响 ......
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