Basic Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 7, 2017; 23(37): 6845-6853
Published online Oct 7, 2017. doi: 10.3748/wjg.v23.i37.6845
Performance verification and comparison of TianLong automatic hypersensitive hepatitis B virus DNA quantification system with Roche CAP/CTM system
Ming Li, Lin Chen, Li-Ming Liu, Yong-Li Li, Bo-An Li, Bo Li, Yuan-Li Mao, Li-Fang Xia, Tong Wang, Ya-Nan Liu, Zheng Li, Tong-Sheng Guo
Ming Li, School of Mechanical Engineering, Xi’an Jiaotong University. Xi’an 710049, Shaanxi Province, China
Ming Li, Zheng Li, Xi’an TianLong Science and Technology Co., Ltd., Xi’an 710018, Shaanxi Province, China
Lin Chen, Yong-Li Li, Bo-An Li, Bo Li, Yuan-Li Mao, Li-Fang Xia, Tong Wang, Ya-Nan Liu, Tong-Sheng Guo, Center of Clinical Laboratory Medicine, 302 Military Hospital of China, Beijing 100039, China
Li-Ming Liu, Department of Laboratory Medicine, Beijing Xiaotangshan Hospital, Beijing 102211, China
Author contributions: Li M, Chen L and Liu LM contributed equally to this work; Li M, Chen L, Liu LM, Li YL, Li BA, Li B, Mao YL, Xia LF, Wang T, Liu YN and Guo TS designed research; Li M, Chen L and Liu LM performed research; Li M and Li Z contributed reagents/analytic tools; Li M, Chen L and Liu LM analyzed data; Li M, Chen L and Liu LM wrote the paper.
Institutional review board statement: The study was reviewed and approved by the 302 Military Hospital of China Medical Ethic Committee.
Institutional animal care and use committee statement: This study didn’t involve animal subjects.
Conflict-of-interest statement: To the best of our knowledge, no conflict of interest exists.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Tong-Sheng Guo, MD, Center of Clinical Laboratory Medicine, 302 Military Hospital of China, 100 Xisihuan Zhonglu, Fengtai, Beijing 100039, China. gtsheng@medtl.cn
Telephone: +86-10-68379628 Fax: +86-10-68379628
Received: May 18, 2017
Peer-review started: May 19, 2017
First decision: June 8, 2017
Revised: August 1, 2017
Accepted: August 15, 2017
Article in press: August 15, 2017
Published online: October 7, 2017
Processing time: 133 Days and 1.3 Hours
Abstract
AIM

To investigate and compare the analytical and clinical performance of TianLong automatic hypersensitive hepatitis B virus (HBV) DNA quantification system and Roche CAP/CTM system.

METHODS

Two hundred blood samples for HBV DNA testing, HBV-DNA negative samples and high-titer HBV-DNA mixture samples were collected and prepared. National standard materials for serum HBV and a worldwide HBV DNA panel were employed for performance verification. The analytical performance, such as limit of detection, limit of quantification, accuracy, precision, reproducibility, linearity, genotype coverage and cross-contamination, was determined using the TianLong automatic hypersensitive HBV DNA quantification system (TL system). Correlation and Bland-Altman plot analyses were carried out to compare the clinical performance of the TL system assay and the CAP/CTM system.

RESULTS

The detection limit of the TL system was 10 IU/mL, and its limit of quantification was 30 IU/mL. The differences between the expected and tested concentrations of the national standards were less than ± 0.4 Log10 IU/mL, which showed high accuracy of the system. Results of the precision, reproducibility and linearity tests showed that the multiple test coefficient of variation (CV) of the same sample was less than 5% for 102-106 IU/mL; and for 30-108 IU/mL, the linear correlation coefficient r2 = 0.99. The TL system detected HBV DNA (A-H) genotypes and there was no cross-contamination during the “checkerboard” test. When compared with the CAP/CTM assay, the two assays showed 100% consistency in both negative and positive sample results (15 negative samples and 185 positive samples). No statistical differences between the two assays in the HBV DNA quantification values were observed (P > 0.05). Correlation analysis indicated a significant correlation between the two assays, r2 = 0.9774. The Bland-Altman plot analysis showed that 98.9% of the positive data were within the 95% acceptable range, and the maximum difference was -0.49.

CONCLUSION

The TL system has good analytical performance, and exhibits good agreement with the CAP/CTM system in clinical performance.

Keywords: Analytical performance; Hepatitis B virus DNA quantification; Clinical performance; Hepatitis B virus; Real-time quantification PCR

Core tip: The TianLong automatic hypersensitive hepatitis B virus DNA quantification system achieved a limit of detection of 10 IU/mL, limit of quantification of 30 IU/mL and good analytical performance in terms of accuracy, precision, reproducibility, linearity, genotype coverage and cross-contamination. In clinical performance, the TL system showed good correlation and agreement with the Roche CAP/CTM system.