Evaluation of the clinical utility of Cobas TaqMan HCV v2.0

• Published in: Kanzo Vol. 56; no. 1; pp. 21 - 23
• Main Authors: Suzuki, Fumitaka, Suzuki, Yoshiyuki, Akuta, Norio, Sezaki, Hitomi, Kawamura, Yusuke, Hosaka, Tetsuya, Kobayashi, Masahiro, Saitoh, Satoshi, Arase, Yasuji, Ikeda, Kenji, Kondo, Masaki, Furutani, Shigeyuki, Sakakura, Yasuhiko, Kobayashi, Mariko, Kumada, Hiromitsu
• Format: Journal Article
• Language: Japanese; English
• Published: The Japan Society of Hepatology 2015
• Subjects: HCV RNA; TaqMan; Viral load
• ISSN: 0451-4203; 1881-3593
• DOI: 10.2957/kanzo.56.21

The correlation and sensitivity of TaqMan HCV v1.0 (v.1.0) and TaqMan HCV v2.0 (v.2.0) were evaluated by using 239 clinical specimens from 40 patients undergoing Telaprevir-based triple therapy. A correlation study was performed with the specimens from patients at baseline, day 1 and day 3 of the therapy and a clinical sensitivity study was performed on day 3, week 1, week 2, and week 4. Analytical sensitivity was measured by using WHO dilution panels (50, 25, 15, 10, 5 IU/mL and negative). Passing-Bablok regression analysis of the correlation study was y=0.907x+0.093 (rs=0.985). When clinical sensitivity was evaluated, there were no significant differences between v1.0 and v2.0 by McNemar analysis. Analytical sensitivities of v1.0 and v2.0 were calculated by Probit analysis (95% hit rate, v1.0: 11.59 IU/mL, v2.0: 10.49 IU/mL). Comparison of the treatment outcome (SVR 12) based on RVR (undetectable HCV RNA at week 4) by v2.0 showed almost the same results as those by v1.0. These results showed that correlation and sensitivity of v.2.0 were the same as for v1.0. Therefore, v2.0 can be used for the medical decision points and guideline rules of HCV treatments which have been established based on v1.0.