ĐÁNH GIÁ PHƯƠNG PHÁP ĐO TẢI LƯỢNG HBV DNA TRÊN HỆ THỐNG COBAS 6800

Abstract

Objects: To verify the quantitative HBV-DNA method by utilizing the COBAS 6800 automatic system
and to evaluate the similarity between the COBAS 6800 system and the CAP/CTM 48 automatic system.
Subjects and methods: Experimental application was conducted according to the CLSI MM06-A2
guideline. We used the positive controls to confirm the accuracy, repeatability and linearity of the COBAS
6800 system, and patient specimens to evaluate the similarity between the COBAS 6800 and the CAP/
CTM 48 system.
Results: The repeatability, accuracy, and linearity of the COBAS 6800 were verified following the
manufacturer's recommendations. The linearity was verified in a range of concentrations from 2.34 to 6.17
log10IU/mL (r2 = 0.997). The results for HBV-DNA quantification on the COBAS 6800 system were similar
(-0.05 log10IU/mL) and correlated excellently with the CAP/CTM 48 system (r2 = 0.98). Conclusions: The
results of HBV DNA quantitation on the COBAS 6800 system were accurate and correlated with the CAP/
CTM 48 system, rendering it a highly reliable clinical tool.