Evaluation of four automated nucleic acid testing systems for the ultrasensitive quantification of hepatitis B virus.

OBJECTIVES

To comprehensively evaluate and compare four commonly used automated nucleic acid testing systems (Roche, Tianlong, Daan, and Sansure) for the quantification of hepatitis B virus, and to promote cross-platform standardization.

METHODS

Linearity was assessed using 10-fold serial dilutions of a high-concentration HBV concentrate. Precision, accuracy, and analytical sensitivity were evaluated using WHO international standards. Clinical performance was assessed using 157 clinical specimens.

RESULTS

Roche exhibited good linearity over 1.0 × 101-2.0 × 108 IU/mL, while Tianlong, Daan, and Sansure showed stable linear detection capability only at concentrations above 100 IU/mL. All four systems exhibited acceptable precision and accuracy, among which Roche performed the best in low-concentration samples. Roche and Tianlong achieved the highest analytical sensitivity of 2.5 IU/mL, while Daan and Sansure reached 5 IU/mL. Using Roche as the reference, the clinical performance of the other three systems was evaluated. These systems exhibited excellent linear correlation (r > 0.97) with Roche, with mean differences of 0.383, 0.228, and -0.111 log10 IU/mL, respectively.

CONCLUSIONS

The four systems differed in performance, with Roche demonstrating the best overall performance, especially at low viral loads. The other three systems showed satisfactory correlation and concordance with Roche and are suitable for resource-limited settings.