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Abstract
Background
Hepatitis B virus (HBV) DNA quantification is necessary for starting and monitoring of antiviral therapy in patients with chronic hepatitis B. This study was intended to assess the clinical performance of Abbott RealTime HBV Quantification kit (Abbott Laboratories, USA).
Methods
The performance was evaluated in terms of precision, linearity, detection sensitivity, cross-reactivity, and carry-over. A correlation with the Real-Q HBV Quantification kit (BioSewoom Inc., Korea) was also examined using serum samples from 64 patients diagnosed with chronic hepatitis B and underwent lamivudine therapy in Asan Medical Center. We verified the trueness of the system by comparing the outputs with the assigned values of the BBI panel (BBI Diagnostics, USA).
Results
Within-run and between-run coefficients of variation (CV) were 3.56-4.71% and 3.03-4.98%, respectively. Linearity was manifested ranging from 53 to 109 copies/mL and the detection sensitivity was verified to be 51 copies/mL. None of hepatitis C virus showed cross-reactivity. No cross-contamination occurred when negative and positive samples were alternatively placed in a row. It showed a good correlation with the Real-Q HBV (r2=0.9609) and the test results for the BBI panel were also well agreed to the assigned values (r2=0.9933).
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Fig. 1.
The linearity range of Abbott RealTime HBV Quantification kit. Claimed linearity was verified with a result ranging from 53 to 109 copies/mL.
Fig. 2.
Correlation of test results between BBI control target value and Abbott RealTime HBV Quantification kit.
Table 1.
Detection limit of Abbott RealTime HBV Quantification kit
| Input HBV (Copies/mL) | Result | ||
|---|---|---|---|
| Replicates | Positive reaction | % | |
| 270 | 10 | 10 | 100 |
| 135 | 4 | 4 | 100 |
| 90 | 7 | 7 | 100 |
| 67.5 | 10 | 10 | 100 |
| 33.75 | 9 | 9 | 100 |
Table 2.
Carry-over tests of Abbott RealTime HBV Quantification kit
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