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Letter to the Editor: Performance Analysis of the Aptima HBV Quant Assay for Hepatitis B virus DNA Quantification in
Joonhong Park1, Jaeeun Yoo2, Joohee Jang3
1Department of Laboratory Medicine, Jeonbuk National University Medical School and Hospital, Jeonju, Korea.
The quantification of hepatitis B virus (HBV) DNA is critical for the diagnosis and management of HBV infections. We evaluated the performance of the Aptima HBV Quant assay for quantitative HBV DNA analysis. The intra-assay coefficient of variation for this assay was 2.08% (mean 3.45 log IU/mL) and 1.10% (mean 5.23 log IU/mL). Linearity ranged from 1.03 to 8.20 log IU/mL. The limit of detection was estimated at 4.31 IU/mL, which corresponded to the 4.29 IU/mL claimed by the manufacturer. All 25 other viral infections were determined to be negative. Passing-Bablok regression analysis showed no significant deviations between Aptima HBV Quant assay and Abbott RealTime HBV assay. The Aptima HBV Quant assay demonstrated comparable performance to the Abbott assay.
The quantification of hepatitis B virus (HBV) DNA is critical for the diagnosis and management of HBV infections. We evaluated the performance of the Aptima HBV Quant assay for quantitative HBV DNA analysis. The intra-assay coefficient of variation for this assay was 2.08% (mean 3.45 log IU/mL) and 1.10% (mean 5.23 log IU/mL). Linearity ranged from 1.03 to 8.20 log IU/mL. The limit of detection was estimated at 4.31 IU/mL, which corresponded to the 4.29 IU/mL claimed by the manufacturer. All 25 other viral infections were determined to be negative. Passing-Bablok regression analysis showed no significant deviations between Aptima HBV Quant assay and Abbott RealTime HBV assay. The Aptima HBV Quant assay demonstrated comparable performance to the Abbott assay.
