Management ofHBV-infected Patients
Sensitivity
The Aptima HBV Quant assay has a Limit of Detection (LoD) of 5.58 IU/mL for plasma and 4.29 IU/mL for serum determined using the 3rd WHO International Standard.
(All tables and figures in this section can be found in the Aptima HBV Quant assay package insert.)
Limit of Detection Using the 3rd WHO International Standard for HBV
Limit of Detection across HBV Genotypes Using Clinical Specimens
Lower Limit of Quantitation (LLoQ)
The Lower Limit of Quantitation (LLoQ) of the Aptima HBV Quant assay is 5.58 IU/mL in plasma samples and 6.34 IU/mL in serum samples, from only 500 μL of reaction volume1. For plasma, since the calculated LLoQ is lower than the calculated LoD of 5.58 IU/mL, the LLoQ for plasma is 5.58 IU/mL for the 3rd WHO International Standard in accordance with EP 17-A2.
Summary of the LLoQ Using the 3rd WHO International Standard for HBV
Summary of LLoQ Across Genotypes in Plasma and Serum
Linear Range
The linear range of the Aptima HBV Quant assay has been thoroughly validated across all major HBV genotypes (A-H) for accurate quantitation, and was established by testing panels of HBV negative human plasma and serum. The Aptima HBV Quant assay has a linear range of 1.0 to 9 log IU/mL.
Linear Range in Plasma and Serum
Linearity Across HBV Genotypes A to H
Precision of the Aptima HBV Quant Assay
In addition to accurate quantitation, the Aptima HBV Quant assay performs precise quantitation across the linear range. Precision is maintained even in low viremia with narrow CV of <20%.
Reproducibility of the Aptima HBV Quant Assay for Genotype A
Reproducibility of the Aptima HBV Quant Assay for Genotype C
Measuring viral loads in High Titer Samples
To assess how accurately the Aptima HBV Quant assay could measure concentrations of HBV DNA in pre-diluted samples, plasma and serum samples that spanned the linear range were diluted 1:3 or 1:100. Each sample was tested neat and diluted in triplicate. Data are shown in the tables below and demonstrate that the Aptima HBV Quant assay accurately recovered concentrations of diluted samples.
Sample Dilution With Aptima Specimen Diluent in Plasma
Sample Dilution With Aptima Specimen Diluent in Serum
Method Correlation
The Aptima HBV Quant assay on the Panther features real-time TMA for highly specific, highly sensitive performance.
Correlation Between the Aptima HBV Quant Assay and Comparator Assay
1. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012; 57(1):167-185. doi:10.1016/j.jhep.2012.02.010.
LLoQ Lower Limit of Quantitation
LoD Limit of Detection