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Aptima HBV Quant Assay
The Aptima HBV Quant assay is licensed for the quantitation of
HBV DNA on the fully automated Panther system.This assay:
 
• Targets highly conserved regions within 2 genes for added
protection against HBV mutations.
 
• Has a wide linear range to accurately quantitate HBV viral
load in patients with chronic HBV infection undergoing
antiviral drug therapy.
 
• Performs with excellent sensitivity across all major HBV
genotypes (A-H).
 
This assay is not available for sale in the US. Please contact
your local sales representative for product availability.
 
About
The Aptima® HBV Quant assay is an in vitro nucleic acid amplification test (NAAT)
for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum
samples on the fully automated Panther® system.
 
This assay is intended for use as an aid in the management of patients with
chronic HBV infection who are undergoing HBV antiviral drug therapy. It
quantitates HBV viral load at baseline and during treatment to aid in assessing
viral response to treatment.
 

Management ofHBV-infected Patients

 
Currently, HBV quantitation is used to determine which patients with chronic
infection should be treated, to monitor response to therapy and to assess
rebounds in viral load that may indicate drug resistance.1
 
The Aptima HBV Quant assay is an in vitro NAAT that utilizes real-time
transcription-mediated amplification (TMA) technology on the Panther system to
quantitate HBV DNA for genotypes A, B, C, D, E, F, G and H. The assay targets 2
highly conserved regions in the polymerase and surface genes (for increased
tolerance to potential mutations).
Performance

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

 

References

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.

Glossary

LLoQ Lower Limit of Quantitation
LoD Limit of Detection