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Virology

The New Aptima HBV Quant Real-Time TMA Assay Accurately Quantifies Hepatitis B Virus DNA from Genotypes A to F

Stéphane Chevaliez, Claude Dauvillier, Fabienne Dubernet, Jean-Dominique Poveda, Syria Laperche, Christophe Hézode, Jean-Michel Pawlotsky
Yi-Wei Tang, Editor
Stéphane Chevaliez
aNational Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France
bINSERM U955, Créteil, France
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Claude Dauvillier
aNational Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France
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Fabienne Dubernet
aNational Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France
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Jean-Dominique Poveda
cLaboratoire Cerba, Cergy-Pontoise, France
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Syria Laperche
dNational Reference Center for Viral Hepatitis B, C, and Delta in Blood Transfusion, Institut National de la Transfusion Sanguine, Paris, France
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Christophe Hézode
bINSERM U955, Créteil, France
eDepartment of Hepatology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France
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Jean-Michel Pawlotsky
aNational Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France
bINSERM U955, Créteil, France
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Yi-Wei Tang
Memorial Sloan-Kettering Cancer Center
Roles: Editor
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DOI: 10.1128/JCM.02219-16
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    FIG 1

    Quantification of HBV DNA levels in a commercial panel containing 5 × 101 (1.7 log) to 5 × 107 (7.7 log) HBV DNA IU/ml (AcroMetrix HBV panel; Thermo Fisher Scientific, Fremont, CA) with the Aptima HBV Quant assay. The average measured values are shown as a function of the expected values. The dashed line represents the equality line.

  • FIG 2
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    FIG 2

    Deming correlation and Bland-Altman plot analysis of HBV DNA levels measured by the Aptima HBV Quant assay in 158 clinical specimens (group 2) containing HBV genotypes A (n = 50), B (n = 8), C (n = 8), D (n = 52), E (n = 38), or F (n = 2). (A) Deming regression of HBV DNA levels measured by the Aptima HBV Quant and CAP/CTM HBV 2.0 assays, respectively; (B) Bland-Altman plot analysis of the Aptima HBV Quant assay versus the CAP/CTM HBV 2.0 assay; (C) Deming regression analysis of HBV DNA levels measured by the Aptima HBV Quant assay versus the Abbott RealTime HBV assay; (D) Bland-Altman plot analysis of the Aptima HBV Quant assay versus the Abbott RealTime HBV assay. In the Bland-Altman plots, the dotted and dashed lines represent mean differences ± 1.96 SD, respectively.

  • FIG 3
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    FIG 3

    Box plot representation of the distribution of the differences between the HBV DNA levels obtained by the Aptima HBV Quant assay and the CAP/CTM HBV 2.0 assay (A) or the Aptima HBV Quant and Abbott RealTime HBV assays (B), according to the HBV genotype. The midline and the lower and upper edges of the boxes represent the median value, 25th percentile, and 75th percentile, respectively. The lower and upper error bars represent the minimum and maximum values, respectively.

  • FIG 4
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    FIG 4

    Quantification of HBV DNA levels in 23 clinical specimens (group 4) infected with HBV bearing amino acid substitutions in the MHR of the S gene (A) and in 18 clinical specimens (group 5) infected with HBV bearing BCP and/or precore mutations (B). HBV DNA levels were measured with the Aptima HBV Quant assay (red squares), the CAP/CTM HBV 2.0 assay (black triangles), or the Abbott RealTime HBV assay (black circles). The red or black dashed lines correspond to the LODs of the Aptima HBV Quant assay (1.0 log IU/ml) and the Abbott RealTime HBV assay (1.0 log IU/ml) or the CAP/CTM HBV 2.0 assay (1.3 log IU/ml), respectively. B-1, blood donor 1; Pt-1, patient 1; gA, genotype A; gB, genotype B; gC, genotype C; gD, genotype D; gE, genotype E; gG, genotype G; nd, not determined due to PCR amplification failure or lack of hybridization to the specific probes in spite of efficient PCR amplification. Amino acid substitutions in the MHR containing the “a” determinant and BCP (AGG or TGA at positions 1762 to 1764) and precore (G or A at position 1896) mutations are indicated.

  • FIG 5
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    FIG 5

    Kinetics of HBV DNA levels measured in patients' plasma specimens with the Aptima HBV Quant (red lines and filled circles) and CAP/CTM HBV 2.0 assays (black lines and filled circles) (A) or the Abbott RealTime HBV assay (black lines and filled circles) (B). The red or black dashed lines correspond to the LODs of the Aptima HBV Quant (1.0 log IU/ml) and CAP/CTM HBV 2.0 (1.3 log IU/ml) assays or the Abbott RealTime HBV assay (1.0 log IU/ml), respectively. HBV DNA levels are shown on the y axis. Red or black asterisks represent detectable but not quantifiable HBV DNA in the Aptima HBV Quant and CAP/CTM HBV 2.0 assays or the Abbott RealTime HBV assay, respectively. gA, genotype A; gB, genotype B; gD, genotype D; gE, genotype E; LAM, lamivudine; ETV, entecavir; ADV, adefovir; TDF, tenofovir.

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The New Aptima HBV Quant Real-Time TMA Assay Accurately Quantifies Hepatitis B Virus DNA from Genotypes A to F
Stéphane Chevaliez, Claude Dauvillier, Fabienne Dubernet, Jean-Dominique Poveda, Syria Laperche, Christophe Hézode, Jean-Michel Pawlotsky
Journal of Clinical Microbiology Mar 2017, 55 (4) 1211-1219; DOI: 10.1128/JCM.02219-16

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The New Aptima HBV Quant Real-Time TMA Assay Accurately Quantifies Hepatitis B Virus DNA from Genotypes A to F
Stéphane Chevaliez, Claude Dauvillier, Fabienne Dubernet, Jean-Dominique Poveda, Syria Laperche, Christophe Hézode, Jean-Michel Pawlotsky
Journal of Clinical Microbiology Mar 2017, 55 (4) 1211-1219; DOI: 10.1128/JCM.02219-16
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    • ABSTRACT
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KEYWORDS

DNA
genotype
hepatitis B virus
Nucleic Acid Amplification Techniques
viral load
HBV DNA
HBV monitoring
real-time TMA
hepatitis B virus

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