Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System
Abstract
1. Introduction
2. Materials and Methods
2.1. Standards
2.2. Clinical Specimens
2.3. HBV DNA Quantification
2.4. Statistical Analysis
3. Results
3.1. Specificity
3.2. Analytical Sensitivity
3.3. Precision
3.4. Linearity of a Standard Panel
3.5. Influence of Genotype on HBV DNA Quantification
3.6. Overall Percent Agreement for the Clinical Cutoffs of 2000 and 20,000 UI/mL
3.7. HBV DNA Monitoring in Patients Treated with Tenofovir-Containing Regimen
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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CAP/CTM HBV Test v2.0 | ||||
---|---|---|---|---|
cobas® HBV Test | <2000 IU/mL | ≥2000 IU/mL | Total | |
<2000 IU/mL | 55 | 6 | 61 | |
≥2000 IU/mL | 3 | 57 | 60 | |
Total | 58 | 63 | 121 | |
<20,000 IU/mL | ≥20,000 IU/mL | Total | ||
<20,000 IU/mL | 84 | 0 | 84 | |
≥20,000 IU/mL | 1 | 36 | 37 | |
Total | 85 | 36 | 121 |
Alinity™ m HBV | ||||
---|---|---|---|---|
cobas® HBV Test | <2000 IU/mL | ≥2000 IU/mL | Total | |
<2000 IU/mL | 39 | 5 | 44 | |
≥2000 IU/mL | 1 | 38 | 39 | |
Total | 40 | 43 | 83 | |
<20,000 IU/mL | ≥20,000 IU/mL | Total | ||
<20,000 IU/mL | 62 | 0 | 62 | |
≥20,000 IU/mL | 0 | 21 | 21 | |
Total | 62 | 21 | 83 |
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Ortonne, V.; Wlassow, M.; Bouvier-Alias, M.; Melica, G.; Poveda, J.-D.; Laperche, S.; Pawlotsky, J.-M.; Chevaliez, S. Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System. Microorganisms 2021, 9, 573. https://doi.org/10.3390/microorganisms9030573
Ortonne V, Wlassow M, Bouvier-Alias M, Melica G, Poveda J-D, Laperche S, Pawlotsky J-M, Chevaliez S. Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System. Microorganisms. 2021; 9(3):573. https://doi.org/10.3390/microorganisms9030573
Chicago/Turabian StyleOrtonne, Valérie, Mélanie Wlassow, Magali Bouvier-Alias, Giovana Melica, Jean-Dominique Poveda, Syria Laperche, Jean-Michel Pawlotsky, and Stephane Chevaliez. 2021. "Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System" Microorganisms 9, no. 3: 573. https://doi.org/10.3390/microorganisms9030573
APA StyleOrtonne, V., Wlassow, M., Bouvier-Alias, M., Melica, G., Poveda, J.-D., Laperche, S., Pawlotsky, J.-M., & Chevaliez, S. (2021). Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System. Microorganisms, 9(3), 573. https://doi.org/10.3390/microorganisms9030573