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|Product Name||Unit Size||Order Number||GTIN|
The Abbott RealTime HBV Viral Load Assay is for quantitation of Hepatitis B virus in chronically infected HBV individuals.
Abbott RealTime HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the Abbott m2000 System DNA reagents and with the Abbott m2000sp and m2000rt instruments for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals. The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Abbott RealTime HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. This assay is not intended for use as a screening test in blood or blood products for HBV or as a diagnostic test to confirm the presence of HBV infection.Limitations of the Procedure
The Abbott RealTime HBV assay is not intended for use in the screening of blood, plasma, or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.
To learn more about RealTime HBV please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hbv-viral-load
|Abbott RealTime HBV Performance*|
|Sensitivity||10 IU/mL for 0.5 mL sample volume
15 IU/mL for 0.2 mL sample volume
|Linear Range||10 IU/mL (1.00 log IU/mL) to 1 billion IU/mL (9.00 log IU/mL)|
|Precision1||Standard Deviation ≤ 0.25 log IU/mL|
|Genotype Detection||Accurate quantitation of genotypes A, B, C, D, E, F, G, H|
|Specimen Type||Serum and Plasma (EDTA)|
|Standardization||World Health Organization (WHO) International Standard for Hepatitis B Virus DNA (97/746)|
|Internal Control||Added to lysis buffer during extraction and detected at all levels|
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