Abbott RealTime HBV

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Product Description
Product Description

The Abbott RealTime HBV Viral Load Assay is for quantitation of Hepatitis B virus in chronically infected HBV individuals.

Intended Use

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
  • Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert).
  • Human serum and plasma (EDTA) may be used with the Abbott RealTime HBV assay. The use of other anticoagulants has not been validated for use with the Abbott RealTime HBV assay.
  • The use of specimens collected in serum tubes that contain Z-clot activator, or similar types of rapid clot activator, may cause inhibited results in the RealTime HBV assay. Therefore, serum collection tubes containing Z-clot activator or similar rapid clot activators should not be used.
  • The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.
  • In rare cases, a very low level positive result may occur from cross contamination during processing of an extremely high copy number adjacent specimen. Carryover rates in representative studies ranged from 0% to 2%. Per treatment guidelines, a 1 log increase is needed in order to impact patient management. In addition, treatment guidelines require two consecutive elevated measurements to occur before changing patient management.
  • A single Entecavir mutation (rtA97V) occurs within the reverse primer. Of all known resistance mutations, it is the only one that occurs within any Abbott RealTime HBV primer or probe sequence. Software simulation predicts that this mutation (rtA97V) would not be expected to interfere with assay results when using RealTime HBV assay conditions.
  • A specimen with a result of “Not Detected” cannot be presumed to be negative for HBV DNA.
  • Precision was established with HBV Genotypes A and C only.
  • Drug interference was evaluated using a plasma matrix, and was not evaluated in serum. The listed drugs were tested in pools, and individual drug effects were not assessed.
  • The interference studies were performed with an HBV DNA concentration of 2,933 IU/mL (3.47 log IU/mL). Potential interference on HBV DNA concentrations close to the assay LLQ (LLoQ) was not assessed.
  • Some of the cross-reactivity studies were performed with nucleic acids (DNA and RNA) only. For further detail, refer to the SPECIFIC PERFORMANCE CHARACTERISTICS section of this package insert.
  • Results from the Abbott RealTime HBV assay should be interpreted in conjunction with other clinical and laboratory findings.
Warnings and Precautions

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.

Rx Only

To learn more about RealTime HBV please visit:

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
Specificity2 100%
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
*Performance data shown from internal verification.
1Total precision includes within-run, between-run and between-lot/instrument components of precision.
2The specificity of the Abbott RealTime HBV assay was evaluated by testing 124 HBV seronegative serum and 125 HBV seronegative plasma specimens.

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