OptiQuant® HBV DNA Quantification Panel

The OptiQuant® HBV DNA Quantification Panel can be used for training and proficiency testing of laboratory personnel, for lot-to-lot comparison of reagent test kits, and to evaluate and compare intra-laboratory and inter-laboratory assessments. This product provides a consistent standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess the analytical performance of nucleic acid test procedures for the quantitative and quantitative determination of hepatitis B viral (HBV) DNA. For Research Use Only. Not for use in diagnostic procedures.

Procedure

The OptiQuant® HBV DNA Quantification Panel members have been carefully formulated to mimic naturally occurring human specimens containing HBV viral DNA. Therefore, the panel can be used with any test procedure designed for measuring HBV DNA in human serum or plasma. Since the panel members contain intact, encapsulated viral particles, the test methodology should include an extraction step that releases the viral DNA and makes it available for transcription, amplification and/or hybridization, as appropriate to the test.

Interpretation of Results

OptiQuant® HBV DNA Quantification Panel members contain HBV DNA at levels calibrated against the WHO 1st International Standard for HBV DNA. Consequently, the assigned values are reported as International Units per milliliter (IU/mL). Commercial test procedures may report results in proprietary units that may differ from International Units as defined by WHO.

Product Description

The positive panel members contain HBV positive plasma that has been diluted in defibrinated, delipidized normal human plasma. The NHP used for manufacture has been tested and found to be negative for HBV DNA, HCV RNA, HIV-1 RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and antibodies to HTLV I - II.

The negative panel member is designed to produce a non-reactive result in quantitative and qualitative nucleic acid assays for HBV DNA, HCV RNA, HIV-1 RNA, antibodies to HIV-1 and HIV-2, antibodies to HCV and antibodies to HTLV I-II.

Each panel member contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.

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Control Configurations

Each control is filled into sterile 2 mL polypropylene vials with screw caps.

OptiQuant® HBV DNA Quantification Panel members are shipped frozen on dry ice.

Storage Instructions

It is recommended that the HBV DNA Quantification OptiQuant®Panel members be stored at -20°C or lower to ensure highest quality. Panel members may be refrozen after the first use, thawed and used a second time with minimal loss of activity. Discard any unused material after the second use. Any controls that appear cloudy or contain precipitates after thawing should be discarded.