OptiQual® HBV DNA Controls
OptiQual® HBV DNA Controls are intended for use in assessing the performance of nucleic acid test procedures for the determination of hepatitis B viral DNA (HBV DNA). They are not intended for use with assays used to screen the blood supply.
Procedure
OptiQual® HBV DNA Controls have been carefully formulated to mimic naturally occurring human specimens containing HBV DNA. Therefore, the controls can be used with any test procedure designed for detecting HBV DNA in human serum or plasma.
Interpretation of Results
HBV DNA OptiQual® controls provide clinical laboratories and manufacturers with inactivated quality controls that have been calibrated using the Roche Cobas Amplicor HBV Monitor™ Assay and the World Health Organization (WHO) International Standard for Hepatitis B Virus (HBV) DNA for Nucleic Acid Amplification Technology (NAT) Assays. This independent set of external controls allows testing laboratories and other end users to compare results obtained by different methodologies, evaluate or compare new nucleic acid test procedures for HBV DNA, and demonstrate assay proficiency and reproducibility within the laboratory environment.
Product Description
The low and mid positive controls contain inactivated HBV positive plasma diluted in normal human plasma (NHP); the high positive control contains active HBV positive plasma diluted in defibrinated, delipidized normal human plasma, which was previously 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 control is designed to produce a non-reactive result in nucleic acid assays for HBV DNA.
Expected results utilizing the OptiQual HBV DNA Controls must be established by the end user for their particular HBV DNA assay.
Each control contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
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Control Configurations
| Description | Catalog Number |
|---|---|
| Negative Control (5 vials, 1.0 mL) In-Vitro Diagnostic Use Only |
96-0001 |
| Low Positive Control (5 vials, 1.0 mL) In-Vitro Diagnostic Use Only |
96-0601 |
| Mid Positive Control (5 vials, 1.0 mL) In-Vitro Diagnostic Use Only |
96-0602 |
| High Positive Control (5 vials, 1.0 mL) Research Use Only |
96-0603 |
Each control is filled into sterile 2 mL polypropylene vials with screw caps.
OptiQual® HBV DNA controls are shipped frozen on dry ice packs.
Storage Instructions
It is recommended that OptiQual® HBV DNA Controls be stored at -20°C or lower to ensure highest quality. Controls 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.
