Analytical excellence in the performance of technically difficult nucleic acid testing for infectious agents requires rigorous process control and is often complicated by tight time and budget constraints. SeraCare | BBI has the tools you need to increase test confidence, control costs, reduce errors and increase efficiency.

ACCURUN Single Analyte Postive Controls

ACCURUN single analyte controls offer the ultimate in flexibility and convenience. These controls are designed to perform in the dynamic range of most manufacturers' assays.

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ACCURUN Nucleic Acid Negative Controls

Control for contamination and background using high quality, stable control materials.

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ACCURUN Drug Resistant Mutants Positive Control

Testing for HIV drug resistance is an important tool in the management of HIV infected patients. These assays are very complex and of critical medical significance, making quality control essential. ACCURUN 515 is prepared from whole HIV-1 RNA at approximately 5,000 copies per ml. Each mutant codon is represented in a mixture of approximately 50% mutant and 50% wild type.

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Qualification Panels

Detect testing problems before they affect laboratory operations!

Convenient cost-effective panels of characterized, diluted samples designed to help testing laboratories:

• Document personnel training
• Troubleshoot assay performance
• Evaluate proficiency
• Qualify incoming reagents
• Meet regulatory requirements

Qualification panels contain one negative member and five positive members that span the dynamic range of a variety of infectious disease assays.

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Basematrix Diluent

Specimens with analyte concentrations 'off scale' or above the upper limit of an assay's range can be a problem for many laboratories. Basematrix is a high quality, human-based, multipurpose diluent designed for use in laboratories performing serological or nucleic acid testing.

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In December of 2002, SeraCare | BBI was awarded ISO13485 certification by G-MED. The ISO13485 is an International Standard for Quality Systems more rigorous than ISO9001 and designed for medical device manufacturers.