OptiQuant® HCV RNA Quantification Panel

The OptiQuant® HCV RNA 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 C viral (HCV) RNA. For Research Use Only. Not for use in diagnostic procedures.

Procedure

The OptiQuant® HCV RNA Quantification Panel members have been carefully formulated to mimic naturally occurring human specimens containing HCV viral RNA. Therefore, the panel can be used with any test procedure designed for measuring HCV RNA 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 RNA and makes it available for transcription, amplification and/or hybridization, as appropriate to the test.

Interpretation of Results

Each panel member, except the Negative, contains HCV viral RNA at a predetermined level calibrated against the WHO International Standard for HCV RNA. Consequently, the assigned values are reported as International Units per milliliter (IU/mL). Commercial, ASR or homebrew test procedures may report results in units that differ from International Units as defined by WHO.

Product Description

The OptiQuant® HCV RNA quantificaltion panel members contain naturally occurring hepatitis C virus adjusted to specific concentrations within a human serum matrix.

The positive panel members were produced by making quantitative dilutions of HCV RNA positive human plasma into 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.

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

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Panel Configuration

Description	Catalog Number
OptiQuant® HCV RNA Panel	94-2011
Configurations
Negative	0.5mL
HCV RNA 5E1	0.5mL
HCV RNA 5E2	0.5mL
HCV RNA 5E3	0.5mL
HCV RNA 5E4	0.5mL
HCV RNA 5E5	0.5mL
HCV RNA 5E6	0.5mL

• The OptiQuant® HCV RNA Panel members are filled into sterile 2mL polypropylene vials with screw caps.
• The OptiQuant® HCV RNA Panel is shipped frozen on dry ice.