OptiQual® GBS Positive Control
As the first standardized control for molecular GBS testing, the OptiQual GBS Positive Control is used to assess the performance of qualitative molecular tests, thus helping laboratories fulfill CLIA guidelines. The OptiQual GBS Positive Control accurately monitors consistency of nucleic acid testing results over time and across reagent lots, assay formats, assay platforms, testing laboratories, and operators. This product is for In Vitro Diagnostic Use.
Procedure
The OptiQual GBS Positive Control is designed to monitor all steps in molecular test procedures that determine the presence of GBS DNA, from extraction to amplification and detection. Because the control contains intact bacteria, the test methodology must include an extraction step that releases the bacterial DNA. Routine use of these controls enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can assist in identifying increases in random or systematic error.
The end user must determine the appropriate volume of OptiQual GBS Positive Control to be utilized in their particular methodology because the volume requirements for extraction methods vary from method to method. The end user may alternatively use a sterile swab compatible with their assay technology to absorb the control material, and process the swab in a manner identical to that required for specimens run in the GBS DNA test procedure being evaluated
Interpretation of Results
Expected results utilizing the OptiQual GBS Positive Control must be established by the end user for their particular GBS DNA assay.
Product Description
The OptiQual GBS Positive Control is an unassayed control carefully formulated to mimic naturally occurring human specimens containing GBS. The control contains intact, inactivated GBS bacteria and was produced by diluting quantified GBS stock into a proprietary enzyme-compatible bacterial matrix.
This product contains 0.05% ProClin 300 as a preservative.
Control Configurations
| Description | Catalog Number |
|---|---|
| OptiQual® GBS Positive Control (5 vials, 0.2 mL) |
96-0041 |
It is recommended that the OptiQual GBS Positive Control be stored at 2 – 8°C to ensure consistent results. The OptiQual GBS Positive Control is designed for single use and excess material in each vial is to be appropriately discarded.