OptiQual® MSSA Positive Control
The OptiQual MSSA Positive Control is intended for use in assessing the performance of nucleic acid test procedures for the determination of the presence of Methicillin-Sensitive Staphylococcus aureus (MSSA) DNA. This control may either be used as a negative run control for MRSA DNA test procedures, or as a positive run control for MSSA DNA test procedures. 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. This product is for In Vitro Diagnostic Use and is CE-marked.
Procedure
The OptiQual MSSA Positive Control has been formulated to mimic naturally occurring human specimens containing MSSA. Additionally, the intact bacteria format of the OptiQual MSSA Positive Control allows for the verification of effective bacterial DNA extraction and purification. The controls are designed to monitor all procedural steps in test procedures for determining the presence of MSSA DNA in human specimens. The OptiQual MSSA Positive Control contains intact bacteria, and the test methodology must include an extraction step that releases the bacterial DNA for amplification and detection, as appropriate to the test.
The end user must determine the appropriate volume of OptiQual MSSA 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 MSSA DNA test procedure being evaluated.
Interpretation of Results
Expected results utilizing the OptiQual MSSA Positive Control must be established by the end user for their particular MSSA DNA assay.
Product Description
The OptiQual MSSA Positive Control contains inactivated MSSA bacterial particles. The positive control was produced by diluting quantified MSSA stock into a proprietary enzymatic and mechanical lysis compatible bacterial matrix.
This product contains 0.05% Proclin 300 as a preservative.
Control Configurations
| Description | Catalog Number |
|---|---|
| OptiQual® MSSA Positive Control (5 vials, 0.2 mL) |
96-0025 |
It is recommended that the OptiQual MSSA Positive Control be stored at 2 – 8°C to ensure consistent results. The OptiQual MSSA Positive Control is designed for single use and excess material in each vial is to be appropriately discarded.