OptiQual® CMV DNA Controls
The OptiQual CMV DNA Controls are intended for use in assessing the performance of nucleic acid test procedures for the determination of human cytomegalovirus DNA (CMV DNA). Routine use of external run 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 research use only. Not for use in Diagnostic Procedures.
Principles of the Procedure
The OptiQual CMV DNA Controls have been carefully formulated to mimic naturally occurring human specimens containing CMV DNA. Therefore, the controls can be used to monitor all procedural steps in any test procedure designed for measuring CMV DNA in human serum, plasma or whole blood. Since the controls contain intact, encapsulated viral particles, the test methodology should include an extraction step that releases the viral DNA and makes it available for transcription, amplification and/or hybridization, as appropriate to the test.
Each control, except the Negative, contains CMV DNA. While the controls are unassayed and do not have assigned values, results are reported as copies per milliliter (copies/mL). Commercial, ASR or homebrew test procedures may report results in other units. Expected results utilizing the OptiQual CMV DNA Controls must be established by the end user for their particular CMV DNA assay.
Control Configurations
| Description | Catalog Number |
|---|---|
| Negative Control (5 vials, 0.5 mL each) |
95-1700 |
| Low Positive Control (5 vials, 0.5 mL each) |
95-1701 |
| High Positive Control (5 vials, 0.5 mL each) |
95-1702 |
Storage Instructions
It is recommended that the OptiQual CMV DNA Controls be stored at -70°C or lower to ensure highest quality. Controls may be stored at 2°C to 8°C for up to 7 days after thawing with minimal loss of activity. Avoid freezing after thawing the material. Any controls that appear cloudy or contain precipitates after thawing should be discarded.