OptiQual® Negative Control
he OptiQual Negative Control is intended for use in assessing the performance of nucleic acid test procedures. This control provides laboratories with a well-characterized, pre-screened negative specimen for use in the evaluation and quality control. This product is for in vitro diagnostic use.
Summary and Explanation
Commercially available nucleic acid test procedures typically contain manufacturer provided controls for assessing assay validity. However, clinical testing laboratories often require that external (or third party) controls be incorporated into routine testing protocols in order to independently assess assay performance and ensure that test procedures meet established quality control requirements. Use of an independent negative run control allows laboratories to compare results obtained by different methodologies, evaluate new test procedures and demonstrate reproducibility within the laboratory environment.
Product Description
The OptiQual Negative Control has been carefully formulated to mimic a naturally occurring normal human specimen, and can be used with any test procedure designed for detecting pathogens in human serum or plasma.
The OptiQual Negative control contains defibrinated, delipidized normal human plasma that was previously found negative for HCV RNA, HBV DNA, HIV-1 RNA, anti-HIV-1 and HIV-2, anti-HCV, anti- HTLV-I-II and HBsAg
The OptiQual Negative Control contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
Control Configurations
| Description | Catalog Number |
|---|---|
| Negative Control (5 vials, 1.0 mL each) |
96-0001 |
It is recommended that the OptiQual Negative control is stored at -20°C or lower to ensure highest quality. Control may be refrozen after first use, thawed and used a second time with minimal loss of activity. Discard any unused material after the second use.