OptiQual® HIV-1 RNA Controls
OptiQual® HIV-1 RNA Controls are intended for use in assessing the performance of nucleic acid test procedures for the determination of human immunodeficiency virus-1 RNA (HIV-1 RNA). It is not intended for use with assays used to screen the blood supply. This product is for in-vitro diagnostic use only.
Procedure
OptiQual® HIV-1 RNA controls have been carefully formulated to mimic naturally occurring human specimens containing HIV-1 RNA. Therefore, the controls can be used with any test procedure designed for detecting HIV-1 RNA in human serum or plasma.
Interpretation of Results
OptiQual® HIV-1 RNA controls provide clinical laboratories and manufacturing facilities with inactivated quality controls that have been calibrated to the World Health Organization (WHO) International Standard for HIV-1 RNA for Nucleic Acid Amplification Technology (NAT) assays. This independent set of external controls allows testing laboratories and other end users to compare results obtained by different methodologies, evaluate or compare new nucleic acid test procedures for HIV-1 RNA, and demonstrate assay proficiency and reproducibility within the laboratory environment.
OptiQual® HIV-1 RNA Controls
The positive controls contain inactivated HIV-1 positive plasma diluted in EDTA-based normal human plasma (NHP). The NHP was previously 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.
The negative control is designed to produce a non-reactive result in nucleic acid assays for HIV-1 RNA. The low positive control and mid positive control are designed to produce reactive results in HIV-1 RNA assays. Expected results utilizing the OptiQual HIV-1 RNA Controls must be established by the end user for their particular HIV-1 RNA assay.
Each 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 |
| Low Positive Control (5 vials, 1.2 mL each) |
96-0401 |
| Mid Positive Control (5 vials, 1.2 mL each) |
96-0402 |
- Each control is filled into sterile 2 mL polypropylene vials with screw caps.
- OptiQual® HIV-1 RNA controls are shipped frozen on dry ice.
Storage Instructions
It is recommended that OptiQual® HIV-1 RNA controls be stored at -70°C or lower to ensure highest quality. Controls may be refrozen after the first use, thawed and used a second time with minimal loss of activity. Discard any unused material after the second use. Any controls that appear cloudy or contain precipitates after thawing should be discarded.