OptiQual® HIV High Controls
OptiQual HIV-1 High Controls are intended for use in assessing the performance of nucleic acid test procedures for the determination of human immunodeficiency virus type 1 (HIV-1) RNA. Routine use of external run controls enable laboratories to monitor day-to-day test variation, and can assist in identifying increases in random or systematic error. The OptiQual HIV-1 High Positive Control is for Research Use Only. Not for use in diagnostic procedures.
The OptiQual HIV-1 High Positive Control contains the 8E5 LAV deletion mutation strain of HIV-1 diluted in an EDTA based normal human plasma (NHP) matrix. The NHP was previously tested and found to be non-reactive for HCV RNA, HBV DNA, HIV-1 RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and antibodies to HTLV I-II.
Interpretation of Results
This control provides clinical laboratories and diagnostic test manufacturers with quality control samples that have been calibrated to the World Health Organization (WHO) International Standard for HIV-1 RNA for NAT assays. This control allows for users to compare results obtained by different methodologies, and demonstrate assay proficiency and reproducibility within the laboratory environment.
Procedure
The OptiQual HIV-1 High Positive Control has been carefully formulated to mimic naturally occurring human specimens containing high levels of HIV-1 RNA. The control contains intact, encapsidated viral particles, and the test methodology must include an extraction step that releases the viral RNA and makes it available for transcription, amplification and/or detection.
Expected results utilizing the OptiQual HIV- High Positive Control must be established by the end user for their particular HIV-2 RNA assay.
This product contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
Control Configurations
| Description | Catalog Number |
|---|---|
| High Positive Control (5 vials, 1.2 mL each) |
96-0403 |
| Negative Control (5 vials, 1.0 mL each) |
96-0001 |
Each control is filled into sterile 2 mL polypropylene vials with screw caps.
Storage Instructions
It is recommended that OptiQual HIV-1 High Positive Control be stored at -20°C or lower to ensure highest quality. The OptiQual HIV-1 High Positive Control is designed for single use and excess material in each vial is to be appropriately discarded.