VioOne™ HIV Profile™ Supplemental Assay
For In Vitro Diagnostic Use
Serologic assay for detection and differentiation of antibodies directed to different gene products of HIV-1 and HIV-2
The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. It is a more specific test used to confirm the presence of HIV-1 and/or HIV-2 antibodies from specimens that were repeatedly reactive in diagnostic screening procedures.
VioOne™ HIV Profile™ Assay uses HIV-1 env, pol, and gag gene product recombinant antigens, and HIV-2 specific transmembrane peptide. See above for procedure and details.
VioOne™ HIV Profile™ Strips
Sample Diluent
Negative Control Serum (Human)
HIV-1/2 Positive Control Serum
Conjugate
Conjugate Diluent
TMB Solution
Peroxide Solution
Wash Buffer Concentrate (provided separately as an accessory)
Plate sealers- adhesive
Note: For any instrument, the manual provided by the manufacturer should be reviewed for additional
information regarding the following:
1. Installation and special requirements.
2. Operation principles, instructions, precautions, and hazards.
3. Equipment calibration.
4. Manufacturer’s specifications and performance capabilities.
5. Service and maintenance information.
6. Quality Control.
Automated diluter/dispenser system (minimum 10 µl with 10% accuracy), test tubes, or equivalent
Aspiration/wash system: The aspiration/wash system must be capable of dispensing a minimum volume of 300 µl, and capable of performing a minimum 30 second soak cycle. Aspirated waste must be contained in a closed system.
Adjustable multi-channel variable volume pipet system capable of delivering 50 – 300 µl ± 5%, and tips.
Adjustable multi-channel variable volume pipet system capable of delivering 5 – 50 µl ± 5%, and tips.
Micropipet(s) capable of delivering, 10 µl ± 10%, 1000 µl ± 5%, and tips
Incubator: A dry incubator or equivalent, capable of maintaining 37 ± 2°C.
Microplate reader: Any microplate reader capable of transmitting light at 450 nm ± 5 nm with a linear absorbance range
of 0 to 2.000.
Timer
Graduated cylinder, 50 ml and 1-2.5 L or equivalent
Reagents/Disposables
2N Sulfuric Acid
Purified Water, USP7 or NCCLS Type I
7 reagent water, or equivalent
Stripholder with uncoated wells
Absorbent paper
V-shaped disposable troughs or equivalent
Disposable gloves
Sodium hypochlorite solution (5%) or liquid bleach
Appropriate biohazard waste containers for materials potentially contaminated with infectious agents
*HIV-2 positive with reactivity to HIV-1 antigens. Refer to package insert.