Derived from purified and inactivated HIV-1 viral lysate proteins, the Avioq HIV-1 Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to HIV-1 (a leading causal agent of AIDS in the U.S.) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with the OraSure® HIV-1 Oral Specimen Collection Device.

The Avioq HIV-1 Microelisa System is intended for use as an aid in diagnosis of infection with HIV-1. It is not intended for use in screening blood donors.   Developed as a standard two-step indirect microelisa system assay, the Avioq HIV-1 Microelisa System contains coated 96-well microwell plates, color-coded, liquid calibrator and positive control, and a ready-to-use liquid substrate. The sample diluent contains sample addition monitoring to allow visualization of color change upon sample addition to microwells.

Kit Configuration and Principle of Test

The product is available in three kit configurations, the 384, 960, and 9600 test kits. Please refer to the 'Literature' tab for additional information, as well as the performance characteristics of this product. The Package Insert is available on the 'Support' menu tab.

The Avioq HIV-1 Microelisa System uses HIV-1 antigens, including inactivated, purified HIV-1 viral lysate proteins, which are coated on the wells of microwell plates, for the detection of antibodies against HIV-1. Upon addition of a diluted test specimen containing antibodies to HIV-1 to a microwell, immune complexes are formed through the interaction between the anti- HIV in the specimen and the HIV antigens coated on the microwell.

Following incubation, the specimen is aspirated and the well is washed with buffer. Subsequently, anti-human immunoglobulin (goat) conjugated with horseradish peroxidase (HRP) is added which binds to the anti-HIV antigen complex during a second incubation. Following a wash and incubation with ABTS (2,2’-azino-di-(3-ethylbenzthiazoline-6-sulfonate)) substrate, a green color is produced. The enzyme reaction is stopped by the addition of a fluoride solution.

The amounts of antibodies to HIV present in the specimen are qualitatively proportional to color intensity. Because of the use of HIV-1 viral lysate as the primary antigens in the test, significant cross-reactivity with HIV-2 specimens was observed.

Ease of Use

• Fast, convenient procedure suitable for automation

• No sample pre-dilution step

• Color-coded calibrator and positive control

• Sample addition monitoring

Time and Cost-Savings

• Excellent sensitivity and specificity in clinical trials providing reduced cost for confirmatory testing

• High correlation between initial and repeat duplicate results

• High positive predictive value that saves unnecessary confirmatory testing

• Direct dilution into microplate well

Confidence in Results

• Color-coded reagents with sample addition monitoring

• Excellent performance characteristics to provide the “Right Answer Sooner”

Instrument Flexibility

• 96-well microplate with 8-well strips

• 10 uL specimen volume for serum/plasma

• Consistent volumes for Wash Buffer, Conjugate, Substrate, and Stop solutions

Safety

• Specimen diluent (Dilsim III) contains HIV-1 inactivator for safe microplate handling

Avioq HIV-1 Brochure

Avioq HIV-1 Test Procedure

Avioq, Inc. is committed to provide microplate instruments to meet customer needs with our growing menu of immunodiagnostic products. The manual instrument options can meet the needs of low, medium, and high volume testing.

Our microplate instrument offering includes options for ELISA Readers, Washers, Incubator, Pipettor/Dilutor, Computer with Data Analysis Software, and Printers.

Both the Avioq HIV-1 (IVD) and Avioq HTLV-I/II assays utilize 8-well strips with sample and reagent volumes that allow instrument flexibility. This includes compatibility with automated pipetting systems and full automated instruments (pipetting + plate processing).

Options provided by Avioq: these options have the validated Avioq assays that have been programmed into the specific instruments. The following instrumentation with the Avioq programming is available only through Avioq.

AVIOQ PART NUMBER	INSTRUMENT TYPE	MODEL NUMBER	SALES FLYER
200173	Microelisa Reader	BioTek ELx800	ELx800 SingleSheet
200174	Microelisa Reader	BioTek Elx808	ELx808 New
7560522	Test Absorbance Plate	BioTek
200170	Microelisa Strip Washer	BioTek ELx50	ELx50 Single Sheet
200172	Microelisa Full Plate Washer	BioTek ELx405	ELx405 Single Sheet
7100745	Dispense/Waste System	BioTek-for ELx405
201280	Pipettor/Dilutor	Hamilton 530b	Hamilton 530b
201180	Incubator (Forced Air)	10-140AE
201175	Computer/Monitor/Keyboard Includes	Dell
201174	Data Analysis Software	BioTek Gen5 CL	Gen5CL
201179	Printer (Laser or Inkjet)	Dell or HP

Requirements

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. Manufacturer's specifications and performance capabilities.

4. Service and maintenance information.

5. Quality control.

Automated Diluter/Dispenser System (minimum 10 ul with 10% accuracy) 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 30 ± 5 second soak cycle. Aspirated waste must be contained in a closed system

Pipettes-Avioq HIV-1

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 ul ± 5 %, and tips Micropipet(s) capable of delivering: 10 ul ± 10 %, 500 ul ± 5 %, and tips

Pipettes-Avioq HTLV-I/II

Adjustable multi-channel variable volume pipet system capable of delivering 50 – 300 µl ± 5 %, and tips. Micropipet(s) capable of delivering 20 µl ± 5%, 100 µl ± 5%, and tips.

Incubator

A dry incubator, heating block, or equivalent capable of maintaining 37 ± 2 ºC

Microelisa Plate Reader

Any microelisa reader capable of transmitting light at 405 nm for HIV-1. Options for HTLV-I/II are single wavelength at 450 nm ± 5 nm or dual wavelength 450 nm ± 5 nm and 620/630 nm ± 5 nm as reference, with a linear absorbance range of 0 to 2.000, a drift of less than 0.005% AU/hr., and a bandwidth at half height of 10 ± 2 nm may be used.