Avioq, Inc.
P.O. Box 12808,
27709
Research Triangle Park, NC
104 T.W. Alexander Drive, 27709 Research Triangle Park, NC
USA
104 T.W. Alexander Drive, 27709 Research Triangle Park, NC
USA
This company is co-exhibitor of
Messe Düsseldorf North America
Location
Hall map
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Our range of products
Product categories
- 03 Diagnostics
- 03.02 Immunochemistry testing, immunology testing
- 03.02.01 Immuno assay testing
Immuno assay testing
- 03 Diagnostics
- 03.02 Immunochemistry testing, immunology testing
- 03.02.03 Diagnostic tests for cancer
Diagnostic tests for cancer
- 03 Diagnostics
- 03.02 Immunochemistry testing, immunology testing
- 03.02.04 Other equipment for immunochemistry and immunology
Other equipment for immunochemistry and immunology
- 03 Diagnostics
- 03.05 Infectious immunology testing
- 03.05.03 Other infectious immunology testing
Other infectious immunology testing
Our products
Product category: Other equipment for immunochemistry and immunology
Avioq HIV-1
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.
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.
About us
Company details
Avioq, Inc., founded in 2005 and incorporated in North Carolina, has headquarters in Research Triangle Park, NC. The Management Team is comprised of 9 individuals (6 PhDs) with over 250 years of experience in the diagnostics industry.
The company’s current products include an FDA approved HIV-1 assay (a Class III device), an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor, and cadaveric samples, which also has CE marking and Health Canada approval. In addition, three other products with CE marking including a homogeneous biochemiluminescence based Flu A/B diagnosis test, a rapid influenza virus drug resistance test and an Oral fluid collection device.
The company has two other HIV products in final development; a 4th Gen HIV-1/2/Ag test and an HIV Profile assay for the detection and estimation of antibody levels directed to different gene products of HIV-1 and HIV-2. The company also offers contract research, development and manufacturing for diagnostic test kits and critical biomaterials to third parties.
Our manufacturing facility is FDA (BLA) licensed and ISO 13485 certified. The facility includes a Bio Safety Level 2 facility for large scale viral lysate production, a suite for production of recombinant antigens produced either in mammalian cells or bacterial cells, a multi-room suite for production of kit components, an area for kit assembly, a QC laboratory, several walk-in refrigeration rooms, and warehouse areas for receiving, quarantining and storage of raw materials.
Bio-manufacturing and analytical capabilities include production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation.
The facility is fully equipped to perform the conjugation of purified antigens or monoclonal antibodies to a marker, e.g., horseradish peroxidase (HRP), alkaline phosphatase (AP), avidin or biotin. Methods for protein characterization include SDS-PAGE, Western Blot, scanning densitometry, protein concentration determination, and HPLC.
Our R&D facility is fully-equipped with modern laboratory spaces. The general laboratory space is divided into dedicated spaces for work in molecular biology, immunology and immunochemistry, microbiology, cell culture, and manufacturing process development. It also has a separate microbiology laboratory designed for work requiring BSL-2 containment conditions.
Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have ample experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD.
Avioq’s Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners. We are compliant with FDA 21 CFR Part 820 and ISO 13485 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training.
The company’s current products include an FDA approved HIV-1 assay (a Class III device), an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor, and cadaveric samples, which also has CE marking and Health Canada approval. In addition, three other products with CE marking including a homogeneous biochemiluminescence based Flu A/B diagnosis test, a rapid influenza virus drug resistance test and an Oral fluid collection device.
The company has two other HIV products in final development; a 4th Gen HIV-1/2/Ag test and an HIV Profile assay for the detection and estimation of antibody levels directed to different gene products of HIV-1 and HIV-2. The company also offers contract research, development and manufacturing for diagnostic test kits and critical biomaterials to third parties.
Our manufacturing facility is FDA (BLA) licensed and ISO 13485 certified. The facility includes a Bio Safety Level 2 facility for large scale viral lysate production, a suite for production of recombinant antigens produced either in mammalian cells or bacterial cells, a multi-room suite for production of kit components, an area for kit assembly, a QC laboratory, several walk-in refrigeration rooms, and warehouse areas for receiving, quarantining and storage of raw materials.
Bio-manufacturing and analytical capabilities include production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation.
The facility is fully equipped to perform the conjugation of purified antigens or monoclonal antibodies to a marker, e.g., horseradish peroxidase (HRP), alkaline phosphatase (AP), avidin or biotin. Methods for protein characterization include SDS-PAGE, Western Blot, scanning densitometry, protein concentration determination, and HPLC.
Our R&D facility is fully-equipped with modern laboratory spaces. The general laboratory space is divided into dedicated spaces for work in molecular biology, immunology and immunochemistry, microbiology, cell culture, and manufacturing process development. It also has a separate microbiology laboratory designed for work requiring BSL-2 containment conditions.
Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have ample experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD.
Avioq’s Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners. We are compliant with FDA 21 CFR Part 820 and ISO 13485 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training.