Avioq HTLV-I/II

HTLV Test

Avioq HTLV KitDerived from purified and inactivated HTLV-I viral lysate, a purified HTLV-II viral lysate, and a recombinant HTLV-I p21E antigen, the Avioq HTLV-I/II Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to HTLV-I/II in human serum or plasma.
The Avioq HTLV-I/II Microelisa System is intended as a screen for donated blood and organs to prevent transmission of HTLV-I and HTLV-II to recipients of cellular blood components and as an aid in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases.    
Developed as a standard two-step indirect microelisa system assay, the Avioq HTLV-I/II Microelisa System contains coated 96-well microwell plates, color-coded, liquid negative and positive controls.  
Kit Configuration and Principle of Test
The product is available in three kit configurations, the 192, 576, 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 in the 'Support' menu tab.
The Avioq HTLV-I/II Microelisa System is an enzyme-linked Immunosorbent assay in which the solid phase (Microwells) is coated with a purified HTLV-I viral lysate, a purified HTLV-II viral lysate, and a recombinant HTLV-I p21E antigen.
With the addition of a diluted test sample containing antibodies to either HTLV-I or HTLV-II, complexes are formed by the interaction of the antibodies in the sample and the solid phase antigens. Following incubation, the sample is aspirated and the well is washed with buffer. Subsequently, anti-human immunoglobulin (goat) conjugated with horseradish peroxidase (HRP) is added which binds the antibody-antigen complex during a second incubation.
Following a wash and incubation with TMB (Tetramethylbenzidine) substrate, a blue color is produced. The enzyme reaction is stopped by the addition of a sulfuric acid solution which changes the color to yellow. The amount of antibody present in the sample is proportional to color development.
Ease of Use
• Fast, convenient procedure: Total incubation time only 2 hours, 30 minutes
• No sample pre-dilution step
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
• Direct dilution into microplate well
Confidence in Results
• Excellent performance characteristics to provide the “Right Answer Sooner”
• 99.95% specificity in random donor population seen in clinical trials (95% confidence interval of 99.89 to 99.98%)
• 100 % Sensitivity as seen in clinical trials (95% confidence interval of 99.97 to 100%)
Instrument Flexibility
• 96-well microplate with 8-well strips: Adaptable to automation and your testing volume
• 20 uL specimen volume for serum/plasma
• Consistent volumes for Wash Buffer, Conjugate, Substrate, and Stop solution
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 NUMBERINSTRUMENT TYPE MODEL NUMBER SALES FLYER
200173 Microelisa ReaderBioTek ELx800ELx800 SingleSheet
200174Microelisa ReaderBioTek Elx808 ELx808 New
7560522Test Absorbance PlateBioTek
200170Microelisa Strip WasherBioTek ELx50ELx50 Single Sheet
200172Microelisa Full Plate WasherBioTek ELx405ELx405 Single Sheet
7100745Dispense/Waste SystemBioTek-for ELx405
201280Pipettor/DilutorHamilton 530bHamilton 530b
201180Incubator (Forced Air)10-140AE
201175Computer/Monitor/Keyboard
Includes		Dell
201174 Data Analysis SoftwareBioTek Gen5 CLGen5CL
201179Printer (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.