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Trinity Uni Gold Hiv Presentation For Tx
 

Trinity Uni Gold Hiv Presentation For Tx

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Presentation for the UniGold HIV assay.

Presentation for the UniGold HIV assay.

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  • Ensure counseling has been given to the subject and subject consent obtained in accordance with local regulations. Picture of pouched device and wash buffer to be added here Allow the kit and samples to reach room temperature (at least 20 minutes) if previously refrigerated. Remove the required number of Uni-Gold™ Recombigen® HIV devices from their pouches. It is not recommended to perform more than 10 tests simultaneously. Lay the devices on a clean flat surface. Label each device with the appropriate patient information / ID. Picture of pipette with gradation to be added here Draw up adequate sample to the first gradation on the pipette (serum or plasma or whole blood: venipuncture) using one of the disposable pipettes supplied. Use only the pipette supplied and do not reuse. See picture. If controls are being run these must be used as described in the package insert provide with the controls. Picture of an open device with sample being dropped on by the pipette (write a patient number on the device) Holding the pipette vertically over the sample port, add one (1) drop of sample (approx. 50µl) carefully and allow to absorb. Ensure air bubbles are not introduced into the sample port. Picture of open device with wash buffer being dropped Holding the bottle in a vertical position, add four (4) drops (approx. 200µl) of the wash reagent from the dropper bottle to the sample port. Allow 10 minutes from the time of wash reagent addition for reaction to occur. The result should be read immediately after the 10 minute incubation time.

Trinity Uni Gold Hiv Presentation For Tx Trinity Uni Gold Hiv Presentation For Tx Presentation Transcript

  • Presentation for Texas HIV / STD meeting in Austin Uni-Gold ™ Recombigen ® HIV Heather Wilson – Account Manager Adam Hewitt – Territory Manager
  • Uni-Gold ™ Recombigen ® HIV
  • Presentation Overview
    • Trinity Biotech Overview
    • Trinity Rapid HIV Experience
    • Why Choose the Trinity Uni-Gold assay
    • Trinity Uni-Gold Procedure
    • Trinity UniGold QC Performance (Hands on)
    • Questions
  • Trinity Biotech Family of Companies
    • Mardx, Primus, Clark laboratories, Sigma Diagnostics, Bartels
    • We specialize in the development, manufacture and marketing of diagnostic test kits, Trinity Biotech’s continued success is based on the fact that as a company it consistently achieves standards of excellence in the quality of all it does.
      • The test kits manufactured by Trinity Biotech are used in the clinical laboratory and point-of-care segments of the diagnostic market to detect infectious diseases, sexually transmitted diseases, blood coagulation and autoimmune disorders. The company is also a significant provider of raw materials to the life sciences industry.
  • Worldwide Corporate Headquarters
      • Number of Employees:
      • 650
      • 3 Main Subsidiaries: UK - Germany – USA
      • Network of 300 Independent
      • Distributors covering 78
      • Countries
    Trinity Biotech plc, Headquarters Bray, Ireland
  • USA Corporate Headquarters
    • Trinity Biotech Inc
    • 400 Connell Drive
    • Suite 7100
    • Berkeley Heights, NJ 07922
    • 800-325-3424
  • Infectious Disease Solutions Western Blot
  • STD’s beyond HIV
    • Trinity manufactures many STD tests for use in the lab. Here are a couple of the ELISA 96 well assays:
    • TrepSure Syphilis – This assay detects both IgG and IgM and has a sensitivity and specificity >99%
    • HSV–Type Specific for HSV 1 IgG and HSV 2 IgG. Very efficient assay with shorter room temperature incubation times.
  • Trinity Rapid HIV Experience
    • Leading manufacturer of HIV Rapid Tests
    • First HIV Rapid Test Produced in 1995
    • Sell more Rapid HIV worldwide then any other US company.
  • Why use the Uni-Gold ™ Recombigen ® HIV
    • Ease of Use
    • Speed
    • 3rd Generation Technology
    • Cost Savings
    • Ease of Use
    • CLIA Waived
      • Add One Drop of Sample
      • Add Four Drops of Buffer
    • Complete Sample Flexibility
      • Serum
      • Plasma
      • Whole blood
    • Storage Flexibility
      • Room Temp
      • Refrigerated
    • Speed
      • Test Results in 10 minutes
    • 3 rd Generation Technology
      • Antigen Sandwich Design Increases
      • Sensitivity
      • Can Detect Antibodies Between 3-8
      • Weeks Earlier Than Other 2 nd
      • Generation Rapid Tests
      • 100% Sensitivity
      • 99.7% Specificity (few false positives)
    • Cost Savings
      • Because Trinity manufactures so many Rapid HIV Tests worldwide, we are able to do so at a lower cost, passing these savings on to our customers.
      • Lower cost = more patients tested!
  • Common Features of Rapid Tests
    • Positives are presumptive and have to be confirmed by confirmatory test
    • CLIA WAIVER
    • FDA restrictions also require that any facility planning to perform rapid tests must have a quality assurance plan – step-by-step activities that ensure testing is carried out correctly, results are accurate, and mistakes are found and corrected
    • Trinity has produced a document; “Uni-Gold Quality Control Guidelines” which can be used for this purpose.
  • (For complete instructions please refer to the Uni-Gold™ Recombigen ® HIV package insert) Uni-Gold™ Recombigen ® HIV Test Procedure
  • Uni-Gold™ HIV Product Information Kit Contents: a) Each kit contains 20 Test Devices b) Wash Reagent (5.0 ml) c) 20 Pipettes d) 25 Fingerstick Pipettes e) 20 Subject Information Leaflets f) Package Insert Always refer to the Directional Insert
  • Uni-Gold™ HIV Assay Procedure
    • Remove the required number of Uni-Gold™ Recombigen® HIV devices from their pouches.
    • It is not recommended to perform more than 10 tests simultaneously .
  • Uni-Gold™ HIV Assay Procedure Lay the devices on a clean flat surface .
  • Uni-Gold™ HIV Assay Procedure (serum, plasma, or WB) Draw up adequate sample to the first gradation on the pipette (serum, plasma or venipuncture whole blood) using one of the disposable pipettes supplied.
  • Uni-Gold™ HIV Assay Procedure
    • Holding the pipette vertically over the sample port, add one (1) free falling drop of sample (approx. 50µl) and allow to absorb into membrane.
    • Do not add full volume of pipette.
  • Uni-Gold™ HIV Assay Procedure Add Four Drops of Wash Solution
  • Uni-Gold ™ HIV Assay Procedure Read test after 10 minutes but no more than 12 minutes following the addition of the patient sample and wash solution.
  •  
  • Uni-Gold™ HIV Fingerstick Procedure
    • Select puncture site and clean with Alcohol Wipe (Dry)
    • Puncture with a sterile lancet just off the center of the finger
    • Wipe away the first drop of blood with a sterile gauze pad
  • Uni-Gold™ HIV Fingerstick Procedure
    • Holding the collection device horizontally , place the tip of the device into the sample. DO NOT squeeze the bulb at any time during collection
    • Maintain this position until the flow of sample into the collection device has stopped (massage if needed, do not excessively squeeze the finger).
    • The device fills by capillary action.
    • Collect the sample until it reaches the black line on the collection device
  • Uni-Gold™ HIV Fingerstick Procedure
    • Hold the collection device vertically (1 inch) over the sample port and squeeze the bulb until the sample is fully discharged into the sample port.
    • If the Collection device does not fully dispense, cover holes adjacent to the black line on the device and repeat the previous step.
    • Allow the sample to absorb into the sample port pad (Full Red Color)
  • Uni-Gold™ HIV Fingerstick Procedure Read test after 10 minutes but no more than 12 minutes following the addition of the patient sample and wash solution.
  • Interpretation
    • Control Line Area
    Test Line Area Sample Port For a CLIA waived test result to be valid, there must be a control line present and full red color in the sample port
  • Interpretation Moderately Complex Environment When using with serum or plasma, color will not appear in the sample port CLIA Waived Environment When using with fingerstick whole blood, red color must appear in the sample port for the test to be valid Uni-Gold™ TRINITY BIOTECH HIV Control Test Sample Uni-Gold™ TRINITY BIOTECH HIV Control Test Sample
  • Interpretation Preliminary Positive Test Result (+) A line of any intensity at the control region and the test region indicates a preliminary positive result . There is full red color in the sample port. Negative (Non-Reactive) Test Result (-) A line of any intensity at the control region only indicates a negative result There is full red color in the sample port. OR
  • Interpretation
    • Any intensity of color is considered to be a “valid line”
    • Both of these tests are considered “preliminary positive” even though the intensity of the lines vary
  • Interpretation (CLIA Waived)
    • Invalid Results
    • Sample port does
    • not have full red
    • color
    • 2. No control line
    • 3. No control line
    1 2 3
  • Interpretation
    • All “ Invalid ” results should be repeated in duplicate with new
    • devices
    • All “Reactive” results should be reported as “Preliminary Positive” and followed up with a confirmatory test
    • All “ Non-Reactive ” (Negative) should be reported as “Negative”
  • Performance 99.7% 95% CI=99.4%-99.9% 99.8% 95% CI=99.4-99.9% 99.7% 95% CI= 99.4-99.9% Specificity 100 % 95% CI =99.5 – 100.0% 100% 95% CI =99.5 – 100.0% 100% 95% CI =99.5- 100.0% Sensitivity Whole Blood (Venipuncture) Plasma Serum Performance
  • Uni-Gold™ HIV QC Performance
    • “ When do I need to run controls?”
      • Have I ran External Controls?
      • Has Anyone ran External Controls with this Lot Number?
      • Has Anyone ran External Controls with this Shipment?
      • Have the storage temperatures been acceptable?
      • Am I in compliance with our Quality Assurance Guidelines?
      • If the answer to any of the above is “No”, you need to run the QC
  • Uni-Gold™ HIV QC Performance Uni-Gold QC Determination When using with Uni-Gold External Kit Controls, the sample port will not have full red color. QC Determination is valid without the full red color in the sample port. Uni-Gold Fingerstick Procedure When using with fingerstick whole blood, full red color must appear in the sample port for the test to be valid Uni-Gold™ TRINITY BIOTECH HIV Control Test Sample Uni-Gold™ TRINITY BIOTECH HIV Control Test Sample
  • Trinity Uni-Gold ™ Recombigen ® HIV
    • Questions?