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Uni-Gold™ HIV

Uni-Gold™ HIV. Janice Pinson MBA, M.T. HIV National Account Manager. Trinity Biotech plc, Headquarters Bray, Ireland. Worldwide Corporate Headquarters. USA Corporate Headquarters. Trinity Biotech Inc 4 Connell Drive Suite 7100 Berkeley Heights, NJ 07922 800-325-3424.

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Uni-Gold™ HIV

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  1. Uni-Gold™ HIV Janice Pinson MBA, M.T. HIV National Account Manager

  2. Trinity Biotech plc, HeadquartersBray, Ireland Worldwide Corporate Headquarters

  3. USA Corporate Headquarters • Trinity Biotech Inc • 4 Connell Drive • Suite 7100 • Berkeley Heights, NJ 07922 • 800-325-3424

  4. Focused meetings and surveys with counselors from the MA pilot sites indicate: • that counselors feel individuals should be able to choose any of several HIV testing options • that rapid HIV testing increases the percentage of clients who receive their HIV test results • that client are comfortable with a finger stick test.

  5. Uni-Gold™ Training Overview • General Rapid HIV Testing Information • Uni-Gold™ Product Information • Uni-Gold™ Quality Control Information • Perform a Fingerstick Uni-Gold™ Procedure • Perform a Uni-Gold™ External QC Test • Uni-Gold™ Quiz

  6. General Rapid HIV Testing Overview • Previous to Rapid Tests, HIV Screening only by EIA • 40% - 60% Patients did not receive results • First CLIA waived Rapid HIV Test FDA Cleared in November of 2002 • Rapid HIV and EIA tests both detect HIV Antibodies (not the HIV Virus) • Sero-conversion – up to 3 Months post-exposure • Antibody tests cannot detect infection immediately after exposure

  7. Trinity Rapid HIV Experience • Formed in 1992 Publicly Traded under TRIB • First HIV Rapid Test Produced in 1995

  8. Uni-Gold™ HIV Offers: • Third Generation Technology • 100% Sensitivity

  9. Time to Detection of HIV Tests

  10. General Rapid HIV Testing Overview • Uni-Gold™ Sensitivity and Specificity

  11. Cross Reactivity

  12. Uni-Gold™ HIV Offers: • No Wasted Product - One Year expiration

  13. Uni-Gold™ HIV Offers: • 100% Sensitivity -Third generation technology • No Wasted Product - One Year expiration • Client Satisfaction - 10 Minutesto results • Fiscal Responsibility – up to 40% more individuals can be tested

  14. Uni-Gold™ HIV Fingerstick Procedure Hand Out Subject Information Leaflet Open a new Test Device and Mark with Patient ID Organize Materials required for Procedure

  15. Uni-Gold™ HIV Fingerstick Procedure • Materials required for Uni-Gold™ Fingerstick Procedure • Uni-Gold™ Fingerstick Collection Device • Uni-Gold™ Test Device (Room Temperature – 20 Minutes, if stored at 2-8° C) • Uni-Gold™ Wash Solution** (blue top dropper) • Uni-Gold™ Subject Information Leaflet • Latex Gloves* • Alcohol Wipes* • Sterile Gauze Pads* • Band-Aid* • Sterile Lancet (BD Genie – Blue Lancet) • Marker/Sharpie* (to ID Test Device)* • Biohazard Container* (use Zip-lock Bags today) • Timer* (One Trinity Timer per Testing Location) *Materials required but not provided with Uni-Gold™ Kit ** Not provided with your equipment today

  16. Use BD “Blue” or similar lancet Should be a “blade” not a needle device Roughly 2.0 mm Depth and 1.5 mm width Should produce a medium to high blood volume Fingerstick Collection

  17. Use the sides of the patient’s middle or ring finger Select Puncture Site and clean with Alcohol Wipe (Dry) Fingerstick Collection

  18. Puncture with a sterile lancet just off the center of the finger Refer to manufacturer’s directions for proper lancet use Fingerstick Collection

  19. Wipe away the first drop of blood with a sterile gauze pad Hold patient’s hand in a downward position Massage gently from hand toward puncture site Fingerstick Collection

  20. Uni-Gold™ HIV Fingerstick Procedure • Place the tip of the device into the sample horizontally. • Do not squeeze the bulb at any time during collection • The sample fills by capillary action, DO NOT SQUEEZE THE BULB • Collect sample until it reaches the black line on the device

  21. 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 reaches the black line (massage if needed, do not excessively squeeze the finger). • The device fills by capillary action.

  22. Uni-Gold™ HIV Fingerstick Procedure • Hold the collection device vertically (1 inch) over the sample port • Squeeze the bulb until the sample is fully dispensed • Allow sample to absorb into the sample port pad (Full Red Color)

  23. Uni-Gold™ HIV Fingerstick Procedure • Please note… • Should the collection device fail to fully dispense when the bulb is squeezed, cover the two small holes located at the black line with two fingers while dispensing the sample into the sample port.

  24. Uni-Gold™ HIV Fingerstick Procedure Add 4 Drops of Wash Solution into the Sample Port Do not touch the sample port with the tip of the wash solution

  25. Uni-Gold™ HIV Fingerstick Procedure After addition of the wash solution, set timer for 10 Minutes Read test after 10 minutes and before 12 minutes

  26. Uni-Gold™ HIV Fingerstick Procedure • Control Line Area For a CLIA waived test result to be valid, there must be a control line present and full red color in the sample port • Test Line Area • Sample Port

  27. Uni-Gold™ HIV Fingerstick Procedure Negative (Non-Reactive) Valid Test Result Control Line Present Test Line Absent Full Red color in the sample port. OR Preliminary Positive (Reactive) Valid Test Result Control Line Present Test Line Present Full Red color in the sample port.

  28. Uni-Gold™ HIV Fingerstick Procedure • Invalid Results • #1 Invalid - Sample port without full red color • #2 Invalid - No control line • #3 Invalid - No control line • If the test is invalid, repeat • the test in duplicate with • fresh devices

  29. Uni-Gold™ Quality Control Review • External Quality Control Intervals as Recommended (by Manufacturer) and Required (by Facility) • All new operators performing patient tests • Each new kit lot# used in testing • Each unique shipment of test kits used in testing • Suspicion that storage temperatures may have been out of range • At other times as specified by your Quality Assurance program • If External QC provided unexpected results… • Repeat once • If failure continues, contact Technical Service Immediately • Internal versus External Quality Control

  30. Uni-Gold™ HIV QC Performance • “When do I need to run controls?” • Have I ran External Controls in the past? • 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 will need to perform the external QC.

  31. Uni-Gold™ HIV QC Performance • Materials required for Uni-Gold HIV QC Performance • Uni-Gold™ Recombigen HIV Kit Controls* (we will share today) • Uni-Gold™ Disposable Pipette • Uni-Gold™ Test Device (Room Temperature – 20 Minutes) • Uni-Gold™ Wash Solution (blue top dropper) • Latex Gloves • Marker/Sharpie (to mark device +/-) • Timer (use your watch or clock for today) • Biohazard Container (use the Zip-lock bags again) * Kit Controls are a separate product from Trinity Biotech (#1206530)

  32. Uni-Gold™ HIV QC Performance Organize all materials required for External QC Performance Open new Test Device and Mark with QC ID (+/-) If the QC Vials are unopened, record date on vial/box

  33. Uni-Gold™ HIV QC Performance Immerse the tip of the Disposable Pipette into the QC Vial Gently press on the bulb to draw a minimal amount of sample From vertical, dispense 1 free-falling Drop into the sample port Allow to absorb into the sample port (No Full Red Color)

  34. Uni-Gold™ HIV QC Performance Add 4 Drops of Wash Solution into the Sample Port Do not touch the sample port with the tip of the wash solution

  35. Uni-Gold™ HIV QC Performance After addition of the wash solution, set timer for 10 Minutes Read test after 10 minutes and before 12 minutes

  36. Control Test Sample Control Test Sample Uni-Gold™ Uni-Gold™ HIV HIV TRINITY BIOTECH TRINITY BIOTECH Uni-Gold™ HIV QC Performance 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 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.

  37. Training Materials Available • Quick Reference Guide (English and Spanish) • Test key and results • Training Web site • Quiz questions • Posters • Trinity trainers

  38. Trouble Shooting Tips • No line - no wash added • Finger stick • First drop is full • Do not push the bulb, works by capillary action. • Fill to black line • If does not release, cover above the black line

  39. Trinity Uni-Gold™ Training Website • http://195.7.51.154/coursemill/index.jsp • Log on to site • Double click on “Create User”Under Organization select ENDUSER for end user training; fill out information to become registered as a user of the system. • Once registered click on “Add Student” • Click on list of Courses, (2 Modules), to register access codes are needed, they are the same as the course ID. Then enroll and proceed to review material and access the tests

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