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

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

3. USA Corporate Headquarters
Trinity Biotech Inc
4 Connell Drive
Suite 7100
Berkeley Heights, NJ 07922

4. that client are comfortable with a finger stick test.
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 Publicly Traded under TRIB
First HIV Rapid Test Produced in 1995

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

10. Time to Detection of HIV Tests

11. General Rapid HIV Testing Overview
Uni-Gold™ Sensitivity and Specificity
Performance
Serum
Plasma
Whole Blood
Sensitivity
100%
95% CI = %
95% CI =99.5 – 100.0%
Specificity
99.7%
95% CI= %
99.8%
95% CI= %
95% CI=99.4%-99.9%

12. Disease State Sample Tested Identified (Non-Reactive)
Cross Reactivity
Disease State Sample Tested
Number
Tested
Correctly
Identified (Non-Reactive) %
Cytomegalovirus Positive 20
100%
Rubella IgG Positive
Epstein Barr Virus Positive
Rheumatoid Factor Positive 10
Anti-Nuclear Antibody Positive
Hepatitis B Core Antibody Positive
Hepatitis B Surface Antigen Positive
Hepatitis C Virus Antibody Positive 30
Other auto immune samples
Other disease states
Recently Vaccinated against Viruses
Total
200

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

14. 100% Sensitivity -Third generation technology
Uni-Gold™ HIV Offers:
100% Sensitivity -Third generation technology
No Wasted Product - One Year expiration
Client Satisfaction - 10 Minutes to results
Fiscal Responsibility – up to 40% more individuals can be tested

15. 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

16. 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

17. Fingerstick Collection
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

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

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

20. Fingerstick Collection
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

21. 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

22. 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.

23. 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)

24. 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.

25. 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

26. 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

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

28. 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.

29. 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

30. 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

31. 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.

32. 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 (# )

33. 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

34. 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)

35. 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

36. 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

37. 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™
TRINITY
BIOTECH
HIV
Control
Test
Sample
Uni-Gold™
TRINITY
BIOTECH
HIV
Control
Test
Sample
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.

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

39. 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

40. Trinity Uni-Gold™ Training Website
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