Uni-Gold

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Uni-Gold HIV
Janice Pinson MBA, M.T. HIV National Account
Manager
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Worldwide Corporate Headquarters

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USA Corporate Headquarters

• Trinity Biotech Inc
• 4 Connell Drive
• Suite 7100
• Berkeley Heights, NJ 07922
• 800-325-3424

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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.

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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

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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

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Trinity Rapid HIV Experience

• Formed in 1992 Publicly
  Traded under TRIB
• First HIV Rapid Test Produced in 1995

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Uni-Gold HIV Offers

• Third Generation Technology
• 100 Sensitivity

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Time to Detection of HIV Tests
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General Rapid HIV Testing Overview

• Uni-Gold Sensitivity and Specificity

Performance Serum Plasma Whole Blood
Sensitivity 100 95 CI 99.5- 100.0 100 95 CI 99.5 100.0 100 95 CI 99.5 100.0
Specificity 99.7 95 CI 99.4-99.9 99.8 95 CI99.4-99.9 99.7 95 CI99.4-99.9
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Cross Reactivity
Disease State Sample Tested Number Tested Correctly Identified (Non-Reactive)
Cytomegalovirus Positive 20 20 100
Rubella IgG Positive 20 20 100
Epstein Barr Virus Positive 20 20 100
Rheumatoid Factor Positive 10 10 100
Anti-Nuclear Antibody Positive 20 20 100
Hepatitis B Core Antibody Positive 20 20 100
Hepatitis B Surface Antigen Positive 20 20 100
Hepatitis C Virus Antibody Positive 30 30 100
Other auto immune samples 10 10 100
Other disease states 20 20 100
Recently Vaccinated against Viruses 10 10 100
Total 200 200 100
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Uni-Gold HIV Offers

• No Wasted Product - One Year expiration

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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

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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
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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

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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

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Fingerstick Collection

• Use the sides of the patients middle or ring
  finger
• Select Puncture Site and clean with Alcohol Wipe
  (Dry)

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Fingerstick Collection

• Puncture with a sterile lancet just off the
  center of the finger
• Refer to manufacturers directions for proper
  lancet use

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Fingerstick Collection

• Wipe away the first drop of blood with a sterile
  gauze pad
• Hold patients hand in a downward position
• Massage gently from hand toward puncture site

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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
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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.

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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)
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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.
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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
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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
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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
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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.

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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

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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

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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.

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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)

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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
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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)
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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
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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
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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.

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Training Materials Available

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

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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

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Trinity Uni-Gold Training Website

• http//195.7.51.154/coursemill/index.jsp
• Log on to site
• Double click on Create UserUnder 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