Uni-Gold™ HIV - PowerPoint PPT Presentation

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Uni-Gold™ HIV

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Uni-Gold HIV Janice Pinson MBA, M.T. HIV National Account Manager Worldwide Corporate Headquarters USA Corporate Headquarters Trinity Biotech Inc 4 Connell Drive ... – PowerPoint PPT presentation

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Title: Uni-Gold™ HIV


1
Uni-Gold HIV
Janice Pinson MBA, M.T. HIV National Account
Manager
2
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
(No Transcript)
10
Time to Detection of HIV Tests
11
General Rapid HIV Testing Overview
  • Uni-Gold Sensitivity and Specificity

12
Cross Reactivity
13
Uni-Gold HIV Offers
  • No Wasted Product - One Year expiration

14
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 patients 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 manufacturers directions for proper
    lancet use

20
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

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 (1206530)

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 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
  • 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
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