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CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE
Uni-Gold™ HIV
Janice Pinson MBA, M.T.HIV National Account Manager
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Worldwide Corporate Headquarters
Trinity Biotech plc, HeadquartersBray, Ireland
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USA Corporate HeadquartersUSA Corporate Headquarters
Trinity Biotech IncTrinity 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
1. Previous to Rapid Tests, HIV Screening only by EIA
2. 40% - 60% Patients did not receive results
3. First CLIA waived Rapid HIV Test FDA Cleared in November of 2002
4. Rapid HIV and EIA tests both detect HIV Antibodies (not the HIV Virus)
5. Sero-conversion – up to 3 Months post-exposure
6. 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% CI=99.4-99.9%
99.7%
95% CI=99.4%-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 patient’s 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 manufacturer’s directions for proper lancet use
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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
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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
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
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Uni-Gold™ HIV Fingerstick Procedure
Preliminary Positive (Reactive) Valid Test Result
Control Line Present
Test Line Present
Full Red color in the sample port.
Negative (Non-Reactive) Valid Test Result
Control Line Present
Test Line Absent
Full Red color in the sample port.
OR
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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, repeatthe test in duplicate withfresh 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 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™
TRINITYBIOTECH
HIV
Control
Test
Sample
Uni-Gold™ HIV QC Performance
Uni-Gold™
TRINITYBIOTECH
HIV
Control
Test
Sample
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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 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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