CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE 1 Uni-Gold HIV Janice Pinson MBA, M.T. HIV National Account Manager.

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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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• No Wasted Product - One Year expiration

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• 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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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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Use the sides of the patient’s middle or ring finger

Select Puncture Site and clean with Alcohol Wipe (Dry)

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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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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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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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•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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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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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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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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After addition of the wash solution, set timer for 10 Minutes

Read test after 10 minutes and before 12 minutes

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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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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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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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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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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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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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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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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™

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

CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE 1 Uni-Gold HIV Janice Pinson MBA, M.T. HIV National Account Manager.

Documents

CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE 1 Uni-Gold HIV Janice Pinson MBA, M.T. HIV National Account Manager.