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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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Presentation on theme: "CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE 1 Uni-Gold HIV Janice Pinson MBA, M.T. HIV National Account Manager."— Presentation transcript:

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

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

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

4 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 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 6 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 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

7 7 Trinity Rapid HIV Experience Formed in 1992 Publicly Traded under TRIB First HIV Rapid Test Produced in 1995

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

9 9

10 10 Time to Detection of HIV Tests

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

12 12 Cross Reactivity Disease State Sample Tested Number Tested Correctly Identified (Non-Reactive) % Cytomegalovirus Positive20 100% Rubella IgG Positive20 100% Epstein Barr Virus Positive20 100% Rheumatoid Factor Positive10 100% Anti-Nuclear Antibody Positive20 100% Hepatitis B Core Antibody Positive20 100% Hepatitis B Surface Antigen Positive20 100% Hepatitis C Virus Antibody Positive30 100% Other auto immune samples10 100% Other disease states20 100% Recently Vaccinated against Viruses10 100% Total %

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

14 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 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 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 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 18 Fingerstick Collection Use the sides of the patients middle or ring finger Select Puncture Site and clean with Alcohol Wipe (Dry)

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

20 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 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 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 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 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 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 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 27 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

28 28 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. OROR

29 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 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 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 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 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 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 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 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 37 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 TRINITY BIOTECH HIV Control Test Sample Uni-Gold HIV QC Performance Uni-Gold TRINITY BIOTECH HIV Control Test Sample

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

39 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 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


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