3 USA Corporate Headquarters Trinity Biotech Inc4 Connell DriveSuite 7100Berkeley Heights, NJ 07922
4 that client are comfortable with a finger stick test. 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 optionsthat rapid HIV testing increases the percentage of clients who receive their HIV test resultsthat client are comfortable with a finger stick test.
5 Uni-Gold™ Training Overview General Rapid HIV Testing InformationUni-Gold™ Product InformationUni-Gold™ Quality Control InformationPerform a Fingerstick Uni-Gold™ ProcedurePerform a Uni-Gold™ External QC TestUni-Gold™ Quiz
6 General Rapid HIV Testing Overview Previous to Rapid Tests, HIV Screening only by EIA40% - 60% Patients did not receive resultsFirst CLIA waived Rapid HIV Test FDA Cleared in November of 2002Rapid HIV and EIA tests both detect HIV Antibodies (not the HIV Virus)Sero-conversion – up to 3 Months post-exposureAntibody tests cannot detect infection immediately after exposure
7 Trinity Rapid HIV Experience Formed in Publicly Traded under TRIBFirst HIV Rapid Test Produced in 1995
8 Third Generation Technology 100% Sensitivity Uni-Gold™ HIV Offers:Third Generation Technology100% Sensitivity
11 General Rapid HIV Testing Overview Uni-Gold™ Sensitivity and SpecificityPerformanceSerumPlasmaWhole BloodSensitivity100%95% CI = %95% CI =99.5 – 100.0%Specificity99.7%95% CI= %99.8%95% CI= %95% CI=99.4%-99.9%
12 Disease State Sample Tested Identified (Non-Reactive) Cross ReactivityDisease State Sample TestedNumberTestedCorrectlyIdentified (Non-Reactive)%Cytomegalovirus Positive20100%Rubella IgG PositiveEpstein Barr Virus PositiveRheumatoid Factor Positive10Anti-Nuclear Antibody PositiveHepatitis B Core Antibody PositiveHepatitis B Surface Antigen PositiveHepatitis C Virus Antibody Positive30Other auto immune samplesOther disease statesRecently Vaccinated against VirusesTotal200
13 No Wasted Product - One Year expiration Uni-Gold™ HIV Offers:No Wasted Product - One Year expiration
14 100% Sensitivity -Third generation technology Uni-Gold™ HIV Offers:100% Sensitivity -Third generation technologyNo Wasted Product - One Year expirationClient Satisfaction - 10 Minutes to resultsFiscal Responsibility – up to 40% more individuals can be tested
15 Uni-Gold™ HIV Fingerstick Procedure Hand Out Subject Information LeafletOpen a new Test Device and Mark with Patient IDOrganize Materials required for Procedure
16 Uni-Gold™ HIV Fingerstick Procedure Materials required for Uni-Gold™ Fingerstick ProcedureUni-Gold™ Fingerstick Collection DeviceUni-Gold™ Test Device (Room Temperature – 20 Minutes, if stored at 2-8° C)Uni-Gold™ Wash Solution** (blue top dropper)Uni-Gold™ Subject Information LeafletLatex 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 lancetShould be a “blade” not a needle deviceRoughly 2.0 mm Depth and 1.5 mm widthShould produce a medium to high blood volume
18 Fingerstick Collection Use the sides of the patient’s middle or ring fingerSelect Puncture Site and clean with Alcohol Wipe (Dry)
19 Fingerstick Collection Puncture with a sterile lancet just off the center of the fingerRefer to manufacturer’s directions for proper lancet use
20 Fingerstick Collection Wipe away the first drop of blood with a sterile gauze padHold patient’s hand in a downward positionMassage 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 collectionThe sample fills by capillary action, DO NOT SQUEEZE THE BULBCollect 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 collectionMaintain 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 portSqueeze the bulb until the sample is fully dispensedAllow 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 PortDo 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 MinutesRead 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 portControl Line AreaTest Line AreaSample Port
28 Uni-Gold™ HIV Fingerstick Procedure Negative (Non-Reactive)Valid Test ResultControl Line PresentTest Line AbsentFull Red color in the sample port.ORPreliminary Positive (Reactive) Valid Test ResultControl Line PresentTest Line PresentFull 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 lineIf the test is invalid, repeatthe test in duplicate withfresh devices
30 Uni-Gold™ Quality Control Review External Quality Control Intervals as Recommended (by Manufacturer) and Required (by Facility)All new operators performing patient testsEach new kit lot# used in testingEach unique shipment of test kits used in testingSuspicion that storage temperatures may have been out of rangeAt other times as specified by your Quality Assurance programIf External QC provided unexpected results…Repeat onceIf failure continues, contact Technical Service ImmediatelyInternal 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 PerformanceUni-Gold™ Recombigen HIV Kit Controls* (we will share today)Uni-Gold™ Disposable PipetteUni-Gold™ Test Device (Room Temperature – 20 Minutes)Uni-Gold™ Wash Solution (blue top dropper)Latex GlovesMarker/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 Uni-Gold™ HIV QC Performance Organize all materials required for External QC PerformanceOpen 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 VialGently press on the bulb to draw a minimal amount of sampleFrom vertical, dispense 1 free-falling Drop into the sample portAllow 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 PortDo 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 MinutesRead test after 10 minutes and before 12 minutes
37 Uni-Gold™ HIV QC Performance Uni-Gold Fingerstick ProcedureWhen using with fingerstick whole blood, full red color must appear in the sample port for the test to be validUni-Gold™TRINITYBIOTECHHIVControlTestSampleUni-Gold™TRINITYBIOTECHHIVControlTestSampleUni-Gold QC DeterminationWhen 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 resultsTraining Web siteQuiz questionsPostersTrinity trainers
39 Trouble Shooting Tips No line - no wash added Finger stick First drop is fullDo not push the bulb, works by capillary action.Fill to black lineIf does not release, cover above the black line
40 Trinity Uni-Gold™ Training Website Log on to siteDouble 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