trinity uni gold hiv presentation for tx
DESCRIPTION
Presentation for the UniGold HIV assay.TRANSCRIPT
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CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE
Presentation forPresentation forTexas HIV / STD meeting in AustinTexas HIV / STD meeting in Austin
Uni-Gold™ Recombigen® HIV
Heather Wilson – Account ManagerAdam Hewitt – Territory Manager
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CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE
Uni-Gold™ Recombigen® HIV
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Presentation Overview
Trinity Biotech Overview
Trinity Rapid HIV Experience
Why Choose the Trinity Uni-Gold assay
Trinity Uni-Gold Procedure
Trinity UniGold QC Performance (Hands on)
Questions
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Trinity Biotech Family of Companies
Mardx, Primus, Clark laboratories, Sigma Diagnostics, Bartels
We specialize in the development, manufacture and marketing of diagnostic test kits, Trinity Biotech’s continued success is based on the fact that as a company it consistently achieves standards of excellence in the quality of all it does.
– The test kits manufactured by Trinity Biotech are used in the clinical laboratory and point-of-care segments of the diagnostic market to detect infectious diseases, sexually transmitted diseases, blood coagulation and autoimmune disorders. The company is also a significant provider of raw materials to the life sciences industry.
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Worldwide Corporate HeadquartersWorldwide Corporate Headquarters
Number of Employees:
650
3 Main Subsidiaries: UK - Germany – USA
Network of 300 Independent
Distributors covering 78
CountriesTrinity Biotech plc,
HeadquartersBray, Ireland
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USA Corporate HeadquartersUSA Corporate Headquarters
Trinity Biotech Inc400 Connell Drive
Suite 7100Berkeley Heights, NJ
07922800-325-3424
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Infectious Disease SolutionsInfectious Disease Solutions
Western Blot
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STD’s beyond HIV
Trinity manufactures many STD tests for use in the lab. Here are a couple of the ELISA 96 well assays:
1. TrepSure Syphilis – This assay detects both IgG and IgM and has a sensitivity and specificity >99%
2. HSV–Type Specific for HSV 1 IgG and HSV 2 IgG. Very efficient assay with shorter room temperature incubation times.
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Trinity Rapid HIV Experience
Leading manufacturer of HIV Rapid Tests
First HIV Rapid Test Produced in 1995
Sell more Rapid HIV worldwide then any other US company.
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Why use the Uni-Gold™ Recombigen® HIV
Ease of Use
Speed
3rd Generation Technology
Cost Savings
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Ease of Use
CLIA Waived
– Add One Drop of Sample– Add Four Drops of Buffer
Complete Sample Flexibility
– Serum– Plasma– Whole blood
Storage Flexibility
– Room Temp– Refrigerated
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Speed
− Test Results in 10 minutes
3rd Generation Technology
− Antigen Sandwich Design Increases
Sensitivity− Can Detect Antibodies Between 3-8
Weeks Earlier Than Other 2nd
Generation Rapid Tests− 100% Sensitivity − 99.7% Specificity (few false positives)
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Cost Savings
– Because Trinity manufactures so many Rapid HIV Tests worldwide, we are able to do so at a lower cost, passing these savings on to our customers.
– Lower cost = more patients tested!
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Common Features of Rapid Tests
Positives are presumptive and have to be confirmed by confirmatory test
CLIA WAIVER
FDA restrictions also require that any facility planning to perform rapid tests must have a quality assurance plan – step-by-step activities that ensure testing is carried out correctly, results are accurate, and mistakes are found and corrected
Trinity has produced a document; “Uni-Gold Quality Control Guidelines” which can be used for this purpose.
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CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE
(For complete instructions please refer to the Uni-Gold™ Recombigen® HIV package insert)
Uni-Gold™ Recombigen® HIV Test Procedure
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Uni-Gold™ HIVProduct Information
Kit Contents:a) Each kit contains 20 Test Devices b) Wash Reagent (5.0 ml)c) 20 Pipettesd) 25 Fingerstick Pipettese) 20 Subject Information Leafletsf) Package Insert
Always refer to the Directional Insert
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Uni-Gold™ HIV Assay Procedure
• Remove the required number of Uni-Gold™ Recombigen® HIV devices from their pouches.• It is not recommended to perform more than 10 tests simultaneously.
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Uni-Gold™ HIV Assay Procedure
Lay the devices on a clean flat surface.
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Draw up adequate sample to the first gradation on the pipette (serum, plasma or venipuncture whole blood)using one of the disposable pipettes supplied.
Uni-Gold™ HIV Assay Procedure (serum, plasma, or WB)
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Uni-Gold™ HIV Assay Procedure
• Holding the pipette vertically over the sample port, add one (1) free falling drop of sample (approx. 50µl) and allow to absorb into membrane. • Do not add full volume of pipette.
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Uni-Gold™ HIV Assay Procedure
Add Four Drops of Wash Solution
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Uni-Gold™ HIV Assay Procedure
Read test after 10 minutes but
no more than 12 minutes
following the addition of the patient sample
and wash solution.
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Uni-Gold™ HIV Fingerstick Procedure
•Select puncture site and clean with Alcohol Wipe (Dry)
•Puncture with a sterile lancet just off the center of the finger
•Wipe away the first drop of blood with a sterile gauze pad
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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 has stopped (massage if needed, do not excessively squeeze the finger).
The device fills by capillary action.
•Collect the sample until it reaches the black line on the collection device
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Uni-Gold™ HIV Fingerstick Procedure
•Hold the collection device vertically (1 inch) over the sample port and squeeze the bulb until the sample is fully discharged into the sample port.•If the Collection device does not fully dispense, cover holes adjacent to the black line on the device and repeat the previous step.•Allow the sample to absorb into the sample port pad (Full Red Color)
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Uni-Gold™ HIV Fingerstick Procedure
Read test after 10 minutes but
no more than 12 minutes
following the addition of the patient sample
and wash solution.
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Interpretation
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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Moderately Complex Environment
When using with serum or plasma, color will not
appear in the sample port
CLIA Waived Environment
When using with fingerstick whole blood, red color must appear in the sample port for the test to be valid
Uni-Gold™
TRINITYBIOTECH
HIV
Control
Test
Sample
Interpretation
Uni-Gold™
TRINITYBIOTECH
HIV
Control
Test
Sample
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Interpretation
Preliminary Positive Test Result (+)
A line of any intensity at the control region and the test
region indicates a preliminary positive result.
There is full red color in the sample port.
Negative (Non-Reactive) Test Result (-)
A line of any intensity at the control region only indicates a
negative result
There is full red color in the sample port.
OR
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Interpretation
Any intensity of color is considered to be a “valid line”
Both of these tests are considered “preliminary positive” even though the intensity of the lines vary
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Interpretation (CLIA Waived)
Invalid Results
1. Sample port does not have full redcolor
2. No control line
3. No control line
1 2 3
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Interpretation
All “Invalid” results should be repeated in duplicate with newdevices
All “Reactive” results should be reported as “Preliminary Positive” and followed up with a confirmatory test
All “Non-Reactive” (Negative) should be reported as “Negative”
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Performance
Performance Serum Plasma Whole Blood (Venipuncture)
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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Uni-Gold™ HIV QC Performance
“When do I need to run controls?”
– Have I ran External Controls?– 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 need to run the QC
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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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Trinity Uni-Gold™ Recombigen® HIV
Questions?