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Trinity Uni Gold Hiv Presentation For Tx
- 1. Presentation for Texas HIV / STD meeting in Austin Uni-Gold ™ Recombigen ® HIV Heather Wilson – Account Manager Adam Hewitt – Territory Manager
- 2. Uni-Gold ™ Recombigen ® HIV
- 7. Infectious Disease Solutions Western Blot
- 15. (For complete instructions please refer to the Uni-Gold™ Recombigen ® HIV package insert) Uni-Gold™ Recombigen ® HIV Test Procedure
- 16. Uni-Gold™ HIV Product Information Kit Contents: a) Each kit contains 20 Test Devices b) Wash Reagent (5.0 ml) c) 20 Pipettes d) 25 Fingerstick Pipettes e) 20 Subject Information Leaflets f) Package Insert Always refer to the Directional Insert
- 18. Uni-Gold™ HIV Assay Procedure Lay the devices on a clean flat surface .
- 19. Uni-Gold™ HIV Assay Procedure (serum, plasma, or WB) Draw up adequate sample to the first gradation on the pipette (serum, plasma or venipuncture whole blood) using one of the disposable pipettes supplied.
- 21. Uni-Gold™ HIV Assay Procedure Add Four Drops of Wash Solution
- 22. 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.
- 27. 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.
- 29. Interpretation 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™ TRINITY BIOTECH HIV Control Test Sample Uni-Gold™ TRINITY BIOTECH HIV Control Test Sample
- 30. 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
- 34. Performance 99.7% 95% CI=99.4%-99.9% 99.8% 95% CI=99.4-99.9% 99.7% 95% CI= 99.4-99.9% Specificity 100 % 95% CI =99.5 – 100.0% 100% 95% CI =99.5 – 100.0% 100% 95% CI =99.5- 100.0% Sensitivity Whole Blood (Venipuncture) Plasma Serum Performance
- 36. Uni-Gold™ HIV QC Performance 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™ TRINITY BIOTECH HIV Control Test Sample
Editor's Notes
- Ensure counseling has been given to the subject and subject consent obtained in accordance with local regulations. Picture of pouched device and wash buffer to be added here Allow the kit and samples to reach room temperature (at least 20 minutes) if previously refrigerated. Remove the required number of Uni-Gold™ Recombigen® HIV devices from their pouches. It is not recommended to perform more than 10 tests simultaneously. Lay the devices on a clean flat surface. Label each device with the appropriate patient information / ID. Picture of pipette with gradation to be added here Draw up adequate sample to the first gradation on the pipette (serum or plasma or whole blood: venipuncture) using one of the disposable pipettes supplied. Use only the pipette supplied and do not reuse. See picture. If controls are being run these must be used as described in the package insert provide with the controls. Picture of an open device with sample being dropped on by the pipette (write a patient number on the device) Holding the pipette vertically over the sample port, add one (1) drop of sample (approx. 50µl) carefully and allow to absorb. Ensure air bubbles are not introduced into the sample port. Picture of open device with wash buffer being dropped Holding the bottle in a vertical position, add four (4) drops (approx. 200µl) of the wash reagent from the dropper bottle to the sample port. Allow 10 minutes from the time of wash reagent addition for reaction to occur. The result should be read immediately after the 10 minute incubation time.