Unigold Recombigen HIV 1/2 Training for HIV Testing Sites

Unigold Recombigen HIV 1/2 Training for HIV Testing Sites
Updated: February 2018 Cicely Richard Office of HIV/AIDS Georgia Department of Public Health Office of HIV/AIDS presents the Unigold Recombigen HIV 1/2 Training for HIV Testing Sites

Unigold Recombigen HIV 1/2 Training for HIV TeSTING Sites
Updated: February 2018 Cicely Richard Office of HIV/AIDS Unigold Recombigen HIV 1/2 Training for HIV TeSTING Sites

Objective The objective of today’s training is to become familiar with the Unigold Recombigen HIV 1/2 test. This is a 3rd generation HIV antibody test. This testing device is currently utilized only by HIV testing sites that are approved to use the DPH rapid/rapid testing algorithm. The objective of today’s training is to become familiar with the Unigold Recombigen HIV 1/2 test. This is a 3rd generation HIV antibody test. This testing device is currently utilized by HIV testing sites that are funded or supported by Georgia Department of Public Health.

Uni-Gold™ Recombigen HIV 1/2 Training
Lou Pastors MT(ASCP National Account Manager Trinity Biotech Phone: The materials presented within this presentation were provided by Trinity Biotech the manufacturers of the Unigold HIV 1/2 testing device

Uni-Gold™ Recombigen® HIV
NAME AND INTENDED USE Uni-Gold™ Recombigen® HIV is a single use rapid immunoassay for the qualitative detection of antibodies to HIV-1 and /or HIV-2 in serum, plasma and whole blood (venipuncture and fingerstick). Uni-Gold™ Recombigen® HIV is intended for use in point of care settings as an aid in diagnosis of infection with HIV-1 and HIV-2. * Uni-Gold™ Recombigen® HIV Package Insert, pg. 1 Please use this product according to its name and intended use. Uni- Gold Recombigen is a single use rapid immunoassay for the qualitative detection of antibodies to HIV -1 and HIV-2. Please keep in mind an immunoassay test relies on biochemistry to measure the presence of HIV antibodies that a person produces as a result of HIV infection. Remember HIV -1 is primarily in the United States and HIV-2 which is predominately in Western Africa. This test can be utilized with serum, plasma, and whole blood ( venipuncture and fingerstick. Please see package insert page 1 for additional information.

HIV Antibodies In order to understand the reason behind using 3rd generation testing, one must understand HIV early infection. Once a person is infected with HIV, the earliest the infection can be detected utilizing HIV testing technology is around Day 11 looking at HIV RNA through a Nucleic Acid Test. Around Day 16 HIV p24 antigen can be detected with 4th generation testing. 3rd generation testing can detect the presence of HIV IGm and IGg antibodies as early as around day 22. And 2nd generation testing detects HIV IGg antibodies after day 40. In the past, the state of Georgia utilized 2nd generation testing devices ( such as oraqick advance, chembio surescheck or clearview) which detected only HIV IGg antibodies around day 40 of infection according to the chart above.

Rapid HIV-1 Screen Performance Data Review
Manufacturer Performance Data from the four available CLIA Waived Rapid HIV-1 Tests when used with a Whole Blood Sample. Sensitivity Specificity Uni-Gold™ 100% 99.7% Clearview Sure Check® 99.9% Determine™ HIV Ag/Ab Combo 4th Generation OraQuick Advance® 99.5% Looking at Uni-Gold’s sensitivity and specificity? Sensitivity is the ability to detect true positives and specificity is the ability for the testing technology to detect true negatives. As you can see in the slide above, Uni-Gold’s sensivity was 100% and its specificity was 99.7%

Uni-Gold™ Recombigen® HIV 1/2 Kit
General Kit Information… 20 Tests Devices per Kit Kit Storage at 35.6° to 80.6°F 12 month expiration from DOM Record Received Date on each Box Product Number: In this particular kit every item is separated and not packaged together in a pouch. The kits should be stored anywhere from 35.6 degrees Fahrenheit to 80.6 degrees Fahrenheit. It has a 12 month expiration form date of manufacturers. Please record the date on each box once you receive the shipment. The product number is also located on the box and kit.

Uni-Gold™ Recombigen® HIV 1/2 Kit
Each Kit Contains: 20 Test Devices 1 Vial of Wash Solution 20 Disposable Pipettes 20 Fingerstick Collection Devices 20 Subject Information Leaflets 1 Package Insert Within each kit, there are 20 test devices, 1 Vial of Wash solution, 20 disposable pipettes ( very similar to INSTI’s pipettes however these pipettes collect 40ul), 20 Fingerstick Collection Devices, and 20 subject Information Leaflets, and 1 Package Insert

Pipette Comparison Please note the Unigold pipettes are NOT the same as the INSTI pipetts. The specimen amount required is different. Pipettes can not be interchanged. At this point, you may be wondering if INSTI uses the same pipette as the Unigold HIV 1/2 testing device. Please note the pipettes are not the same and the specimen amount required is different. Pipettes can not be interchanged.

Uni-Gold™ Recombigen® HIV 1/2 Controls
Each Set of Controls Contains: 1 Vial of Positive HIV-1 Control – O.5mL 1 Vial of Positive HIV-2 Control – 0.5mL 1 Vial of Negative HIV Control – 0.5mL 1 Package Insert Always Store at 2⁰ to 8⁰ C 12 Month Expiration from DOM Open Vial Stability is One Month Product Number: For each set of controls that you receive, it will contain: 1 Vial of Positive HIV-1 Control – O.5mL 1 Vial of Positive HIV-2 Control – 0.5mL 1 Vial of Negative HIV Control – 0.5mL 1 Package Insert Always Store at 2⁰ to 8⁰ C 12 Month Expiration from Date of Manufacturers. Open Vial Stability is One Month Product Number:

Uni-Gold™ Rapid HIV Fingerstick Procedure
Materials required for Uni-Gold™ Fingerstick Procedure Uni-Gold™ Test Device (Room Temp, 20 Minutes stored at 2-8° C) Uni-Gold™ Wash Solution (blue top dropper provided in Kit) Uni-Gold™ Fingerstick Collection Device (provided in Kit) Uni-Gold™ Subject Information Leaflet (provided in Kit) Lancet* (Any Blade Lancet Capable of a 50 µl Bleed) Sterile Gauze*, Alcohol Wipe*, and Band Aid* Latex Gloves* Marker/Sharpie* Biohazard Container* Sharps Container* Timer* (Timers provided by Trinity Biotech upon request) *Materials required but not provided with Uni-Gold™ Kit Please look over the list of materials required for the Uni-Gold Fingerstick Procedure. Uni- Gold of course provides the test device which one must use at Room Temperature if the test device is stored between 2-8 degrees Celsius ( Degrees Fahrenheit to 46.4 Degrees Fahrenheit it must be allowed to warm to room temperature for 20 minutes. The Uni-Gold Wash solution provided in the kit has a blue top dropper, the fingerstick collection device are both provided in the kit and packaged separately as stated before. The Uni-Gold kit does not contain the following however these materials are required: Lancet* (Any Blade Lancet Capable of a 50 µl Bleed) Sterile Gauze*, Alcohol Wipe*, and Band Aid* Latex Gloves* Marker/Sharpie* Biohazard Container* Sharps Container* Timer* (Timers provided by Trinity Biotech upon request)

Please sure to organize your materials for the procedure, record information for your logs, and mark testing device with Patient ID. Please follow your organizations protocols and procedures regarding logging the patient information and testing devices. Organize Materials required for Procedure Open a new Test Device and mark with Patient ID

Identify fingerstick location, clean the area with Alcohol Wipe, and allow to dry Make puncture with Lancet Wipe away the first drop of blood with a sterile gauze pad Identify the fingerstick location ( usually the ring or middle finger) clean the area with an alcohol wipe and allow to dry. Then make the puncture with the Lancet. Wipe away the first drop of blood with a sterile guaze pad. Please note with INSTI one does not need to wipe away the first drop of blood.

Make sure a full drop of blood is available before starting the collection process Obtain a full drop of blood before starting the Collection

To begin the fingerstick collection process, hold the fingerstick collection device horizontally and then use the tip of the collection device to the sample surface. Do not squeeze the bulb to collect the sample as the testing device uses capillary action to fill the collection device to the black line. Holding the Fingerstick Collection Device horizontally Touch the tip of the Collection Device to the sample surface Fill the Fingerstick Collection Device to the black line Do NOT squeeze the bulb to collect the sample

As depicted, dispense the sample into the sample port by squeezing the bulb to dispense the sample. Please allow the sample to absorb into the membrane. Dispense the Sample into the Sample Port Squeezing the bulb to dispense the Sample Allow the sample to absorb into the membrane

Once the sample has been absorbed into the membrane. Add 4 drops of wash solution into the sample port. Be careful to not touch the sample port with the tip of the wash solution Add 4 Drops of Wash Solution into the Sample Port Do not touch the sample port with the tip of the wash solution

After the wash solution has been added, set your timer for 10 minutes. Read the testing device after 10 minutes and before 12 minutes After addition of the Wash Solution, set timer for 10 Minutes Read the test after 10 minutes and before 12 minutes

For a CLIA waived test result to be valid, there must be a control line present and full red color in the sample port Control Line Area Test Line Area For a CLIA which stands for ( Clinical Laboratory Improvement Amendment) waived test result to be vaild there must be a control line present and a full red color in the sample port. Sample Port

Negative (Non-Reactive) Valid Test Result Control Line Present Test Line Absent Full Red color in the sample port. Preliminary Positive (Reactive) Valid Test Result Control Line Present Test Line Present Full Red color in the sample port. Please take a look at the pictures of the testing devices. Note the test device to the left of your screen is negative or nonreactive. This is a vaild test result because there is a control line present, the test line is absent and there is a full red color in the sample port. Note the test device to the right of your screen is preliminary positive ( reactive) . This is a valid test result because the control and test lines are present and there is a full red color in the sample port.

Uni-Gold™ Quality Control (QC) Performance
“When do I need to run controls?” Have I ever 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. As we move on to Quality Control Performance in order to assess the question “ When do I need to run controls?” Please consider the following questions: Have I ever ran External controls in the past? 2.Has Anyone ran External Controls with this Lot Number? 3. Has Anyone ran External Controls with this Shipment? 4. Have the Storage temperature been acceptable? 5 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 Quality Controls

Materials required for Uni-Gold HIV QC Performance Uni-Gold™ Recombigen HIV Kit Controls Uni-Gold™ Disposable Pipette Uni-Gold™ Test Devices (3) Uni-Gold™ Wash Solution Latex Gloves Marker/Sharpie Timer (use your watch or clock for today) Biohazard Container * Kit Controls are a separate product from Trinity Biotech (# ) The following materials are required for the Uni- Gold HIV Quality Control Performance: Uni-Gold Rcombigen HIV Kit Controls, Uni-Gold Disposable Pipette ( This is larger than the Unigold Collection Device). Three Uni- Gold test devices, Uni-Gold Wash solution, latex gloves, marker/sharpie , timer, and biohazard container.

Organize all materials required for the External Quality Control Performance. Open 3 new test devices and mark with a sharpie or maker the Quality Control ID ( HIV 1 +, HIV 2 +, and Negative). If the Qualtiy Control Vials are unopened, record the date on th vial /box. Please remember they are stable for 1 month after opening. Organize all materials required for External QC Performance Open new Test Devices (3) and Mark with QC ID (1+,2+, Neg) If the QC Vials are unopened, record date on vial/box

In order to begin the QC process, immerse the tip of the Disposable Pipette into the QC Vial . Gently press the bulb to draw a minimal amount of sample. Holding the pipette vertically, dispense 1 free- fall drop into the sample port. Allow it to absorb int the sample port. 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

At this point, add 4 drops of Wash Solution into the sample port. Do not touch the sample port with the tip of the wash solution. Add 4 Drops of Wash Solution into the Sample Port Do not touch the sample port with the tip of the wash solution

After adding the wash solution, set your timer for 10 minutes. Read the test after 10 minutes and before 12 minutes. After addition of the wash solution, set timer for 10 Minutes Read test after 10 minutes and before 12 minutes

Uni-Gold™ HIV QC Performance Note…
Uni-Gold Venipuncture 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 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. Please note when using the Uni-Gold External Kit controls the sample port will not have a full red color. QC Determination is valid without the full red color in the sample port.

The link below is to an video demonstration of the UniGold Recombigen HIV 1/2 Fingerstick Procedure. Please note this is for use as a training guide only. The most current Instructions should always be reviewed prior to testing.”

Thank you for participating in the Unigold Recombigen HIV 1/2 Training for HIV Testing Sites. Please direct any of your questions or concerns to your Regional Coordinator.

Uni-Gold™ Recombigen HIV 1/2 Training
Lou Pastors MT(ASCP National Account Manager Trinity Biotech Phone:

Unigold Recombigen HIV 1/2 Training for HIV Testing Sites

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