1. Preparation of QC and Training Panels
International Laboratory Branch
Division of Global HIV/AIDS & Tuberculosis
Centers for Disease Control and Prevention

2. Outline
Describe the considerations for preparation and characterization of a specimen bank
Review the step-by-step process
Explain the components within the QC and Training panels
Summarize the verification process for the QC and training panel
Define conditions for usage of the panels

3. Prior to the TOt

4. General Considerations for a Specimen Bank4
General Considerations for a Specimen Bank
Obtain rejected whole blood units from the blood bank
The blood specimen must be re-tested using the rapid test algorithm (National HIV RDT algorithm)
Process confirmed HIV positive and few negative blood units into plasma
Centrifuging the blood at 3000 rpm for 10 minutes
Test HIV positive specimens with RTRI to determine recent or LT status
Continue collecting, re-testing, and characterizing the positive blood specimens to expand the collection for future HIV research
A small/sizable number of negatives should be included in the collection
Also mention for the specimen bank that negatives should also be stored in the collection, however the laboratory only needs to store several tubes.

5. Characterization of HIV-1 Positive Samples5
Characterization of HIV-1 Positive Samples
Characterize HIV positive specimens using rapid test for recent infection assay (RTRI) (e.g. Asante HIV-1 Rapid Recency Test or Maxim Swift Rapid Infection Assay)
Identify samples that are clearly HIV negative, HIV-1 recent infection, and HIV-1 long-term infection based on the results of the RTRI
Heat inactivate HIV positive specimens
Set up water bath at 56 °C
Incubate sample in 50ml tube at this temperature for 30 mins.
Ensure sample level is completely immersed in the water bath

6. 6
Assembling the Panel
Print specimen labels indicating specimen ID, preparation date, and name of laboratory where panels are prepared
Label as many 2 mL v-bottom microtubes as needed
Aliquot 100 µL sample into these properly labelled microtubes and cap immediately
Handle ONLY ONE specimen and ONLY ONE set of tubes at a time

7. Recommended Composition of QC and Training Panel7
Recommended Composition of QC and Training Panel
Verify the status of every specimen
There should be 3 samples for the QC panel, and no less than 10 samples for the training panel
There should be no ambiguity with the results for samples used for QC
Assign specimen IDs as shown; IDs do not have to be assigned in the same order
Specimen IDs
HIV Status
Negative Control
HIV negative
Recent Control
HIV-1 recent
Long-term Control
HIV-1 long-term
TP-1
TP-2
TP-3
TP-4
TP-5
TP-6
TP-7
TP-8
TP-9
TP-10

8. Verification of the QC and Training Panel8
Verification of the QC and Training Panel
Randomly select at least 3 sets of QCs and Training panels from the freezer and re-test using the HIV-1 RTRI
3 laboratorians should perform testing independently on all samples (if 5 sets were selected then 5 laboratorians should test)
Record the visual results from all operators in the Reference Results Form

9. Reference Results Generation9
Reference Results Generation LT
Recent
Negative
Recent
The final interpretation, which is the best of 3 results, will serve as the reference value for future comparisons

10. Panel Storage and Stability10
Panel Storage and Stability
Storage:
Short-term storage (<7 days): store at 4°C.
Long-term storage: store at -20°C.
Stability:
A maximum of 5 freeze-and-thaw cycles are acceptable.
Label thawed specimens with the date removed and name/initials of the laboratory tech

11. Usage of the panels

12. Usage of the Training and QC Panel12
Usage of the Training and QC Panel
Use the Training panel during RTRI training to ascertain the competency and readiness of the trainees to provide this testing service
Use the QC panel to verify performance of RTRI kits
Once a month per site
When storage temperature exceeds the manufacturer’s recommended storage conditions
On each new lot of HIV-1 RTRI kits (NRL only)
On each new shipment of HIV-1 RTRI kits (NRL only)

13. Record QC Results in the QC Logbook Form-Asante13
Record QC Results in the QC Logbook Form-Asante

14. Record QC Results in the QC Logbook Form-Maxim Swift14
Record QC Results in the QC Logbook Form-Maxim Swift

15. Review How should the specimens from the blood bank be re-tested?15
Review
How should the specimens from the blood bank be re-tested?
What is the composition of the QC and training panel?
How many laboratorians are needed to verify the panels?
At what temperature should the panels be stored at?
What is the stability of the panels?
When should the panels be used?

16. Thank You