1. HIV-1 Rapid Test for Recent Infection
Lab Tools
International Laboratory Branch
Division of Global HIV/AIDS & Tuberculosis
Centers for Disease Control and Prevention

2. List of Laboratory-Specific Tools
SOP for Rapid Recency Assay Testing/Detailed Word Document
Job Aide
Training panel and QC panel from HQ
Site level Data Capture Form (also used for training)
Training panel data capture form (aggregate)
RTRI QC Logbook
SOP for panel preparation in-country (QC and Training panel)
Generating Reference Results on new panel (Data Form)
Rapid Recency Presentations (6)
Lab Training Readiness Checklist
Training Supply Calculator

3. 1a. SOP for Asante Rapid Recency Assay
Detailed SOP that contains everything you need to know about the assay
But not practical to use at testing site

4. 1b. SOP for Maxim Swift Recent Infection Assay
Detailed SOP that contains everything you need to know about the assay
But not practical to use at testing site

5. Asante HIV-1 Rapid Test for Recent Infection Job-Aid-Visual
Check kit before use. Use only kit that is not expired or test device not damaged.
If using stored specimens (blood or plasma), bring specimens to room temperature prior to use.
Always use universal safety precautions when handling specimens. Keep work areas clean and organized.
This outline does not replace the product insert or your standard operating procedure (SOP).
Store kit:
2 - 30°C 1 2 3 4 5 6
Label patient or specimen ID number on sample buffer tube. Remove the lid. Discard into a biohazard bag
Remove a specimen collection loop from the vial of loops in the kit
Touch the round end of the loop allowing the specimen to wick up into the loop from the tube or from finger prick
Transfer the loopful of sample directly into the open sample buffer tube. Agitate the loop in the tube to thoroughly mix the sample with sample buffer.
Discard the specimen collection loop into a biohazard bag
Collect test items from test kit and assemble other accessories 7 8 9 10 11 12
Emphasize that this is to be used at site of testing, the testing bible for quick reference
Open the foil pouch and remove the test strip.
Insert the Test strip into the liquid in the sample buffer tube with the arrows pointing toward the liquid.
Let the sample buffer tube with test strip stand on a rack.
Start timer and wait for 20 minutes. At the end of 20 minutes remove strip from the sample buffer.
Touch the lower end of the strip to paper towel to drain excess buffer
Lay the strip flat on the bench and read the results immediately C V LT
Interpretation:
C= Control Line
V= Verification Line
LT= Long Term Line
Long Term= all three lines (C, V, and LT)
Recent = Lines C and V only
Negative = C only
Invalid results = No C line or lines C & LT without V 13 C V LT
Invalid
Long term
Invalid
Recent
Invalid
Negative
Invalid
Record results
Invalid

6. Maxim Swift RIA for Recent Infection Job-Aid-Visual
Check kit before use. Use only kit that is not expired or test device not damaged.
If using stored specimens (blood or plasma), bring specimens to room temperature prior to use.
Always use universal safety precautions when handling specimens. Keep work areas clean and organized.
This outline does not replace the product insert or your standard operating procedure (SOP).
Store kit:
4 - 30°C 1 2 3 4
Collect test items from test kit and assemble other accessories needed but not provided
Label client or specimen ID on the Running Buffer Tube and place tube on stand
Remove the cassette and label with specimen ID
Collect specimen (plasma/serum or blood) using the transfer pipette (to the 1st mark) 5 6 7 8
Gently squeeze the pipette to transfer sample into Buffer Tube
Mix the sample by pipetting in and out 3-5 times. Minimize bubbles. Transfer 100 µl (at the 2nd mark) of mixed sample into the cassette
Discard the transfer pipette into a biohazard bag
Incubate samples for exactly 20 minutes and read immediately after. 9
Recent C T LT
Negative
Long term
Interpretation
Invalid Results
C= Control Line
T= Test Line
LT= Long Term Line
Defective
cassette
Long Term= all three lines (C, T & LT)
Recent = Lines C and T only
Negative = C only
Invalid = No control line, or lines C & LT without T
No C line
Lines C & LT, no T
Record results

7. 3a. Site-level Data Capture Form - Asante

8. 3b. Site-level Data Capture Form - Swift

9. Example of Site-level Data Capture Form-Asante

10. 3. Training Panel Data Capture Form

11. Example of Training Panel Data Capture Form
Expected, acceptable
Not expected, not acceptable
Pass
Pass
Pass
Pass
Fail
Few specimens are known to flip-flop between recent and long term
No specimen should flip-flop between positive and negative
Advise trainee to retest incase wrong specimen was used

12. Example of Training Panel Data Capture Form
Example from 15 individuals trained in Country A

13. 4. Asante Standard QC Logbook

14. 5. Standard Operating Procedures: QC and Training Panel Preparation
Countries will require TP and QC specimens for implementation

15. Panel Development Rationale
Training of CDC using CDC QC and training panels
ToTs in country using CDC QC and training panels
Prepare country QC and training panels during ToT
Training of site-level testers using country panels
4 people/country
20-30 people/country
Hundreds/country

16. Best Way to Assemble a Specimen Panel
Obtain all rejected whole blood or plasma units from the local blood bank (HIV positive or negative)
If whole blood, prepare plasma from whole blood
Characterize with respect to their HIV status using country specific HIV test algorithm
Characterize HIV-positive specimens as Recent or LT using Rapid Test for Recent Infection
Label, Aliquot and store aliquots at -20 or below

17. Suggested Composition of the QC and Training Panel
Specimen IDs
HIV Status
QC Long Term
HIV-1 Long Term
QC Recent
HIV-1 Recent
QC Negative
HIV Negative
TP-1
TP-2
TP-3
TP-4
TP-5
TP-6
TP-7
TP-8
TP-9
TP-10
3-member QC Specimens
10-member TP
Specimens

18. Example of Panel Screening

19. 6. Reference Results Form

20. Example of Reference Results
Reference Results Form
Asante Results (Visual results from five independent runs)
Kit Lot #:
JK 2602
Kit Expiration date:
9-Dec-18
Date Tested:
12-Oct-18
Classification
Sample ID
Asdesach
Ifa
Ayisha
Johannes
Kindye
Final Expected Results
QC Long Term LT
2018 AA 00
QC Recent
Recent
Pooled 2016 HAR ADM 0013
QC Negative
Negative
Pooled 2016 BAH
TP-1
2016 AA 015
TP-2
TP-3
TP-4
TP-5
2017 AA 183
TP-6
TP-7
TP-8
TP-9
TP-10

21. 7. Rapid Recency Presentations21
7. Rapid Recency Presentations A B C D E F

22. 8. Lab Training Readiness Checklist
Helps to plan training

23. 8. Readiness Checklist pg. 2

24. 9. Training Supply Calculator

25. Thank You!