HIV1 Rapid Test for Recent Infection LAB TOOLS

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 2. Job Aide 3. Training panel and QC panel from HQ 1. a. b. 4. 5. 6. 7. 8. 9. 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 1 a. 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 1 b. 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

Asante HIV-1 Rapid Test for Recent Infection Job-Aid-Visual q q 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). 1 2 Collect test items from test kit and assemble other accessories Label patient or specimen ID number on sample buffer tube. Remove the lid. Discard into a biohazard bag 8 7 Open the foil pouch and remove the test strip. 4 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 9 Insert the Test strip into the Let the sample buffer tube liquid in the sample buffer with test strip stand on a tube with the arrows pointing rack. toward the liquid. Interpretation: C= Control Line V= Verification Line LT= Long Term Line 13 Record results 3 • • 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 Store kit: 2 - 30°C 5 10 6 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 11 Start timer and wait for 20 minutes. At the end of 20 minutes remove strip from the sample buffer. 12 Lay the strip flat on the Touch the lower end of the strip to paper towel to bench and read the results immediately drain excess buffer C V LT Invalid Long term Invalid Recent Invalid Negative Invalid

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

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

8 3 b. 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 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

15 Panel Development Rationale Training of ISME @ CDC using CDC QC and training panels 4 people/country Training of sitelevel testers using country panels Hundreds/country To. Ts in country using CDC QC and training panels 20 -30 people/country Prepare country QC and training panels during To. T

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 QC Long Term HIV Status HIV-1 Long Term QC Recent HIV-1 Recent QC Negative HIV Negative TP-1 HIV-1 Long Term TP-2 HIV-1 Recent TP-3 HIV Negative TP-4 HIV-1 Recent TP-5 HIV-1 Long Term TP-6 HIV-1 Recent TP-7 HIV Negative TP-8 HIV-1 Recent TP-9 HIV-1 Long Term TP-10 HIV-1 Recent 3 -member QC Specimens 10 -member TP Specimens

18 Example of Panel Screening

19 6. Reference Results Form

20 Example of Reference Results Form Asante Results (Visual results from five independent runs) Kit Lot #: Kit Expiration date: JK 2602 Date Tested: 12 -Oct-18 9 -Dec-18 Sample ID Asdesach Ifa Ayisha Johannes Kindye Final Expected Results Classification QC Long Term LT 2018 AA 00 LT LT LT QC Recent Pooled 2016 HAR 004 + 2017 ADM 0013 Recent Recent QC Negative Pooled 2016 BAH 0098 + 0097 + 0051 Negative Negative TP-1 TP-2 LT Recent 2016 AA 015 Pooled 2016 HAR 004 + 2017 ADM 0013 LT Recent LT Recent TP-3 Negative Pooled 2016 BAH 0098 + 0097 + 0051 Negative Negative TP-4 Recent Pooled 2016 HAR 004 + 2017 ADM 0013 Recent Recent TP-5 LT 2017 AA 183 LT LT LT TP-6 Recent Pooled 2016 HAR 004 + 2017 ADM 0013 Recent Recent TP-7 Negative Pooled 2016 BAH 0098 + 0097 + 0051 Negative Negative TP-8 Recent Pooled 2016 HAR 004 + 2017 ADM 0013 Recent Recent TP-9 LT 2018 AA 00 LT LT LT TP-10 LT 2018 AA 00 LT LT LT

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

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

23 8. Readiness Checklist pg. 2

24 9. Training Supply Calculator

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