INSTIHIV 1 Rapid Test

TrainingTrainer’s Manual

INSTI TrainingTrainers Manual

The objective of this manual is to orient trainers to the material covered in the INSTI HIV 1 rapid test training (“the training”). Once familiarized with the material, trainers should be able to successfully lead the training and assess the competency of each participant to run and read the INSTI test. This manual contains a training agenda, a list of materials, a copy of the Power Point complete with trainer’s notes, and copies of each document used in the training.

The training is meant to either stand alone, or be part of a larger course, such as the HIV Counselor Training. This training was created to familiarize participants with the components and features of the INSTI test, how to run the test, and how to read and interpret the test results. Participants must successfully complete every portion of the agenda (see next page); failure to complete any portion will result in failure of the entire training. Once a participant passes the training, that person is certified to run and read the INSTI test in any HPS-funded site.

Acknowledgements: Thank you to Jenny Broker, Emalie Huriaux, Joe Imbriani, Amy Kile-Puente, Thomas Knoble, Oscar Macias, Tracey Packer, and Deanna Sykes, for their combined contributions in creating this training manual. Training Objectives

1. Participants will demonstrate proper use of universal precautions.2. Participants will exhibit appropriate techniques conducting the INSTI test.3. Participants will be able to describe the key elements of the INSTI quality

assurance requirements. 4. Participants will correctly interpret INSTI test results.5. Participants will be able to accurately explain the meaning of rapid test results.

Training Agenda

1 hour, 15 minutes PresentationConsists of a Power Point presentation providing an overview of the INSTI test and procedures:- Testing guidelines- Test accuracy- Quality assurance- Universal precautions- Filling out paperwork- How to run and read the test- Internal and external controls- Correcting written mistakes

15 minutes Break (at trainer’s discretion)

15 minutes Trainer demoTrainers run a test while participants watch and follow the expanded checklist in their manuals.- One trainer reads from the short checklist while the other

trainer demonstrates the steps- trainers describe each step in detail- Control samples are used

15 minutes Guided practiceEach participant performs one INSTI test while the trainer verbally guides them through each step.- Trainer will read from expanded checklist- Participants will follow referring to short checklist - Trainers will bring control sample vial to participants- While tests are running trainers will present slides on reading

results and do group reading practice

30 minutes Dyad practiceParticipants work in pairs and observe each other running one INSTI test.- One participant observes as the other performs the test,

including filling out paperwork- Participants use the short checklist- Observer speaks up if a step is skipped or if something is

done incorrectly, but otherwise stays silent- Trainers bring control sample vials when ready- Trainers help only as needed- While tests are running trainers present slides about internal

and external controls

1 hour 30 minutes 5 test runs and results panel quiz

Each participant runs and reads 5 INSTI tests on their own and reads 12 result images. - Participants run 5 tests continuously - Trainer prepares participants with reminders about double-

checking paperwork, being organized, and following the short checklist

- Trainers observe one complete test from start to finish from each participant

- Each participant must also correctly read 12 test result images

Materials

INSTI supplies for each participanto Absorbent workspace covero Biohazard Bago Control pipettes (7 per participant)o INSTI test kits (7 per participant)o Latex and non-latex gloves (S-XL)o Thermometer/clocks

INSTI CAT form (appendix 2) Laboratory Log (appendix 3) HIV testing form (appendix 4) INSTI Result Panel Quiz – practice version and versions A-C (appendices 5-8) Client Identification Stickers Spill Kit

Note to Trainers

Before you facilitate this training, it is imperative that you are extremely familiar with the INSTI testing procedure. There is a lot of material describing the entire testing procedure on the following pages. It will also be important to review the checklist in the preface of this manual and be sure that you have all the necessary materials.

Be sure to read the INSTI package insert at least once before conducting this training. It may be found online at:

http://www.biolytical.com/insti_documents/50-1097IFU48TestsROW.pdf

It is also very important to become familiar with the section below each slide which contains Purpose/Objectives of the Slide, Additional Talking Points, and Notes.

– Purpose/Objectives of the Slide – describes the slide and rationale/objective of slide being included.

– Additional Talking Points – Many slides are self-explanatory, and some slides require further explanation. Additional Talking Points provides suggested dialog relevant to the slide, which is important information for a trainer to pass on to the participants. This section is written in quotations. The objective is not for you to present this information entirely as written but to be an example of how to say it. It is suggested that you find your own way of presenting it.

– Notes – a message or a training tip for the trainer.

INSTI is a simple test with visual interpretation of test results. CLIA (federal law) requires anyone performing a laboratory test classified as waived to follow the manufacturer’s instructions contained in the package insert. California has additional requirements for quality assurance standards and procedures. These are detailed in the California Office of AIDS HIV Testing Guidelines.

The INSTI package insert specifies that each new operator must perform positive HIV-1 controls as well as negative controls before performing the test on patients. To meet requirements for a CLIA waiver, the manufacturer conducted clinical trials that demonstrated that persons with no laboratory experience could accurately perform the test after reading only written instructions (i.e. without receiving specific training on how to perform the test).

The INSTI test is FDA-approved for use with whole blood samples obtained by finger stick or venipuncture. The test delivers negative or reactive results in one minute. Rapid HIV tests provide opportunities for persons to learn their HIV antibody test results on the day they are tested. Use of rapid HIV tests can substantially increase the number of persons who learn of their HIV status.

The INSTI test is a rapid, point-of-care test designed to detect HIV antibodies. The test kit is operated by collecting a whole blood sample in the provided pipette and transferring it to a solution which is deposited into the test device, followed by 2 other solutions. Immediately after this procedure is completed, the results are ready for interpretation.

INSTI Appendices:

Appendix 1: Extended INSTI CATAppendix 2: INSTI CATAppendix 3: Laboratory LogAppendix 4: HIV testing form

Appendix 1: Extended INSTI CAT

DETAILED STEPS FOR INSTI HIV 1 TEST PROCEDURE USING BLOOD and CONTROL SAMPLE

EXPANDED VERSION

1. Gather materials1. Absorbent workspace cover (chux)

2. Biohazard containers (sharps container and biohazard bag, within comfortable and safe reach)

3. Bleach cleaning solution (10% bleach, 90% water) or several medical biohazard wipes or a “spill kit” for clean-up in the event of a spill.

4. Thermometer

5. Good lighting

6. Pen

7. Unopened test device pouch

8. Gloves

9. Client number stickers (for use with lab log)

10. Lab log or lab slip

11. Client Information Form (CIF)

12. INSTI Competency Assessment Test (CAT) checklist

2. Examine test device poucha. Test pouch must be unopened.

b. Test pouch should be at room temperature, between 59 and 86 degrees Fahrenheit. (If test kits are stored refrigerated, allow test kit to come to room temperature before using).

3. Record date of test on lab log/lab slip

4. Record lot number on lab log/lab slipa. Lot number is stamped on back of package next to the word “LOT”.

5. Record expiration date on lab log/lab slipa. Expiration day, month, and year is stamped below lot number.

b. Record exactly as seen.

NOTE: Do not use device if expired.

6. Record initials or counselor ID on lab log/lab slipa. Record initials of tester operating the test device and reading results on lab

log/lab slip.

7. Open pouch, remove test device, lay flat on absorbent pad (chux) so that tab is positioned below the test membrane unit well

8. Affix client number sticker to test devicea. Affix client number sticker to the tab on the bottom of the test device below the

test membrane unit well.

9. Affix client number sticker to CIF and lab log a. From the same sheet of number stickers, affix a sticker to the CIF, lab log (or

lab slip if necessary), and any other paperwork that must be linked (e.g., consent form, etc.)

10. Put on glovesa. Universal precautions require that all health care providers use gloves and

other protective gear as appropriate when dealing with potentially infectious fluids.

b. Use gloves when handling the following:

1. Blood samples;

2. Control vials or proficiency specimens;

3. Used test devices;

4. Other materials that may have come into contact with potentially infectious fluids.

11. Collect sample – whole blood/control samplea. Collecting blood:

1. Follow all directions according to your finger stick device and phlebotomy training to puncture finger (or collect a venipuncture sample);

Membrane unit well

Tab

2. Touch the end of the pipette to the second drop of finger stick blood. Blood will automatically be drawn up into the pipette by capillary action.

3. “Pulse” the finger to get a continual bead of blood until the pipette is filled to the black line (notice the black line in the above photograph). It takes the equivalent of approximately 3 drops of blood to fill the pipette.

4. If the blood begins to spread on the finger, wipe the spot dry with a sterile gauze pad and resume squeezing and pulsing the finger to produce another bead of blood.

b. Collecting control sample:

1. Squeeze bulb of control pipette and dip into control vial;

2. Draw control fluid up into the pipette to the 50ul line.

Fill line

12. Visually examine pipette a. Examine pipette carefully to ensure that the pipette is filled to the fill line with

blood or control sample.

b. Do not hold pipette above head to inspect as control sample is bio hazardous.

13. For either the blood or control pipette: Transfer the liquid to the uncapped Solution 1 bottle by completely squeezing the bulb.

IMPORTANT: When using blood, if the sample does not dispense into the Solution 1bottle when squeezing the bulb, cover the air hole on the black line with the fingers of your other hand and squeeze the bulb again.

14. Dispense pipette, blood or control, in biohazard container a. Immediately discard the pipette into a biohazard container when finished.

b. Discard any other materials that have contacted potentially infectious agents in biohazard containers according to site guidelines.

15. After placing the control liquid into Solution 1, re-cap Solution 1 and invert several times.16. Pour Solution 1 with specimen into unit membrane well

17. Dispose of Solution 1 bottle in biohazard container immediately18. Allow to absorb completely, then immediately proceed to the next step19. Pour Solution 2 into the center of the membrane unit well. Solution 2 bottle may be disposed in regular trash

20. Allow to absorb completely, then immediately proceed to the next step21. Pour Solution 3 into the center of the membrane unit well. Solution 3 bottle may be disposed in regular trash

22. Allow to absorb completely, then visually interpret the results

23. Remove glovesa. Remove gloves by grasping cuff and pulling off so that glove turns inside out,

to safely contain any bio hazardous agents.

24. Record temperaturea. Record the temperature on the lab log/lab slip in the space labeled ‘Begin

Test-Time’ and ‘Begin Test-Temperature.’

b. Temperature range for testing must be within 59 and 86 degrees Fahrenheit.

25. Verify that client ID number on lab log/lab slip and test device are the same

26. Accurately record result and end time and temperaturea. Carefully examine the result window and record the correct result on the lab

log/lab slip.

b. Record the current time and temperature on the lab log/lab slip in the space labeled ‘End Test-Time’ and ‘End Test-Temperature.’

NON-REACTIVEOnly one blue controlspot appears on top

REACTIVETwo blue spots appear, one control and one test

spot NOTE: one spot may be darker than the other

INVALIDA missing control spot is an INVALID result

27. Check lab log/lab slip for completeness and accuracy of information, including test result.

28. Put on gloves before disposing of used test device into biohazard container.

Appendix 2: INSTI CATINSTI Competency Assessment Test (CAT) Checklist

CATs are required before starting testing and 6 months after starting and are observed by site coordinator. Annual CATs must be observed and signed by HIV Prevention Section staff. Completed CAT checklists must be filed in the

tester’s personnel file and a copy must be faxed to SFHPS, 415-934-4868.

Date:_______________ Site Name and Number_____________________________

Test Reader’s Name____________________ Initials or Tech ID________________

Gather materials: test kit, (control) pipette, pen, lab form, client ID stickers. Examine test kit pouch (unopened, room temperature). Record test date on lab log. Record lot number on lab log. Record expiration date on lab log. Record initials or tech ID on lab log. Open the test kit packet and arrange contents on absorbent pad (chux). Place a client ID sticker on lab log. Place a client sticker on the CIF. Remove INSTI test device from its foil packet – do not touch unit well membrane with fingers. Place a client ID sticker on the bottom tab of the INSTI test device. Put on gloves. Open red Solution 1 vial. Swirl and then open control fluid vial. Squeeze bulb of control pipette and insert into control vial. Release bulb and draw control fluid up to the fill line (50 ul). Dispense fluid into red Solution 1vial. Dispose of pipette in a biohazard container. Recap red Solution 1 vial and invert 3 or 4 times. Reopen red Solution 1 vial and pour contents into the test device’s until well membrane. Dispose of empty red Solution 1 vial in a biohazard container. Invert blue Solution 2 vial 3 or 4 times and then open. When Solution 1 contents have been absorbed (about 30 seconds) pour contents of blue Solution

2 vial into unit well membrane. Dispose of blue Solution 2 vial in regular trash. When Solution 2 contents have been absorbed (about 20 seconds) pour contents of gray Solution

3 vial into unit well membrane. Dispose of Solution 3 vial in regular trash. Interpret results. Remove gloves. Record sample number from control vial (for training only). Record temperature, temperature within 59 to 86 degree range. Verify that the client number on the lab form and INSTI test device are the same. Accurately record the result on the lab form. Check lab form for completeness and accuracy of information, including test result.

Notes:_______________________________________________________________

Authorized evaluator name:_____________________________________________

Evaluator’s signature:___________________________________________________

Type of test: ____Initial CAT ____6 month CAT ____Annual C

Appendix 3: Laboratory Log

Appendix 4: HIV test form