OraQuick ADVANCE How to Run the Test Appendix G Clearview Stat-Pak Presentation OraQuick ADVANCE How to Run the Test Purpose / Objectives of Slide: Title page Talking Points: “This presentation is about testing with the OraQuick ADVANCE Rapid Test.” Notes: Feel free to customize slide with trainer information

Overview Background Presentation Demo of the test Practice tests - You will practice running 2 tests We will not be testing anyone in the room Proficiency Test - You will run 5 tests without assistance Run, read, and document 5 tests Read results of 10 test images Pass / fail course, must get 100% to pass Purpose / Objectives of Slide: Give overview and frame Additional Talking Points: “We will cover the basics of this test, show how to run the test, and you will get a chance to practice a couple times. After that you all will be given 5 tests and you will be asked to run them perfectly. All paperwork will need to be 100% correct. Also one of the trainers will need to observe you running one of your 5 tests and ask you to correctly read 10 test images. We will cover what you need to pass in much greater detail later.” Notes: Do not cover the Proficiency requirements in too much detail, just do some fore shadowing.

What Do You Know About Rapid HIV Tests? Purpose / Objectives of Slide: Assess knowledge of class Additional Talking Points: Brainstorm: “Before we get started, tell me what you know about rapid testing.” Notes: You can write up responses on a chart paper, or do this verbally

Intro to OraQuick ADVANCE Rapid Test One-step test Visual interpretation Uses blood or oral fluid Looks for HIV antibodies Results in 20 to 40 minutes Purpose / Objectives of Slide: Brief overview of features of the test Additional Talking Points: No additional talking points. Notes: Cover this slide quickly, used to transition in to coming materials.

In California…. Individuals who have been trained by CDPH/OA and are working in a OA-funded HIV testing site can run HIV/Hep C rapid tests OR Are working in an HIV testing site that meets these two criteria: Utilizes HIV counseling staff who are trained by OA or its agents and Has a quality assurance plan (QA) approved by the local health department in the jurisdiction where the site is located and has HIV testing staff who comply with specific QA requirements.* They must also be certified to perform finger sticks (or be occupationally exempt, like nurses) Purpose / Objectives of Slide: Is to give participants an understanding of what this certification covers Additional Talking Points: “Completion of this training will allow you to run a CLIA waived test. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy and reliability of patient test results. You will be acting as a lab, therefore, and you will be acting under these standards. You can only run HIV rapid tests. Traditionally these tests are run by trained lab staff. There is allowance in the laws for government funded HIV prevention programs to have lay persons (or non-lab staff) run HIV and Hep. C tests. These people must pass this training. There is also an allowance in the laws for lay staff to do finger sticks.” Notes: This slide is not required. Participants often have misunderstood where and under what circumstances they are “Certified” to run tests. * QA requirements are specified in Section 1230 of Title 17 of the California Code of Regulations

Package Insert Contains instructions CLIA requires following the manufacturer’s instructions to the letter!! Purpose / Objectives of Slide: Introduce the package insert and give background for why they must follow manufacturer instructions to the letter Additional Talking Points: “When a manufacturer wants something approved, they write the instructions on how to run the product. The instructions include things like how long to run, how to store, and the temperature range in which the test must be run. Then, the FDA takes the product and follows these instructions and looks to see if the test works when following the instructions. If the test performs correctly they approve the test and the instructions, or ‘Package Insert’. Then anyone using this product must follow these instructions. If the user does not follow the instructions, and the test does not perform properly, the user is responsible. Each box of test kits will have a copy of the Package Insert. I would recommend you read it before you start testing.” Notes: This slides helps participants understand why they must follow instructions so closely

Subject Information Brochure Contains information about the test that is relevant to the client Package Insert says, “All subjects must receive the Subject Information Brochure” Purpose / Objectives of Slide: Shows what the Subject Information Brochure looks like Additional Talking Points: “This is written for the client. It tells them about the test and how it works.” Notes: No additional notes Check in with your site to see how this is handled

Test Accuracy We’re going to talk about how well the test works You do not need to memorize the details - only need to know test is very accurate There are two components of test accuracy: Sensitivity Specificity Purpose / Objectives of Slide: Transition Slide, introduces the concepts of test accuracy, along with sensitivity and specificity Additional Talking Points: No additional talking points Notes: No additional notes

Specificity When a test finds something, it should be the right thing Tests ability to detect a true negative Purpose / Objectives of Slide: Introduce concept of specificity Additional Talking Points: “When a manufacturer is developing a screening test, the goal is to make it so specific that when it finds something it is finding the right thing. In labs they often call it a test’s ability to detect a true negative. If it detects a true negative, it doesn’t necessarily mean that the person has a negative diagnosis. It means that nothing showed up in the test.” Notes: Keep it simple

Specificity More specific than standard HIV test (EIA) Test is very accurate (but not perfect) Screening test is designed to be very sensitive. Due to this design, we sacrifice a little specificity. Must confirm preliminary positives (SOC, false+) Draw blood and send to lab (conventional oral test is back up) Test True Neg Tested Neg False Pos Specificity EIA 1 467 442 25 94.7% EIA RR 463 4 99.1% OraQuick I 464 1 99.8% OraQuick RR Purpose / Objectives of Slide: Covers manufactures numbers around specificity Additional Talking Points: “This is data about specificity. Specificity is about the test’s ability to detect true negatives. The manufacturer had 464 samples. They ran the OraQuick on all and found 463 negatives and 1 reactive which was actually negative, thereby being a false positive. They ran the samples again and had the same results. This means the OraQuick test’s specificity was 99.8%. When they used an EIA, a traditional lab test, they used 467 samples and the EIA said that 25 of those samples were reactive when they were actually all negative. When the samples were tested again, it said that 4 were reactive and they were actually negative too. These results gave the EIA a 94.7% and 99.1% specificity. Obviously it was picking something up that was not specific to HIV. In a lab where EIAs are run they run additional tests to rule out error before a client hears the information. Even though the OraQuick had one false positive test, it is considered a highly specific test. The OraQuick is more reliable than traditional lab tests.” Notes: Keep in mind that no test for HIV, the flu, pregnancy, or anything else is 100% accurate. (467 v 464 because they ran out of some of the samples)

Sensitivity The ability of a test to find what it’s looking for and not miss anything. Test’s ability to detect a true positive Purpose / Objectives of Slide: Introduce the concept of sensitivity Additional Talking Points: “When a manufacturer is developing a screening test, the goal is to make it so sensitive that it does not miss anything! In labs they often call it a test’s ability to detect a true positive. If the test detects a true positive, it is highly likely that HIV is there, but this must be confirmed with laboratory testing before giving a client a positive result.” Notes: Keep this simple

Sensitivity Rapid test is at least as sensitive as conventional HIV test (EIA) RR = repeatedly reactive Test True Pos Tested Pos False Neg Sensitivity EIA 1 340 100% EIA RR OraQuick 1 OraQuick RR Purpose / Objectives of Slide: Cover manufactures numbers around sensitivity Additional Talking Points: “This is data about sensitivity. Sensitivity is the test’s ability to detect true positives. The manufacturer had 340 samples. They ran the OraQuick on all and found 340 reactives. They ran tests on the samples a second time and got the same results. This means the OraQuick sensitivity was 100%. When they used an EIA, they got the same results. The OraQuick test is a highly sensitive test, just as sensitive as the laboratory EIA test.” Notes: Keep this simple

Combining Specificity and Sensitivity An ideal test would find the right thing (specificity) and not miss anything (sensitivity) Purpose / Objectives of Slide: A simple explanation of specificity and sensitivity Additional Talking Points: No further talking points. Notes: Slide is self-explanatory

A net that gets all the tuna and none of the dolphins Think of a Tuna net…. Purpose / Objectives of Slide: A visual of the previous slide Additional Talking Points: No further talking points needed. Notes: No additional notes A net that gets all the tuna and none of the dolphins

Because Test is Highly Sensitive… We do not need to confirm negatives We do, however, always need to confirm reactive/ preliminary positives Purpose / Objectives of Slide: Cover why we do not confirm negative samples Additional Talking Points: “Since the OraQuick is so sensitive it rarely misses anything and therefore we do not need to confirm negatives. If HIV antibodies are present they will most likely be picked up. If someone has recently been exposed they may not have a sufficient amount of antibodies for the test to detect. Therefore covering the window period with the client is very important. We always want to run additional tests for reactive or preliminary positive results.” Notes: No additional notes

Both tests were reactive 2 Different Tests Stat-Pak 1st Test _ + + Negative, please come back and see us in 6 months OraQuick Test Reactive, 2nd Test _ + Both tests were reactive your next step is to see a doctor and we can help you with that Purpose / Objectives of Slide: Illustration of the Rapid Testing Algorithm (RTA) Additional Talking Points: “This slide illustrates how an OraQuick ADVANCE rapid test is used to ‘verify’ a Stat-Pak reactive result. The OraQuick rapid test is not a confirmatory test and therefore the second reactive result would still be called a reactive result, not a positive result, when disclosed to the client (a confirmatory result, or positive diagnosis, can only come from a clinical laboratory where many tests would be run on the sample). A blood sample is taken and sent to a lab whenever a rapid test shows a reactive result. If only one rapid test is performed at a site, the client would be encouraged to return the following week to receive their confirmatory result. If the Rapid Testing Algorithm is used and a second rapid test from a different manufacturer is performed, the client is advised to see their doctor as their next step rather than return to the test site for the confirmatory result. The only time 2 of the same brand rapid tests are run on the same client is when the first test result is invalid. If the RTA is used, the second test must always be from a different manufacturer, such as the OraQuick ADVANCE Rapid Test.” Notes: No additional notes Lab Testing

With Clients… Emphasize that the test is extremely accurate De-emphasize statistics and percentages For example “This test is highly accurate” Purpose / Objectives of Slide: Covers what to say to clients about specificity and sensitivity Additional Talking Points: “Best practice is not to share numbers with clients. Clients may fixate in the 0.1% degree of error. Just assure them that the test is highly accurate. For reactive samples you run additional tests and you also cover the window period.” Notes: No additional notes

Quality Assurance Requirements QA are practices and procedures which ensure that every client receives an accurate test result QA reduces human error as much as possible Purpose / Objectives of Slide: Introduce the concept of Quality Assurance Additional Talking Points: “We will cover many aspects of quality assurance. The goal is to remove error, especially human error.” Notes: No additional notes

Components of Quality Assurance Personal and logistical characteristics External controls Lab space Universal precautions Purpose / Objectives of Slide: Introduces components of quality assurance Additional Talking Points: “Now we will talk about what quality assurance means. Many things need to be in place in order to assure the integrity of rapid test results. Some of them involve the abilities and attributes of the testing operator, or technician, and other things involve the physical space and testing environment. These are the quality assurance components we will be addressing in the next few slides.” Notes: Read the slide

Must Have… Steady hand Good eye sight Organizational skills Adequate lighting Purpose / Objectives of Slide: Examples of areas where quality assurance is very important Additional Talking Points: “Quality Assurance means having good eye sight for all steps of running and reading the test, adequate lighting for reading the test results, and good organizational skills. An uncluttered, organized space is very important, as are skills for keeping order and insuring the accuracy and integrity of the testing process. Testing should be done in diffused light, such as from ceiling lights or from a task or desk lamp. A spotlight, such as a flashlight, should not be used as a lighting source because it could cause an incorrect interpretation of the test result. More Quality Assurance details will be covered in upcoming slides.” Notes: No additional notes Full/bright light, task light Do not use a flashlight

External Controls Fluids made from human plasma Biohazards – wear gloves! Controls can be negative, positive for HIV-1, or positive for HIV-2 Expire 56 days after opening Purpose / Objectives of Slide: Explain what external controls are Additional Talking Points: “OraQuick ADVANCE Rapid Test Controls are made from de-neutered HIV virus. They need to be stored in a refrigerator between 35 and 46 degrees Fahrenheit. They are considered to be a bio hazard and gloves need to be worn when handling them.” Notes: No additional notes

External Controls are Used for: Training, we will use them today Determining if test is working properly Determining if lighting is adequate Determining if the test reader has sufficient eye site Purpose / Objectives of Slide: Explain what external controls are used for Additional Talking Points:“When running controls you always know what the result should be. If the result is different from what it should be, this could be an indication that there is something wrong with the test device or that there was an error in the way the operator ran the test. Also, if when running a positive control the result appears to be negative, that could be an indication that the lighting is insufficient. Running controls are also a good way of determining whether a person’s eye sight is good enough to accurately read results in a variety of lighting conditions.” Notes: No additional notes

HIV-1 vs HIV-2 Two different strains Both are transmitted the same way HIV-2 is less infectious HIV-2 progresses more slowly HIV-2 found in West Africa and is rarely found elsewhere Purpose / Objectives of Slide: Clears up confusion and explain the difference between HIV 1 and HIV 2 Additional Talking Points: “HIV 1 is the most common form of HIV that we see in the United States and in most of the world. The HIV 2 strain is almost only found in West Africa. It is rare that there would be an HIV 2 infection found in California but the OraQuick ADVANCE Rapid Test automatically tests for both. A reactive result with an OraQuick test would not indicate in any way if the antibodies detected developed because of HIV 1 or HIV 2.” Notes: The question about the difference between HIV 1 and HIV 2 always comes up in trainings, which is why this slide was included.

When to Run External Controls New operator New setting or conditions changed significantly New test kit lot or shipment Out of range testing area or storage area temperature Two invalid results in a row Every 40 tests or once a month (whichever comes first) Why? Purpose / Objectives of Slide: Describes protocols around external controls Additional Talking Points: “Your supervisor will take care of protocols, but you need to understand these things – you will be the one who notices if or when the temperature is out of range, when lighting is poor, etc.” Notes: No additional notes

Temperature Control Perform test, 59-99 degrees If testing temperature is out of required temperature range stop testing If out of temp range, run controls before proceeding (ask State) Store test: 35-80 degrees Purpose / Objectives of Slide: Important QA information all testers need to know Additional Talking Points: “If testing temperature is out of required temperature range stop testing – state policy” (stricter than manufacturer’s guidelines) Notes: No additional notes

Lab Space A space for undisturbed test processing Your site is a lab Separate from counseling area No smoking, eating or drinking Purpose / Objectives of Slide: Clarifies that any space where a test is being run is considered a lab Additional Talking Points: “It is important that you think of any testing area as being a laboratory. And because of that, it is important that this space is separate from where your client will be counseled. It should be an area where there will be no smoking, food, or any other contaminants that might otherwise affect the integrity of the test. It should also be a place that will only be accessed by you and other test counselors who are running tests, or phlebotomists, and not by the general public or unrelated staff. Your site is a lab. An RV can be a lab, a room in a venue-based site can be a lab. Wherever you run and read a test will be a lab for as long as you are testing.” Notes: No additional notes

Universal Precautions The universal practice of avoiding contact with patients' bodily fluids (blood), by means of the wearing of nonporous articles such as medical gloves Purpose / Objectives of Slide: Introduce Universal Precautions Additional Talking Points: “Universal Precautions are in place to protect both you and your clients from possible exposure to contaminants. Even a pen can become a possible contaminant if handled with the same gloves that previously came in contact with body fluids or control samples. Being aware of what you touch with and without gloves is important. And being aware of the gloves themselves during removal is also very important. The next slide describes when to wear gloves and how to remove your gloves safely.” Notes: No additional notes

Gloves Wear them when handling blood or blood products, and…. TODAY – whenever you touch the control fluid vials!!!! How often do you change them? How do you remove them? Purpose / Objectives of Slide: Instructions on how to remove gloves Additional Talking Points: “Universal Precautions is the concept that all body fluids, (blood, nasal secretions, feces) are perceived as harmful and should be handled in a way that prevents infection. One way we do this is to wear gloves. Today (and always) whenever handling control fluids you must be wearing gloves. Change gloves for every client, every test. Here are instructions on how to remove your gloves, 1. Hold one hand out with its palm facing up. 2. With your other hand pinch a portion of that glove between the wrist and the palm and pull glove off so that it turns inside out as you remove it. 3. You are now holding an inside-out glove in your remaining gloved hand. 4. Crumple the removed glove into the palm of your gloved hand and hold it there. 5. Take your ungloved index finger and slide it under the remaining glove, between the skin and the glove of the gloved hand. 6. Use that finger to pull the glove down over the palm of your hand, turning that glove inside out and over the removed glove as you go. 7 You now have a glove inside of a glove, both inside out. Dispose of gloves in a bio hazard bag.” Notes: No additional notes

Sharps: Handling & Disposal Sharps are Medical instruments that are used to puncture the skin (syringes, lancets, needles) Dispose of sharps immediately, in a hard red plastic bio bin! Do NOT dispose of sharps in a red bio hazard bag Purpose / Objectives of Slide: To review what sharps are and how to dispose of them Additional Talking Points: “Sharps are items that are sharp and/or are metallic which have been used to break the skin, for example needles or lancets. Used sharps can puncture someone’s skin and transmit diseases and therefore should be perceived as dangerous. Sharps, with or without safety devices, must be disposed of in a red, hard plastic sharps container with a lid. Never reach into a sharps container and never fill past the full line on the outside of the container.” Notes: During finger stick training covered sharps containers should always be used

Biohazard Bags: Handling & Disposal Bandages, used cotton and gauze, and gloves with body fluids on them are bio hazardous waste By law, if fluid cannot be squeezed out of the cotton, gauze, etc., the waste item can be disposed of in regular trash. Purpose / Objectives of Slide: To introduce the biohazard waste bags and cover where to dispose of gloves, bandages, and gauze Additional Talking Points: “Red plastic bio hazard bags are to be used to dispose of all non-sharps materials that have been exposed to blood or body fluids. This can include, bandages, cotton, and gauze. As it stands today, in California these items may legally be disposed of in everyday paper bags and trash containers if they are not soaked with blood or fluids, as would be the case with cotton or gauze after the first drop of blood is wiped away after a finger stick. Check with your site to find out where you are instructed to dispose of non-sharps bio hazardous waste.” Notes: No additional notes

For Today’s Training Place loops and used test kits in the sharps container Place gloves and all other trash in the brown paper bag Purpose / Objectives of Slide: An illustration of where participants are instructed to dispose of training waste Additional Talking Points: “For the duration of this Proficiency Training the hard red plastic sharps containers will not have lids on them. We will not be using sharps and will be using these containers to dispose of loops and used test kits. All other materials, gloves, left over lab stickers, etc., will be disposed of in brown paper bags.” During finger stick training, we will be using covered sharps containers.” Notes: No additional notes

Always use blue or black ink only! Paperwork Needed Expanded Checklist Short Checklist (Competency Assessment Test list) Rapid testing log or lab slip Lab stickers HIV Testing Form Always use blue or black ink only! Purpose / Objectives of Slide: Introduce forms/paperwork that are required in this training and at test sites Additional Talking Points: “These are the forms that will be used when you start running tests, both here and at your site. They must be filled out correctly in order to pass this training and with every client you test at your site. We will talk about how to properly correct mistakes a little later.” Notes: No additional notes

Appendix G Clearview Stat-Pak Presentation Purpose / Objectives of Slide: Gathering Test Kit Materials Additional Talking Points: “This slide shows what items are needed in order to run an OraQuick test. You would also need an absorbent pad, or ‘chux’, gloves, and any necessary forms.” See notes below. Notes: Mention which materials are needed for testing that are included in the test kit. Review what is included in the test kit. Stress the importance of checking the test kit before it is used. Mention that any bio hazardous fluid or material must be kept on the chux, such as control vials.

Introduction to the Test Control line Test line Flat pad Purpose / Objectives of Slide: A visual of what the Stat-Pak testing device looks like Additional Talking Points: “This is what the OraQuick testing device looks like. Often, we refer to this device as the ‘paddle’. Notice how the different areas are named so that you will know what we are referring to when we instruct you in running your first practice test.” Notes: No additional notes

Trainers Demonstrate Trainer Reads Other Trainer preforms test Participants follow along (Expanded Checklist) Purpose / Objectives of Slide: Introduce trainers’ demo of how to run the test Additional Talking Points: “Now we are going to run a test as you watch and follow along on the expanded checklist. When you run your practice and final tests you will follow the short checklist.” Notes: Trainers do demo of running test using detailed checklist

Participants’ First Practice No food or drink Listen to detailed steps: Only do what we tell you to do Do all steps in order If you finish a step quickly, wait for the next step Purpose / Objectives of Slide: Participant’s first practice test Additional Talking Points: “Now you will run your first practice test. I will be using the long checklist and will read the instructions to you and you will follow the steps exactly as I read them. Follow along referring to the short checklist. Do not do anything until I tell you to do it and do exactly what I tell you to do, only! We all need to be on the same step at the same time. When we get to the step where you have to take a sample from the vial, we will bring the vial over to you. In about 15 or 20 minutes you will do a second practice test on your own following the short checklist. IMPORTANT – when putting the vial in the test stand remember to slide it into one of the 3 chambers from the top and do NOT snap it in to place! Snapping the vial in to place could cause the developer solution to splash out making the test kit unusable.” Notes: Remind participants that they will use the shorter checklist on their proficiency test and that they must use it! Read long checklist as participants run tests – they follow along with shorter version. Go around room with control fluid (2 vials) – let people pick a vial, explain that they have to do steps 11-13 once they get the fluid from you. Have two trainers start at opposite ends, each with a negative and positive vial, and meet in the middle.

Reading Time Results in 20-40 minutes If a reactive result appears before 20 minutes have passed, the result may still not be read until at least 20 minutes have passed Purpose / Objectives of Slide: Explanation of how much time has to pass before an accurate result can be read Additional Talking Points: “From one rapid test brand to another the times it takes for them to process will vary. With OraQuick results can be read at 20 minutes but no later than 40 minutes after the testing device was introduced into the test developer solution vial and the time was logged down. You cannot read a preliminary positive result until 20 minutes have passed regardless of how soon the ‘T’ line appears.” Note: Warn participants to use the same clock for reading beginning time and end time

OraQuick Test Results Two lines: Negative result Reactive result “C” - Control line “T” - Test line Negative result Reactive result Invalid result Purpose / Objectives of Slide: Illustrates what negative and preliminary positive results look like Additional Talking Points: “Notice the triangles next to the letters ‘C’ and ‘T’. The lines must appear within the area of the triangles for the test to be valid, as in this slide. If a line appears in the proper areas of both the ‘C’ line and the ‘T’ line, the result is reactive. If a line appears in the proper area of the ‘C’ line and no line appears in the ‘T’ line, the result is negative. If there is any result other than what you see in this slide, the result is invalid. You will see examples of invalid test results in upcoming slides.” Notes: No additional notes

If you ever have an unusual result, What causes invalids? Human error (e.g., no specimen) Unknown Manufacturer error If you ever have an unusual result, do not deliver it Purpose / Objectives of Slide: Discussion of why invalid results might happen Additional Talking Points: “You cannot usually tell why an invalid result occurred. Sometimes if no lines are present at all it can be because there was insufficient or no sample introduced into the vial, or the vial had no developer solution in it. There could be other reasons, but most important is that you do not deliver an invalid result to a client. Instead, just rerun the test. If you get 2 invalid results in a row, that is an indication that you need to stop and run controls to see if there might be something wrong with the test kit lot.” Notes: No additional notes

What does it mean if a client has an invalid test result What does it mean if a client has an invalid test result? What does the darkness of the lines mean? Purpose / Objectives of Slide: The meaning of faint or partial lines and of invalid test results Additional Talking Points: “In regard to the client being tested, if a test result is invalid, it most likely had nothing to do with the client’s sample and therefore says nothing about the client’s HIV status. Sometimes the lines are lighter and sometimes they are darker. This also means nothing. A line is a line. Dark or light, it’s still a line.” Notes: No additional notes NOTHING

C T A B D E F G H Purpose / Objectives of Slide: Practice results Additional Talking Points: “Here are examples, A to H, of various results you might encounter when running tests. Notice the variations of lines. In example C – does it matter if ‘C’ line is darker than ‘T’ line? Does it that matter if ‘T’ line faint? What does a faint ‘T’ line mean? In example E – what do we think happened here? In example F – what do we think happened here? In example G – after 20 minutes have passed, how would you read this result? In example H – does it matter that T line is darker than C line? Does it matter that it is pink in the background?” Notes: No additional notes

Participants’ Second Practice Pair up One person run a test at their own pace, using the short checklist Partner observe them and help only as needed (e.g., if you see any steps that were missed, say something) Switch Use the checklist!!!! Purpose / Objectives of Slide: Opportunity for participants to practice on their own using the short checklist Additional Talking Points: “This is your last practice test before you do the 5 proficiency tests. This time I will not read the instructions to you. Instead, you will follow the short checklist yourself, step by step. You will pair up with a neighbor and one person will perform the test while the other person watches. The person watching can point out errors as you go but otherwise should remain silent. When it is time to affix a client number sticker to the HIV Testing Form, make sure you do not cover the one from the first test. At the end of the day we should see 7 different stickers on the HIV Testing Form and 7 different stickers on the lab log. As with your first practice test let us know when you are ready for the control sample and we will bring the vial over for you to dip your loop in to. As soon as you are finished and your test is processing, switch roles and continue with the other person beginning their second practice test. When it is time to log your results, check your paperwork carefully and make sure that it is correct (including the am’s and pm’s).” Notes: Have two trainers take a positive and a negative vial each and pass around – meet in the middle. Walk around to observe and answer questions. Ask participants what result they got the first time and give them a different vial this time.

Internal Control – The “C” Line The control line is the “C” line Internal control tells us: Specimen was adequately applied Proper hydration Migration of reagents past the “T” zone. Internal & external controls are standard lab practice – not a sign of test kit unreliability Purpose / Objectives of Slide: Describes what the Internal Control is while 2nd practice test is processing Additional Talking Points: “The ‘C’ line is an internal control. Regardless of how all other conditions seem to be, if a ‘C’ line doesn’t appear when running a test, there is something wrong. It could be the test device – use another one. Maybe not enough specimen was introduced (or none at all). If a ‘C’ line is visible, the test device is operating properly.” Notes: No additional notes

Test Line – The “T” Line The “T” line is the “test line”. It works with the external control fluids to: tell us if the result is reactive or non-reactive. tell us if the reader can see lines. tell us if there is proper lighting. tell us if the reader’s eyesight is adequate to run the test. Purpose / Objectives of Slide: Describes the “T” line Additional Talking Points: “Provided that the ‘C’ line is visible and in its proper area, the ‘T’ line, or Test Line lets us know whether the result is reactive or negative. It also lets us know if lighting conditions are adequate enough to run tests in that environment and if the reader’s eye site is good enough to detect lines when they are present.” Notes: No additional notes

Controls Work Together If the internal control & the external controls both tell us the test kit is working, why do we need both? Because they tell us something different! “C” line tells us test kit is working properly “T” line tells us the test kit can detect HIV antibodies when they’re present Purpose / Objectives of Slide: Importance of “C” and “T” lines Additional Talking Points: “The two lines tell us different things. The Control Line, tells us that the test kit is working properly and that fluid has migrated past the ‘T’ line and has reached the ‘C’ line. The Test Line tells us whether or not antibodies are present and if testing conditions, and our eye site, allow us to detect that line when antibodies are there.” Notes: No additional notes

Results of Practice Test Did you get the correct result? Any questions? The control fluid that we use provides a “challenge sample” Light control line verifies lighting is OK Verifies test kit detecting small amount of antibody Darkness of line NOT related to viral load, disease progression, or anything else about the client Purpose / Objectives of Slide: Discussion about results and characteristics of the lines Talking Points: “Now that you have run 2 tests you have noticed how the lines can vary from one test to the next. The control samples that are used are formulated to make this test-reading experience challenging. Remember that the size or intensity of a line doesn’t mean anything but notice how important good lighting and following proper procedures will be wherever you might be testing. Whenever in doubt of how to read a test result due to faint lines it is helpful to get a second set of eyes to look at it, another trained test operator.” Notes: No additional notes

If a Client Asks to See the Test Kit, What Would You Do? Say “No” – Why? Could compromise confidentiality Only trained personnel may read the test Test is disposed of in biohazard bag as soon as it’s read Think about the picture with the pink background – if you have a light line would you be able to see it on this test? Purpose / Objectives of Slide: Addresses what to do if clients ask to see the test device Talking Points: No additional talking points needed Notes: Self-explanatory slide

How Do You Correct a Written Mistake? A single crossed-out line, corrected entry written clearly above, include date and initials of the individual making the change. At no time should an original entry be obliterated or otherwise made illegible by a change on the record.   7:22pm T.K. 12/15/2011 End time: 7:12pm Purpose / Objectives of Slide: Instructions on how to correct a written mistake on a form and what to write with Talking Points: “As with so many of the things we talked about today there is only one way to correct a mistake on a form, as shown on this slide. A lab log or lab slip is a medical record and can not be altered in any way that might make it appear to be falsified or forged. All other forms linked to a client with identifying numbers or dates should be corrected in the same manner. Never use ‘White Out’! And never try to modify a number to make it look like another number. The illustration in the slide is the only acceptable way to correct a mistake. When recording information or logging results do not use a pencil. Only use a pen with blue or black ink.” Notes: No additional notes

Proficiency tests coming next…. Purpose / Objectives of Slide: Give participants a chance to ask any final questions Additional Talking Points: “Any question before you start your proficiency?” Notes: No additional notes Any questions? Proficiency tests coming next….

OraQuick HIV Test Proficiency: Words of Caution Follow the checklist!!!! This is not a test of memorization Run five tests using five different vials Put your name on the top of your paper(s) Take your time, double & triple checking your work If you make a mistake on your paperwork and you catch it, you can fix it. and I catch it, you will have to come back another day Purpose / Objectives of Slide: To frame the proficiency piece Additional Talking Points: “Please follow the short checklist. Write your your name on the lab log, HIV Testing Form, and any other paperwork. Take your time, and check your paperwork. If you catch a mistake you can fix it, if we find an error in your paperwork you will not pass. Remember to keep your workspace clear of anything you are not using on the current test you are running, including stickers from previous tests. Remember to log in the appropriate column the letter/number of the control vial used for each test and do not use the same control twice. At the end of running five tests you should have used 5 different controls and should have 5 different letters/numbers logged down. Do NOT throw away any test devices after you have logged down the results. We will do that after we have read them and matched them to your lab log. Once you insert the testing device into the vial you cannot disturb the test, so make sure that you position your very first test on a space on your chuck where it will not be in your way as you continue to run the next 4 tests. Be organized and be sure to match the client sticker on the test to the client sticker on the lab log before logging results. Don’t rely on the pattern in which you arranged your test devices on your chuck when logging results.” Notes: No additional notes