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Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read

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Presentation on theme: "Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read"— Presentation transcript:

1 Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read
Purpose / Objectives of Slide: Title page Talking Points: “This presentation is about testing with the Clearview COMPLETE Rapid Test.” Notes: Feel free to customize slide with trainer information

2 Overview Background Presentation Demo of the test
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 12 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 then you will get a chance to practice a couple times. After that you all will be given 5 tests and asked to run them perfectly. All paperwork will need to be 100%. Also one of the trainers will need to observe you running one of your 5 tests and ask you to correctly read 12 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.

3 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

4 Intro to Clearview COMPLETE Rapid Test
One-step test Visual interpretation Uses blood Looks for HIV antibodies Results within 15 minutes Purpose / Objectives of Slide: Brief overview of test Additional Talking Points: “Note that Clearview Complete reactive results can be read as soon as line is visible. This is not true for all rapid HIV test”. Notes: Cover this slide quickly, used to foreshadow up coming materials

5 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: 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 that allows 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 that allow 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

6 California State Law State law allows certified HIV test counselors to conduct finger sticks for the purpose of collecting blood samples for HIV and hepatitis C testing This law does not allow you to do venipuncture Objective of slide: To inform about the law regarding counselors doing fingersticks Talking points: No additional talking points Notes: Read the slide

7 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 manufacture 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 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

8 Subject Information Notice
Contains information about the test that is relevant to the client Package Insert says, “All subjects must receive the Subject Information Notice” Check in with your site to see how this is handled Purpose / Objectives of Slide: Introduce Subject Information Notice, understand why it must be handed out Additional Talking Points: “The Subject Information Notice contains information about the test and basic HIV information. I would encourage you to read it. The Package Insert (manufacturer’s instructions) says it must be given to each person receiving a test, therefore its required. When you return to your site check in with your coordinator and find out how they handle this.” Notes: No additional notes

9 Test Accuracy We’re going to talk about how well the test works
You do not need to memorize what I’m saying - 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

10 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.” Notes: Keep it simple

11 Specificity Table 6 page 16 of package insert
Study Population Samples COMPLETE Nonreactive EIA Nonreactive True Negative Low-Risk 691 690 687 High-Risk 776 740 735 Total 1467 1430 1422 1431 1 time Clearview COMPLETE read (+) when client was (-) 9 times lab EIA tests read (+) when client was (-) Calculated specificity of Clearview COMPLETE assay in these studies is 99.9% EIA was 99.3% Purpose / Objectives of Slide: Cover manufactures numbers around specificity Additional Talking Points: “This is data about specificity that you will find on page 16 in the Package Insert. The manufacturer had 1467 samples. They ran the Clearview COMPLETE on all and found 1430 negatives and 37 reactives. One of those reactives was actually a negative. This means the test’s specificity was 99.9%. When they used an EIA, a traditional lab test, the EIA said 9 samples were reactive when they were actually negative. In a lab they run additional tests to rule out error before client hears the information. Even though the Clearview COMPLETE missed one, it is considered a highly specific test. The Clearview COMPLETE is more reliable than traditional lab tests.” Notes: The green “Low Risk” and “High Risk” rows confuse the issues. Only concentrate on the gray shaded row, and the True Negative column and the COMPLETE Nonreactive column. Keep in mind that no test, for the flu, pregnancy, or anything else is 100% accurate.

12 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.” Notes: Keep this simple

13 Sensitivity Table 1 page 9 of package insert
Study Population Samples COMPLETE Reactive EIA Repeatedly Reactive WB reactive True Positive Known Positive 604 600 602 High Risk 776 36 41 35 Total 1380 636 643 637 638 Clearview COMPLETE missed 2 positives EIA missed 0 positives (however EIA read 5 positives that were actually negatives) Calculated sensitivity of the Clearview COMPLETE assay in these studies is 99.7%. Purpose / Objectives of Slide: Cover manufactures numbers around sensitivity Additional Talking Points: “This is data about sensitivity that you will find on page 9 in the Package Insert. The manufacturer had 1380 samples. They ran the Clearview COMPLETE on all and found 636 reactives. Actually there were 638 reactives and the Clearview COMPLETE missed 2. This means the Clearview COMPLETE sensitivity was 99.7% (99.690%). When they used an EIA, the EIA didn’t miss any positives but said 5 samples were positive when they were actually negative. The test was too sensitive. In a lab they run additional tests to rule out error, before clients hear the information. Even though the Clearview COMPLETE missed 2 it is a highly sensitivity test.” Notes: The green “Known Positive” and “High Risk Positives” rows confuse the issues. Only concentrate on the gray shaded row - the True Positive column and the COMPLETE Reactive column.

14 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: No additional notes

15 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

16 Because Test is Highly Sensitive…
We do not need to confirm negatives We do, however, always need to confirm reactive results Purpose / Objectives of Slide: Cover why we do not confirm negative samples Additional Talking Points: “Since the Clearview COMPLETE is so sensitive, 99.7%, 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 results.” Notes: No additional notes

17 Both tests were reactive
2 Different Tests Clearview COMPLETE 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 a second rapid test is used to ‘verify’ a Clearview COMPLETE reactive result. The second rapid test is not a confirmatory test and therefore the second reactive result would still be called reactive 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 Clearview COMPLETE 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. Please note that if the RTA is not used the second test would be a confirmatory test which is run at a lab. The client would be directed to return to the testing site a week later to receive their confirmatory result.” Notes: No additional notes Lab Testing

18 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 client. 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

19 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

20 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

21 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 is having good eye sight for all steps of running and reading the test, having adequate lighting for reading the test results, and having 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. Lighting should be diffused lighting 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. 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 flash light

22 External Controls fluids made from human plasma
Biohazards – wear gloves! Negative, Positive for HIV-1, Positive for HIV-2 Purpose / Objectives of Slide: Explain what external controls are Additional Talking Points: “Controls are made from de-neutered HIV virus. They need to be stored in a refrigerator between 36 and 46 degrees Fahrenheit and have a 24 month shelf life from the date they were manufactured. They are considered to be a bio hazard and gloves need to be worn when handling them.” Notes: No additional notes

23 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 for running this test in those lighting conditions. Running controls is 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

24 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 Stat-Pak HIV test automatically tests for both. A reactive result with a Stat-Pak 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.

25 When to Run External Controls
New operator New test kit lot or shipment Two invalid results in a row Out of temperature range in testing area or in storage area Every 40 tests or once a month (whichever comes first) 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

26 How to Run Controls Use Accessory Kit (#92115)
Use a fresh pipette, collect control from vial Transfer control to a fresh weigh boat Collect control from weight boat using sampling tip of device Purpose / Objectives of Slide: Describes materials needed and steps in running controls Additional Talking Points: “Squeeze the pipette bulb fully and then dip the tip into the control fluid inside the control vial. Release the pressure on the pipette bulb and allow the control fluid to flow inside the pipette. Then hold the pipette over the weigh boat and once again squeeze the pipette bulb until all of the control fluid has been transferred into the weigh boat. The amount of control fluid in the weigh boat does not have to be measured as long as the pipette bulb was squeezed fully and then released when extracting control fluid from the vial. When you introduce the sample tip of the testing device into the control fluid in the weigh boat, the correct amount of fluid will be drawn up into the testing device. The same thing happens when introducing the testing device’s sample tip to the drop of blood from a finger stick.” Notes: No additional notes

27 How to Run Controls Purpose / Objectives of Slide: Illustrates steps in running controls Additional Talking Points: No additional talking points Notes: No additional notes

28 Temperature Control Perform test, 64-86 degrees
If testing temperature is out of required temperature range stop testing If out of temp range, run controls before proceeding Store test: 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

29 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: Clarify 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 and in 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

30 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 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. 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 when removing them is also very important. The next slide describes when to wear gloves and how to remove your gloves safely.” Notes: No additional notes

31 Gloves Wear them when handling blood or blood products
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: “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 that 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. Crumble 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

32 Sharps: Handling & Disposal
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 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: No additional notes

33 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 biohazard 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 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

34 For Today’s Training Place used test kits in the sharps container
Place gloves and all other trash in the brown paper bags Purpose / Objectives of Slide: An illustration of where participants are instructed to dispose of training waste Additional Talking Points: “For the duration of the 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 used test kits. All other materials, gloves, left over lab stickers, etc., will be disposed of in brown paper bags.” Notes: No additional notes

35 These forms help make sure samples are not mixed up
Paperwork Needed Expanded Checklist Short Checklist (Competency Assessment Test) Rapid testing log or lab slip Lab stickers HIV Testing Form These forms help make sure samples are not mixed up 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

36 Test Materials Purpose / Objectives of Slide: Gathering Test Kit Materials Additional Talking Points: “This slide illustrates the items that come with the Clearview COMPLETE test packet. In addition to the items you see here you must also have an absorbent pad, or chux, alcohol wipes, and gauze pads or cotton. Notes: Stress the importance of checking the test kit before it is used, that it is unopened and contains the absorbent desiccant packet. Mention that any bio hazardous fluid or material must be kept on the chux, such as control vials.

37 Testing Device Control area Test area Blue line Test stand Buffer cap
-Purpose / Objectives of Slide: A visual of what the Clearview COMPLETE testing device looks like Additional Talking Points: “This is what the Clearview COMPLETE testing device looks like. This test device is much different than other test devices in that it does not have labeled control and test areas as with Stat-Pak and OraQuick devices. The areas shown in red in this slide are the places where lines would need to appear in order for the test to be considered valid. You will see a variety of how test results appear in following slides. Important: Notice the ‘buffer cap’ which sits inside the test stand. During a test, the test stand holds both the test device and the buffer cap. The test device passes into the stand and punctures the buffer cap and is inserted all the way in to it. There it rests until results are ready. Important: Notice the blue line. The test stand is a frosted plastic object with a clear area at the top of the stand. If the test device has been inserted correctly into the buffer cap, the blue line on the test device should show clearly through the clear area of the test stand. If it does not, it needs to be pushed down further. The following slides will illustrate how the device is used to collect a finger stick blood sample and to run a test.” Notes: No additional notes

38 Remove Buffer Cap Remove buffer cap from test device
Place buffer cap in stand Purpose / Objectives of Slide: Illustrates how to remove the buffer cap Additional Talking Points: “The Clearview COMPLETE comes in 3 pieces – the stand and the test device with buffer cap. The buffer cap is stored inside the test device and has to be removed and inserted into the stand before using. The stand is separate and serves to hold the buffer cap and the test device while the test is running.” Notes: No additional notes

39 Collect Blood Sample After performing finger stick, wipe away first drop of blood. Touch device’s blood sample tip to second drop of blood Blood will travel into the sample tip Purpose / Objectives of Slide: To show how the test device collects the sample Additional Talking Points: “The ‘blood sample tip’ is similar to a pipette in the way that it draws the sample up into it just by touching the tip to the sample. It only draws the sample into the tip and not all of the way into the test device. That will only happen when the tip makes contact with the buffer solution inside the buffer cap.” Notes: No additional notes

40 Push Device Tip into Buffer Cap
You will feel 3 snaps: Snap 1: through foil Snap 2: into cap Snap 3: fully seated (blue line is visible through clear area of the stand) Purpose / Objectives of Slide: Shows how to insert the test device into the stand and buffer cap Additional Talking Points: “After collecting the sample, insert the test device into the stand and feel it touch the foil cap. Push it through the foil cap and all the way down as far as it will go until the blue line is visible through the clear area of the stand. Notice how the two arrows in the illustration show how in step 3 the test device is fully seated in the buffer cap and the blue line is visible through the clear area near the top of the stand.” Notes: This could be done in one continuous motion. However, when done slowly you will probably hear 3 separate clicks.

41 Confirm Device is Fully Seated
If you do not see pink/purple flow within 3 minutes, Push Again! (then start timer) Purpose / Objectives of Slide: To illustrate how the test device should be seated to run a test properly Additional Talking Points: “If the test device has been inserted properly the blue line should be visible in the clear area of the stand and the test window should start showing a pinkish-purplish color as the sample and buffer solution both travel up into the test device. After the test device has been seated properly inside the stand and buffer cap the test begins to run and the time and temperature should be logged down in their proper places. If three minutes has passed and the test window shows no sign of color, this means the test device is not seated properly in the buffer cap and needs to be pushed down further. If this happens don’t forget to adjust the test’s start time. Notes: No additional notes

42 Trainers Demonstration
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 expanded checklist

43 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 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 expanded 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.” Notes: Remind participants that they will get to use the short checklist on their proficiency test and that they must use it! Read long checklist as participants run tests – they follow along with the shorter version. Go around the room with control fluid (2 vials) – let people pick a vial. Have two trainers start at opposite ends, each with a negative and positive vial, and meet in the middle.

44 Reading Time Negative results in 15-20 minutes
Reactive results as soon as clear test line and control line develop 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 Clearview COMPLETE a negative result can be read at 15 minutes but no later than 20 minutes after the device was introduced into the buffer cap and that time was logged down. However, a reactive result can be read as soon as both Control and Test lines appear in their designated areas (but no later than 20 minutes).” Note: Warn participants to use the same clock for reading beginning time and end time

45 Results Interpretation
Purpose / Objectives of Slide: A visual example of all possible results Additional Talking Points: “This slide illustrates the three possible results and their variations in relation to their control and test areas. The upper part of the test window is always the control area and the lower part of the window is always the test area when the test device is positioned with the sample tip facing down, as it should always be when running tests. As with most rapid tests, when the control line is in its proper area and there is no other line, the result is called negative. Also, if 2 lines appear, and both in their proper control and test areas, the result is called reactive. If after 15 minutes there are no lines, or lines appear outside of their designated areas, the result is considered invalid. Notes: No additional notes

46 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 sample tip and buffer cap. It could also be because the buffer cap wasn’t punctured sufficiently and the sample/buffer solution didn’t draw up into the testing device. If this is the case, this should be apparent within 3 minutes and the test device should be pushed fully down into the buffer cap after which time the testing process should begin and you will notice the fluid travel up into the test device. If you get an invalid result, 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

47 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 is a line. Dark or light, partial or whole, it’s still a line.” Notes: No additional notes NOTHING

48 Results Purpose / Objectives of Slide: Practice reading of 12 Clearview COMPLETE test results Additional Talking Points: “Together we will identify how each of these Clearview COMPLETE tests read.” Notes: Have participants call out what each result is

49 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 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 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 pipette 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.

50 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 the Internal Control 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) or the sample tip was not seated fully into the buffer cap. If a ‘C’ line is visible, the test device is operating properly and there has been a sufficient amount of both specimen and buffer introduced into the test device.” Notes: No additional notes

51 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 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 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

52 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. One, the ‘C’ line, tells us that the test kit is working properly and that fluid has migrated past the ‘T’ area and has reached the ‘C’ area. The other one 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 (T line).” Notes: No additional notes

53 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: Inspection of result lines Additional 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

54 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 Additional Talking Points: No additional talking points needed. Notes: Read slide

55 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 Additional 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

56 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….

57 Clearview COMPLETE 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 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. Also 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 fluid twice. At the end of running five tests you should have used 5 different controls and should have 5 different letter/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 fully seat the test device into the stand/buffer cap 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

58 Additional Resources The current package insert (including instructions for operation) for the Clearview COMPLETE Clearview COMPLETE test is on the Alere website at: The California Quality Assurance Guidelines are available on the Office of AIDS website at: (ASK STATE ) Purpose / Objectives of Slide: To provide additional resources Additional Talking Points: “If you would like more information here are some places where you can get more information on the Clearview COMPLETE.” Notes: No additional notes

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